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      • id1507
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      • abstract_of_study<div>\n Background: Local data availability on HPV disease burden, prevalence, vaccination coverage and impact of vaccination has been challenging in Africa due to the absence or lack of cancer registers, vaccination registers, population databases and electronic health information systems. Therefore, generating local data and promoting capacity building at local institutes is critical to sustaining HPV vaccination programs. Furthermore, among programmatic challenges, the initial training of healthcare professionals (HCWs) prior to the introduction is deemed insufficient. National stakeholders in Africa have emphasized the need for refresher training and capacity building of the healthcare workforce for sustained implementation.</div>\n<div>\n Study Objectives: Therefore, using a multi-pronged approach, our study will 1) generate local data on vaccination coverage, HPV infection prevalence and HPV vaccination impact using first-void urine (FVU) in Kenya, Senegal and Uganda, 2) investigate training challenges among HCWs at the national and district level, 3) assess gaps in HCWs' training in Kenya and Uganda.</div>\n<div>\n Study Methodology: This study adopts a multiple-methods approach addressing the above stated objectives. To address the objective of measuring HPV infection prevalence and impact using first void urine, we will use an observational cross-sectional study design to collect samples in Kenya including HPV vaccinated females as part of Gavi demonstration project, and adolescent females vaccinated under national immunization program and control groups for respective study groups. To address the objectives of investigating training challenges among HCWs at the national and district level, we will adopt a mixed-method study design to conduct survey and in-depth interviews with healthcare workers at the health facility. Identical studies will be conducted in Senegal and Uganda.</div>\n<div>\n Expected Outcome/Results: This study aims to evaluate the long-term immune response induced by the HPV vaccine and assess infection prevalence using a non-invasive first-void urine sampling device. By measuring vaccine impact in targeted settings, the study will generate local data on vaccine effectiveness and impact. Additionally, it will explore the feasibility of implementing similar studies at the host institute to facilitate knowledge transfer and skill development in conducting such sampling methods. Furthermore, the study will identify key challenges in training healthcare workers, essential for the successful implementation of HPV vaccination programs. It will also propose sustainable training approaches and methods for assessing healthcare workers' knowledge to ensure program effectiveness and sustainability.</div>\n
      • study_title<p>\n Generating local data on HPV vaccination impact and training needs at the level of vaccine implementers – A feasibility study</p>\n
      • laymans_summary<div>\n This study aims to understand how well HPV vaccination programs are working and to identify areas where healthcare workers may need more training in Kenya, Uganda, and Senegal. This protocol will specifically cover activities in Kenya. The primary goal is to gather information on the effectiveness of HPV vaccines and assess the training of healthcare workers who administer them. </div>\n<div>\n To measure the vaccine's impact, the study will collect urine samples from both vaccinated and unvaccinated girls and women in the three countries. These samples will be tested to see how well the vaccine is helping the body build long-term protection and to track HPV infection rates 126 among the participants.</div>\n<div>\n The study will also explore training challenges faced by healthcare workers involved in giving the HPV vaccine. Through surveys and interviews, researchers will identify gaps in knowledge and training to understand what improvements are needed. </div>\n<div>\n The findings are expected to provide important local data on vaccine coverage, HPV infection rates, and immune responses. Additionally, the study will offer suggestions on how to improve healthcare worker training for more effective HPV vaccination programs. The research will follow ethical standards to protect participant privacy, and everyone will have the option to withdraw at any time. Ultimately, this work aims to strengthen HPV vaccination efforts and improve training for those who deliver the vaccines.</div>\n
      • short_titleHPV vaccine feasibility study
      • protocol_noECCT/25/02/02
      • version_no4.4
      • date_of_protocol20-09-2024
      • study_drugHPV vaccine feasibility study
      • disease_conditionHumanpapillomavirus infection
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
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      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_name(Colli-Pee® 20 mL device, Novosanis, CE marked
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.org
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      • declaration_applicantDr. Catherine Kiptiness
      • declaration_date105-02-2025
      • declaration_principal_investigatorProf Nelly Mugo
      • declaration_date205-02-2025
      • placebo_presentNo
      • study_objectives<p>\n 1) To demonstrate feasibility to measure vaccine induced long-term immune response (vaccination status) and infection prevalence using first-void urine sample in Gavi pilot vaccinated cohort</p>\n<ul>\n <li>\n To demonstrate feasibility to measure vaccine induced immune response and infection prevalence using first-void urine sample in National Immunization Program vaccinated cohort</li>\n <li>\n To assess the feasibility (implementation aspect) of conducting such studies in various African settings</li>\n</ul>\n<p>\n 2) Investigate training challenges among HCWs on HPV vaccination</p>\n<ul>\n <li>\n Identify and understand challenges to implement training among implementers or trainers</li>\n</ul>\n<div>\n 3) Assess gaps in HCWs’ training</div>\n<ul>\n <li>\n To standardize HPV vaccine barometer survey (i.e., to determine level of knowledge among HCWs)</li>\n</ul>\n
      • principal_inclusion_criteria<p>\n <strong><u>INCLUSION CRITERIA</u></strong></p>\n<p>\n <strong><u>Inclusion criteria for the Gavi pilot cohort</u></strong></p>\n<ul>\n <li>\n  Female age 18 – 30 years who were included in the pilot vaccination of the Gavi demonstration program cohort</li>\n <li>\n  Willing to give informed consent to the research team and fill out a short survey</li>\n</ul>\n<p>\n <strong><u>Inclusion criteria for National Immunization Program (NIP) cohort</u></strong></p>\n<ul>\n <li>\n Young adolescents and adults (targeted by the NIP)</li>\n <li>\n Willing to give informed consent to the research team and obtain parental consent and fill out a short survey</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong><u>EXCLUSION CRITERIA</u></strong></p>\n<ul>\n <li>\n Pregnancy – performance of antibody detection in urine sample of a pregnant women has not been studied</li>\n <li>\n Immunocompromised women due to lower immune response</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n To demonstrate feasibility to measure vaccine induced long-term immune response (vaccination status) and infection prevalence using first-void urine sample in Gavi pilot vaccinated cohort</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
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      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyObservational cross-sectional study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <span background-color:=\"\" font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">KEMRI-CCR Partners in Health & Research Development - PHRD (Formerly Partners in Prevention) Thika Project, has over 100 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc). Principal Investigator: Dr. Nelly R. Mugo MBChB, MMED, MPH Site Principal Investigator: Dr. Kenneth Ngure BScN, MPH, MSc, PhD Site Co investigator: Lynda Oluoch & </span>Dr. Betty W. Njoroge: <span font-size:=\"\" style=\"background-color: rgb(249, 249, 249); color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">MBChB, MSc, MPH Sub investigators: Dr. Catherine Kiptinness, BPharm, MPH, Site pharmacist of Record, Site Coordinator</span></p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The study is being done in Kenya</span></p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Uganda - Approved on 28 Oct 2024; Single site</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration12 months
      • design_controlled_randomisedNo
      • 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_comparatorUnvaccinated girls
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-CCR PHRD( (THIKA) PROJECT
      • single_site_physical_addressThika Section 9, OAU Road, Near Thika Nursing home
      • single_site_contact_personDr. Catherine Kiptinness
      • single_site_telephone+254 67222561
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites
      • multi_country_listKenya, Uganda and Senegal.
      • data_monitoring_committeeNo
      • total_enrolment_per_site400
      • total_participants_worldwide1200
      • 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_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
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      • investigator1_given_nameProf. Nelly
      • investigator1_middle_name
      • investigator1_family_nameMugo
      • investigator1_qualificationPrincipal Clinical Research Scientist, Center for Clinical Research
      • investigator1_professional_addressKenya Medical Research Institute (KEMRI) Nairobi, Kenya
      • investigator1_telephone0733629665
      • investigator1_emailrwamba@uw.edu
      • organisations_transferred_Yes
      • number_participants400
      • notification
      • approval_date29-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-03-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted05-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed
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      • balance_site(null)
      • final_date(null)
      • modified2025-04-29 10:55:46
      • created2025-01-24 08:23:02
      • total_sites1
      • ecitizen_invoice350320
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        • id1224
        • application_id1507
        • given_nameProf Kenneth
        • middle_name
        • family_nameNgure
        • qualificationMPH, PhD
        • professional_address19865
        • telephone0722362219
        • emailkngure@pipsthika.org
        • created2025-02-04 14:47:03
        • modified2025-03-11 11:29:57
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        • created2025-02-04 14:47:03
        • modified2025-03-11 11:29:57
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        • id803
        • application_id1507
        • sponsorMERCK SHARP & DOHME LLC
        • sponsor_typeOthers
        • contact_personProf Nelly Mugo
        • addressKenya Medical Research Institute (KEMRI) Nairobi, Kenya
        • telephone_number+254 67222561
        • fax_number
        • cell_number0733629665
        • email_addressrwamba@uw.edu
        • created2025-02-04 14:47:03
        • modified2025-03-11 11:29:57
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      • 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
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      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressssusa.submissions@iconplc.com
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      • 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
  • 2(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
      • 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 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
      • 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 17:27:54
      • created2025-02-07 14:00:57
      • total_sites1
      • ecitizen_invoice354574
    • InvestigatorContact(array)
      • 0(array)
        • 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
    • SiteDetail(array)
      • 0(array)
        • id1843
        • application_id1512
        • county_id42
        • 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
        • site_capacity(null)
        • misc(null)
        • created2025-02-07 14:11:54
        • modified2025-02-24 16:17:43
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • 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
  • 3(array)
    • Application(array)
      • id1514
      • 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  </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  </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<p>\n  </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.</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/25/02/06
      • 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); Prof Omu Anzala (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  </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  </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  </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>Research Clinic</strong></p>\n<p>\n The KAVI-ICR Kenyatta National Hospital (KNH) Research Clinic is located within the premises of the College of Health Sciences, University of Nairobi. The Institute is made up of 3 wings. One wing exclusively hosts the KAVI-ICR Research Laboratory which comprises of 5 laboratories (Safety, PBMC, Tissue Culture, Molecular and Pathogen Sequencing Labs). The floor also hosts our biorepositories that we use to freeze our samples, lab staff offices as well as the institution’s main back up UPS. The second wing hosts administrative, finance, Information Technology (IT), research offices as well as the mucosal lab. This same wing also hosts the investigational product pharmacy. The third wing primarily host the research clinic comprising of a reception/waiting area, 3 counseling rooms, 3 clinic rooms, 1 procedure room, a fully equipped emergency room, research offices, a data room and secure filing room. The second and the third wing also have conference rooms capable of sitting between 20 – 40 people as well as facilitating teleconference meetings. The pharmacy, laboratory and data rooms and offices have secure restricted access doors.</p>\n<p>\n Routine medical care for trial participants is provided on-site at the clinic, including general medical care, medication dispensing, HIV counselling and testing, family planning counselling, and provision of HIV post-exposure prophylaxis. The emergency room has resuscitation equipment including a cardiac defibrillator, oxygen cylinders, and emergency drugs in the event of anaphylaxis. Our procedure room is equipped for protocol specific requirements such administration of investigational product and venous blood sample collection.</p>\n<p>\n The nearby Kenyatta National Hospital is the main referral facility for non-study related health care and has capacity to provide:</p>\n<ol>\n <li>\n Treatment of cervical lesions by cryotherapy or by loop electrosurgical excision procedure (LEEP) at the Cervical Cancer Screening Clinic</li>\n <li>\n Treatment and follow-up of cervical cancer at the Gynecology Outpatient Clinic</li>\n <li>\n HIV care and treatment at the Comprehensive Care Clinic</li>\n <li>\n Outpatient and inpatient care for most medical conditions including COVID-19 disease</li>\n <li>\n Inpatient care for most surgical conditions</li>\n</ol>\n<p>\n In case of medical emergencies at the research clinic, participants will be evacuated by ambulance service to Coptic Hospital for inpatient care including Intensive Care Unit admission if necessary.</p>\n<p>\n KAVI-ICR has also identified community-based organizations that offer support for drug and alcohol addictions as well as victims of gender-based violence.</p>\n<p>\n <strong>Personnel</strong></p>\n<p>\n The site has adequate staff with vast experience in conducting clinical trials. In addition to the principal and sub-investigators, the site has the following staff who will be involved directly in conducting the trial:</p>\n<ol>\n <li>\n Clinical Officers – 4</li>\n <li>\n Nurse Counselors – 4</li>\n <li>\n Community Liaison Officers – 3</li>\n <li>\n Pharmaceutical Technologists – 2</li>\n <li>\n Laboratory Staff - 5</li>\n <li>\n IT Manager – 1</li>\n <li>\n Data Clerks – 2</li>\n</ol>\n<p>\n All research staff are trained in Good Clinical Practice (GCP) and Protection of Human Subjects Research (HSP) at minimum. All staff undergo periodic Standard Operating Procedures (SOP) training as well as Study Specific Procedures (SSP) training prior to the beginning of the trial and as frequently as is required thereafter.</p>\n<p>\n <strong>Pharmacy</strong></p>\n<p>\n The pharmacy is located on the 3rd floor at the University of Nairobi, College of Health Sciences in Kenyatta National and Referral Hospital in Nairobi along Ngong Road. This pharmacy space measures approximately 24 square meters and is divided into pharmacy office and the vaccine (IP) pharmacy. The IP pharmacy has a Sanyo MDF -80°C freezer, a Panasonic -80°C freezer, a Sanyo 2-8 refrigerator, a class II biosafety cabinet, open shelves and a lockable cabinet which act as room temperature storage unit. The room has an air conditioner unit for ambient temperature regulation. All these units are powered by the mains electricity but there exists a UPS and two generators on site which work as back-up facilities. </p>\n<p>\n Transmitters connected to the freezer, fridge and the lockable cabinet send data to the pharmacy computer, which is programmed to call relevant staff in the event of temperature excursions or power failure, and which downloads the temperature data stored in the Eltek Temperature Monitoring system. Room temperature can also be controlled in a similar manner. Access to the pharmacy is restricted and is limited to the pharmacy staff by the use of magnetic access cards. All visitors to the pharmacy must sign a visitor’s log and must be accompanied by at least one of the pharmacy staff. Security of the entire site including the pharmacy, is maintained by the University of Nairobi security staff. A back-up pharmacy is available at the KAVI-Kangemi site for emergency transfer of the Investigational Products in case of catastrophic power failure. Monitoring of the pharmacy activities is usually conducted by a single monitor facilitated by the study sponsor. Pharmacy staff who are un-blinded do not participate in the safety assessment of volunteers. </p>\n<p>\n <strong>Laboratory</strong></p>\n<p>\n The main lab occupies the 2^nd floor of the KAVI-ICR building at the College of Health sciences (University of Nairobi) and it is accredited to Good Clinical Laboratory Practice standards (GCLP). The laboratory is also registered with KMLTTB (Kenya Medical Technicians and Technologists Board) which is the regulatory body under Ministry of Health, Kenya governing all diagnostic and clinical research laboratories in the country. The lab has capacity to perform HLA molecular tissue typing, serological assays for HIV, HBV, and HCV (using ELISA) and RPR (syphilis), hematology (CBC and differential), biochemistry (liver and renal function tests), urinalysis, and pregnancy tests, PCR tests (CT/NG, HIV Viral Load), PBMC separation, intracellular cytokine staining, mucosal sample processing, ELISpot, FlowCytometry, HIV Viral mobility assays and a variety of basic immunological assays e.g. B cell sorting and antibody response determination. There is ongoing capacity building to improve the ability to conduct COVID-19 related trials. Turn-around time for results is approximately 3 days but more critical results can be provided within 24hours.</p>\n<p>\n KAVI-ICR has engaged the services of the Pathologists LANCET Kenya laboratories as a back-up and referral to the main KAVI lab.</p>\n<p>\n <strong>Data Management</strong></p>\n<p>\n Data management is mainly through online and offline data capture system and datafax. In addition to the electronic swipe cards that limit access to the data office, access to the database is password controlled and staff have limited access levels to the database. Study documents that contain volunteer identifiers are stored separately in fireproof cabinets located in a different office within the site facilities. There are 2 computers dedicated to data entry. During power outages, all critical operations are supported by a diesel-powered generator and a UPS system. The site has data management SOPs including data backup and disaster management. Off-site long-term archiving of study documents is outsourced to a company called The Filing Room. </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.<br />\n  </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\nTurkey\nNew Zealand
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment with 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, PO 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 We hereby wish to respond to the second Screening Queries for the site of Prof Omu Anzala: ECCT/25/02/06.</p>\n<p>\n The cover letter and additional documents have been added under Section 13, Checklist. </p>\n<p>\n  </p>\n<p>\n Kind regards</p>\n<p>\n Gerald Carstens</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 Kenya AIDS Vaccine Initiative (KAVI) Institute of Clinical Research, Nairobi
      • 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 17:27:29
      • created2025-02-07 14:01:13
      • total_sites1
      • ecitizen_invoice354576
    • InvestigatorContact(array)
      • 0(array)
        • id1228
        • application_id1514
        • given_nameOmu
        • middle_name
        • family_nameAnzala
        • qualificationMBChB, Dip Epidemiology, M Infectious Diseases, PhD, Postdoctoral IMM
        • professional_addressKAVI-Institute of Clinical Research (KAVI - ICR), Faculty of Health Science, University of Nairobi, KNH Complex, Off Mbagathi Way, P.O. Box 19676-00202, Nairobi, Kenya
        • telephone+254 20 2717 694
        • emailoanzala@kaviuon.org
        • created2025-02-07 14:01:13
        • modified2025-02-24 16:38:46
    • SiteDetail(array)
      • 0(array)
        • id1841
        • application_id1514
        • county_id47
        • site_nameKAVI-Institute of Clinical Research (KAVI - ICR)
        • physical_addressFaculty of Health Science, University of Nairobi, KNH Complex, Off Mbagathi Way, P.O. Box 19676-00202, Nairobi, Kenya
        • contact_detailsTel: +254 20 2717694, P.O. Box 19676
        • contact_personProf Omu Anzala
        • site_capacity(null)
        • misc(null)
        • created2025-02-07 14:11:49
        • modified2025-02-24 16:38:46
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id806
        • application_id1514
        • sponsorSponsor: Antiva Biosciences, Inc.
        • sponsor_typeIndustry
        • contact_personAnnie Warsi, MD MAS
        • address555 Twin Dolphin Drive, Suite 620 Redwood City, CA, 94065
        • telephone_number+16508221400
        • fax_numberNA
        • cell_number+1 408 401 6086
        • email_addressawarsi@antivabio.com
        • created2025-02-07 14:11:49
        • modified2025-02-24 16:38:46
  • 4(array)
    • Application(array)
      • id1513
      • 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. 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.</p>\n<p>\n  </p>\n<p>\n 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/25/02/07
      • 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), Prof Elizabeth Anne Bukusi (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  </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  </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<p>\n  </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<p>\n  </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<p>\n  </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  </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<p>\n  </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 The KEMRI-RCTP facility has:</p>\n<p>\n <strong>1.   Reception and waiting bay:</strong></p>\n<p>\n Provides seating area with good air circulation. Enough seats for 20 participants at a time.</p>\n<p>\n <strong>2.   Six Clinic rooms:</strong></p>\n<p>\n The rooms each have a desk, chairs for participant and staff, an examination coach, examination lamp, BP machine, thermometer, desktop computers, waste bins and sharps container, privacy curtain.</p>\n<p>\n <strong>3.   Pharmacy:</strong></p>\n<p>\n Room has access control and is temperature-controlled with an Air Conditioner maintaining ambient temperature between 15-30°C. It is equipped with a pharmaceutical fridge (2-8°C), two desktop computers, bar code scanners, printer, lockable storage cabinets, ergonomic chairs, thermometers for temperature monitoring.</p>\n<p>\n <strong>4.   Laboratory:</strong></p>\n<p>\n Room is temperature controlled with an Air Conditioner maintaining ambient temperature between 15-30°C. The are temperature monitoring system, 4 printers, 3 desktops, 2 safety cabinets, GeneXpert machine, 2 light microscopes, 2 refrigerated centrifuge, ELISA machine, 2-8°C refrigerator, -20°C freezer, -40°C freezer, five -80°C freezers, Cobas biochemistry machine, Coulter full hemogram machine, incubator.</p>\n<p>\n <strong>5.   Data room:</strong></p>\n<p>\n The room has 10 computers with uninterrupted power supply, printer, label printer, lockable storage cabinets, seats, desk.</p>\n<p>\n <strong>6.   Administration office:</strong></p>\n<p>\n Has desks, desktop computers, seats and lockable storage cabinets.</p>\n<p>\n <strong>7.   Open Office:</strong></p>\n<p>\n Has adequate sitting space that can accommodate 30 Staff.</p>\n<p>\n <strong>8.   Washrooms:</strong></p>\n<p>\n Clean washrooms for both staff and participants.</p>\n<p>\n  </p>\n<p>\n The site also has a backup generator for backup power supply, archival space for storage of archived documents and material., and internet connection.</p>\n<p>\n Emergency facilities: The site has an emergency trolley and portable first aid kit that may be used in the event of an emergency. The facility is also located within a hospital facility that may handle referral cases.</p>\n<p>\n <strong><u>PERSONNEL</u></strong></p>\n<p>\n <strong>Elizabeth Bukusi, MBChB, MMed, MPH, PhD, Principal Investigator</strong></p>\n<p>\n She will provide substantial oversight of all activities that take place at the Kisumu site. As the site Principal Investigator (PI) for the KEMRI team leading activities, she will work closely with the coordinating center and provide oversight of implementation of all research components, including study and intervention design, preparation of data collection instruments, intervention implementation, data collection and management, as well as fiscal and administrative management of the study.</p>\n<p>\n <strong>Josephine Odoyo, Internal monitor</strong></p>\n<p>\n Josephine Odoyo is a trained nurse by profession and has wide experience in sexual and reproductive health research having coordinated earlier clinical trials at the Kisumu site. She will be assisting the principal investigators in the planning and implementation stage of the project and offering regulatory services ensuring quality is maintained throughout the study implementation.</p>\n<p>\n <strong>Victor Omollo, MBChB, MPH, Sub-Investigator</strong></p>\n<p>\n Dr. Omollo will take the lead as a sub-investigator with experience having coordinated the POWER open- label PrEP delivery among adolescent girls and young women under RCTP-KEMRI and has been a Co-PI in other studies, including MK-4482-013 study, IMPOWER, and Pharmacy PrEP delivery study. He will assist the primary site coordinator in ensuring the smooth functioning of the research project, coordinating communications with regulatory boards, staff, and investigators, and assisting investigators with implementation, planning, and problem-solving to ensure project goals are met.</p>\n<p>\n <strong>Felix Mogaka, MBChB, MPH, Sub-investigator, primary site coordinator</strong></p>\n<p>\n Dr. Mogaka will be responsible for coordinating the site activities as well as acting as a physician for the study participants, review safety and Adverse event (AE) monitoring, and safety reporting to the study safety monitor, sponsor, and regulatory review bodies. As a coordinator, he will oversee the day-to- day running of the site on behalf of the site PI and supervision of site personnel, development of standard operating procedures including preparation and study results dissemination to the relevant regulatory review boards.</p>\n<p>\n <strong>Greshon Rota, B.Pharm, Pharmacist of Records</strong></p>\n<p>\n The Pharmacist of records will be involved in all matters pertaining to the Pharmacy and Poisons Board (PPB) in regard to the registration of the protocol and act as a link between the Study and PPB. He will assist in dispensing drugs and provide adherence counseling. He will also be responsible for tracking the amount of study drug kits and ensuring documentation of the same.</p>\n<p>\n <strong>Clinical Officer</strong></p>\n<p>\n The clinical officer will assist the study medical officer and physician in performing clinical assessments, carry out medical examinations and prescribe medication as required to the participants. Recognize, monitor, and report study adverse events and help in their management.</p>\n<p>\n <strong>Laboratory Technologist and Manager</strong></p>\n<p>\n The Lab Technologists will be responsible for performing all the lab tests required for the participants, maintaining and charting the temperature logs in the laboratory, preparing samples for archiving and shipment, and ensuring proper storage is done. They will also maintain the Study documents in files and folders appropriately monitor any abnormal results for participants and notify the clinicians appropriately. The Laboratory Manager will be responsible for the overall management of the laboratory, authoring the laboratory SOPs, ensuring that all equipment is serviced and calibrated, and ensuring that all tests are done as per the study protocol.</p>\n<p>\n <strong>Data Manager and data quality assurance officer</strong></p>\n<p>\n The data manager will be responsible for the overall management of the study data ensuring all the needed databases are created and reports generated on a timely basis as needed for each database. Ensuring the confidentiality of participants' data by creating a link log between the participants' study ID and participant's names which will be kept separately under double locked cabinets. The QA officer will be responsible for ensuring quality checks are done on data and all other aspects of the study and will work in collaboration with the coordinator to ensure the study data and processes are of the highest quality. Will also be responsible for entering all the participants data in the appropriate database, and checking data for accuracy, completeness, and consistency. They will also file participant’s binders in an orderly sequence.</p>\n<p>\n <strong>Community Liaison Recruitment and Retention Officer</strong></p>\n<p>\n The Community Liaison Recruitment and Retention Officer will be responsible for planning and mapping out the areas of participant recruitment, overseeing preparing SOPs and acting as a community linkage with the project. He/she will organize the stakeholder meetings and prepare the required IEC materials necessary for the project.</p>\n<p>\n <strong>Front Office Manager</strong></p>\n<p>\n The receptionist will be responsible for receiving the participants, registering their details, and guiding them to the appropriate staff for screening, enrolment, and follow-up visits. He/she will also schedule clinic visit dates for the participants reimburse the participants for their transport and ensure they also receive refreshments. He/she also ensures that there are sufficient screening folders, name charts, medical charts, and CRF files for upcoming screening and enrollment visits.</p>\n<p>\n <strong>HTS Counselor and Mobilizer</strong></p>\n<p>\n The HTS counselors will be responsible for community mobilization, counseling and testing the participants regarding HIV and referring them appropriately. Those who turn positive will be counseled and referred appropriately.</p>\n<p>\n <strong>Drivers</strong></p>\n<p>\n The drivers will assist with all project driving and delivery needs. They will transport staff members to various project activities and assist in the follow-up and recruitment of study participants and locating them where necessary during the accelerated mobilization. They will also be responsible for vehicle maintenance and keeping track of vehicle work tickets/logs.</p>\n<p>\n <strong>Study Administrator</strong></p>\n<p>\n This administrator will be responsible for assisting in overall planning for the project in liaison with the coordinator, PI, and the Chief Finance Administrator and assist in budget preparation, maintaining of proper audit trail for study funds and expenditures, generating monthly invoices, and other financial reports as required in the subcontract. He will also be responsible for handling and accounting for the field advance given to the project.</p>\n<p>\n <strong>Finance Manager</strong></p>\n<p>\n The Finance & Admin Manager is based in Nairobi. She is instrumental in terms of procurement of equipment and fast tracking of project payments to suppliers. She forwards letters to the headquarters and follow up payments on behalf of the Kisumu site. She also facilitates staff contracts, sub-contracts and petty cash advances. In collaboration with the Study Coordinator and the PI she will ensure timely sub-contract agreements; budget preparation and monitoring of line items to ensure they conform to budgets.</p>\n<p>\n <strong>Human Resource Manager</strong></p>\n<p>\n The Human Resource Manager is responsible for the recruitment of personnel and all staff related issues such as disciplinary, medical insurance, salaries and remuneration among others.</p>\n<p>\n <strong>Office Assistants</strong></p>\n<p>\n The office assistants will be responsible for delivering messages for study needs and ensure that there is a clean environment for participants. They will liaise with the administrator in sending and receiving parcels and courier services. They will also clean the office area, washrooms, and building surrounding, and maintain of study clinic grounds.</p>\n<p>\n <strong>ICT Officer</strong></p>\n<p>\n The ICT officer will be responsible for ensuring that the internet connectivity is of the right quality and speed to enable study activities such as online training, meetings, and data capture to be done with very minimal interruption. He/she will be in charge of network administration of the study.</p>\n<p>\n <strong>PA to the Principal Investigator</strong></p>\n<p>\n The PA to the principal Investigator ensures that the calendar for Prof. Bukusi is updated and that her appointments are scheduled efficiently and convenient for the operations of the project.</p>\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<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n The submission to the Turkey MoH occurred on 27 June 2024.</p>\n<p>\n  </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<p>\n  </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 \nTurkey
      • 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, PO 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 Prof Elizabeth Anne Bukusi (ECCT/25/02/07) has been re-submitted, including a cover letter and additional documents 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>\n <span style=\"font-family: Arial, sans-serif; font-size: 10pt;\">Gerald Carstens</span></p>\n
      • approval_date13-03-2025
      • submitted1
      • deleted0
      • deleted_date(null)
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      • date_submitted24-02-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted07-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonSatisfactory feedback on review comments
      • final_report(null)
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      • balance_site(null)
      • final_date(null)
      • modified2025-04-17 17:27:44
      • created2025-02-07 14:01:00
      • total_sites1
      • ecitizen_invoice354575
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        • id1227
        • application_id1513
        • given_nameElizabeth
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, Cert (Intl Health) PhD, PGD (Ethics), MBE, CIP.
        • professional_addressKEMRI-RCTP, KEMRI CIS Building Lumumba Sub-County Hospital, Along Ondiek Highway, P.O Box 614-40100, Kisumu, Kenya
        • telephone+254 723 686 156
        • emailebukusi@rctp.or.ke
        • created2025-02-07 14:01:00
        • modified2025-02-24 16:25:23
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        • site_nameKEMRI-RCTP
        • physical_addressKEMRI CIS Building, Lumumba Sub-County Hospital Along Ondiek Highway, P.O Box 614-40100, Kisumu, Kenya
        • contact_details+254 7995 808 08, P.O. Box 614
        • contact_personDr Felix Mogaka
        • site_capacity(null)
        • misc(null)
        • created2025-02-07 14:11:49
        • modified2025-02-24 16:25:23
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          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • id807
        • application_id1513
        • sponsorAntiva Biosciences, Inc.
        • sponsor_typeIndustry
        • contact_personAnnie Warsi, MD MAS
        • address555 Twin Dolphin Drive, Suite 620 Redwood City, CA, 94065
        • telephone_number+16508221400
        • fax_numberNA
        • cell_number+14084016086
        • email_addressawarsi@antivabio.com
        • created2025-02-07 14:11:49
        • modified2025-02-24 16:25:23
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    • 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