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      • id1448
      • user_id659
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong><u>Trial Design:</u></strong></p>\n<p>\n This will be a multicenter, open-label, randomized, parallel-group, non-inferiority study in adults and children with uncomplicated P. falciparum malaria (P. falciparum with or without other Plasmodium spp. co-infection). After completion of the Core phase of the study, patients may enter in the Extension phase (single-group).</p>\n<p>\n <strong><u>Purpose:</u></strong></p>\n<p>\n This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection).</p>\n<p>\n In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase</p>\n<p>\n <strong><u>Study Rationale:</u></strong></p>\n<p>\n This Phase 3 study includes a Core phase and an Extension phase.</p>\n<p>\n The Core phase of this study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for 3 days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection) in order to support marketing authorization application for KLU156. There is an unmet medical need for anti-malarial combination treatment including a partner drug with a new mechanism of action to counter the emergence of resistance to artemisinin.</p>\n<p>\n The Extension phase is designed to assess the safety, tolerability and efficacy of repeated treatment with KLU156 for a maximum of two years in patients who have completed the Core phase without experiencing early treatment failure (ETF) nor any study treatment-related SAE and who consent to participate in the Extension phase.</p>\n<p>\n  </p>\n<p>\n <strong><u>P</u></strong><strong><u>rimary objective(s) </u></strong></p>\n<p>\n ● Core phase:</p>\n<ul style=\"list-style-type:circle;\">\n <li>\n To confirm the efficacy of KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by P.falciparum (with or without other Plasmodium spp. coinfection) by demonstrating that KLU156 is noninferior to Coartem (non‑inferiority margin = 5%) based on the PCR-corrected ACPR at Day 29.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong><u>Secondary objective(s)</u></strong></p>\n<p>\n ● Core phase:</p>\n<ul style=\"list-style-type:circle;\">\n <li>\n Key secondary objective: To further confirm the efficacy of KLU156 by demonstrating non-inferiority of KLU156 to Coartem (NI margin 7.5%) based on the uncorrected ACPR at Day 29</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong><u>●</u></strong><strong><u> Extension phase:</u></strong></p>\n<ul style=\"list-style-type:circle;\">\n <li>\n To assess the safety and tolerability over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by <em>P. falciparum </em>(with or without other <em>Plasmodium </em>spp<em>. </em>co-infection) for a maximum of 2 years.</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To evaluate efficacy over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by <em>P. falciparum </em>(with or without other <em>Plasmodium </em>spp<em>. </em>co-infection) for a maximum of 2 years.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong><u>Exploratory objective(s)</u></strong></p>\n<p>\n ● <strong>Core phase:</strong></p>\n<ul style=\"list-style-type:circle;\">\n <li>\n To explore the transmission-blocking activity of KLU156 (direct membrane feeding assay (DMFA)) at selected sites</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To quantify parasites that are below the detection level of microscopy using quantitative PCR (qPCR) as a diagnostic tool.</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To explore the impact of PCR methods on efficacy estimates.</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To assess <em>in vitro </em>susceptibility profile of tested parasites at selected sites (if feasible).</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To assess the effect of the main ADME gene factors on ganaplacide PK at selected sites (if feasible).</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To assess the pharmacokinetics of ganaplacide and lumefantrine in malaria patients.</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To explore the acceptability, palatability and ease of administration of KLU156.</li>\n</ul>\n<p>\n Ø  To explore the emergence of drug resistance markers and the relationship between parasite genotypes of interest and parasite clearance kinetics/efficacy.</p>\n<p>\n  </p>\n<p>\n ● <strong>Extension phase:</strong></p>\n<p>\n Ø  To assess the efficacy over repeated treatment with KLU156.</p>\n<p>\n To explore the emergence and/or selection of drug resistance markers and the relationship between parasite genotypes of interest and parasite clearance kinetics/efficacy, upon repetitive treatment.</p>\n<p>\n  </p>\n<p>\n <strong>Study Population:</strong></p>\n<p>\n The study population will consist of male and female patients ≥ 5 kg of body weight and ≥ 2 months of age with confirmed uncomplicated <em>P. falciparum </em>malaria. Only patients with malaria symptoms and a <em>P. falciparum </em>count ≥ 1,000 parasites/μL and ≤ 200,000 parasites/μL (with or without other <em>Plasmodium </em>spp. co-infection) will be included in the study. Approximately 1,500 patients will be enrolled in the study (see <strong><u>Section 9.9 of the Protocol v00</u></strong> for more details on sample size determination).</p>\n
      • study_title<p>\n A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatment </p>\n
      • laymans_summary<p>\n Analysis of the efficacy, safety and tolerability of a new combination of ganaplacide and lumefantrine in adults and children with uncomplicated malaria</p>\n
      • short_titleKALUMA Study
      • protocol_noECCT/24/08/06
      • version_no00
      • date_of_protocol14-06-2022
      • study_drugKLU156 (Ganaplacide/Lumefantrine Solid Dispersion Formulation)
      • disease_conditionUncomplicated Plasmodium falciparum malaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameKLU156 (Ganaplacide/Lumefantrine Solid Dispersion Formulation)
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameCoartem/Riamet Dispersible & Comparator. Coartem/Riamet 80/480mg
      • comparator_registeredyes
      • comparator_countriesCountry Local Brand Name Marketing Authorization Holder – Company name \nBenin Coartem Novartis Pharma AG \nBotswana Riamet Novartis Pharma Services AG \nBurkina Faso Coartem Novartis Pharma AG \nCameroon Coartem Novartis Pharma AG \nCongo (Brazzaville) Coartem Novartis Pharma AG \nCongo, Democratic Republic Coartem Novartis Pharma AG \nEthiopia Coartem Novartis Pharma Schweiz AG \nGabon Coartem Novartis Pharma AG \nGhana Coartem Novartis Pharma Services AG \nGuinea Coartem Novartis Pharma AG \nIvory Coast Coartem Novartis Pharma AG \nKenya Coartem NVS Kenya Ltd \nLiberia Coartem Novartis Pharma Services AG \nMadagascar Riamet Novartis Pharma Services AG \nMalawi Riamet Novartis Pharma Services AG \nMali Coartem Novartis Pharma AG \nMozambique Riamet Medis Farmaceutica Lda \nNamibia Coartem Novartis Pharma Services AG \nNiger Coartem Novartis Pharma AG \nNigeria Coartem Novartis Nigeria Limited \nSenegal Coartem Novartis Pharma AG \nSudan Coartem Novartis Pharma Schweiz AG \nTanzania Riamet NVS Kenya Ltd \nTogo Coartem Novartis Pharma AG \nUganda Riamet NVS Kenya Ltd \nZambia Riamet Novartis Pharma Services AG \nZimbabwe Riamet Novartis Pharma Services AG \n
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressraps.clinicaltrials@novartis.com
      • applicant_covering_letter1
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      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
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      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDenish Maisiba
      • declaration_date121-08-2024
      • declaration_principal_investigatorBernhards Ogutu
      • declaration_date221-08-2024
      • placebo_presentNo
      • study_objectives<p>\n <strong><u>P</u></strong><strong><u>rimary objective(s) </u></strong></p>\n<p>\n ● Core phase:</p>\n<p>\n Ø  To confirm the efficacy of KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by P.falciparum (with or without other Plasmodium spp. coinfection) by demonstrating that KLU156 is noninferior to Coartem (non‑inferiority margin = 5%) based on the PCR-corrected ACPR at Day 29.</p>\n<p>\n  </p>\n<p>\n <strong><u>Secondary objective(s)</u></strong></p>\n<p>\n ● Core phase:</p>\n<p>\n Ø  Key secondary objective: To further confirm the efficacy of KLU156 by demonstrating non-inferiority of KLU156 to Coartem (NI margin 7.5%) based on the uncorrected ACPR at Day 29</p>\n<p>\n Ø  To confirm the efficacy of KLU156 by assessing uncorrected and PCR-corrected ACPR at additional time points, as well as fever and parasite clearance times (FCT and PCT), gametocyte carriage over time between the two treatment arms.</p>\n<p>\n Ø  To compare the safety and tolerability profile of the two treatment arms on AEs, general laboratory, vital signs and ECG measurements.</p>\n<p>\n  </p>\n<p>\n ● <strong>Extension phase:</strong></p>\n<p>\n Ø  To assess the safety and tolerability over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by <em>P. falciparum </em>(with or without other <em>Plasmodium </em>spp<em>. </em>co-infection) for a maximum of 2 years.</p>\n<p>\n Ø  To evaluate efficacy over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by <em>P. falciparum </em>(with or without other <em>Plasmodium </em>spp<em>. </em>co-infection) for a maximum of 2 years.</p>\n<p>\n  </p>\n<p>\n <strong><u>Exploratory objective(s)</u></strong></p>\n<p>\n  </p>\n<p>\n ● <strong>Core phase:</strong></p>\n<p>\n Ø  To explore the transmission-blocking activity of KLU156 (direct membrane feeding assay (DMFA)) at selected sites</p>\n<p>\n Ø  To quantify parasites that are below the detection level of microscopy using quantitative PCR (qPCR) as a diagnostic tool.</p>\n<p>\n Ø  To explore the impact of PCR methods on efficacy estimates.</p>\n<p>\n Ø  To assess <em>in vitro </em>susceptibility profile of tested parasites at selected sites (if feasible).</p>\n<p>\n Ø  To assess the effect of the main ADME gene factors on ganaplacide PK at selected sites (if feasible).</p>\n<p>\n Ø  To assess the pharmacokinetics of ganaplacide and lumefantrine in malaria patients.</p>\n<p>\n Ø  To explore the acceptability, palatability and ease of administration of KLU156.</p>\n<p>\n Ø  To explore the emergence of drug resistance markers and the relationship between parasite genotypes of interest and parasite clearance kinetics/efficacy.</p>\n<p>\n  </p>\n<p>\n ● <strong>Extension phase:</strong></p>\n<p>\n Ø  To assess the efficacy over repeated treatment with KLU156.</p>\n<p>\n To explore the emergence and/or selection of drug resistance markers and the relationship between parasite genotypes of interest and parasite clearance kinetics/efficacy, upon repetitive treatment</p>\n
      • principal_inclusion_criteria<p>\n <strong>Key Inclusion criteria (Core phase):</strong></p>\n<p>\n 1. Male or female patients ≥ 5 kg of body weight and ≥ 2 months of age</p>\n<p>\n 2. Microscopically confirmed diagnosis of uncomplicated <em>P. falciparum </em>malaria with an asexual <em>P. falciparum </em>parasitemia ≥ 1,000 and ≤ 200,000 parasites/μL at the time of pre-screening with or without other <em>Plasmodium </em>spp. co-infection.</p>\n<p>\n 3. Axillary temperature ≥ 37.5 ºC or oral temperature ≥ 38.0 ºC or tympanic/rectal temperature ≥ 38.5 ºC; or history of fever during the previous 24 hours (at least documented verbally)</p>\n<p>\n 4. Negative pregnancy test for patients of childbearing potential</p>\n<p>\n 5. Signed informed consent must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian. If the parent/legal guardian is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide it along with parent/legal guardian consent or as per local ethical standards</p>\n<p>\n 6. The patient and/or their parent/legal guardian is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong>Key Exclusion criteria (Core phase)</strong></p>\n<p>\n 1. Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization)</p>\n<p>\n 2. Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19)</p>\n<p>\n 3. Severe malnutrition. For patients ≥ 12 years: body mass index (BMI) < 16.0. For children < 12 years: less than 70% of median normalized WHO reference weight or very low midupper arm circumference (MUAC < 115 mm)</p>\n<p>\n 4. Repeated vomiting (defined as > 3 times in the 24 hours prior to start of screening) or severe diarrhea (defined as > 3 watery stools in the 24 hours prior to start of screening)</p>\n<p>\n 5. Clinically relevant abnormalities of electrolyte balance which require correction, e.g.,hypokalemia, hypocalcemia or hypomagnesemia</p>\n<p>\n 6. Anemia (hemoglobin level <7 g/dL)</p>\n<p>\n 7. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., Human immunodeficiency virus (HIV) patients on antiretroviral therapy (ART) or tuberculosis (TB) patients on treatment),</p>\n<p>\n or which may jeopardize the patient in case of participation in the study.</p>\n<p>\n 8. Any of the following:</p>\n<p style=\"margin-left:.2in;\">\n • Aspartate Aminotransferase/ Alanine Aminotransferase (AST/ALT) > 3 x the upper limit of normal (ULN), regardless of the</p>\n<p style=\"margin-left:.2in;\">\n     level of total bilirubin</p>\n<p style=\"margin-left:.2in;\">\n • Total bilirubin > 3 x ULN</p>\n<p style=\"margin-left:.2in;\">\n • Resting QT interval corrected by Fridericia’s formula (QTcF) > 450 ms at screening</p>\n<p>\n 9. Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life is unknown)</p>\n<p>\n 10. History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease</p>\n<p>\n 11. Pregnant or nursing (lactating) patients.</p>\n<p>\n  </p>\n
      • primary_end_points<p>\n <strong><u>Endpoint(s) for primary objective(s)</u></strong></p>\n<p>\n PCR-corrected adequate clinical and parasitological response (ACPR) at Day 29 (i.e., 28 days post-first</p>\n<p>\n dose administration)</p>\n<p>\n  </p>\n<p>\n <strong><u>Endpoint(s) for secondary objective(s)</u></strong></p>\n<p>\n <strong>Core Phase</strong>:</p>\n<p>\n  </p>\n<p>\n Ø  Uncorrected ACPR at Day 29</p>\n<p>\n Ø  PCR-corrected and uncorrected ACPR at Days 22 and 43 (i.e., 21 and 42 days post-first dose administration). Incidence rate of recrudescence and new infection at Days 22, 29 and 43. Parasite and Fever Clearance Times. Proportion of patients with parasitemia at 12, 24, 48 and 72 h after treatment. Disappearance or development of gametocytemia in patients with or without gametocytemia at baseline (pre-first dose administration), respectively.</p>\n<p>\n Ø  Standard safety/tolerability assessments: Adverse event (AE)/serious adverse event (SAE) incidence and severity, laboratory abnormalities and ECG abnormalities.</p>\n<p>\n  </p>\n<p>\n <strong>Extension Phase:</strong></p>\n<p>\n Ø  KLU156-related AE/SAE incidence and severity by malaria episode. AE/SAE incidence and severity, laboratory abnormalities and ECG abnormalities by malaria episode.</p>\n<p>\n Ø  PCR-corrected and uncorrected ACPR at Day 29 by malaria episode. Gametocyte carriage over time by malaria episode.</p>\n<p>\n  </p>\n<p>\n <strong><u>Endpoint(s) for exploratory objective(s)</u></strong></p>\n<p>\n <strong>Core Phase</strong>:</p>\n<p>\n  </p>\n<p>\n Ø  Direct membrane feeding assay will be performed at selected sites to assess the transmission-blocking activity by determining oocyst density and infection prevalence in female <em>Anopheles gambiae </em>mosquito colonies.</p>\n<p>\n Ø  Presence of sub-microscopic density of <em>P.falciparum </em>asexual forms at baseline, Day 1 (6h, 12h), Day 2 (24h, 36h), Day 3 (48h), Days 4, 22, 29, and 43, parasite clearance time using qPCR.</p>\n<p>\n Ø  Proportion of patients with PCR corrected and uncorrected ACPR at Days 22, 29 and 43 using different parasite genotyping methods and algorithms.</p>\n<p>\n Ø  Parasite susceptibility to ganaplacide and lumefantrine <em>in vitro</em>.</p>\n<p>\n Ø  Associations between ganaplacide Day 8 levels and pharmacogene Open Reading Frame (ORF) Diversity.</p>\n<p>\n Ø  Drug concentration at 48 h, 54 h and 168 h.</p>\n<p>\n Ø  Response to questionnaire of acceptability, palatability and ease of administration.</p>\n<p>\n Ø  Presence of parasite specific gene mutations (<em>pfmdr1, pfcrt, pfkelch13, pfcarl</em>, <em>pfugt </em>and additional parasite genes of interest).</p>\n<p>\n  </p>\n<p>\n <strong>Extension Phase:</strong></p>\n<p>\n Ø  Incidence rate of recrudescence and new infections at Day 29 by malaria episode. Incidence rate of malaria episode for a maximum of 2 years.</p>\n<p>\n Presence of parasite specific gene mutations (<em>pfmdr1, pfcrt, pfkelch13, pfcarl</em>, <em>pfugt </em>and additional parasite genes of interest) along the time of trial</p>\n
      • scope_diagnosis0
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      • scope_safety1
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      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyTolerability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>Site 1600:</u></strong></p>\n<p>\n KEMRI/CGHR- Kenya Medical Research Institute/Centre for Global Health Research, Kisumu, Kenya, Off Kisumu-Busia Road, P.O.Box 1578- 40100, Kisumu</p>\n<p>\n The Siaya County Referral Hospital Clinical Research Center</p>\n<p>\n The KEMRI/Centre for Global Health Research facility is situated with the Siaya County Referral Hospital (SCRH). The SCRH is the largest hospital in Siaya County, western Kenya and is designed for care and treatment of all medical (pediatric and adult), surgical and obstetric patients, both in the outpatient and inpatient settings. This is a level four referral facility that provides healthcare to the general public in the whole of Siaya County and some adjacent counties - Busia, Vihiga and Kisumu.</p>\n<p>\n The hospital has a total bed capacity of 420 patients that include 50 in the pediatric inpatient ward and 100 in the adult medical wards (both male and female wards). Additional special units in addition to the traditional inpatient wards include a Renal/Dialysis unit and an intensive care unit with bed capacities of 5 each. Currently, the ICU has only 2 functional beds/ventilators in operation. The hospital is staffed by consultant doctors in all the general disciplines, medical officers, Pharmacists, Dentists, clinical officers, nurses, radiographers and sonographers, laboratory and pharmaceutical technologists. The specialist doctors include two Pediatricians, two Physicians/Internists, three Surgeons, one Psychiatrist, one psychologist and an Obstetrician/Gynecologist.</p>\n<p>\n The site has a waste disposal policy and this in in line with the regulatory requirements of the hospital. There is also a quality assurance policy which is implemented at the hospital according to ISO standards. The hospital has an ISO-accredited laboratory capable of carrying routine tests including biochemistry, hematology, microbiology and basic microscopy.</p>\n<p>\n <strong><u>Site 1601:</u></strong></p>\n<p>\n Kombewa Clinical Research Centre, Off Kisumu-Bondo Road, Opposite Kombewa County Hospital,</p>\n<p>\n P.O. Box 54-40100, Kisumu Kenya</p>\n<p>\n Kombewa CRC has adequate staff and facilities to conduct the trial. The site has the following cadres of staff; 4 pediatrician, 4 medical offices, 1 regulatory officer, 5 study coordinators, 6 clinical officers, 7 Lab technologist, 9 nurses, 1 pharmacist, 2 pharmaceutical technologist, 6 data clerks and 38 filed workers. The unit has two storey building consisting of office space, laboratory, clinical rooms, pharmacy, emergency room, observation room and records storage rooms.</p>\n<p>\n  </p>\n<p>\n <strong><u>Site 1602</u></strong>:</p>\n<p>\n Ahero Clinical Trials Unit. P.O.BOX 54-40100 Kisumu-Kenya</p>\n<p>\n  </p>\n<p>\n Ahero Clinical Trials Unit site is located within the Ahero county hospital in Nyando Sub- County, Kisumu County. Ahero County Hospital is level 4 hospital, with a bed capacity of 40, which receives referral from surrounding peripheral health facilities within Nyando Sub County and is able to accommodate both outpatient and in-patient adults and pediatric patients for several days.</p>\n<p>\n Staffing [ Human Workforce]</p>\n<p>\n The hospital has a total staff of over 100 health workers including, 2 Medical Officers,15 Clinical Officers,1 Pharmacist, 6 pharmaceutical technologists, Laboratory technologists and 40 Nurses.</p>\n<p>\n The Study Site in addition has: 2 Pediatricians,1 Medical Officer,3 Clinical officers,6 nurses,2 Pharmacist ,1 Pharmaceutical technologist ,1 Pharmaceutical technician, 1Field Coordinator, 2 Field Supervisors, 22 Community health workers, 1Data Manager,4 Data Clerks, 5 Laboratory technologist ,1 laboratory technician and microscopists with certificate for malaria microscopy proficiency testing (PT), regulatory officers, quality assurance officers and administrative officer. Some of our investigators are also part of Ethical Committee at SERU.</p>\n<p>\n  </p>\n<p>\n <strong><u>Institutional facilities</u></strong></p>\n<p>\n Ahero Clinical Trials Unit which is within the Ahero County Hospital is mainly used for research related activities including clinical trials. It holds clinical rooms, emergency room with a fully equipped crash cart, temperature-controlled pharmacy and laboratory, data room with stable internet connectivity for 24hours, Active Archival storage space and monitoring room.</p>\n<p>\n There are also several facilities within the hospital, which complement research activities. These include:</p>\n<p>\n •An ISO 15189:2012 accredited laboratory which is well-equipped and that handles both routine and specialized tests including, biochemistry, hematology and microbiology.</p>\n<p>\n •Adult and Pediatric wards that can accommodate any admission referral from the study</p>\n<p>\n •Vital signs equipment is available in both the out-patient and in-patient departments and at the Ahero Clinical Trials Unit site. The study site has also 1 ECG machine as well.</p>\n<p>\n •Continuous supply of oxygen from commercial supply from bulk oxygen cylinder.</p>\n<p>\n  </p>\n<p>\n <strong><u>Waste Management and Handling.</u></strong></p>\n<p>\n The site has established protocols for waste handling and disposal. This is based on sorting the</p>\n<p>\n waste according to the different biohazard level. The waste is then disposed according to protocol.</p>\n<p>\n There is an incinerator at the hospital to assist in the proper destruction and disposal of the waste.</p>\n<p>\n  </p>\n<p>\n <strong><u>Quality assurance policies and protocols.</u></strong></p>\n<p>\n The site has quality assurance SOPs that it follows for all its procedures. The staff are well trained</p>\n<p>\n and refresher courses are offered on a regular basis. Quality control / quality assurance checks and</p>\n<p>\n source data verification happens on the three major levels:</p>\n<p>\n Level 1 – Self Quality Check: Done on completion of study procedures while still seated with the</p>\n<p>\n participant</p>\n<p>\n Level 2 – Quality Control Check: Which entails QC checks that will be performed by the clinic</p>\n<p>\n QA officer/MO/SSC on a real-time basis and any errors picked will be addressed there and then.</p>\n<p>\n Level 3 – Quality Assurance Check: Done level are done at the data entry center by the data entry</p>\n<p>\n team during the receiving of the data from the field, clinics and during entry into the data base</p>\n<p>\n system to assure completeness and legibility.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n <span class=\"normaltextrun\"><span style=\"font-size: 9pt; line-height: 107%; font-family: Calibri, sans-serif; color: black; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">Malaria is not endemic in Switzerland. Hence, the trial cannot be conducted in Switzerland.</span></span><span class=\"eop\"><span style=\"font-size: 9pt; line-height: 107%; font-family: Calibri, sans-serif; color: black; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\"> </span></span></p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Agency</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>HA submission Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:20px;\">\n <p>\n Burkina Faso</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n ANRP</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n 17-Oct-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Gabon</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n ANMAPS</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n 15-May-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:20px;\">\n <p>\n Ghana</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n Ghana FDA</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n 10-Nov-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:20px;\">\n <p>\n Rwanda</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n Rwanda FDA</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n 03-May-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:20px;\">\n <p>\n Uganda</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n NDA</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n 25-Oct-2023</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>HA approval</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>No. of sites</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n DRC</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n 30-Oct-2023</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n India</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 20-Feb-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:22px;\">\n <p>\n Ivory Coast</p>\n </td>\n <td style=\"width:213px;height:22px;\">\n <p>\n 25-Apr-2024</p>\n </td>\n <td style=\"width:213px;height:22px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Niger</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 07-Mar-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Nigeria</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 24-May-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Tanzania</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 27-May-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Mali</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 18-Mar-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Burkina Faso</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 15-Jan-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 1</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Reason for rejection</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n N/A</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n  N/A</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_halted<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Reason for halt of trial</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n N/A</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n N/A</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • estimated_durationThe study duration will be 43 days (Core phase) plus 24 months (Extension phase).
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorCoartem/Riamet
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states15
      • number_of_sites3
      • multi_country_listBurkina Faso\nIvory Coast\nGabon\nGhana\nIndia\nKenya\nMali\nMozambique\nNiger\nRwanda\nTanzania\nZambia\nDRC\nUganda\nNigeria\n
      • data_monitoring_committeeYes
      • total_enrolment_per_siteA maximum of 60 patients per site across all 3 sites
      • total_participants_worldwideApproximately 1,500 patients
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyminors (Children from 2 to 12 years of age) require Legal Guardian / parental signature and approval
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationM Med
      • investigator1_professional_addressStrathmore University – CREATES
      • investigator1_telephone254733966065
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_No
      • number_participants180
      • notification
      • approval_date26-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-08-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted22-08-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-30 19:11:43
      • created2024-07-26 13:38:14
      • total_sites3
      • ecitizen_invoice322282
    • InvestigatorContact(array)
      • 0(array)
        • id1116
        • application_id1448
        • given_nameDr Patricia
        • middle_nameOdera
        • family_nameOjwang
        • qualificationMBChB, Master of Medicine in Paediatrics and Child health
        • professional_addressKEMRI/CGHR- Kenya Medical Research Institute/Centre for Global Health Research, Kisumu, Kenya,
        • telephone254 720 487 325
        • emailpattojey@gmail.com or pojwang@kemri.go.ke
        • created2024-07-26 14:27:37
        • modified2024-10-29 11:19:44
      • 1(array)
        • id1119
        • application_id1448
        • given_nameDr. Bernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB, MMED Paediatrics and Child health
        • professional_addressKombewa Clinical Research Centre, Off Kisumu-Bondo Road, Opposite Kombewa County Hospital,
        • telephone+254 733 811613 or +254 733 333530
        • emailOgutu6@gmail.com
        • created2024-07-30 03:16:28
        • modified2024-10-29 11:19:44
      • 2(array)
        • id1120
        • application_id1448
        • given_nameDr.Bernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB, MMED Paediatrics and Child health
        • professional_addressAhero Clinical Trials Unit. P.O.BOX 54-40100 Kisumu-Kenya
        • telephone+254 733 811613 or +254 733 333530
        • emailOgutu6@gmail.com
        • created2024-07-30 03:16:28
        • modified2024-10-29 11:19:44
    • SiteDetail(array)
      • 0(array)
        • id1758
        • application_id1448
        • county_id41
        • site_nameSite 1600: Kenya Medical Research Institute/Centre for Global Health Research Siaya
        • physical_addressOff Kisumu-Busia Road, Kisumu
        • contact_detailsPhone number: +254 720 487 325 P.O.Box 1578- 40100,
        • contact_personDr. Patricia Ojwang or Dr. Simon Kariuki
        • site_capacity(null)
        • misc(null)
        • created2024-07-26 14:27:37
        • modified2024-10-29 11:19:44
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 1(array)
        • id1760
        • application_id1448
        • county_id42
        • site_nameSite 1601:Kombewa Clinical Research Centre
        • physical_addressOff Kisumu-Bondo Road, Opposite Kombewa County Hospital, Kisumu Kenya
        • contact_detailsPhone Number: +254 733 811613 or +254733333530 22 P.O. Box 54-40100
        • contact_personDr. Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-07-30 03:39:20
        • modified2024-10-29 11:19:44
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1761
        • application_id1448
        • county_id42
        • site_nameAhero Clinical Trial Unit
        • physical_addressKisumu -Kenya
        • contact_detailsPhone Number: +254704616214 P.O.BOX 54-40100
        • contact_personDr. Bernhards Ogutu Dr. John Orimbo
        • site_capacity(null)
        • misc(null)
        • created2024-07-30 03:39:20
        • modified2024-10-29 11:19:44
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id766
        • application_id1448
        • sponsorNovartis Pharma AG
        • sponsor_typeIndustry
        • contact_personDr. Yannick Brunner
        • addressNovartis Campus Lichtstrasse 35 CH-4056 Basel Switzerland
        • telephone_number0041 76 360 56 97
        • fax_number
        • cell_number0041 76 360 56 97
        • email_addressyannick.brunner@novartis.com
        • created2024-07-26 14:27:37
        • modified2024-10-29 11:19:44
  • 1(array)
    • Application(array)
      • id607
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n A safe and effective HIV vaccine is presently an elusive cornerstone of HIV prevention. A successful global prophylactic HIV vaccine will likely need to protect against the diverse strains and clades of HIV that may be encountered. This study is a randomized, double-blind, placebocontrolled, parallel-group, multicenter, Phase 1/2a study in healthy HIV-uninfected adult men and women between the ages 18 to 50 years, inclusive. Vaccines used in this study are Ad26.Mos4.HIV, Clade C gp140, and Mosaic gp140. The primary objectives of this study are to assess safety/tolerability of the different vaccine regimens and to assess env-binding antibody responses of the 2 different vaccine regimens. In total, 150 participants will participate in this study with 25 participants in Group 1, 100 participants in Group 2, and 25 participants in Group 3. Kericho site will enroll 25 participants. Participants will receive intramuscular doses of study vaccine or placebo at 4 time points: Ad26.Mos4.HIV or placebo will be given at Weeks 0 and 12; Ad26.Mos4.HIV together with either Clade C gp140 plus adjuvant or a combination of Mosaic and Clade C gp140 plus adjuvant, or placebo will be given at Weeks 24 and 48. The study will be conducted in 3 phases: a 6-week screening period; a 48-week vaccination period during which subjects will be vaccinated at baseline (Week 0) and at Weeks 12, 24, and 48; and a follow-up period to the final visit at Week 72. The duration of the subject’s participation will be approximately 76 weeks.</p>\n
      • study_title<p>\n A randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in healthy HIV-uninfected adults to assess safety/tolerability and immunogenicity of 2 different prime/boost regimens: priming with tetravalent Ad26.Mos4.HIV and boosting with tetravalent Ad26.Mos4.HIV and either Clade C gp140 plus adjuvant OR a combination of Mosaic and Clade C gp140 plus adjuvant</p>\n
      • laymans_summary<div>\n <p>\n Human immunodeficiency virus (HIV) is a virus spread through certain body fluids that attacks the body's immune cells. Over time, HIV can destroy so many immune cells that the body cannot fight off infections and disease.</p>\n <p>\n Vaccination is one of the most effective ways to prevent sickness caused by some viruses. A vaccine often contains or produces a non-functional part of the virus that is recognized by the body's protective immune system. The body then produces a response that prevents sickness if the person is exposed to that same virus again. This study is part of research to try to find a possible vaccine against HIV infection.</p>\n <p>\n The investigational treatment (HIV vaccine) is made up of 3 vaccines regimens:</p>\n <p>\n •            Participants will receive Ad26.Mos4.HIV or placebo at Weeks 0 and 12</p>\n <p>\n •            Participants will receive Ad26.Mos4.HIV and either Clade C glycoprotein (gp)140 plus adjuvant (aluminium phosphate) at Weeks 24 and 48, or</p>\n <p>\n •            A combination of Mosaic and Clade C gp140 plus adjuvant (aluminium phosphate), or placebo, at Weeks 24 and 48</p>\n <p>\n In this study, researchers want to know the safety of the investigational treatment. Additionally, researchers want to understand the immune responses induced by the vaccine regimens by performing some tests. Results of this study will serve as a guide for further studies.</p>\n <p>\n Participants can take part in this study if they are healthy based on medical history, physical examination, and vital sign measurements. The study will have the following phases:</p>\n <p>\n 1.   Screening phase: This period will last for a maximum of 6 weeks and will confirm if participants can take part in the study.</p>\n <p>\n 2.   Vaccination phase: After screening, participants will be put into one of 3 groups randomly</p>\n <p>\n (by chance), called Group 1, Group 2 and Group 3. Participants in Group 1 and 2 will receive investigational treatment (HIV vaccine) at Weeks 0, 12, 24, and 48. All vaccines will be given by an injection under the skin. All participants in Group 3 will receive placebo at Weeks 0, 12, 24, and 48. A placebo does not contain the study vaccine but looks like it and is given in the same way. Placebo is given so researchers can confirm changes are due to treatment and not by chance.</p>\n <p>\n 3.   Follow-up phase: After last dose, there will be follow-up phase of 6 months to continue monitoring the participants’ health and to note if there are any side effects reported by the participants.</p>\n <p>\n 4.   Long term extension (LTE) phase: Participants from Group 1 and 2, who have received all 4 vaccine doses and test negative for HIV infection at Week 72 will have the option to enter the LTE phase. All other participants discontinued the study after last dose. Participants who choose to continue will receive an optional booster dose of vaccine at about 3 years after the 4th vaccination at week 72.</p>\n <p>\n During the study, participants will undergo different study evaluations and tests. These include recording of side effects, clinical laboratory tests, vital signs (such as temperature, heart rate and blood pressure), and physical exams. Blood samples will be taken at several time points to know how many people responded to the vaccine regimen and to what extent.</p>\n <p>\n A committee will review the results to make sure the participants in the study are safe from serious side effects.</p>\n <p>\n The overall duration of the study can be up to 4 years and 6 months.</p>\n</div>\n<p>\n  </p>\n
      • short_titleAd26.Mos4.HIV Prime/Ad26.Mos4.HIV with Clade C gp140 plus adjuvant +/- Mosaic boost
      • protocol_noECCT/17/05/04
      • version_noProtocol_Ammed 1 v3.0
      • date_of_protocol02-12-2016
      • study_drugHIV Vaccine Candidates
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_name0.9% Normal Saline
      • comparator_registeredYes
      • comparator_countriesNormal Saline is registered worldwide, including Kenya.
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjosphat.kosgei@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi1
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Josphat Kosgei
      • declaration_date112-05-2017
      • declaration_principal_investigatorDr Josphat Kosgei
      • declaration_date212-05-2017
      • placebo_presentYes
      • study_objectives<p>\n The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Each potential subject must satisfy all of the following criteria to be enrolled in the study: 1. Each subject must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is voluntarily willing to participate in the study. 2. Subjects are ≥18 to ≤50 years old on the day of signing the ICF. 3. Subject must be healthy on the basis of medical history, physical examination, and vital signs measurement performed at screening. 4. Subjects must meet following laboratory criteria prior to randomization*: a) Hemoglobin: Women ≥10.5 g/dL; Men ≥11.0 g/dL b) White cell count: 2,500 to 11,000 cells/mm3, inclusive c) Absolute neutrophil count: >1,000 cells/mm3 d) Platelets: 125,000 to 450,000 per mm3, inclusive e) Urinalysis: protein <1+, blood <1+ (men) and <2+ (women), and glucose negative f) Alanine aminotransferase (ALT)/aspartate aminotransferase (AST): <1.25x upper limit of normal (ULN) g) Creatinine: <1.1x ULN *If laboratory screening tests are out of range, repeat of screening tests is permitted once. 5. Subjects are negative for HIV infection at screeninga. 6. All female subjects of childbearing potential must have a negative serum (-human chorionic gonadotropin [-hCG]) at the screening visit, and a negative urine pregnancy test pre-dose on Day 1b. 7. Contraceptive requirements for heterosexually active female subjects (from 28 days prior first vaccination up until 3 months after last vaccination)c: a) If not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level >40 IU/L) or surgically sterile: no additional contraception required. b) If of child-bearing potential, but has a vasectomized partner (after vasectomy: sperm count below the limit of detection if procedure occurred <1 year agod): no additional contraception required. c) If of child-bearing potential, but has a non-vasectomized partner, or partner had a a If possible, the site should select an assay that is US FDA-approved b Note: negative urine pregnancy also required prior to the second, third, and fourth vaccinations c Verbal assurance should be given that adequate birth control measures have been followed for 28 days prior to first vaccination d Based on verbal confirmation JNJ-55471468, JNJ-55471494, JNJ-55471520, JNJ-55471585, JNJ-64219324, JNJ-64219311 Clinical Protocol VAC89220HPX2003 Amendment 1 31 Approved, Date: 2 December 2016 positive sperm count after a vasectomy procedure of <1 year agod, should be practicing an acceptable effective method of contraception. Acceptable methods for this study include: ï‚· Hormonal contraception, ï‚· Intrauterine device (IUD), ï‚· Intrauterine hormone-releasing system (IUS), ï‚· Male or female condom with or without spermicide, ï‚· Cap, diaphragm or sponge with vaginal spermicide, or ï‚· Sexual abstinence * *Sexual abstinence is considered an effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study vaccine. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the subject. Women who are not heterosexually active at screening, but become sexually active during the study must agree to utilize an effective method of birth control as mentioned above. 8. Contraceptive requirements for heterosexually active male subjects (from day of first vaccination until 3 months after last vaccination): a) If male subject had a vasectomy (after vasectomy: sperm count below the limit of detection if procedure occurred <1 year agod): no additional contraception required. b) If male subject did not have a vasectomy or had a positive sperm count after a vasectomy procedure of <1 year agod: contraceptive methods will depend on child-bearing potential of female partner: same criteria to be followed as for female subjects in inclusion criterion 7. 9. A woman must agree not to donate eggs (ova, oocytes) for the purpose of assisted reproduction after the first dose until 3 months after receiving the last dose of study vaccine or placebo. A man must agree not to donate sperm after the first dose until 3 months after receiving the last dose of study vaccine or placebo. 10. Subjects are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures. 11. Subjects are amenable to HIV-risk reduction counseling and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. 12. Subjects are assessed by the clinic staff as being at low risk for HIV infection (for guidelines see Attachment 2). 13. Passed the test of understanding (TOU, see Attachment 3). The TOU must be completed by all subjects, as the first assessment after signing of the ICF.</p>\n
      • principal_exclusion_criteria<p>\n 1. Subject has chronic hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus [HCV] Ab test; if positive, HCV ribonucleic acid (RNA) PCR test will be used to confirm active versus past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonase. Active syphilis documented by serology unless positive serology is due to past treated infection. 2. In the 12 months prior to randomization, subject has a history of newly acquired herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B. 3. Subject has any condition, including any clinically significant acute or chronic medical condition, for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. In case of questions, the investigator is encouraged to contact the study responsible physician. 4. Subject has had major surgery (eg, requiring general anesthesia) within the 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned through the course of the study. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate. 5. Subject has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation). 6. Subject has had major psychiatric illness and/or substance abuse problems during the past 12 months (including hospitalization or periods of work disability) that in the opinion of the investigator would preclude participation. 7. Current or past drug/alcohol use that investigator assesses poses any more than a remotely increased risk of the ability of the subject to comply with the protocol requirements. 8. Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study, or within 3 months after the last dose of vaccine or placebo. 9. Subject is a man who plans to father a child while enrolled in this study, or within 3 months after the last dose of vaccine or placebo. 10. Subject has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine or placebo, plans to receive within 14 days after the first study vaccination, or plans to receive within 14 days before or after the second, third or fourth vaccination.</p>\n
      • primary_end_points<p>\n ï‚· Solicited local and systemic adverse events (AEs) for 7 days after each vaccination. ï‚· AEs for 28 days after each vaccination. ï‚· Discontinuations from vaccination/from study due to AEs. ï‚· Serious adverse events (SAEs) and AEs of special interest (AESIs) during the course of the study. ï‚· Env-specific binding Abs (titers and breadth).</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The KEMRI/WRP CRC is the primary HIV research site in USAMRD-K. Situated on the grounds of the Kericho District Hospital (KDH)/Ministry of Health (MoH), the 7100 square feet CRC supports both HIV research and care & treatment in the southern Rift Valley Province. The CRC is composed of a clinical area including a central pharmacy that has the capacity to support both vaccine and therapeutic studies as well as provide additional non-study medicines for HIV and other non-study related care. The CRC was expanded with a new complex building, which was completed in 2012. The CRC is a designated satellite HIV and TB clinic under the KDH. The CRC laboratory is Kenya’s first and the only College of American Pathologist (CAP) accredited laboratory and boasts of a state-of-the-art Information Technology (IT) center that supports both HIV research and treatment programs. Both the CRC pharmacy and laboratory are approved by the National Institute of Allergy and Infectious Diseases/Division of AIDS (NIAID/DAIDS) to participate in DAIDS sponsored vaccine (Site # 1521) and therapeutics (Site #12501) studies, the only research site with such approval in Kenya.</p>\n
      • other_details_explanation<p>\n Not Applicable.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU, approval date 10 May 2017.</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_duration72 weeks
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI WALTER REED KERICHO
      • single_site_physical_addressHOSPITAL ROAD
      • single_site_contact_personDR JOSPHAT KOSGEI
      • single_site_telephone0729110122
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states13
      • number_of_sites
      • multi_country_listUSA, RWANDA, SOUTH AFRICA, UGANDA
      • data_monitoring_committeeYes
      • total_enrolment_per_site25
      • total_participants_worldwide150
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLinet
      • investigator1_middle_name
      • investigator1_family_nameCherono
      • investigator1_qualificationBSc (Nursing)
      • investigator1_professional_addressKEMRI/WRP Kericho
      • investigator1_telephone+254 798 482198
      • investigator1_emaillinet.cherono@usamru-k.org
      • organisations_transferred_Yes
      • number_participants25
      • notification
      • approval_date07-07-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase 1/2a study in healthy HIV-uninfected adult men and women between the ages 18 to 50 years, inclusive. Vaccines used in this study were Ad26.Mos4.HIV, Clade C gp140, and Mosaic gp140. The primary objectives of this study were to assess safety/tolerability of the different vaccine regimens and to assess env-binding antibody responses of the 2 different vaccine regimens. In total, 150 participants were enrolled into this study across all study sites, with 25 participants in Group 1, 100 participants in Group 2, and 25 participants in Group 3. Kericho site was approved to enroll up to 25 participants. Participants received intramuscular doses of study vaccine or placebo at 4 time points: Ad26.Mos4.HIV or placebo were given at Weeks 0 and 12; Ad26.Mos4.HIV together with either Clade C gp140 plus adjuvant or a combination of Mosaic and Clade C gp140 plus adjuvant, or placebo were given at Weeks 24 and 48. Participation in this study was divided into 3 phases for each participant: a 6-week screening period; a 48-week vaccination period during which participants were vaccinated at baseline (Week 0) and at Weeks 12, 24, and 48; and a follow-up period to the final visit at Week 72. The total duration of participation in this study was approximately 72-78 weeks. The Long-Term Extension phase lasted for 3 years after week 72. This phase included 6 visits that occurred 6 months apart.</p>\n<p>\n Kericho site was approved to enroll up to 25 participants and of these, 5 participants were enrolled, 1 female and 4 were male, aged between 18-40 years old, all of them completed all study activities. They are healthy males and female who are blacks not of any special groups.</p>\n<p style=\"margin-left:.25pt;\">\n During the study period, there were few adverse events reported at the Site, none of which were related to the Study procedures. Attached herein is the Site-specific Adverse Event Log.</p>\n<p>\n The following publications resulted from this study:</p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n The Abbreviated Final Clinical Study Report , LTE (Week 216) and Late Boost (Week 288) Analysis is attached herein.</li>\n <li>\n Stieh DJ, Barouch DH, Comeaux C, et al, for the ASCENT/HVTN118/HPX2003 Study Team. <strong>Safety and immunogenicity of Ad26-vectored HIV vaccine with mosaic immunogens and a novel mosaic envelope protein in HIV-uninfected adults</strong>: A Phase 1/2a study. J Infect Dis.2023;227:939-950.</li>\n</ol>\n<p style=\"margin-left:.25pt;\">\n All paper files associated with this study will be indefinitely stored by the Kericho site in a secure location.</p>\n<p style=\"margin-left:.25pt;\">\n The study database will be securely stored on password-protected file systems by the study sponsor. In addition, all specimens have been sent to the study sponsor as per the clinical trial agreement (specimen shipping log is attached herein). Neither the study database nor the specimens contained personally identifiable information from the participants.</p>\n<p style=\"margin-left:.25pt;\">\n There are currently no plans for future specimen or analysis of individual participant data by study site personnel. Any plans for future (non-aggregated) analyses will be reviewed and approved by the applicable IRBs prior to the work being completed.</p>\n<h2>\n Primary Objectives</h2>\n<ul>\n <li>\n To assess the safety and tolerability of the different vaccination regimens.</li>\n <li>\n To assess Env-binding Ab responses of the 2 different vaccine regimens.</li>\n</ul>\n<h2>\n Secondary Objectives</h2>\n<ul>\n <li>\n To assess neutralizing Ab responses, Ab functionality (as assessed by phagocytosis), and Ab isotyping.</li>\n <li>\n To assess T-cell responses.</li>\n</ul>\n<h2>\n Exploratory Objectives</h2>\n<ul>\n <li>\n To explore whether the Ad26 vector is shed after vaccination.</li>\n <li>\n To explore Ab functionality (other than phagocytosis).</li>\n <li>\n To explore Ab Fc characterization.</li>\n <li>\n To explore T-cell and Ab epitope mapping.</li>\n <li>\n To explore gene expression patterns using PBMCs.</li>\n <li>\n To explore B-cell responses.</li>\n <li>\n To explore immune responses against the viral vector.</li>\n <li>\n To explore the social impact of participation in an HIV-vaccine study for subjects via a social impact questionnaire.</li>\n</ul>\n<p align=\"left\" style=\"margin-left:35.25pt;\">\n  </p>\n<p align=\"left\" style=\"margin-left:.5in;\">\n  </p>\n<p align=\"left\" style=\"margin-left:.5in;\">\n  </p>\n<p>\n  </p>\n<h2>\n  </h2>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • implication_results<p>\n From the Results:</p>\n<p>\n <strong>LTE Phase</strong></p>\n<p>\n ·       No new safety concerns were identified in the LTE follow-up phase of the study for participants who did not receive a late boost vaccination. No AEs were reported that were considered to be related to the study vaccine regimen received in the main study. Six of these participants experienced 1 or more SAEs. No AESIs of HIV-1 infection were reported.</p>\n<p>\n ·       Env-binding Ab responses to gp140 Mos1 decreased in magnitude over study time, but a 100% responder rate was maintained in both the Clade C-Mos and Clade C groups through Week 216. In both vaccination groups, IFNγ T-cell responses induced by HIV peptide pools were present through Week 96, but showed a downward trend in response rate and magnitude compared to the end of the main study (Week 72).</p>\n<p>\n <strong>Late Boost Phase</strong></p>\n<p>\n ·       The safety profile of the late boost vaccination was acceptable and consistent with that of the vaccination regimen in the main study. Solicited AEs were mostly of Grade 1 or 2 and short-lived. One participant each in the Clade C-Mos and placebo groups experienced an unsolicited SAE. Both of these SAEs occurred during the late boost follow-up phase and neither SAE was considered related to the study vaccine by the investigator. One participant in the placebo group reported an AESI of HIV-1 infection during the follow-up period of the Late Boost phase which was not considered to be serious or related to the study vaccine by the investigator. No cases of TTS were observed.</p>\n<p>\n ·       Late boost vaccination with Ad26.Mos4.HIV and bivalent gp140 resulted in an Env-bindingAb response of comparable magnitude to the peak response during the main phase of thestudy, and the response rate remained at 100% throughout the Late Boost phase.</p>\n<p>\n ·       Ad26 nAb titers to the vaccine vector were increased to a higher level compared with the main study. The magnitude of nAbs against Ad26 did not appear to negatively impact vaccine immunogenicity with respect to the ELISA Mos1 response magnitude.</p>\n<p>\n Overall, a good retention with a slight waning of ICS responses was observed between the peak immunogenicity timepoint of the main study and at the time of late boost administration. Following the late boost, CD4+ T-cell responses towards Env peptide pools were boosted to higher levels than those observed in the main study, whereas CD8+ T-cell responses either decreased or reached a similar level to as observed in the main study.</p>\n
      • quantity_importedFind attached RV 469 Study Product Recovery Reports
      • quantity_dispensedFind attached RV 469 Study Product Recovery Reports
      • quantity_destroyedAd26.Mos4 35, Clade C GP140 11, Aluminium Phosphate 12, Sodium Chloride 0.9% 20, Mosaic GP 140 12.
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2025-03-05 08:18:56
      • created2017-05-28 20:15:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id385
        • application_id607
        • given_nameJosphat
        • middle_name
        • family_nameKosgei
        • qualificationMBChB, MSc, DLSHTM
        • professional_addressKEMRI/WRP Kericho
        • telephone+254 729 110 122
        • emailjosphat.kosgei@usamru-k.org
        • created2017-05-28 20:29:22
        • modified2020-06-02 13:16:20
    • SiteDetail(array)
      • 0(array)
        • id485
        • application_id607
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2017-05-28 20:29:22
        • modified2020-06-02 13:16:20
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id309
        • application_id607
        • sponsorJanssen Vaccines & Prevention B.V.
        • sponsor_typeIndustry
        • contact_person
        • addressArchimedesweg 4, 2333 CN Leiden, Netherlands
        • telephone_number+31 71 519 9100
        • fax_number
        • cell_number+31715199100
        • email_addressJanssenIDVNL@its.jnj.com
        • created2017-05-28 20:29:22
        • modified2020-06-02 13:16:20
  • 2(array)
    • Application(array)
      • id1417
      • user_id908
      • trial_status_id1
      • abstract_of_study<p>\n Human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI), and it is estimated that ~85% of all women will be infected during their lifetime. While most HPV infections are transient and clear within a couple of years, persistent hrHPV types are associated with 95% of cervical cancer cases, with genotypes 16 and 18 being the most common. Worldwide, the overall burden of cervical cancer and related deaths ranks fourth among all cancers for women. In Sub-Saharan Africa, cervical cancer continues to be a significant health burden. In 2023, estimates show up to 5236 new cases of cervical cancer in Kenya. Over 60% of the cases were related to HPV 16 and 18. Anecdotal evidence suggests that the burden cuts across the country and is more pronounced in rural Kenya; western Kenya included; where resources are more scarce. Current management guidelines call for expectant management and re-testing in 12 months for hrHPV-positive (hrHPV+) women without evidence of high-grade cervical dysplasia (i.e., CIN2/3) or malignancy. This means women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix.</p>\n<p>\n The study drug, ABI-2280, is a pro-drug of a potent human DNA polymerase inhibitor, for topical intravaginal treatment of several precancerous and potentially precancerous conditions related to human papillomavirus (HPV) infection, including persistent hrHPV infection in women. This Phase 1b/2 placebo-controlled global, multicenter study will primarily evaluate the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. A total of 160 patients will be enrolled globally.</p>\n<p>\n The primary endpoint in the sentinel cohorts (first 8 subjects of each cohort) will be the incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. The primary endpoint of the full expanded cohorts (i.e., all 40 subjects in the cohort) will be to evaluate clearance of the hrHPV infection at Week 1<a>2. </a>As there are currently, no approved treatments for hrHPV infections, findings from this study will be key in providing an option for treating persistent hrHPV infection before progression to the pre-cancerous stage and ultimately to cervical cancer.</p>\n
      • study_title<p>\n A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts</p>\n
      • laymans_summary<p>\n Human Papillomavirus (HPV) is a common virus that can affect both men and women. There are several types of HPV, with some considered high-risk for causing cancers, particularly cervical cancer in women. High-risk HPV (hrHPV) infections are a global health concern. These infections are often spread through intimate contact and can persist for years without causing symptoms. In some cases, however, hrHPV infections can lead to the development of cancers, including cervical cancers. Globally, hrHPV is a widespread issue. It is estimated that over 80% of sexually active individuals may acquire an HPV infection at some point in their lives. Cervical cancer, primarily caused by hrHPV, is a leading cause of cancer-related deaths among women in many parts of the world, particularly in low- and middle-income countries where access to screening and preventive measures is limited. There are currently no treatments options for persistent hrHPV, and women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix. A topical treatment that is safe and effective in clearing persistent hrHPV would be beneficial in not only preventing progression of infection to pre-cancer and cervical cancer, but also in reducing potential transmission of the virus. The study drug, ABI-2280 is an experimental drug, developed to treat persistent hrHPV infection. The purpose of this study is to identify the effect, good or bad of ABI-2280 while identifying the highest tolerated dose. This will be compared against placebo to tell how well ABI-2280 works against hrHPV. Placebo is an inactive substance that contains no active ingredient but looks like the study drug. A total of 160 participants will be enrolled globally across 5 countries. Participants will be allocated by chance to receive ABI-2280 (3 out of 4 chance) or placebo (1 out of 4 chance) and assigned to one of up to 11 treatment groups where different doses may be evaluated. Subject participation will involve a combination of visits to the clinic and wellness visits (contact by telephone, email, or text) over approximately 30 weeks total and a final follow-up visit at Week 52 (about one year after the first dose). Some of the risks of participating in the study include mild to severe side effects of the study drug. These will be closely monitored by the study team. Although the study drug may or may not benefit the participants, information learned may help guide the treatment of other patients with persistent hrHPV infection. The results of the study will be shared openly and information on the trial provided to healthcare professionals and to the public, at scientific congresses, in clinical trial registries, and in peer-reviewed journals. The results will also be shared with the study participants.</p>\n
      • short_titleEvaluate clearance of HPV
      • protocol_noECCT/24/08/01
      • version_no3.0
      • date_of_protocol09-05-2024
      • study_drugABI-2280 Vaginal Insert
      • disease_conditionHuman papillomavirus (HPV) infection
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registeredNot applicable
      • comparator_countriesNot applicable
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressssusa.submissions@iconplc.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGerald Carstens
      • declaration_date101-08-2024
      • declaration_principal_investigatorProf Chite Asirwa
      • declaration_date201-08-2024
      • placebo_presentYes
      • study_objectives<div>\n <u><strong>Primary Objectives: </strong></u></div>\n<ul>\n <li>\n For sentinel cohorts: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo.  </li>\n <li>\n For fully expanded cohorts, including sentinel: To evaluate type-specific hrHPV DNA test negativity at Week 12 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (eg, Roche cobas®) and extended genotyping (eg, Seegene) as needed. </li>\n</ul>\n<div>\n  </div>\n<div>\n <div>\n <u><strong>Secondary Objectives: </strong></u></div>\n <ul>\n <li>\n For fully expanded cohorts, including sentinel: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo.  </li>\n <li>\n For fully expanded cohorts, including sentinel: To evaluate persistence of type-specific hrHPV DNA test negativity at Week 24 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (eg, Roche cobas®) and extended genotyping (eg, Seegene) as needed.</li>\n </ul>\n <div>\n  </div>\n <div>\n <u><strong>Exploratory Objectives: </strong></u></div>\n <ul>\n <li>\n To evaluate persistence of type-specific hrHPV DNA test negativity at Week 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test and extended genotyping as needed.  </li>\n <li>\n To explore hrHPV DNA test negativity for persistent cervical hrHPV genotypes 16 (HPV-16) and/or 18 (HPV-18) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert, as assessed by an HPV DNA test and extended genotyping as needed. </li>\n <li>\n To evaluate complete hrHPV DNA test negativity (i.e., absence of detectable hrHPV DNA for any genotype) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test.</li>\n </ul>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. Female sex, 25 to 55 years of age (inclusive). </div>\n<div>\n 2. Able and willing to provide informed consent. </div>\n<div>\n 3. Positive hrHPV result on at least 2 consecutive tests prior to randomization:</div>\n<div>\n a. One hrHPV+ result at least 12 months prior to screening</div>\n<div>\n b. A second hrHPV+ result at screening, as measured using the Roche cobas® HPV test.  </div>\n<div>\n Any intervening hrHPV tests between (a) and (b) must all be positive in order to be eligible. </div>\n<div>\n Approximately 33% of participants enrolled shall have HPV-16 and/or -18, although the quota may be adjusted while the study is ongoing at the Sponsor’s discretion. </div>\n<div>\n 4. Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1. </div>\n<div>\n 5. Generally, in good health, with no clinically significant pulmonary, cardiac, gastrointestinal, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease. Medical conditions that are not severe, are well-controlled, and stable are acceptable with the approval of the Medical Monitor. </div>\n<div>\n 6. Able and willing to abstain from vaginal douching, insertion of any vaginal products other than the investigational product (study drug and retaining device/vaginal applicator), and sexual intercourse for 48 hours prior to dosing and 48 hours after each dose, for the duration of study medication administration. </div>\n<div>\n 7. Must agree to use highly effective contraception as defined by Clinical Trials Facilitation and Coordination Group guidance (Version 1.1, 21 Sep 2020) starting at screening and continuing throughout the study. Under the guidance of the Principal Investigator (PI), participants will be informed of reliable birth control methods to include oral, transdermal, injectable or implantable hormonal contraceptives; long-acting reversible contraceptive methods; complete (not periodic abstinence); or permanent sterilization. Intrauterine devices (IUDs) are acceptable but should be inserted at least 1 month prior to enrollment; however, the use of vaginally administered contraception methods such as a spermicide or Nuvaring® are not allowed. </div>\n<div>\n <div>\n 8. Generally experiencing regular menstrual cycles (as determined by the PI), unless using long-acting reversible contraception that induces amenorrhea (eg, Mirena IUD, Norplant, continuous oral contraceptives) or post-menopausal. Post-menopausal participants must be without evidence of genitourinary atrophy. Women with prolonged amenorrhea due to other causes (eg, athletes, perimenopause) may also be eligible with the approval of the Medical Monitor. </div>\n <div>\n 9. Willing to provide access to medical records consisting of hrHPV test results and pathology reports, if available. </div>\n <div>\n 10. Willing to defer HPV vaccination until after the Week 24 EOS/Early Termination (ET) visit. </div>\n <div>\n 11. Able and willing to adhere to protocol-specified assessments and procedures, including ability and willingness to use a retaining device or vaginal applicator as directed in the participant instructions for use by Day 1. </div>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n 1. History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia. </div>\n<div>\n 2. Women who are pregnant, plan to become pregnant in the next 6 months, or lactating females. </div>\n<div>\n 3. History of cancer, except basal cell or squamous cell carcinoma of the skin. </div>\n<div>\n 4. History of genital herpes with outbreak within 6 months prior to Day 1, or active non-HPV vaginal infection. </div>\n<div>\n 5. Have an active pelvic infection (eg, that was detected by a positive urine screen for gonorrhea or chlamydial infection, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, positive bimanual exam consistent with pelvic inflammatory disease). </div>\n<div>\n 6. Current or recent (within 6 weeks of Day 1) abnormal vaginal discharge and/or abnormal vaginal bleeding. </div>\n<div>\n 7. Had a therapeutic abortion or miscarriage less than 6 weeks prior to Day 1. </div>\n<div>\n 8. Any clinically significant immune suppressing condition. </div>\n<div>\n 9. Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives. </div>\n<div>\n 10. Use of topical imiquimod, 5-fluorouracil or other antiviral/antiproliferative therapies in the genital area within 3 months prior to Day 1. </div>\n<div>\n 11. Taking any of the following medications: corticosteroids (non-systemic corticosteroids are allowed), immunomodulatory treatments, any prescription that in the opinion of the Investigator could interfere with the interpretation of the results, or any over-the-counter intravaginal preparation within 2 weeks of Day 1. </div>\n<div>\n 12. Hypersensitivity to any component of the product formulation excipients and/or other nucleoside analogues (such as cidofovir, etc.). </div>\n<div>\n 13. Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of Day 1. </div>\n<div>\n 14. Known to be positive for human immunodeficiency virus. </div>\n<div>\n 15. Vaccination (even 1 dose) with a prophylactic HPV vaccine (ie, Gardasil®, Gardasil®-9 or Cervarix®) within the last 3 months prior to Day 1. </div>\n<div>\n 16. History or current diagnosis of cervical cancer, suspected or confirmed. </div>\n<div>\n 17. History of hysterectomy; patients who have undergone subtotal/supracervical hysterectomy and have a residual cervix that does not preclude appropriate placement of a retaining device or sampling of the endocervix for hrHPV may be eligible. </div>\n<div>\n 18. Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.  </div>\n
      • primary_end_points<div>\n <u><strong>For sentinel cohorts:</strong></u></div>\n<div>\n For each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. </div>\n<div>\n  </div>\n<div>\n <u><strong>For fully expanded cohorts, including sentinel: </strong></u></div>\n<div>\n For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 12 as assessed by an HPV DNA test (eg, Roche cobas®) and extended genotyping (eg, Seegene) as needed. </div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 1b/2
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-size:14px;\"><u><strong>Site 501: Prof Chite Asirwa</strong></u></span></p>\n<p>\n The study will take place at the International Cancer Institute (ICI) in Eldoret, Kenya. Recruitment will be conducted at the research and care clinic along Nandi Road in Eldoret town.</p>\n<p>\n The ICI research and care clinic is staffed by qualified research personnel, including 1 Medical hematologist-oncologist, 1 General Surgeon, 3 medical officers, 3 Pharmacists, 1 clinical officer, 3 nurses, 1 consultant pathologist, 3 laboratory technologists, 2 patient navigators, 2 quality assurance officers, and 6 data entry clerks. ICI has a research and molecular diagnostics laboratory for sample testing, which includes Chemistry, Hematology, Histology, Cytology, and Molecular testing, including the Roche cobas® HPV test, Antibody testing, and Telepathology. The lab has a total of 5 refrigerators. 2 refrigerators for 2-8 degrees storage and 3 freezers for -70 degrees storage.</p>\n<p>\n The site also features a registration area, 3 consultation rooms, 3 examination rooms, 1 cervical cancer screening room, a treatment administration area, a records and data storage unit, adequate study monitoring space, and a pharmacy with 5 research-grade refrigerators. The emergency room is fully equipped with equipment such as an oxygen supply, defibrillator, nebulizing machine, suction pumps, and a fully stocked emergency cart to handle all on-site emergencies. The International Cancer Institute currently operates a daily cervical cancer screening program, which provides patients with access to screening services including HPV DNA testing. ICI is also involved in several other randomized controlled trials, with a key focus on hemat-oncology clinical trials. The study site is situated near five major hospitals in the town that provide 24-hour emergency services. It is located 2 km from the country's second-largest referral facility, Moi Teaching and Referral Hospital.</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"728\">\n <tbody>\n <tr>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Full Name</strong></p>\n </td>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Role</strong></p>\n </td>\n <td style=\"width:170px;height:38px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:180px;height:38px;\">\n <p>\n <strong>Email Address</strong></p>\n </td>\n <td style=\"width:76px;height:38px;\">\n <p>\n <strong>Years of clinical trial experience</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Prof. Fredrick Chite Asirwa</strong></p>\n </td>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Principal Investigator</strong></p>\n </td>\n <td style=\"width:170px;height:38px;\">\n <p>\n Medical Hemat-Oncologist</p>\n </td>\n <td style=\"width:180px;height:38px;\">\n <p>\n <a href=\"mailto:chite@intercancer.com\"><strong>chite@intercancer.com</strong></a></p>\n </td>\n <td style=\"width:76px;height:38px;\">\n <p>\n <strong>19</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Dr. Nicholas Kisilu Muema</strong></p>\n </td>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Sub-Investigator</strong></p>\n </td>\n <td style=\"width:170px;height:38px;\">\n <p>\n General Surgeon</p>\n </td>\n <td style=\"width:180px;height:38px;\">\n <p>\n <a href=\"mailto:nkkisilu33@intercancer.com\"><strong>nkkisilu33@intercancer.com</strong></a></p>\n </td>\n <td style=\"width:76px;height:38px;\">\n <p>\n <strong>8</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;height:41px;\">\n <p>\n <strong>Dr. David Muyodi</strong></p>\n </td>\n <td style=\"width:151px;height:41px;\">\n <p>\n <strong>Sub-Investigator</strong></p>\n </td>\n <td style=\"width:170px;height:41px;\">\n <p>\n Medical Officer</p>\n </td>\n <td style=\"width:180px;height:41px;\">\n <p>\n <strong><u>dmuyodi@intercancer.com</u></strong></p>\n </td>\n <td style=\"width:76px;height:41px;\">\n <p>\n <strong>15</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Dr. Lilian Adhiambo Ouma</strong></p>\n </td>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Sub-Investigator</strong></p>\n </td>\n <td style=\"width:170px;height:38px;\">\n <p>\n Medical Officer</p>\n </td>\n <td style=\"width:180px;height:38px;\">\n <p>\n <a href=\"mailto:louma@intercancer.com\"><strong>louma@intercancer.com</strong></a></p>\n </td>\n <td style=\"width:76px;height:38px;\">\n <p>\n <strong>6</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Dr. Grace Jepkemei Cheruiyot</strong></p>\n </td>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Study Doctor</strong></p>\n </td>\n <td style=\"width:170px;height:38px;\">\n <p>\n Medical Officer</p>\n </td>\n <td style=\"width:180px;height:38px;\">\n <p>\n <a href=\"file:///C:/Users/IT%20ADMIN/Downloads/grace.cheruiyot@intercancer.com\"><strong>grace.cheruiyot@intercancer.com</strong></a></p>\n </td>\n <td style=\"width:76px;height:38px;\">\n <p>\n <strong>1</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Dr. Mandela Ogada Brian</strong></p>\n </td>\n <td style=\"width:151px;height:38px;\">\n <p>\n <strong>Pharmacist</strong></p>\n </td>\n <td style=\"width:170px;height:38px;\">\n <p>\n Pharmacist</p>\n </td>\n <td style=\"width:180px;height:38px;\">\n <p>\n <a href=\"file:///C:/Users/IT%20ADMIN/Downloads/mandela.ogada@intercancer.com\"><strong>mandela.ogada@intercancer.com</strong></a></p>\n </td>\n <td style=\"width:76px;height:38px;\">\n <p>\n <strong>2</strong></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <span style=\"font-size:14px;\"><u><strong>Site 503: Dr Kevin Makori Gesimba</strong></u></span></p>\n<div>\n <p>\n Victoria Cancer Care and Research Centres (VCCRC) is a leading institution dedicated to advancing cancer care, treatment, and Research. The VCCRC clinics are equipped with the necessary equipment and departments including reception, triage areas, emergency area, consultation rooms, examination rooms and treatment areas. The clinic goal is to provide high quality care through patient-centric care, ensuring optimal diagnosis, therapeutic interventions and multi-disciplinary approaches, palliative care and survivorship, clinical trials and capacity building in appropriate clinical skills. VCCRC’s clinical care model employ the integrated model which is fed by specialized hematology and oncology clinics, research, palliative care, patient navigation and telemedicine. Among the clinics is VCCRC-Bosongo Hospital oncology and clinical research unit. It has outpatient services and in patient management. This ensures continuity of care from the outpatient clinic for such patients.</p>\n <p>\n The VCCRC laboratory is committed to offering diagnostic cancer services to all patients and research support within the institution. It is accredited by the Kenya Medical Laboratory Technicians and Technologists Board. The lab has established, implemented, and continuously endeavors to maintain a quality management system in line with the required standards. The lab has three sections: histopathology, hematology and chemistry. Common functions and tests performed in the laboratory medicine department include Diagnostic pathology, hematology, clinical chemistry, immunology and serology, microbiology, transfusion medicine, Point of care attesting, Biobanking; collection and storage of biological samples.</p>\n <p>\n The Diagnostic Imaging facility has the following imaging modalities: X-ray, Ultrasound, CT scan.</p>\n <p>\n VCCRC has a well-equipped research pharmacy for preparation and storage of medicine, fitted with Class IIIB biosafety cabinet, environmental monitoring devices, lockable cabinets for drug storage. The research pharmacy is headed by a lead research pharmacist who is qualified by education, oncology and clinical trials experience. There is also a general pharmacy that serves other general patients in different therapeutic areas.</p>\n <p>\n VCCRC adheres strictly to protocols approved by the Ethics Committee. All research activities are conducted in accordance with GCP guidelines and local regulatory requirements including the expert committee on clinical trials of the Kenya Pharmacy and Poisons Board. Rigorous documentation practices at VCCRC ensure compliance with regulatory standards. We maintain comprehensive records of protocols, informed consent forms, and regulatory submissions. VCCRC also has expertise in preparing and efficient management of regulatory submissions to local health authorities and FDA for multinational studies through their sponsors.</p>\n <p>\n Clinical Research Team: VCCRC has a multidisciplinary team including principal investigators, sub-investigators, clinical research coordinators (CRCs), research nurses, pathologists, and nutritionists. The team is qualified by education, training and experience. The investigators are experienced in oncology-specific clinical trials, with specialization in various cancer types and treatment modalities. The institution also has a non-clinical research team including research administration, data management, quality assurance and control officers, participant recruitment coordinators and monitoring team. The research team is qualified by education, training and experience. Continuous education and training programs ensure staff proficiency in GCP, protocol adherence, and patient safety. We also have CRCs and research nurses certified in relevant specialties e.g., oncology nursing, clinical research. VCCRC has a lead Principal Investigator/CEO who is experienced in leadership and working together with the board of directors, they provide strategic guidance and ensuring adherence to ethical and regulatory standards. We also have a collaborative approach with sponsors and investigators to optimize study conduct and participant safety.</p>\n <p>\n VCCRC clinics have access to a broad patient population from diverse socioeconomic and ethnic backgrounds. We have also established relationships with referring physicians and community networks to facilitate patient recruitment. Our goal is to inclusivity and diversity in clinical trials in Africa. The site employs proactive recruitment plans tailored to study requirements and patient demographics and use electronic health records and patient databases for efficient identification and enrollment. The facility puts emphasis on patient education and informed consent processes to ensure understanding and compliance in clinical trials. They also offer support services like transportation, counselling, and translation services to enhance participant accessibility and retention.</p>\n <p>\n Data Management Infrastructure: VCCRC utilizes state-of-the-art electronic data capture (EDC) systems compliant with regulatory requirements e.g., 21 CFR Part 11. They boast with robust data security measures to protect participant confidentiality and integrity. The site has standardized data entry and validation processes to ensure accuracy and completeness. This includes regular data quality checks and audits conducted by dedicated data managers and internal monitors.</p>\n <p>\n Quality Assurance: VCCRC has a comprehensive QA program covering all aspects of clinical trial conduct, from protocol adherence to data management. The program incorporates internal audits and external inspections preparedness to maintain high standards and compliance.</p>\n <p>\n Collaborations: VCCRC has a directorate for clinical research and partnerships which is working to have partnerships with leading academic institutions for collaborative research initiatives and access to specialized expertise; industry partnerships including pharmaceutical and biotechnology companies to conduct sponsored clinical trials, and to have strategic alliances for access to novel therapies and cutting-edge technologies to patients; Community and Patient Advocacy Groups  to foster patient-centered research and support trial recruitment efforts. VCCRC has established a community advisory board whose members participate in community outreach programs to raise awareness about clinical trials and cancer research.</p>\n <p>\n The facility offers continuing education and training programs for staff to stay abreast of advances in oncology research and clinical trial methodologies. We will also invest in recruitment of key opinion leaders and experts to strengthen research capabilities and leadership. VCCRC is poised to become a prominent hub for oncology and hematology clinical research. With a commitment to quality, innovation, and community engagement, our site is positioned for continued growth and impactful contributions to cancer treatment advancements in the future.</p>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n There is a plan to conduct the study in the United States, the host country of the sponsor.  Currently, the sponsor is discussing the clinical/nonclinical and manufacturing development plan with the US FDA.  The outcomes of these discussions will determine the timing of the submission of a US IND to the FDA.</p>\n
      • other_details_regulatory_notapproved<p>\n The submission to the Turkey MoH occurred on 27 June 2024.</p>\n
      • other_details_regulatory_approved<p>\n 1. New Zealand MedSafe approval dated 04 Jun 2024. Number of sites: 8</p>\n<p>\n 2. Australia TGA approval/acknowledgement dated 13 Feb 2024. Number of sites: 1</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2 years starting April 2024
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo Vaginal Insert
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites7
      • multi_country_listAustralia\nKenya\nMexico\nNew Zealand\nTurkey
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment.\n2-6 participants per site
      • total_participants_worldwide160
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFredrick
      • investigator1_middle_nameChite
      • investigator1_family_nameAsirwa
      • investigator1_qualificationMBChB
      • investigator1_professional_addressInternational Cancer Institute (ICI) Research, Training and Development Center P.O. Box 8088 30100, Nandi Road, Eldoret, Kenya
      • investigator1_telephone+254 700 522 149
      • investigator1_emailchite@intercancer.com
      • organisations_transferred_Yes
      • number_participants40
      • notification<p>\n Clarification of PI family name: </p>\n<p>\n Please note that the Principal Investigator at Site 503, Victoria Cancer Care & Research Centres, Dr Kevin Makori Gesimba, interchangibly uses his middle name as his surname/family name. Thus, some documents for the Principal Investigator might only refer to "Kevin Makori", whereas some documents refer to his full names: "Kevin Makori Gesimba". The Clinical Trial Agreement lists his full names and surname, and we recently updated all the ICFs to add his surname. As this was a minor administrative change, we left the version number and date the same, and added the tracked changed versions in this application to show you where the minor updates were made for clarification.</p>\n<p>\n We confirm that "Kevin Makori" is the same legal person and Principal Investigator as "Kevin Makori Gesimba".</p>\n
      • approval_date16-10-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted01-08-2024
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication approved after satisfactory feedback to evaluation comments
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-17 17:29:17
      • created2024-06-12 11:56:29
      • total_sites(null)
      • ecitizen_invoice325494
    • InvestigatorContact(array)
      • 0(array)
        • id1075
        • application_id1417
        • given_nameFredrick
        • middle_nameChite
        • family_nameAsirwa
        • qualificationMBChB
        • professional_addressInternational Cancer Institute (ICI) Research, Training and Development Center P.O. Box 8088 30100, Nandi Road, Eldoret, Kenya
        • telephone+254 700 522 149
        • emailchite@intercare.com
        • created2024-06-12 12:24:19
        • modified2024-08-01 18:40:30
      • 1(array)
        • id1076
        • application_id1417
        • given_nameKevin
        • middle_nameMakori
        • family_nameGesimba
        • qualificationMBChB, MMed Clinical Oncology
        • professional_addressVictoria Cancer Care and Research Centres (VCCRC), P.O. Box 1376 – 40500, Nyamira, Kenya
        • telephone+254 795064222
        • emailkevin.makori@victoriaoncology.com
        • created2024-06-12 12:24:22
        • modified2024-08-01 18:40:30
    • SiteDetail(array)
      • 0(array)
        • id1719
        • application_id1417
        • county_id27
        • site_nameInternational Cancer Institute (ICI)
        • physical_addressInternational Cancer Institute (ICI), Eldoret, Kenya
        • contact_details+254723045771
        • contact_personDr Lilian Ouma
        • site_capacity(null)
        • misc(null)
        • created2024-06-12 12:24:19
        • modified2024-08-01 18:40:30
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 1(array)
        • id1720
        • application_id1417
        • county_id46
        • site_nameVictoria Cancer Care and Research centre
        • physical_addressVictoria Cancer Care and Research centre, Kisii Road, Nyamera, Kenya
        • contact_details+254718016212
        • contact_personDr Kevin Makori (Gesimba)
        • site_capacity(null)
        • misc(null)
        • created2024-06-12 12:24:22
        • modified2024-08-01 18:40:30
        • County(array)
          • id46
          • county_nameNyamira
          • created2012-06-15 10:27:32
          • modified2012-06-15 10:27:32
    • Sponsor(array)
      • 0(array)
        • id751
        • application_id1417
        • sponsorAntiva Biosciences, Inc.
        • sponsor_typeIndustry
        • contact_personAnnie Warsi, MD MAS
        • address555 Twin Dolphin Drive, Suite 620 Redwood City, CA, 94065
        • telephone_number+16508221400
        • fax_number
        • cell_number+1 408 401 6086
        • email_addressawarsi@antivabio.com
        • created2024-06-12 12:24:19
        • modified2024-08-01 18:40:30
  • 3(array)
    • Application(array)
      • id1511
      • user_id908
      • trial_status_id1
      • abstract_of_study<p>\n Human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI), and it is estimated that ~85% of all women will be infected during their lifetime. While most HPV infections are transient and clear within a couple of years, persistent hrHPV types are associated with 95% of cervical cancer cases, with genotypes 16 and 18 being the most common. Worldwide, the overall burden of cervical cancer and related deaths ranks fourth among all cancers for women. In Sub-Saharan Africa, cervical cancer continues to be a significant health burden. In 2023, estimates show up to 5236 new cases of cervical cancer in Kenya. Over 60% of the cases were related to HPV 16 and 18. Anecdotal evidence suggests that the burden cuts across the country and is more pronounced in rural Kenya; western Kenya included; where resources are more scarce. Current management guidelines call for expectant management and re-testing in 12 months for hrHPV-positive (hrHPV+) women without evidence of high-grade cervical dysplasia (i.e., CIN2/3) or malignancy. This means women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix.</p>\n<p>\n The study drug, ABI-2280, is a pro-drug of a potent human DNA polymerase inhibitor, for topical intravaginal treatment of several precancerous and potentially precancerous conditions related to human papillomavirus (HPV) infection, including persistent hrHPV infection in women. This Phase 1b/2 placebo-controlled global, multi-centre study will primarily evaluate the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. A total of 160 patients will be enrolled globally.</p>\n<p>\n The primary endpoint in the sentinel cohorts (first 8 subjects of each cohort) will be the incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. The primary endpoint of the full expanded cohorts (i.e., all 40 subjects in the cohort) will be to evaluate clearance of the hrHPV infection at Week 12. As there are currently, no approved treatments for hrHPV infections, findings from this study will be key in providing an option for treating persistent hrHPV infection before progression to the pre-cancerous stage and ultimately to cervical cancer.</p>\n
      • study_title<p>\n A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts</p>\n
      • laymans_summary<p>\n Human Papillomavirus (HPV) is a common virus that can affect both men and women. There are several types of HPV, with some considered high-risk for causing cancers, particularly cervical cancer in women. High-risk HPV (hrHPV) infections are a global health concern. These infections are often spread through intimate contact and can persist for years without causing symptoms. In some cases, however, hrHPV infections can lead to the development of cancers, including cervical cancers. Globally, hrHPV is a widespread issue. It is estimated that over 80% of sexually active individuals may acquire an HPV infection at some point in their lives. Cervical cancer, primarily caused by hrHPV, is a leading cause of cancer-related deaths among women in many parts of the world, particularly in low- and middle-income countries where access to screening and preventive measures is limited. There are currently no treatments options for persistent hrHPV, and women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix. A topical treatment that is safe and effective in clearing persistent hrHPV would be beneficial in not only preventing progression of infection to pre-cancer and cervical cancer, but also in reducing potential transmission of the virus.</p>\n<p>\n The study drug, ABI-2280 is an experimental drug, developed to treat persistent hrHPV infection. The purpose of this study is to identify the effect, good or bad of ABI-2280 while identifying the highest tolerated dose. This will be compared against placebo to tell how well ABI-2280 works against hrHPV. Placebo is an inactive substance that contains no active ingredient but looks like the study drug. A total of 160 participants will be enrolled globally across 5 countries. Participants will be allocated by chance to receive ABI-2280 (3 out of 4 chance) or placebo (1 out of 4 chance) and assigned to one of up to 11 treatment groups where different doses may be evaluated. Subject participation will involve a combination of visits to the clinic and wellness visits (contact by telephone, email, or text) over approximately 30 weeks total and a final follow-up visit at Week 52 (about one year after the first dose). Some of the risks of participating in the study include mild to severe side effects of the study drug. These will be closely monitored by the study team. Although the study drug may or may not benefit the participants, information learned may help guide the treatment of other patients with persistent hrHPV infection. The results of the study will be shared openly and information on the trial provided to healthcare professionals and to the public, at scientific congresses, in clinical trial registries, and in peer-reviewed journals. The results will also be shared with the study participants.</p>\n
      • short_titleClearance of High-Risk HPV
      • protocol_noECCT/25/02/04
      • version_no3.0
      • date_of_protocol09-05-2024
      • study_drugABI-2280 Vaginal Insert
      • disease_conditionHuman papillomavirus (HPV) infection
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressssusa.submissions@iconplc.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGerald Carstens
      • declaration_date124-02-2025
      • declaration_principal_investigatorProf Fredrick Chite Asirwa (NPI); Dr Jacqueline Mirera (PI)
      • declaration_date224-02-2025
      • placebo_presentYes
      • study_objectives<p>\n <strong>Primary Objectives: </strong></p>\n<p>\n For sentinel cohorts: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate type-specific hrHPV DNA test negativity at Week 12 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n <strong>Secondary Objectives:</strong></p>\n<p>\n For fully expanded cohorts, including sentinel: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate persistence of type-specific hrHPV DNA test negativity at Week 24 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n <strong>Exploratory Objectives:</strong></p>\n<p>\n To evaluate persistence of type-specific hrHPV DNA test negativity at Week 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test and extended genotyping as needed. </p>\n<p>\n To explore hrHPV DNA test negativity for persistent cervical hrHPV genotypes 16 (HPV-16) and/or 18 (HPV-18) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert, as assessed by an HPV DNA test and extended genotyping as needed.</p>\n<p>\n To evaluate complete hrHPV DNA test negativity (i.e., absence of detectable hrHPV DNA for any genotype) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test.</p>\n
      • principal_inclusion_criteria<p>\n 1. Female sex, 25 to 55 years of age (inclusive).</p>\n<p>\n 2. Able and willing to provide informed consent.</p>\n<p>\n 3. Positive hrHPV result on at least 2 consecutive tests prior to randomization:</p>\n<p>\n a. One hrHPV+ result at least 12 months prior to screening</p>\n<p>\n b. A second hrHPV+ result at screening, as measured using the Roche cobas® HPV test. </p>\n<p>\n Any intervening hrHPV tests between (a) and (b) must all be positive in order to be eligible.</p>\n<p>\n Approximately 33% of participants enrolled shall have HPV-16 and/or -18, although the quota may be adjusted while the study is ongoing at the Sponsor’s discretion.</p>\n<p>\n 4. Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.</p>\n<p>\n 5. Generally, in good health, with no clinically significant pulmonary, cardiac, gastrointestinal, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease. Medical conditions that are not severe, are well-controlled, and stable are acceptable with the approval of the Medical Monitor.</p>\n<p>\n 6. Able and willing to abstain from vaginal douching, insertion of any vaginal products other than the investigational product (study drug and retaining device/vaginal applicator), and sexual intercourse for 48 hours prior to dosing and 48 hours after each dose, for the duration of study medication administration.</p>\n<p>\n 7. Must agree to use highly effective contraception as defined by Clinical Trials Facilitation and Coordination Group guidance (Version 1.1, 21 Sep 2020) starting at screening and continuing throughout the study. Under the guidance of the Principal Investigator (PI), participants will be informed of reliable birth control methods to include oral, transdermal, injectable or implantable hormonal contraceptives; long-acting reversible contraceptive methods; complete (not periodic abstinence); or permanent sterilization. Intrauterine devices (IUDs) are acceptable but should be inserted at least 1 month prior to enrollment; however, the use of vaginally administered contraception methods such as a spermicide or Nuvaring® are not allowed.</p>\n<p>\n 8. Generally experiencing regular menstrual cycles (as determined by the PI), unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant, continuous oral contraceptives) or post-menopausal. Post-menopausal participants must be without evidence of genitourinary atrophy. Women with prolonged amenorrhea due to other causes (e.g., athletes, perimenopause) may also be eligible with the approval of the Medical Monitor.</p>\n<p>\n 9. Willing to provide access to medical records consisting of hrHPV test results and pathology reports, if available.</p>\n<p>\n 10. Willing to defer HPV vaccination until after the Week 24 EOS/Early Termination (ET) visit.</p>\n<p>\n 11. Able and willing to adhere to protocol-specified assessments and procedures, including ability and willingness to use a retaining device or vaginal applicator as directed in the participant instructions for use by Day 1.</p>\n
      • principal_exclusion_criteria<p>\n 1. History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia.</p>\n<p>\n 2. Women who are pregnant, plan to become pregnant in the next 6 months, or lactating females.</p>\n<p>\n 3. History of cancer, except basal cell or squamous cell carcinoma of the skin.</p>\n<p>\n 4. History of genital herpes with outbreak within 6 months prior to Day 1, or active non-HPV vaginal infection.</p>\n<p>\n 5. Have an active pelvic infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, positive bimanual exam consistent with pelvic inflammatory disease).</p>\n<p>\n 6. Current or recent (within 6 weeks of Day 1) abnormal vaginal discharge and/or abnormal vaginal bleeding.</p>\n<p>\n 7. Had a therapeutic abortion or miscarriage less than 6 weeks prior to Day 1.</p>\n<p>\n 8. Any clinically significant immune suppressing condition.</p>\n<p>\n 9. Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives.</p>\n<p>\n 10. Use of topical imiquimod, 5-fluorouracil or other antiviral/antiproliferative therapies in the genital area within 3 months prior to Day 1.</p>\n<p>\n 11. Taking any of the following medications: corticosteroids (non-systemic corticosteroids are allowed), immunomodulatory treatments, any prescription that in the opinion of the Investigator could interfere with the interpretation of the results, or any over-the-counter intravaginal preparation within 2 weeks of Day 1.</p>\n<p>\n 12. Hypersensitivity to any component of the product formulation excipients and/or other nucleoside analogues (such as cidofovir, etc.).</p>\n<p>\n 13. Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of Day 1.</p>\n<p>\n 14. Known to be positive for human immunodeficiency virus.</p>\n<p>\n 15. Vaccination (even 1 dose) with a prophylactic HPV vaccine (i.e., Gardasil®, Gardasil®-9 or Cervarix®) within the last 3 months prior to Day 1.</p>\n<p>\n 16. History or current diagnosis of cervical cancer, suspected or confirmed.</p>\n<p>\n 17. History of hysterectomy; patients who have undergone subtotal/supracervical hysterectomy and have a residual cervix that does not preclude appropriate placement of a retaining device or sampling of the endocervix for hrHPV may be eligible.</p>\n<p>\n 18. Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study. </p>\n
      • primary_end_points<p>\n For sentinel cohorts:</p>\n<p>\n For each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo.</p>\n<p>\n For fully expanded cohorts, including sentinel:</p>\n<p>\n For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 12 as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 1b/2
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Clinical Research Health Network (CREA-N) clinical trials unit (CTU) at Machakos Level 5 Hospital is a collaboration between Machakos County Department of Health and Emergency Services & CREA-N based on a memorandum of understanding that was established to support and develop clinical research capacity in response to relevant health research priorities. CREA-N has sufficient capacity to support the operationalisation of the protocol:</p>\n<p>\n <strong><u>Infrastructure:</u></strong></p>\n<p>\n CREA-N has dedicated research facilities at Machakos Level 5 Hospital in compliance with ICH-GCP principles:</p>\n<p>\n a. Kenya Accredited Service (KENAS) Laboratory</p>\n<ol style=\"list-style-type:upper-roman;\">\n <li>\n Short-term and long-term sample storage capabilities (20C, -200C& -800C)</li>\n <li>\n Real-time temperature monitoring of samples and remote alarm system for out-of-range temperatures</li>\n <li>\n Established vendors relationships to support sample testing where the capability is not available internally and for safety monitoring e.g., Lancet Laboratories. </li>\n</ol>\n<p>\n b. Pharmacy</p>\n<ol style=\"list-style-type:lower-roman;\">\n <li>\n Cold-chain capabilities for vaccine management</li>\n <li>\n Real-time temperature monitoring of samples and remote alarm system for out-of-range temperatures</li>\n</ol>\n<p>\n c. Research clinic and procedure rooms that can be scaled based on study require-ments.</p>\n<p>\n d. Technology: Paperless eSource technology for enhanced investigator(s) oversight</p>\n<p>\n e. Emergency management for study related adverse events.</p>\n<p>\n f. Established external vendors supporting the clinical trials ecosystem for established capabilities ranging from logistics and laboratory services.</p>\n<p>\n <strong>Personnel:</strong></p>\n<p>\n All staff participating in the conduct of clinical trials at CREA-N CTU, are trained on the protocol, study specific procedures and are qualified by education for the roles they are engaged in, in compliance with ICH-GCP principles, local and global guidelines governing the conduct of clinical trials. Staffing demands are scaled per study, according to the stage of an ongoing trial and the number of con-current trials at the research unit. </p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Dedicated research staff: CREA-N maintains a team of dedicated clinical trials staff to ensure consistency and quality across all studies. The staff ensure adequate train-ing, conduct, management and evaluation of projects and teams. Dedicated staff rep-resent the medical, nursing, pharmacy, laboratory, data management, community engagement, study coordination and technology departments.  </li>\n <li>\n Collaborative staff: CREA-N is embedded in the Machakos County health delivery system and based on the collaborative agreement between CREA-N and Machakos County Department of Health and Emergency Services. Multidisciplinary teams from the health system based on the specific needs of a trial are established per trial for the successful delivery of studies. For example, in collaboration with the permanent CTU staff, the community health workers will proactively drive the community engagement strategy based on the target geographies that the study will recruit from. This team will be scaled as needed during the different phases of the trial.</li>\n</ol>\n<p>\n The collaborative partnership between the Machakos County Department of Health and Emergency Services and CREA-N allow for flexible deployment of infrastructure and personnel to support the fluctuating needs of the trial over the next 5 years.  </p>\n<p>\n We have the following staff engaged for this study Principal Investigator - 1, Co-Investigators - 3, Medical Officers -1, Study clinicians - 2, Pharmacists - 2, Pharmaceutical Technologist - 1, Study nurses - 4, QA/QC officers - 2, Laboratory personnel – 3 and Community liaison officers - 2, Community health volunteers - 8. The numbers shall be adjusted based on workload and concurrent trials taking place. </p>\n<p>\n All study staff are qualified by training, education, and experience. They are all registered, certified, and licensed by professional regulatory bodies. These requirements are confirmed during a competitive recruitment by strict human resource criteria. Staff documents are kept by the human resource department and updated annually and as required by ICH-GCP guidelines.</p>\n<p>\n Principal Investigator: Dr Mirera Jacqueline</p>\n<p>\n Roles: Has overall trial oversight, budgetary negotiations, sponsor communication, safety, ethical and regulatory communication. Oversight over clinical care provision.</p>\n<p>\n Co-Investigators:  Dr Alvin Wachira, Dr Sharon Mueni and Dr Wycliffe Oruru</p>\n<p>\n Roles: Daily management of trial aspects including participant recruitment, follow-up, safety monitoring, data management, staff supervision, clinical care provision and supervise IP management. Supports PI and has roles that may be delegated such as ethical and sponsor communication.</p>\n<p>\n Reviewing potential Study participants for eligibility, supervising Clinical Officers, reviewing laboratory results, adverse event surveillance and documentation, providing first-hand clinical care to participants. Data entry and reporting Serious Adverse Events.</p>\n
      • other_details_explanation<p>\n There is a plan to conduct the study in the United States, the host country of the sponsor.  Currently, the sponsor is discussing the clinical/nonclinical and manufacturing development plan with the US FDA.  The outcomes of these discussions will determine the timing of the submission of a US IND to the FDA.</p>\n
      • other_details_regulatory_notapproved<p>\n The submission to the Turkey MoH occurred on 27 June 2024.</p>\n
      • other_details_regulatory_approved<p>\n 1. New Zealand MedSafe approval dated 04 Jun 2024. Number of sites: 8</p>\n<p>\n 2. Australia TGA approval/acknowledgement dated 13 Feb 2024. Number of sites: 1</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2 years starting April 2024
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo Vaginal Insert
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites7
      • multi_country_listAustralia\nKenya\nMexico\nNew Zealand
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment. 2-6 participants per site
      • total_participants_worldwide160
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFredrick
      • investigator1_middle_nameChite
      • investigator1_family_nameAsirwa
      • investigator1_qualificationMBChB
      • investigator1_professional_addressInternational Cancer Institute (ICI) Research, Training and Development Center, P.O. Box 088 30100, Nandi Road, Eldoret, Kenya
      • investigator1_telephone+254 700 522 149
      • investigator1_emailchite@intercancer.com
      • organisations_transferred_Yes
      • number_participants40
      • notification<p style=\"margin:0in\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Dear PPB Reviewer,<o:p></o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\"><o:p> </o:p></span></p>\n<p style=\"margin:0in\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">The application for Dr Jacqueline Mirera (ECCT/25/02/04) has been re-submitted, including a cover letter and the additional document as requested in the Second Screening Queries. <o:p></o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\"><o:p> </o:p></span></p>\n<p style=\"margin:0in\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Thank you for your review.<o:p></o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\"><o:p> </o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Kind regards<o:p></o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Gerald Carstens<o:p></o:p></span></p>\n
      • approval_date06-03-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-02-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted07-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonWe appreciate that the study has been approved for other sites where original application was made to PPB. After review of this application and the Site-Specific Addendum, PPB is satisfied and approves clinical study activities at CREA-N Machakos Level 5 Hospital Site
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-17 17:28:05
      • created2025-02-06 17:51:18
      • total_sites1
      • ecitizen_invoice354400
    • InvestigatorContact(array)
      • 0(array)
        • id1225
        • application_id1511
        • given_nameJacqueline
        • middle_name
        • family_nameMirera
        • qualificationMBChB, MBA-HCM, Fellowship in Epidemiology
        • professional_addressCREA-N Machakos Level 5 Hospital Site, Off Kitui-Makueni Road, P.O. Box 19-90100, Machakos, Kenya
        • telephone+254 715 867 708
        • emailjacquline.mirera@crean-health.com
        • created2025-02-06 17:51:18
        • modified2025-02-24 16:09:57
    • SiteDetail(array)
      • 0(array)
        • id1839
        • application_id1511
        • county_id16
        • site_nameCREA-N Machakos Level 5 Hospital Site
        • physical_addressOff Kitui-Makueni Road, P.O. Box 19-90100 Machakos, Kenya
        • contact_details+254 715 867 708, PO Box 19
        • contact_personDr Jacquline Mirera
        • site_capacity(null)
        • misc(null)
        • created2025-02-06 18:07:15
        • modified2025-02-24 16:09:57
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
    • Sponsor(array)
      • 0(array)
        • id804
        • application_id1511
        • sponsorAntiva Biosciences, Inc.
        • sponsor_typeIndustry
        • contact_personAnnie Warsi, MD MAS
        • address555 Twin Dolphin Drive, Suite 620 Redwood City, CA, 94065
        • telephone_number+16508221400
        • fax_numberN/A
        • cell_number+1 408 401 6086
        • email_addressawarsi@antivabio.com
        • created2025-02-06 18:07:15
        • modified2025-02-24 16:09:57
  • 4(array)
    • Application(array)
      • id1512
      • user_id908
      • trial_status_id1
      • abstract_of_study<p>\n Human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI), and it is estimated that ~85% of all women will be infected during their lifetime. While most HPV infections are transient and clear within a couple of years, persistent hrHPV types are associated with 95% of cervical cancer cases, with genotypes 16 and 18 being the most common. Worldwide, the overall burden of cervical cancer and related deaths ranks fourth among all cancers for women. In Sub-Saharan Africa, cervical cancer continues to be a significant health burden. In 2023, estimates show up to 5236 new cases of cervical cancer in Kenya. Over 60% of the cases were related to HPV 16 and 18. Anecdotal evidence suggests that the burden cuts across the country and is more pronounced in rural Kenya; western Kenya included; where resources are more scarce. Current management guidelines call for expectant management and re-testing in 12 months for hrHPV-positive (hrHPV+) women without evidence of high-grade cervical dysplasia (i.e., CIN2/3) or malignancy. This means women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix.</p>\n<p>\n The study drug, ABI-2280, is a pro-drug of a potent human DNA polymerase inhibitor, for topical intravaginal treatment of several precancerous and potentially precancerous conditions related to human papillomavirus (HPV) infection, including persistent hrHPV infection in women. This Phase 1b/2 placebo-controlled global, multi-centre study will primarily evaluate the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. A total of 160 patients will be enrolled globally.</p>\n<p>\n The primary endpoint in the sentinel cohorts (first 8 subjects of each cohort) will be the incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. The primary endpoint of the full expanded cohorts (i.e., all 40 subjects in the cohort) will be to evaluate clearance of the hrHPV infection at Week 12. As there are currently, no approved treatments for hrHPV infections, findings from this study will be key in providing an option for treating persistent hrHPV infection before progression to the pre-cancerous stage and ultimately to cervical cancer.</p>\n
      • study_title<p>\n A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts</p>\n
      • laymans_summary<p>\n Human Papillomavirus (HPV) is a common virus that can affect both men and women. There are several types of HPV, with some considered high-risk for causing cancers, particularly cervical cancer in women. High-risk HPV (hrHPV) infections are a global health concern. These infections are often spread through intimate contact and can persist for years without causing symptoms. In some cases, however, hrHPV infections can lead to the development of cancers, including cervical cancers. Globally, hrHPV is a widespread issue. It is estimated that over 80% of sexually active individuals may acquire an HPV infection at some point in their lives. Cervical cancer, primarily caused by hrHPV, is a leading cause of cancer-related deaths among women in many parts of the world, particularly in low- and middle-income countries where access to screening and preventive measures is limited.</p>\n<p>\n There are currently no treatments options for persistent hrHPV, and women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix. A topical treatment that is safe and effective in clearing persistent hrHPV would be beneficial in not only preventing progression of infection to pre-cancer and cervical cancer, but also in reducing potential transmission of the virus. The study drug, ABI-2280 is an experimental drug, developed to treat persistent hrHPV infection. The purpose of this study is to identify the effect, good or bad of ABI-2280 while identifying the highest tolerated dose. This will be compared against placebo to tell how well ABI-2280 works against hrHPV. Placebo is an inactive substance that contains no active ingredient but looks like the study drug. A total of 160 participants will be enrolled globally across 5 countries. Participants will be allocated by chance to receive ABI-2280 (3 out of 4 chance) or placebo (1 out of 4 chance) and assigned to one of up to 11 treatment groups where different doses may be evaluated.</p>\n<p>\n Subject participation will involve a combination of visits to the clinic and wellness visits (contact by telephone, email, or text) over approximately 30 weeks total and a final follow-up visit at Week 52 (about one year after the first dose). Some of the risks of participating in the study include mild to severe side effects of the study drug. These will be closely monitored by the study team. Although the study drug may or may not benefit the participants, information learned may help guide the treatment of other patients with persistent hrHPV infection. The results of the study will be shared openly and information on the trial provided to healthcare professionals and to the public, at scientific congresses, in clinical trial registries, and in peer-reviewed journals. The results will also be shared with the study participants.</p>\n
      • short_titleClearance of High-Risk HPV
      • protocol_noECCT/25/02/05
      • version_no3.0
      • date_of_protocol09-05-2024
      • study_drugABI-2280 Vaginal Insert
      • disease_conditionHuman papillomavirus (HPV) infection
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
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      • comparatorNo
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      • ecct_not_applicable0
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      • email_addressssusa.submissions@iconplc.com
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      • declaration_applicantGerald Carstens
      • declaration_date124-02-2025
      • declaration_principal_investigatorProf. Fredrick Chite Asirwa (NPI); Dr Irene Diana Odhiambo (PI)
      • declaration_date224-02-2025
      • placebo_presentYes
      • study_objectives<p>\n <strong>Primary Objectives: </strong></p>\n<p>\n For sentinel cohorts: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate type-specific hrHPV DNA test negativity at Week 12 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n <strong>Secondary Objectives:</strong></p>\n<p>\n For fully expanded cohorts, including sentinel: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate persistence of type-specific hrHPV DNA test negativity at Week 24 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n <strong>Exploratory Objectives:</strong></p>\n<p>\n To evaluate persistence of type-specific hrHPV DNA test negativity at Week 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test and extended genotyping as needed. </p>\n<p>\n To explore hrHPV DNA test negativity for persistent cervical hrHPV genotypes 16 (HPV-16) and/or 18 (HPV-18) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert, as assessed by an HPV DNA test and extended genotyping as needed.</p>\n<p>\n To evaluate complete hrHPV DNA test negativity (i.e., absence of detectable hrHPV DNA for any genotype) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test.</p>\n
      • principal_inclusion_criteria<p>\n 1. Female sex, 25 to 55 years of age (inclusive).</p>\n<p>\n 2. Able and willing to provide informed consent.</p>\n<p>\n 3. Positive hrHPV result on at least 2 consecutive tests prior to randomization:</p>\n<p>\n a. One hrHPV+ result at least 12 months prior to screening</p>\n<p>\n b. A second hrHPV+ result at screening, as measured using the Roche cobas® HPV test. </p>\n<p>\n Any intervening hrHPV tests between (a) and (b) must all be positive in order to be eligible.</p>\n<p>\n Approximately 33% of participants enrolled shall have HPV-16 and/or -18, although the quota may be adjusted while the study is ongoing at the Sponsor’s discretion.</p>\n<p>\n 4. Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.</p>\n<p>\n 5. Generally, in good health, with no clinically significant pulmonary, cardiac, gastrointestinal, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease. Medical conditions that are not severe, are well-controlled, and stable are acceptable with the approval of the Medical Monitor.</p>\n<p>\n 6. Able and willing to abstain from vaginal douching, insertion of any vaginal products other than the investigational product (study drug and retaining device/vaginal applicator), and sexual intercourse for 48 hours prior to dosing and 48 hours after each dose, for the duration of study medication administration.</p>\n<p>\n 7. Must agree to use highly effective contraception as defined by Clinical Trials Facilitation and Coordination Group guidance (Version 1.1, 21 Sep 2020) starting at screening and continuing throughout the study. Under the guidance of the Principal Investigator (PI), participants will be informed of reliable birth control methods to include oral, transdermal, injectable or implantable hormonal contraceptives; long-acting reversible contraceptive methods; complete (not periodic abstinence); or permanent sterilization. Intrauterine devices (IUDs) are acceptable but should be inserted at least 1 month prior to enrollment; however, the use of vaginally administered contraception methods such as a spermicide or Nuvaring® are not allowed.</p>\n<p>\n 8. Generally experiencing regular menstrual cycles (as determined by the PI), unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant, continuous oral contraceptives) or post-menopausal. Post-menopausal participants must be without evidence of genitourinary atrophy. Women with prolonged amenorrhea due to other causes (e.g., athletes, perimenopause) may also be eligible with the approval of the Medical Monitor.</p>\n<p>\n 9. Willing to provide access to medical records consisting of hrHPV test results and pathology reports, if available.</p>\n<p>\n 10. Willing to defer HPV vaccination until after the Week 24 EOS/Early Termination (ET) visit.</p>\n<p>\n 11. Able and willing to adhere to protocol-specified assessments and procedures, including ability and willingness to use a retaining device or vaginal applicator as directed in the participant instructions for use by Day 1.</p>\n
      • principal_exclusion_criteria<p>\n 1. History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia.</p>\n<p>\n 2. Women who are pregnant, plan to become pregnant in the next 6 months, or lactating females.</p>\n<p>\n 3. History of cancer, except basal cell or squamous cell carcinoma of the skin.</p>\n<p>\n 4. History of genital herpes with outbreak within 6 months prior to Day 1, or active non-HPV vaginal infection.</p>\n<p>\n 5. Have an active pelvic infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, positive bimanual exam consistent with pelvic inflammatory disease).</p>\n<p>\n 6. Current or recent (within 6 weeks of Day 1) abnormal vaginal discharge and/or abnormal vaginal bleeding.</p>\n<p>\n 7. Had a therapeutic abortion or miscarriage less than 6 weeks prior to Day 1.</p>\n<p>\n 8. Any clinically significant immune suppressing condition.</p>\n<p>\n 9. Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives.</p>\n<p>\n 10. Use of topical imiquimod, 5-fluorouracil or other antiviral/antiproliferative therapies in the genital area within 3 months prior to Day 1.</p>\n<p>\n 11. Taking any of the following medications: corticosteroids (non-systemic corticosteroids are allowed), immunomodulatory treatments, any prescription that in the opinion of the Investigator could interfere with the interpretation of the results, or any over-the-counter intravaginal preparation within 2 weeks of Day 1.</p>\n<p>\n 12. Hypersensitivity to any component of the product formulation excipients and/or other nucleoside analogues (such as cidofovir, etc.).</p>\n<p>\n 13. Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of Day 1.</p>\n<p>\n 14. Known to be positive for human immunodeficiency virus.</p>\n<p>\n 15. Vaccination (even 1 dose) with a prophylactic HPV vaccine (i.e., Gardasil®, Gardasil®-9 or Cervarix®) within the last 3 months prior to Day 1.</p>\n<p>\n 16. History or current diagnosis of cervical cancer, suspected or confirmed.</p>\n<p>\n 17. History of hysterectomy; patients who have undergone subtotal/supracervical hysterectomy and have a residual cervix that does not preclude appropriate placement of a retaining device or sampling of the endocervix for hrHPV may be eligible.</p>\n<p>\n 18. Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study. </p>\n
      • primary_end_points<p>\n For sentinel cohorts:</p>\n<p>\n For each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo.</p>\n<p>\n For fully expanded cohorts, including sentinel:</p>\n<p>\n For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 12 as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 1b/2
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Victoria Biomedical Research Institute (VIBRI) Clinical Research Site</strong></p>\n<p>\n Kisumu County Referral Hospital, Off Ang’awa Avenue, P.O. Box 7180, Postal Code</p>\n<p>\n 40100, Kisumu</p>\n<p>\n <strong>Staff experience</strong></p>\n<p>\n VIBRI has over 100 members of staff who are delegated and involved in clinical research studies including investigators, study coordinators, clinicians, nurses, laboratory technologists, pharmacists, data clerks, field assistants and administrative staff. This study will involve 8 investigators, and at least 2 study Coordinators, 2 pharmacists, 6 laboratory technologists among other cadres of staff.</p>\n<p>\n <strong>Site infrastructure</strong></p>\n<p>\n a. The site has a separate Clinical Research department/Unit.</p>\n<p>\n b. The site has separate room(s) or space for Clinical Research.</p>\n<p>\n c. The site has space for storage of study-related materials (Lab kits, etc.).</p>\n<p>\n d. The site has separate room/space for Monitoring.</p>\n<p>\n e. The site has study document storage.</p>\n<p>\n f. The site has separate space for informed Consent Process.</p>\n<p>\n g. Space for archival of data after completion of trial: The site has an archival room/arrangement where paper source documents are stored for at least 10 years. The responsible person will be the study Principal Investigator but on a day-to-day basis the VIBRI Management will oversee the storage.</p>\n<p>\n - Location: VIBRI CRC, Kisumu County Referral Hospital, Rachuonyo   County Hospital, and Bondo County Hospital.</p>\n<p>\n h. 6 Computers available for study: Desktops, on Fibre Optic Cable, 25 Mbps.</p>\n<p>\n <strong>Emergency facilities</strong></p>\n<p>\n VIBRI is located near both private and public referral health facilities, which operate 24 hours a day. The site is equipped with an emergency 2 crash cart, and the clinical team have received training in Basic Life support (BLS) and advanced cardiac life support (ACLS)to handle emergency at site before referral to appropriate health facility in case of emergency.</p>\n<p>\n On-site: X-rays, 12-Lead ECG, Ultrasonography</p>\n<p>\n Access to Echocardiography (Kisumu Heart Centre)</p>\n<p>\n Access to CT scan (Aga Khan, West Kenya Imaging).</p>\n<p>\n <strong>Equipment (fridges freezers, equipment for study, pharmacy)</strong></p>\n<p>\n VIBRI have 4 -80⁰C storage freezers, 4 -20⁰C, 4 refrigerated centrifuges, 2 incubators, 3 biosafety hoods, chemistry and hematology analysers, temperature data loggers among other equipment. The pharmacy is equipped with cold chain capacity and investigational product preparation equipment including: 2 2-8⁰C vaccine refrigerators, 2 -20⁰C freezers, with data loggers for temperature monitoring, biosafety hoods for investigational product preparation, computers, printers among other equipment.</p>\n<p>\n <strong>Pharmacy/IP Storage</strong></p>\n<ul>\n <li>\n Dedicated Refrigerator for IP storage (+2~8 â—¦C) with temperature monitor.</li>\n <li>\n Dedicated freezer for IP storage (-20 â—¦C) with temperature monitor.</li>\n <li>\n Cold chain equipment and monitoring process:\n <ul>\n <li>\n Under alarm system 24h/day all year</li>\n <li>\n Testo Saveris Data Loggers</li>\n <li>\n Backup generator with automatic switch</li>\n </ul>\n </li>\n <li>\n Back-up storage: Yes, back-up refrigerator.</li>\n</ul>\n<p>\n <strong>General Laboratory</strong></p>\n<ul>\n <li>\n Deep freezer (-70â—¦C) facility for storing of blood/serum sampling.</li>\n <li>\n Deep freezer (-20â—¦C) facility for storing of blood/serum sampling.</li>\n <li>\n Non-imaging lab facility: Complete Blood Count and 5 Differentials, Liver Function (AST, ALT, Bilirubin, etc) and Renal Function Tests (Creatinine, BUN, Electrolytes).</li>\n <li>\n Lab is acting as referral laboratory.</li>\n <li>\n Cooling and non-cooling (ambient and refrigerated) centrifuge.</li>\n <li>\n Accreditation: Yes, Certificate: ISO 15189 by KENAS</li>\n</ul>\n
      • other_details_explanation<p>\n There is a plan to conduct the study in the United States, the host country of the sponsor.  Currently, the sponsor is discussing the clinical/nonclinical and manufacturing development plan with the US FDA.  The outcomes of these discussions will determine the timing of the submission of a US IND to the FDA.</p>\n
      • other_details_regulatory_notapproved<p>\n The submission to the Turkey MoH occurred on 27 June 2024.</p>\n
      • other_details_regulatory_approved<p>\n 1. New Zealand MedSafe approval dated 04 Jun 2024. Number of sites: 8</p>\n<p>\n 2. Australia TGA approval/acknowledgement dated 13 Feb 2024. Number of sites: 1</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2 years starting April 2024
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo Vaginal Insert
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites7
      • multi_country_listAustralia\nKenya\nMexico\nNew Zealand
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment. 2-6 participants per site
      • total_participants_worldwide160
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFredrick
      • investigator1_middle_nameChite
      • investigator1_family_nameAsirwa
      • investigator1_qualificationMBChB
      • investigator1_professional_addressInternational Cancer Institute (ICI) Research, Training and Development Center, P.O. Box 088 30100, Nandi Road Eldoret, Kenya
      • investigator1_telephone+254 700 522 149
      • investigator1_emailchite@intercancer.com
      • organisations_transferred_Yes
      • number_participants40
      • notification<p>\n Dear PPB Reviewer,</p>\n<p>\n The application has been re-submitted, including a cover letter and the additional document as requested in the Second Screening Queries. The additional documents were uploaded under Section 13, Checklist. Attached to this response is the cover letter for our easy reference.</p>\n<p>\n Thank you for your review.</p>\n<p>\n Kind regards</p>\n<p>\n Gerald Carstens</p>\n
      • approval_date07-03-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-02-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted07-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonWe appreciate that the study has been approved for other sites where original application was made to PPB. After review of this application and the Site-Specific Addendum, PPB is satisfied and approves clinical study activities at Victoria Biomedical Research Institute Kisumu County Referral Hospital
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      • final_date(null)
      • modified2025-04-17 17:27:54
      • created2025-02-07 14:00:57
      • total_sites1
      • ecitizen_invoice354574
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        • id1226
        • application_id1512
        • given_nameIrene
        • middle_nameDiana
        • family_nameOdhiambo
        • qualificationMBChB, MBA, HSDC
        • professional_addressVictoria Biomedical Research Institute Kisumu County Referral Hospital, Off Ang’awa road, P.O. Box 7180-40100, Kisumu, Kenya
        • telephone+254 722 243 100
        • emaildodhiambo@vibriafrica.org
        • created2025-02-07 14:00:57
        • modified2025-02-24 16:17:43
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        • site_nameVictoria Biomedical Research Institute, Kisumu County Referral Hospital
        • physical_addressOff Ang’awa road, P.O. Box 7180-40100, Kisumu, Kenya
        • contact_details+254 722 243 100, PO Box 7180
        • contact_personDr Irene Diana Odhiambo
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        • created2025-02-07 14:11:54
        • modified2025-02-24 16:17:43
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          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • id808
        • application_id1512
        • sponsorAntiva Biosciences, Inc.
        • sponsor_typeIndustry
        • contact_personAnnie Warsi, MD MAS
        • address555 Twin Dolphin Drive, Suite 620 Redwood City, CA, 94065
        • telephone_number+16508221400
        • fax_number
        • cell_number+1 408 401 6086
        • email_addressawarsi@antivabio.com
        • created2025-02-07 14:11:54
        • modified2025-02-24 16:17:43
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    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php