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    • Application(array)
      • id568
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n The abstract/synopsis of this protocol is detailed on Page 15 of the protocol attached.</p>\n
      • study_title<p>\n A randomized, obsever-blind, placebo controlled, two-part, Phase 2 study to evaluate the Safety, Tolerability and Immunogenicity of Two prime-boost regimen of the candidate Prophylactic vaccines for Ebola Ad26-ZEBOV and MVA-BN Filo.</p>\n
      • laymans_summary<div>\n The sponsor, in collaboration with Bavarian Nordic GmbH (BN) and Walter Reed Army Institute of Research (WRAIR), is investigating the potential of a prophylactic Ebola vaccine regimen comprised of the following 2 candidate Ebola vaccines: Ad26.ZEBOV is a monovalent vaccine expressing the full length Ebola virus (EBOV, formerly known as Zaire ebolavirus) Mayinga glycoprotein (GP), and is produced in the human cell line PER.C6®. MVA-mBN226B, further referred to as Modified Vaccinia Ankara (MVA)-BN-Filo®, is a multivalent vaccine expressing the Sudan virus (SUDV) GP, the EBOV GP, the Marburg virus (MARV) Musoke GP, and the Tai Forest virus (TAFV, formerly known as Côte d’Ivoire ebolavirus) nucleoprotein (NP), and is produced in chicken embryo fibroblast cells. The EBOV GP expressed by MVA-BN-Filo has 100%</div>\n<div>\n homology to the one expressed by Ad26.ZEBOV.</div>\n<div>\n Two populations will be studied in this protocol: healthy adults and human immunodeficiency virus (HIV)-infected adults, ages 18-70 years inclusive, will be enrolled.</div>\n
      • short_titleRV 456: Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo
      • protocol_noECCT/16/11/05
      • version_noApproved version dated 08 March 2016
      • date_of_protocol08-03-2016
      • study_drugEbola Ad26.ZEBOV and MVA-BN-Filo vaccines
      • disease_conditionEbola
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameNormal Saline Placebo
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjosphat.kosgei@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
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      • declaration_applicantDr Josphat Kosgei
      • declaration_date114-11-2016
      • declaration_principal_investigatorDr Fredrick Sawe
      • declaration_date214-11-2016
      • placebo_presentYes
      • study_objectives<div>\n Primary Objectives</div>\n<div>\n • To assess the safety and tolerability of different vaccination schedules of Ad26.ZEBOV and</div>\n<div>\n MVA-BN-Filo administered intramuscularly (IM) as heterologous prime-boost regimens in healthy</div>\n<div>\n adults and in HIV-infected adults, with Ad26.ZEBOV prime and MVA-BN-Filo boost vaccination</div>\n<div>\n on Days 1 and 29, respectively and MVA-BN-Filo prime and Ad26.ZEBOV boost vaccination on</div>\n<div>\n Days 1 and 15, respectively.</div>\n<div>\n • To assess the immune responses to the EBOV GP (as measured by [enzyme-linked immunosorbent</div>\n<div>\n assay] ELISA antibody concentration) of different vaccination schedules of Ad26.ZEBOV and</div>\n<div>\n MVA-BN-Filo administered IM as heterologous prime-boost regimens in healthy adults and in</div>\n<div>\n HIV-infected adults, with Ad26.ZEBOV prime and MVA-BN-Filo boost vaccination on Days 1 and</div>\n<div>\n 29, respectively and MVA-BN-Filo prime and Ad26.ZEBOV boost vaccination on Days 1 and 15,</div>\n<div>\n respectively.</div>\n
      • principal_inclusion_criteria<p>\n Healthy adults, both HIV negative and positive, aged 18 to 70 years.</p>\n
      • principal_exclusion_criteria<p>\n Recepient of Ebola vaccine previosly.</p>\n<p>\n Has been diagnosed with Ebola virus infection.</p>\n
      • primary_end_points<p>\n Safety, as assessed by adverse events.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The site has the capacity to conduct the study, in terms of human resources, infrastructure, experience, emergency facilities. This is well detailed in the Site Specific Addendum attached.</p>\n
      • other_details_explanation<p>\n Not Applicable</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU approved on October 17 2016.</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable.</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable.</p>\n
      • estimated_duration64 weeks
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites2
      • multi_country_listUSA, Kenya, Nigeria, Uganda, Tanzania, Mozambique
      • data_monitoring_committeeYes
      • total_enrolment_per_site100 in Kericho and 50 in Kombewa, Kisumu
      • total_participants_worldwide575
      • 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_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameChebet
      • investigator1_family_nameNgetich
      • investigator1_qualificationBSc (Nursing), CRA
      • investigator1_professional_addressKEMRI/WRP Kericho
      • investigator1_telephone+254 713 603 217
      • investigator1_emailelizabeth.ngetich@usamru-k.org
      • organisations_transferred_Yes
      • number_participants150
      • notification
      • approval_date02-03-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This study was a  Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Fil. The primary objectives of this study were to  assess the safety and tolerability of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as heterologous prime-boost regimens in healthy adults and in HIV-infected adults, with Ad26.ZEBOV prime and MVA-BN-Filo boost vaccination on Days 1 and 29, respectively and MVA-BN-Filo prime and Ad26.ZEBOV boost vaccination on Days 1 and 15, respectively.</p>\n<p>\n People without HIV (PWOH) and people living with HIV (PLWH) aged 18-70 years were enrolled at six sites in five African countries: Kenya, Mozambique, Nigeria, Tanzania, and Uganda. A CD4+ cell count >200 cells/μL at screening was an eligibility requirement for PLWH, and those with a screening CD4+ cell count >200 to <350 cells/μL must have been on stable antiretroviral therapy (ART; no regimen change in the four weeks preceding screening). All participants provided written informed consent. The RV 456b study enrolled healthy subjects and HIV-infected subjects, both male and female (aged 18 to 70 years inclusive). There are no changes from the anticipated population.</p>\n<p>\n No study-related SAE was reported for the RV 456b during the study. The majority of solicited AEs across all sites were of mild-to-moderate severity in the 14- and 28-day interval groups. Additionally, most solicited AEs were ≤3 days in duration (61% and 91% of solicited local AEs in the vaccine and placebo groups, respectively, and 53% and 50% of solicited systemic AEs, respectively). The most frequent (occurring in >20% of participants) solicited local AEs were injection-site pain and injection-site pruritus, while the most frequent (occurring in >40% of participants) solicited systemic AEs were fatigue, headache, and myalgia. All SAEs were considered unrelated to the study vaccine. No deaths were reported.</p>\n<p>\n  </p>\n
      • implication_results<p>\n This is the first study to demonstrate safety and EBOV GP-specific immunogenicity in PLWH with an Ebola vaccination regimen of MVA-BN-Filo followed by Ad26.ZEBOV 14 days later. These results show that an accelerated vaccination schedule is well tolerated in both PWOH and PLWH and induces a broad array of durable humoral and cellular immune responses. These findings support continued consideration for accelerated regimen development for rapid deployment among outbreak responders and relevant global populations at immediate risk.</p>\n<p>\n The following publications resulted from this study:</p>\n<ul>\n <li>\n Ake, J.A.; Paolino, K.; Hutter, J.N.; Cicatelli, S.B.; Eller, L.A.; Eller, M.A.; Costanzo, M.C.; Paquin-Proulx, D.; Robb, M.L.; Tran, C.L.; et al. <em><strong>Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People with and without Human Immunodeficiency Virus: A Randomized Clinical Tria</strong></em>l. Vaccines 2024, 12, 497. https://doi.org/10.3390/vaccines12050497</li>\n <li>\n Betty Mwesigwa, Fredrick Sawe, Janet Oyieko, Joel Mwakisisile, Edna Viegas, Gideon Akindiran Akintunde, Josphat Kosgei, Afoke Kokogho, Nyanda Ntinginya, Ilesh Jani, Georgi Shukarev, Jay W Hooper, Steven A Kwilas, Lucy A Ward, Janice Rusnak, Callie Bounds, Rachel Overman, Christopher S Badorrek, Leigh Anne Eller, Michael A Eller, Christina S Polyak, Amber Moodley, Chi L Tran, Margaret C Costanzo, David J Leggat, Dominic Paquin-Proulx, Prossy Naluyima, Dickson Nkafu Anumendem, Auguste Gaddah, Kerstin Luhn, Jenny Hendriks, Chelsea McLean, Macaya Douoguih, Hannah Kibuuka, Merlin L Robb, Cynthia Robinson, Julie A Ake, <em><strong>Safety and Immunogenicity of Accelerated Heterologous Two-dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa</strong></em>, Clinical Infectious Diseases, 2024;, ciae215, https://doi.org/10.1093/cid/ciae215</li>\n</ul>\n<p>\n  </p>\n<p>\n  </p>\n
      • quantity_importedFind attached RV 456 Study Product Recovery Reports
      • quantity_dispensedFind attached RV 456 Study Product Recovery Reports
      • quantity_destroyedFind attached RV 456 Study Product Recovery Reports
      • quantity_exportedFind attached RV 456 Study Product Recovery Reports
      • balance_siteFind attached RV 456 Study Product Recovery Reports
      • final_date0000-00-00
      • modified2024-10-17 16:17:40
      • created2016-11-14 06:53:35
      • total_sites(null)
      • ecitizen_invoice(null)
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      • 0(array)
        • id367
        • application_id568
        • given_nameFredrick
        • middle_nameKipyego
        • family_nameSawe
        • qualificationMBChB, MMED
        • professional_addressKEMRI/WRP Kericho
        • telephone+254 703 247 902
        • emailfredrick.sawe@usamru-k.org
        • created2016-11-14 07:06:27
        • modified2020-03-18 07:52:01
    • SiteDetail(array)
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        • id447
        • application_id568
        • county_id35
        • site_nameKEMRI/WRP Kericho
        • physical_addressKericho
        • contact_detailsP.O. Box 1357-20200
        • contact_personDr Fredrick Sawe
        • site_capacity(null)
        • misc(null)
        • created2016-11-14 07:06:27
        • modified2020-03-18 07:52:01
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id448
        • application_id568
        • county_id42
        • site_nameKEMRI/WRP Kombewa, Kisumu
        • physical_addressKombewa
        • contact_details+254 721 996 988
        • contact_personDr Janet Oyieko
        • site_capacity(null)
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        • created2016-11-14 07:44:29
        • modified2020-03-18 07:52:01
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id293
        • application_id568
        • sponsorCrucell Holland B.V., a Janssen pharmaceutical company of Johnson & Johnson
        • sponsor_typeIndustry
        • contact_person
        • addressArchimedesweg 4, 2333 CN Leiden, Netherlands
        • telephone_number+31715199100
        • fax_number
        • cell_number+31715199100
        • email_addressJanssenIDVNL@its.jnj.com
        • created2016-11-14 07:06:27
        • modified2020-03-18 07:52:01
  • 1(array)
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      • id569
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      • trial_status_id5
      • abstract_of_study<p>\n SYNOPSIS A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo. The sponsor, in collaboration with Bavarian Nordic (BN) and Walter Reed Army Institute of Research (WRAIR), is investigating the potential of a prophylactic Ebola vaccine regimen comprised of the following 2 candidate Ebola vaccines: Ad26.ZEBOV is a monovalent vaccine expressing the full length Ebola virus (EBOV, formerly known as Zaire ebolavirus) Mayinga glycoprotein (GP), and is produced in the human cell line PER.C6®. MVA-mBN226B, further referred to as Modified Vaccinia Ankara (MVA)-BN-Filo®, is a multivalent vaccine expressing the Sudan virus (SUDV) GP, the EBOV GP, the Marburg virus (MARV) Musoke GP, and the Tai Forest virus (TAFV, formerly known as Côte d’Ivoire ebolavirus) nucleoprotein (NP), and is produced in chicken embryo fibroblast cells. The EBOV GP expressed by MVA-BN-Filo has 100% homology to the one expressed by Ad26.ZEBOV. Two populations will be studied in this protocol: healthy adults and human immunodeficiency virus (HIV)-infected adults, ages 18-70 years inclusive, will be enrolled. Ad26.ZEBOV and MVA-BN-Filo will be evaluated as a heterologous prime-boost regimen. The first schedule to be evaluated is prime vaccination with MVA-BN-Filo followed by a boost with Ad26.ZEBOV 14 days later. In the second schedule, Ad26.ZEBOV is used to prime a filovirus-specific immune response and MVA-BN-Filo is used to boost the immune response 28 days later. The EBOV GP that is currently circulating in West Africa has 97% homology to the EBOV GP used in this vaccine regimen. STUDY RATIONALE • Enlarge the safety and immunogenicity database for the Ad26.ZEBOV/MVA-BN-Filo 1, 29-day prime-boost regimen in healthy adults. • Assess the safety and immunogenicity of Ad26.ZEBOV/MVA-BN-Filo 1, 29-day prime-boost regimen in HIV-infected subjects and determine the effect of vaccination on HIV disease. • Enlarge the safety and immunogenicity database for MVA-BN-Filo/Ad26.ZEBOV 1, 15 day prime-boost regimen in healthy adults and HIV-infected adults.</p>\n<p>\n  </p>\n
      • study_title<p>\n A Randomized, Observer-blind, Placebo-controlled, Two part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo</p>\n
      • laymans_summary<p>\n Ebola virus disease is caused by an infection with a virus known as the Ebolavirus. The disease is characterized by symptoms such as fever, body aches, diarrhoea, bleeding, and vomiting. According to the World Health Organization, the number of people who die among the population having Ebola virus disease ranges from 25% to 90%. Vaccination is one of the most effective ways to prevent illness caused by viruses. A vaccine contains a non-functional part of the virus that is recognized by the body's protective immune system. The body then produces a response that prevents illness if the person is exposed to that virus again. This process is known as an immune response. The investigational treatment consists of a 2 dose vaccine regimen, 1 dose of Ad26.ZEBOV and 1 dose of MVA-BN-Filo vaccine, for the prevention of Ebola virus disease (Zaire ebolavirus species). This combination will be given at 2 different intervals between the 2 vaccine doses. The first schedule will include MVA-BN-Filo as the first dose followed by Ad26.ZEBOV as the second dose. The second schedule will include Ad26.ZEBOV as the first dose followed by MVA-BN-Filo as the second dose. In this study, researchers want to know the safety of the Ebola vaccine regimen in healthy adults and in human immunodeficiency virus (HIV*)-infected adults when administered using different vaccination schedules and interval. In addition, researchers want to understand the immune responses induced by the Ebola vaccine regimen by performing some tests. *HIV infection affects cells of the immune system and decreases their ability to fight infections. Participants can take part in this study if they have never received an Ebola vaccine, have not been diagnosed with Ebola virus disease, and have not travelled to any place where Ebola virus disease was confirmed up to 1 month before the study starts. Participants in the HIV-infected cohort should have a documented HIV infection within 6 months before the study start and be taking medicines for the treatment of HIV infection for the duration of the study. During the study, all participants will go through screening to confirm if they can take part in the study. Once enrolled, participants will be divided into 2 groups, healthy adults and participants with HIV infection between 18 to 70 years of age. All participants will receive either study vaccine (Ad26.ZEBOV, MVA-BN-Filo) or placebo, which does not contain the study vaccine, but looks like it. All vaccines will be given as an injection in the muscle. This study will be conducted in 2 parts: • • In Part 1 performed in the USA, participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15. • • In Part 2 performed in Africa, participants will be further divided into 2 groups. • o Participants in Group 1 will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 29. • o Participants in Group 2 will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15. During the study, participants will undergo different study assessments and tests. These include blood tests, vital signs (such as pulse, blood pressure, and temperature), electrocardiograms, physical exams, and pregnancy test for women. Any side effects reported by the participants will also be recorded throughout the study. Blood samples will be taken at several time points to understand how many participants responded to the vaccine regimen and to what extent. There will be a follow-up phase up to 1 year after the second dose to monitor the participants’ health and to collect blood samples for immune response assessments. The overall duration of the study will be approximately 3 years.</p>\n
      • short_titleRV456
      • protocol_noECCT/16/11/04
      • version_noAmendment 2
      • date_of_protocol08-03-2016
      • study_drugAd26.ZEBOV and MVA-BN-Filo
      • disease_conditionEBOLA
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmargaretodongo@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
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      • applicant_registration_ctr(null)
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      • applicant_hard_copies(null)
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      • applicant_contractual_agreement(null)
      • declaration_applicantSTACEY MAUREEN OKALLO GONDI
      • declaration_date114-11-2016
      • declaration_principal_investigatorDR JANET OYIEKO
      • declaration_date214-11-2016
      • placebo_presentYes
      • study_objectives<p>\n The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOVand MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.</p>\n
      • principal_inclusion_criteria<p>\n 4.1. Inclusion Criteria 4.1.1. Inclusion Criteria for Healthy Adult Subjects Each potential subject must satisfy all of the following criteria to be enrolled in the study. 1. Each subject must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. In case the subject cannot read or write, the procedures must be explained and informed consent must be witnessed by a literate third party not involved with the conduct of the study. 2. Subject must be a man or woman aged 18 to 70 years of age, inclusive at screening. 3. Subject must be healthy in the investigator’s clinical judgment on the basis of medical history, physical examination and vital signs performed at screening. 4. Subject must be healthy on the basis of clinical laboratory tests and ECG (only in subjects >50 years) performed at screening. If the results of the laboratory screening tests and ECG are outside the institutional normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator. However, the subject should not be included when hemoglobin is lower than the institutional normal reference range (or below the values in Attachment 3 when that range is not available). Note: The safety laboratory assessments at screening are to be performed within 28 days prior to the prime vaccination and may be repeated if they fall outside this time window. Note: In case of menstruation, urinalysis must be postponed but a result should be available before the prime vaccination. All urinalyses should be collected as freshly voided, mid-stream, clean catch samples obtained after proper cleansing. Note: If laboratory screening tests are out of range and deemed clinically significant, repeat of screening tests is permitted only once using an unscheduled visit during the screening period to assess eligibility. 5. Before randomization (on Day 1), a woman must be either: − Of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies, beginning at least 28 days prior to vaccination until at least 3 months after the boost vaccination. The sponsor considers the following methods of birth control to be highly effective: established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods (condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository); male partner sterilization (the vasectomized partner should be the sole partner for that subject). More restrictive measures may be required by the site. Note: Reliance on abstinence or natural family planning are not acceptable birth control methods for sexually active women of child-bearing potential. VAC52150 (Ad26.ZEBOV/MVA-BN-Filo [MVA-mBN226B]) Clinical Protocol VAC52150EBL2003 Amendment 2 49 Status: Approved, Date: 8 March 2016 OR − Not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 2 years) or permanently sterilized (eg, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy. Note: If the social situation of a woman changes after start of the study (eg, woman who is not heterosexually active becomes active), she must begin a highly effective method of birth control, as described above. 6. A woman of childbearing potential must have a negative urine β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a negative urine β-hCG pregnancy test immediately prior to each study vaccine administration. Note: If the pregnancy test result is positive, in order to maintain subject confidentiality, the investigator will ensure adequate counseling and follow-up will be made available. 7. A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to prime vaccination until at least 3 months after the boost vaccination, unless a vasectomy was performed more than 1 year prior to screening. 8. Subject must be available and willing to participate for the duration of the study visits and follow-up. 9. Subject must be willing and able to comply with the protocol requirements, including the Prohibitions and Restrictions specified in Section 4.3. 10. Subject must be willing to provide verifiable identification. 11. Subject must have a means to be contacted. 12. Subject must pass the test of understanding (TOU) (passing score: ≥90%) (Attachment 1).</p>\n
      • principal_exclusion_criteria<p>\n 1. Has received any candidate Ebola vaccine. 2. Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to epidemic Ebola areas less than 1 month prior to screening. Note: Participation of international volunteers to Ebola operations is allowed, but they should comply with the prohibitions and restrictions as specified in Section 4.3. 3. Has received any experimental candidate Ad26- or MVA-based vaccine in the past or received any other investigational drug or investigational vaccine or used an invasive investigational medical device within 3 months prior to screening. Note: Receipt of any approved vaccinia/smallpox vaccine or Ad-based candidate vaccine other than Ad26 at any time prior to study entry is allowed. 4. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines [eg, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for Ad26.ZEBOV vaccine; tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine]), including known allergy to egg, egg products and aminoglycosides. VAC52150 (Ad26.ZEBOV/MVA-BN-Filo [MVA-mBN226B]) Clinical Protocol VAC52150EBL2003 Amendment 2 51 Status: Approved, Date: 8 March 2016 5. Subject with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature ≥38.0ºC on Day 1 will be excluded from prime vaccination at that time, but may be rescheduled for prime vaccination at a later date. 6. HIV type 1 or type 2 infection. Note: If the HIV test result is positive, in order to maintain subject confidentiality, the investigator will ensure adequate counseling and follow-up will be made available. 7. A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the boost vaccination. 8. Presence of significant conditions (eg, history of seizure disorders, (auto)immune disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis treatment, other systemic infections) or clinically significant findings during screening of medical history, ECG (only in subjects >50 years), physical examination, vital signs or laboratory testing for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments. Note: Subjects who have recently received treatment for acute, uncomplicated malaria are eligible for participation if at least 3 days have elapsed from the conclusion of a standard, recommended course of therapy for malaria; subjects who are acutely ill with malaria at the time of screening should complete therapy and wait an additional 3 days after completion before screening for the study. Note: Subjects with sickle cell trait can be included. 9. History of or underlying liver or renal insufficiency, or significant cardiac, vascular, pulmonary (eg, persistent asthma), gastrointestinal, endocrinic, neurologic, hematologic, rheumatologic, psychiatric or metabolic disturbances or eczema. 10. History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered cured. Subjects with malignancies who are currently being treated or are not surgical cures are excluded. 11. Major surgery (per the investigator’s judgment) within the 4 weeks prior to screening or planned major surgery through the course of the study (from screening until completion of the study, see Section 10.1). 12. Post-organ and/or stem cell transplant whether or not with chronic immunosuppressive therapy. 13. Receipt of any disallowed therapies as noted in Section 8 before the planned administration of the prime vaccine on Day 1. 14. Is currently participating in or planning to participate in another clinical study during the study. Note: Participation in an observational clinical study is allowed. VAC52150 (Ad26.ZEBOV/MVA-BN-Filo [MVA-mBN226B]) Clinical Protocol VAC52150EBL2003 Amendment 2 52 Status: Approved, Date: 8 March 2016 15. Donation of a unit of blood within 8 weeks before Day 1 or plan to donate blood until 42-days post-boost. 16. Receipt of blood products or immunoglobulin within 3 months prior to screening and during participation in the study. 17. Current or past abuse of alcohol, recreational or narcotic drugs, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with the study procedures. 18. History of chronic urticaria (recurrent hives). 19. Subject cannot communicate reliably with the investigator. 20. Subject who, in the opinion of the investigator, is unlikely to adhere to the requirements of the study. 21. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.</p>\n
      • primary_end_points<p>\n Primary Endpoints The primary endpoints are: • Safety as determined by: − Adverse events, collected until the 42-day post-boost visit. − Serious adverse events, collected until the end of the study. − Solicited local and systemic adverse events (reactogenicity), collected until 7 days after each vaccination. • Magnitude, kinetics and durability of humoral immune response against the EBOV GP by determining binding antibody levels using ELISA (in ELISA units/mL and/or endpointtiters) until the 21-day post-boost visit.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The KEMRI/WRP Kombewa Clinical Research Center(KCRC) is designed for large clinical trials and has a full clinical laboratory including microbiology capability.Over the years the site has carried out vaccine, drug and epidemiologicalThe KCRC has been recognized (report of the George Institute, 2007) as one of the premier sites in Africa to conduct clinical trials.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 YEARS
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPLACEBO
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKOMBEWA CLINICAL RESEARCH CENTRE
      • single_site_physical_addressOFF KISUMU BONDO ROAD, OPPOSITE KOMBEWA SUB COUNTY HOSPITAL
      • single_site_contact_personDR JANET OYIEKO
      • single_site_telephoneTEL +25471996988
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_statesNumber countries 6
      • number_of_sites
      • multi_country_listKenya, Uganda, Tanzania, Mozambique, Nigeria, USA
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKombewa Site 50
      • total_participants_worldwide575
      • 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_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJANET
      • investigator1_middle_name
      • investigator1_family_nameOYIEKO
      • investigator1_qualificationMD, MMed (Paeds)
      • investigator1_professional_addressP.O BOX 54
      • investigator1_telephone+254721996988
      • investigator1_emailjanet.oyieko@usamru-k.org
      • organisations_transferred_No
      • number_participantsKombewa Site 50
      • notification
      • approval_date28-01-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-04-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n This study was conducted in the USA (Part 1) and Africa (Part 2) and evaluated the safety, tolerability and immunogenicity of 2-dose heterologous vaccination regimens using Ad26.ZEBOV (5×1010 vp) and MVABN-Filo (1×108 Inf.U) in HIV-uninfected and HIV-infected adult participants. One regimen consisted of Ad26.ZEBOV on Day 1 (dose 1) followed by MVA-BN-Filo (dose 2) 28 days later (Part 2, Group 1), and one regimen consisted of MVA-BN-Filo on Day 1 (dose 1) followed by Ad26.ZEBOV (dose 2) 14 days later (Part 1 and Part 2, Group 2). Both regimens evaluated in this study were well-tolerated and no safety concerns were identified. Overall, adverse events reported post vaccination were mild in the majority of participants and transient in nature. No deaths or serious adverse events considered to be related to study vaccine were reported. There were no immediate reportable events, and only 1 participant did not receive dose 2 due to an adverse event of transient grade 1 leukocytosis considered possibly related to study vaccine by the investigator. Both regimens used in this study induced binding antibody responses (FANG ELISA) at 21 days post</div>\n<div>\n dose 2 in almost all (96% to 99%) participants in Part 1 and Part 2. Pooled FANG ELISA data for theMVA-BN-Filo, Ad26.ZEBOV 14-day interval schedule in Part 1 and Part 2 were generally similar to those from either study part alone. At 21 days post dose 2, the GMC in HIV-uninfected participants was higher than the GMC in HIV-infected participants. In both groups (HIV-uninfected and HIV-infected), responses were observed until the last assessment 1 year post dose 2, when a difference between the GMCin HIV-uninfected vs. HIV-infected participants was still present for the MVA-BN-Filo, Ad26.ZEBOV</div>\n<div>\n regimen. At 21 days post dose 2 in Part 1, EBOV GP-specific CD4+ T-cell responses were observed in 52% of HIV-uninfected and 39% of HIV-infected participants. EBOV GP-specific CD8+ T-cell responses were observed at this timepoint in 30% of HIV-uninfected and 22% of HIV-infected participants.</div>\n
      • implication_results<div>\n In summary, this is the first study to demonstrate safety and EBOV GP-specific immunogenicity in PLWH with an Ebola vaccination regimen of MVA-BN-Filo followed by</div>\n<div>\n Ad26.ZEBOV 14 days later. These results show that an accelerated vaccination schedule is well tolerated in both PWOH and PLWHand induces a broad array of durable humoral and cellular immune responses. These findings support continued consideration for accelerated regimen development for rapid deployment among outbreak responders and relevant global populations at immediate risk.</div>\n
      • quantity_imported210
      • quantity_dispensed153
      • quantity_destroyed57
      • quantity_exported0
      • balance_site0
      • final_date2025-08-22 15:57:20
      • modified2025-08-22 15:57:20
      • created2016-11-14 11:11:48
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id368
        • application_id569
        • given_nameJANET
        • middle_name
        • family_nameOYIEKO
        • qualificationMD, MMed (Paeds)
        • professional_addressP.O BOX 54
        • telephone+254721996988
        • emailjanet.oyieko@usamru-k.org
        • created2016-11-14 11:31:40
        • modified2020-04-23 12:12:13
    • SiteDetail(array)
      • 0(array)
        • id449
        • application_id569
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-11-14 11:31:40
        • modified2020-04-23 12:12:13
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id294
        • application_id569
        • sponsorCrucell Holland B.V.
        • sponsor_typeIndustry
        • contact_personCynthia B. Robinson, MD
        • addressP.O. Box 2048 2301 CA Leiden The Netherlands
        • telephone_number +1 215 793-7681
        • fax_number +1 215 986-1027
        • cell_number +1 215 793-7681
        • email_addressCRobins6@its.jnj.com
        • created2016-11-14 11:31:40
        • modified2020-04-23 12:12:13
  • 2(array)
    • Application(array)
      • id395
      • user_id581
      • trial_status_id5
      • abstract_of_study<p>\n This is a randomized, observer-blind, placebo-controlled, parallelgroup, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-, 56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy adults and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV infected participants and in healthy children in 2 age strata.</p>\n<p>\n The study consists of a screening phase of up to 8 weeks, a vaccination phase in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a postvaccination phase and long-term follow-up phase until Day 365.</p>\n<p>\n Participants in Cohort 1 substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). All participants within a cohort will be followed in a blinded manner by the site until the last subject in that cohort has completed the study.</p>\n<p>\n This study will be conducted in Africa and the enrollment will take place sequentially in three cohorts: the first cohort will consist of healthy participants (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50 years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include children aged 4 to 11 years inclusive will be enrolled. Within each cohort, participants will be randomized in a 5:1 ratio to receive active vaccine versus placebo.</p>\n<p>\n Safety evaluations will include assessments of adverse events, an electrocardiogram (ECG) for adult participants at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body temperature), clinical laboratory and pregnancy testing. An independent data monitoring committee (IDMC) will be established to monitor data on a regular basis to ensure the continuing safety of the participants enrolled in the study.</p>\n<p style=\"margin-left: 7pt;\">\n  </p>\n
      • study_title<p>\n A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa</p>\n
      • laymans_summary<p>\n Ebola virus disease is caused by an infection with a virus known as the Ebolavirus. The disease is characterized by symptoms such as fever, body aches, diarrhoea, bleeding, and vomiting.</p>\n<p>\n Vaccination is one of the most effective ways to prevent illness caused by viruses. A vaccine contains a non-functional part of the virus that is recognized by the body's protective immune system. The body then produces a response that prevents illness if the person is exposed to that virus again.</p>\n<p>\n The investigational treatment consists of a 2 dose vaccine regimen, 1 dose of Ad26.ZEBOV vaccine, followed by 1 dose of MVA-BN-Filo vaccine, for the prevention of Ebola virus disease (Zaïre ebolavirus species). The regimen has been studied in 14-, 28-, 56- and 84-day intervals in other clinical studies.</p>\n<p>\n In this study, researchers want to know the safety of the Ebola vaccine regimen in different groups or cohorts of participants at 28-, 56-, and 84-day schedules. In addition, researchers want to understand the immune responses induced by the vaccine regimens by performing some tests.</p>\n<p>\n Participants can take part in this study if they have never received an Ebola vaccine, have not been diagnosed with Ebola virus disease, and have not travelled to any place where Ebola virus disease was confirmed up to 1 month before the study starts. Participants in the human immunodeficiency virus (HIV*)-infected cohort should have a documented HIV infection for at least 6 months before study start and taking medicines for the treatment of HIV infection for the duration of the study.</p>\n<p>\n *HIV infection affects cells of the immune system and decreases their ability to fight infections.</p>\n<p>\n During the study, participants will go through screening to confirm if they can take part in the study. Participants will then be divided into 4 groups as shown below.</p>\n<ul>\n <li>\n Cohort 1: Healthy adult and elderly participants between 18 to 70 years of age</li>\n <li>\n Cohort 2: Participants with HIV infection between 18 to 50 years of age</li>\n <li>\n Cohort 2b: Healthy children between 12 to 17 years of age</li>\n <li>\n Cohort 3: Healthy children between 4 to 11 years of age</li>\n</ul>\n<p>\n Within each Cohort, participants will be further divided into 2 or 3 groups to test the different intervals between the first and the second vaccine.</p>\n<p>\n All participants will receive either study vaccine (Ad26.ZEBOV and MVA-BN-Filo) or placebo, which does not contain the study vaccine, but looks like it. All vaccines will be given as an injection in the muscle. The first dose (Ad26.ZEBOV or placebo) will be given on Day 1 and the second dose (MVA-BN-Filo or placebo) will be given on either Day 29, 57, or 85, depending on which group and cohort the participant is in.</p>\n<p>\n At selected study sites for Cohort 1, a third vaccination with Ad26.ZEBOV (booster dose), will be given at least 1 year after the first dose to participants who are eligible and agree to a booster vaccination. This booster dose will only be studied at 28- and 56-day schedule to assess safety and immune responses induced by the booster dose.</p>\n<p>\n During the study, participants will undergo different study assessments and tests. It includes blood tests, vital signs (such as pulse, blood pressure, and temperature), electrocardiograms, physical exams, pregnancy test for women, and any side effects reported by the participants. Blood samples will be taken at several time points to know how many people responded to the vaccine regimen and to which extent. There will be a follow-up phase until Day 365 to monitor participants’ health. Participants in Cohort 1 who receive the booster vaccination with Ad26.ZEBOV will also be followed up for safety and immune response assessments up to 1 year after the booster vaccination.</p>\n<p>\n The overall duration of the study can be up to 3 to 4 years.</p>\n
      • short_titleJanssen Ebola vaccine study
      • protocol_noECCT/15/05/01
      • version_no1.0
      • date_of_protocol30-03-2015
      • study_drugEbola Ad26.ZEBOV and MVA-BN-Filo
      • disease_conditionEbola prevention
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameNormal saline 0.9%
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmkatwere@its.jnj.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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • 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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantOctavia Magopane
      • declaration_date108-05-2015
      • declaration_principal_investigatorProf Omu Anzala
      • declaration_date208-05-2015
      • placebo_presentYes
      • study_objectives<p>\n The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata</p>\n
      • principal_inclusion_criteria<p style=\"margin-left:27.0pt;\">\n This study will enroll a planned total number of 1188 subjects, who never received any candidate Ebola vaccine before and without prior exposure to Ebola virus (including travel to epidemic Ebola areas less than 1 month prior to screening) or diagnosis of Ebola virus disease.</p>\n<p>\n             The study is comprised of 4 cohorts, which will be enrolled sequentially:</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 1: healthy adult and elderly subjects (aged 18 years up to 70 years inclusive)</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 2a:  HIV-infected subjects (aged 18 to 50 years inclusive, healthy children in 3 age strata)</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 2b: adolescents aged 12 to 17 years inclusive</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 3: children aged 6 to 11 years inclusive</p>\n<p style=\"margin-left:.75in;\">\n ·      Cohort 4: young children aged 1 to 5 years inclusive</p>\n<p style=\"margin-left:.75in;\">\n The inclusions and exclusion criteria has been well indicated in section 4 of the protocol. </p>\n
      • principal_exclusion_criteria<p>\n The inclusions and exclusion criteria has been well indicated in section 4 of the protocol. </p>\n
      • primary_end_points<p>\n <strong>Primary Objective</strong></p>\n<p>\n The primary objective is to assess the safety and tolerability of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as heterologous prime-boost regimens on Days 1 and 29, Days 1 and 57, or Days 1 and 85, in healthy adults, including elderly subjects, HIV-infected subjects and healthy children in 3 age strata.</p>\n<p>\n <strong>Secondary Objective</strong></p>\n<p>\n The secondary objective is to assess immune responses to the EBOV GP over time of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered IM as heterologous prime-boost regimens on Days 1 and 29, Days 1 and 57, or Days 1 and 85, in healthy adults, including elderly subjects, HIV-infected subjects and healthy children in 3 age strata.</p>\n<p>\n <strong>Exploratory Objectives</strong></p>\n<p>\n The exploratory objectives are:</p>\n<p>\n To further explore humoral and cellular immune responses to different EBOV GPs and the adenovirus and MVA backbone of the various vaccination schedules tested.</p>\n<p>\n To explore humoral and cellular immune responses to the SUDV GP, MARV GP and TAFV NP, if assays are available.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The site Principal Investigator: </p>\n<p>\n <strong>Prof. Omu Anzala MBCHB PHD</strong></p>\n<p>\n Principal Investigator</p>\n<p>\n KAVI –Institute of Clinical Research</p>\n<p>\n College of Health Sciences -University of Nairobi</p>\n<p>\n PO Box 19676 Nairobi, Kenya</p>\n<p>\n Tel: +254 727555279</p>\n<p>\n Fax: 2714613</p>\n<p>\n Email: <a href=\"mailto:oanzala@kaviuon.org\">oanzala@kaviuon.org</a></p>\n<p>\n  </p>\n<p>\n The Sub-Investigator are as follows.</p>\n<p>\n <strong>Dr. Gaudensia N. Mutua MBChB MPH</strong></p>\n<p>\n Sub- Investigator</p>\n<p>\n KAVI-ICR Kangemi Site</p>\n<p>\n College of health Sciences -University of Nairobi</p>\n<p>\n PO Box 19676 Nairobi, Kenya</p>\n<p>\n Tel: +254 733826815</p>\n<p>\n Email: <a href=\"mailto:gmutua@kaviuon.org\">gmutua@kaviuon.org</a></p>\n<p>\n <strong>Dr. Gina Muthoni Ouattara MBChB</strong></p>\n<p>\n Sub Investigator KAVI-ICR KNH Site</p>\n<p>\n College of health Sciences -University of Nairobi</p>\n<p>\n PO Box 19676 Nairobi, Kenya</p>\n<p>\n Tel: +254 722659169</p>\n<p>\n Fax: 2714613</p>\n<p>\n Email: <a href=\"mailto:gouattara@kaviuon.org\">gouattara@kaviuon.org</a></p>\n<p>\n <strong>Dr Joshua Kimani</strong></p>\n<p>\n Sub - Investigator<br />\n SWOP Clinic Network<br />\n University of Nairobi/University of Manitoba<br />\n PO Box 19676-00202 Nairobi, Kenya<br />\n Tel +254-733719711<br />\n Email: <a href=\"mailto:jkimani@csrtkenya.org\"><strong>jkimani@csrtkenya.org</strong></a></p>\n<p>\n  </p>\n<p>\n The site has a total of 60 members of staff. Doctors ,Clinical officers, Nurses, Lab technologist, ICT staff,community, Finance and Administration. </p>\n<p>\n There are three facilities KAVI-ICR (KNH and Kangemi) and Comprehensive care Clinic  for HIV positive volunteers. Emergency facilities are in place at all facilities. The site also has established CAB members. </p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Uganda NDA: 08 May 2015</p>\n<p>\n Ministère de la Santé de la République de Côte d’Ivoire: 08 May 2015</p>\n<p>\n Monsieur le Ministre de la Santé S/C Burkina Faso: 08 May 2015</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable </p>\n
      • other_details_regulatory_halted<p>\n Not applicable </p>\n
      • estimated_duration12 Months
      • 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_comparatorSaline 0.9%
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI –Institute of Clinical Research
      • single_site_physical_addressKAVI Institute of Clinical Research ( KAVI-ICR) 2nd Floor, College of Health Sciences University of Nairobi, Kenyatta National Hospital Along Ngong Road
      • single_site_contact_personJacquelyn Rita Nyange
      • single_site_telephone+ 254 722 207417
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites
      • multi_country_listKenya, Uganda, Tanzania, Ghana, Burkina Faso and Ivory Coast.
      • data_monitoring_committeeYes
      • total_enrolment_per_site250 at a single site
      • total_participants_worldwide1188
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • 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_othersYes
      • subjects_others_specifyA cohort of HIV infected participants will be enrolled in the study.
      • investigator1_given_nameProf Omu
      • investigator1_middle_nameAggrey
      • investigator1_family_nameAnzala
      • investigator1_qualificationMBCHB, PHD
      • investigator1_professional_addressKAVI Institute of Clinical Research ( KAVI-ICR) 2nd Floor, College of Health Sciences University of Nairobi, Kenyatta National Hospital Along Ngong Road
      • investigator1_telephone+254 727555279
      • investigator1_emailoanzala@kaviuon.org
      • organisations_transferred_No
      • number_participants250
      • notification<p>\n A joint review has been requsted with particioanting Health Authority. </p>\n
      • approval_date17-12-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-05-05 09:24:32
      • created2015-05-08 14:40:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id269
        • application_id395
        • given_nameProf Omu
        • middle_nameAggrey
        • family_nameAnzala
        • qualificationMBCHB, PHD
        • professional_addressKAVI Institute of Clinical Research ( KAVI-ICR) 2nd Floor, College of Health Sciences University of Nairobi, Kenyatta National Hospital Along Ngong Road
        • telephone+254 727555279
        • emailoanzala@kaviuon.org
        • created2015-05-08 17:54:24
        • modified2020-05-05 09:24:32
    • SiteDetail(array)
      • 0(array)
        • id325
        • application_id395
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-05-08 17:54:24
        • modified2020-05-05 09:24:32
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id208
        • application_id395
        • sponsorJanssen Vaccines & Prevention B.V.
        • sponsor_typeIndustry
        • contact_personNicolette Muller
        • address2 Medical Road, Midrand, South Africa
        • telephone_number+27 11 518 7037
        • fax_number+27 11 518 7102/3
        • cell_number+27 76 620 0359
        • email_addressnmuller@its.jnj.com
        • created2015-05-08 17:54:24
        • modified2020-05-05 09:24:32
  • 3(array)
    • Application(array)
      • id757
      • user_id71
      • trial_status_id5
      • abstract_of_study<p>\n This is a phase 1 study designed to evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults. Given the small sample size there is no formal hypothesis to be tested. If the safety profile and immunogenicity of one or more dose levels is deemed acceptable, then the results will be used to generate hypotheses for further study in a larger trial. Primary Objectives 1.To evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults Secondary Objectives 1.To determine the immunogenicity of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults Exploratory Objectives 1.To assess additional adaptive and innate immune responses induced by the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted 2.To characterize Env-specific memory B cell repertoire</p>\n
      • study_title<p>\n A randomized, double-blinded, placebo-controlled, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of recombinant HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in healthy, HIV--1 uninfected adults</p>\n
      • laymans_summary<p>\n The purpose of this study is find out if the study vaccine is safe and how your immune system responds to it. Although there have been many clinical trials conducted with other HIV vaccine candidates, only a few vaccines have been tested for their efficacy (that is, whether or not the vaccine protects against HIV infection and/or progression to AIDS). Three of these vaccines, Vaxgen’s AIDSVAX, Merck’s MRK-Ad5, and a combined regimen of a DNA and an Ad5-based vaccine showed no efficacy. AIDSVAX used in combination with another study vaccine called ALVAC-HIV was tested for efficacy. The risk of HIV infection was reduced by 31% in volunteers who received the vaccine compared to placebo. Other HIV vaccines are being tested worldwide. In addition, we hope to learn what kinds of side effects may be caused by the study vaccine, and how severe those side effects will be. This means that you may experience the side effects listed in the risks section of this consent document or others that are not yet known. We will also study how your immune system responds to the study product.</p>\n
      • short_titleA randomized, double-blinded, placebo-controlled, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of recombinant HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in healthy, HIV--1 uninfected adults
      • protocol_noECCT/19/05/01
      • version_noIAVI W001
      • date_of_protocol27-11-2018
      • study_drugHIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, or Placebo
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjnyange@kaviuon.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantProf Omu Anzala
      • declaration_date108-05-2019
      • declaration_principal_investigatorN/A
      • declaration_date208-05-2019
      • placebo_presentYes
      • study_objectives<p>\n This is a phase 1 study designed to evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults. Given the small sample size there is no formal hypothesis to be tested. If the safety profile and immunogenicity of one or more dose levels is deemed acceptable, then the results will be used to generate hypotheses for further study in a larger trial.</p>\n<p>\n Primary Objectives 1. To evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults</p>\n<p>\n Secondary Objectives 1. To determine the immunogenicity of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults</p>\n<p>\n Exploratory Objectives 1. To assess additional adaptive and innate immune responses induced by the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted 2. To characterize Env-specific memory B cell repertoire</p>\n
      • principal_inclusion_criteria<p>\n 1.Healthy male and female, including transgender individuals, as assessed by a medical history, physical exam, and laboratory tests 2.At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first vaccination 3.Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study 4.In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to vaccination and participation in the trial; written informed consent will be obtained from the volunteer before any study-related procedures are performed 5.Willing to undergo HIV testing, risk reduction counselling and receive HIV test results 6.All individuals born female engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception for 4 months following the last investigational product administration, including: • Condoms (male or female) with or without spermicide • Diaphragm or cervical cap with spermicide • Intrauterine device, or contraceptive implant • Hormonal contraception • Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has [1] documentation of azoospermia by microscopy (< 1 year ago), or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy) • Not be of reproductive potential, such as having undergone hysterectomy, bilateral oophorectomy, or tubal ligation, postmenopausal (> 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level > 40 IU/L); surgically sterile: no additional contraception required Note: The Sponsor considers the above methods of contraception to be effective. More restrictive measures may be required by the site. 7. All volunteers born female, who are not heterosexually active at screening, must agree to utilize an effective method of contraception if they become heterosexually active, as outlined above 8. All volunteers born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures (Appendix A and B) 9. All sexually active volunteers born male, regardless of reproductive potential, (unless anatomically sterile [all sites] or in a monogamous relationship with a female partner who uses a documented method of birth control [US sites only]) must be willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until at least 4 months after the last vaccination. to avoid exposure of partners to investigational product in ejaculate and to prevent conception with female partners 9.10. Willing to forgo donations of blood, or any other tissues during the study and, for those who test HIV-positive due to vaccine-induced antibodies, until the anti-HIV antibody titers become undetectable</p>\n
      • principal_exclusion_criteria<p>\n 1. Confirmed HIV-1 or HIV-2 infection 2. Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of corticosteroids (the use of topical, nasal, or inhaled steroids is permitted), immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months. The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks prior to enrolment in this study 3. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the volunteer unsuitable for participation in the study 4. Reported risk risky behavior for HIV infection within 12 months prior to vaccination, as defined by: • Unprotected sexual intercourse with a known HIV infected person, a partner known to be at high risk for HIV infection or a casual partner (i.e., no continuing established relationship) • Engaged in sex work • Frequent excessive daily alcohol use or frequent binge drinking, or any use of illicit drugs • History of newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV-2, chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B • US sites: Four or more sexual partners; Kenya site: three or more sexual partners 5. If female, pregnant or planning a pregnancy during the period of enrolment until 4 months after the last study vaccination; or lactating 6. Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions.) (Note: A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has IM injections and blood draws without any adverse experience, is eligible) 7. Infectious disease: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (for US sites: HCV Ab positive and HCV RNA positive, for KenyanAfrican site: HCV Ab positive only) treatment for chronic hepatitis C infection in the past year, or active syphilis (positive RPR confirmed by TPHA); active tuberculosis (for African site only) 8. History of splenectomy 9. Any of the following abnormal laboratory parameters listed below: Hematology  Absolute Neutrophil Count (ANC) – all volunteers: ≤1,000/mm3  Absolute Lymphocyte Count (ALC) – all volunteers: ≤650/mm3  Hemoglobin - African volunteers: <9.5 g/dl in females; <11.0 g/dl in males  Hemoglobin - US volunteers: <10.5 g/dl in females; <11.0 g/dl in males  Platelets - African volunteers: <100,000 cells/mm3  Platelets - US volunteers: <125,000 cells/mm3 Chemistry  Creatinine >1.1 x upper limit of normal (ULN)  ALT >1.25 x ULN  AST >1.25 x ULN Urinalysis Clinically significant abnormal dipstick confirmed by microscopy:  Protein = 1+ or more  Blood = 2+ or more (not due to menses) 10. Receipt of live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with Investigational Product; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product. (Exception is live attenuated influenza vaccine within 14 days) 11. Receipt of blood transfusion or blood-derived products within the previous 3 months 12. Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study; Concurrent participation in an observational study not requiring any blood or tissue sample collection is not an exclusion 13. Prior receipt of another investigational HIV vaccine candidate or HIV monoclonal antibody (Note: receipt of placebo in a previous HIV vaccine trial will not exclude a volunteer from participation if documentation is available and the Medical Monitor gives approval) 14. History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration) 15. Psychiatric condition that compromises safety of the volunteer and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years prior to screening, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years 16. Seizure disorder: A participant who has had a seizure in the last 3 years prior to screening is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years) 17. A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy (A history of a completely excised malignancy that is considered cured is not an exclusion) 18. Active, serious infections requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrolment 19. Body mass index (BMI) ≥35 20. Body weight <110 pounds (505 kg); for US sites only 21. If, in the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial 22. Requirement for Massachusetts General Hospital – Translational and Clinical Research Center (MGH-TCRC, Boston, US) site only: NSAID/Aspirin use that cannot be held for 5 days prior to the leukapheresis procedure</p>\n
      • primary_end_points<p>\n Safety and tolerability: 1. Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7-day follow-up period after each vaccination 2. Proportion of volunteers with moderate or greater and/or vaccine related unsolicited adverse events (AEs), including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination 3. Proportion of volunteers with vaccine-related serious adverse events (SAEs) throughout the study period 4. Proportion of volunteers in each group with potential immune-mediated diseases (pIMD) from the day of injection throughout the study period</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Number of study team - 13</p>\n<p>\n Dr Gaudensai Mutua, MBchB- Sub Investigator</p>\n<p>\n Dr Moses Masika MBchB- Laboratory manager</p>\n<p>\n Elizabeth Mueni  Msc- Study coordinator</p>\n<p>\n Jacquelyn Nyange Msc- Regulatory compliance</p>\n<p>\n Kefa Bosire PhD- Study pharmacist</p>\n<p>\n Site facilities include clinic, Laboratory and Data facilities</p>\n<p>\n Emegency facilities- There is a designated fully equiped emergency room at the site.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 years
      • 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 controlled
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI-ICR KNH SITE
      • single_site_physical_addressCollege of health sciences, Kenyatta National Hospital
      • single_site_contact_personDr Gaudensia Mutua
      • single_site_telephone+254 733 826 815
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_statesone
      • number_of_sites
      • multi_country_listUnited States of America
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwideApproximately 60 volunteers (50 vaccine/10 placebo recipients) will be included in the study.
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailoanzala@kaviuon.org
      • organisations_transferred_No
      • number_participants24
      • notification<p>\n NONE</p>\n
      • approval_date08-07-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_reportThe study was a randomized, double-blind, placebo-controlled dose-escalation phase 1 study\nfor five groups of volunteers which included HIV-uninfected adults aged 18-50 years old from\nthree clinical sites: Kenya AIDS Vaccine Initiative, Fred Hutchinson Cancer Research Center,\nand Massachusetts General Hospital. Group 1 (US volunteers) and Group 4 (Kenya volunteers)\nwere assigned three intramuscular (IM) injections of BG505 SOSIP.664 gp140 at 30 μg or\nplacebo with a 10/2 vaccine/placebo ratio. Group 2 (US volunteers) and Group 5 (Kenya\nvolunteers) were assigned three IM injections of BG505 SOSIP.664 gp140 at 100 μg or placebo\nwith a 10/2 vaccine/placebo ratio. Group 3 (US volunteers) was assigned three IM injections of\nBG505 SOSIP.664 gp140 at 300 μg or placebo with a 10/2 vaccine/placebo ratio
      • implication_results<p>\n None</p>\n
      • quantity_imported
      • quantity_dispensed
      • quantity_destroyed
      • quantity_exported
      • balance_site
      • final_date0000-00-00
      • modified2025-07-16 13:24:58
      • created2019-02-04 12:10:48
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id470
        • application_id757
        • given_nameOmu
        • middle_name
        • family_nameAnzala
        • qualificationMBChB, PhD
        • professional_addressP.O Box 19676
        • telephone+254 727 555 279
        • emailOanzala@kaviuon.org
        • created2019-02-04 12:11:35
        • modified2020-05-13 20:03:17
    • SiteDetail(array)
      • 0(array)
        • id596
        • application_id757
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-02-04 12:11:35
        • modified2020-05-13 20:03:17
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id366
        • application_id757
        • sponsorInternational AIDS Vaccine Initiative (IAVI)
        • sponsor_typeOthers
        • contact_personFrances Priddy, MD MPH
        • address125 Broad Street, 9th Floor
        • telephone_number+1 212 328 7461
        • fax_numberN/A
        • cell_number+1 212 328 7461
        • email_addressfpriddy@iavi.org
        • created2019-02-04 12:11:35
        • modified2020-05-13 20:03:17
  • 4(array)
    • Application(array)
      • id1095
      • user_id693
      • trial_status_id7
      • abstract_of_study<p>\n <strong>The Abstract </strong></p>\n<p>\n Sickle cell disease is one of the most commonly inherited blood disorders in the world characterized by Vaso-occlusive crises, anemia, stroke and multiple organ damage. Vaso-occlusive crises is the most common presentation of sickle cell disease (Salinas Cisneros and Thein 2020).Vaso-occlusive crises is caused by activation of the endothelial cells, neutrophils, monocytes and platelets by the sickled red blood cells. The activation of these cells leads to their expression of the p-selectin molecule promoting the aggregation and adhesion of these cells to one another and to the endothelial cells leading to clot formation and blockage of the microvascular channels (Salinas Cisneros and Thein 2020). There is only one known cure of sickle cell disease which is the hematopoietic stem cell transplant (HSCT) that is not easily accessible to most patients due to its cost and unavailability in the country. Most patients with sickle cell disease are therefore mainly on supportive treatment. These reasons inform the need for more affordable and accessible treatments. The study participants will be randomly allocated to either receive a placebo or inclacumab in the ratio of 1:1. They will receive the intravenous treatment every 12 weeks through Week 36. The mechanism of action is to counter the action of p-selectin molecule leading to reduced adhesion of molecules hence reduced episodes of vaso-occlusive crises. The study aims to assess the safety and efficacy of inclacumab as compared to placebo in reducing the frequency of vasoocclusive crises. During the study period participants can receive standard of care treatment except for crizanlizumab. The study will be carried out in approximately 75 sites with a sample size of 240 participants.</p>\n<p>\n <strong>INTRODUCTION</strong></p>\n<p>\n Sickle cell disease (SCD) is an autosomal recessive disease characterized by chronic hemolysis, inflammation and vaso-occlusion presenting as recurrent pain episodes (variously termed sickle cell-related pain crises or VOCs), multi-organ dysfunction, and early death (Kato, 2018). Vaso-occlusion in SCD is driven by a series of complex and often redundant receptor–ligand interactions involved in the adhesion of circulating cells to the damaged endothelium and exposed sub-endothelium. Extensive research demonstrates that P-selectin mediated cellular interactions with sickled red blood cells (RBCs), leukocytes and platelets play a crucial role in the pathophysiology of vasoocclusion in SCD. By contrast, blocking P-selectin-mediated cellular interactions or reducing the levels of P-selectin reduces or eliminates vaso-occlusion in animal models. Taken together, these data led to the hypothesis that blocking P-selectin could reduce the risk of VOCs in SCD patients. Results from a randomized, placebocontrolled Phase 2b trial of crizanlizumab, a humanized monoclonal antibody, in SCD bolstered the hypothesis that blocking the interaction of P-selectin with its receptors could prevent vasoocclusion and VOCs (Ataga, 2017). In summary, there is a high unmet need for treatment options in SCD and there is a scientific rationale, supported by clinical data, that pselectin inhibition has the potential to reduce the risk for acute vaso-occlusions.</p>\n<p>\n <strong>JUSTIFICATION/RATIONALE</strong></p>\n<p>\n Allogeneic HSCT remains the only curative therapy for sickle cell disease. It is however unavailable for most of patients due to its high cost and it being available only in high income countries. It is also associated with various transplant complications (Kassim and Sharma 2017). Three therapies, hydroxyurea (HU [DROXIA®, 2017]; (also known as hydroxycarbamide), L-glutamine (ENDARI, 2017) and crizanlizumab (ADAKVEO®, 2019), have been approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to reduce VOCs in patients with SCD (Charache, 1995; Niihara, 2018; Ataga, 2017). The effectiveness of HU is impaired by low compliance rates and frequent treatment discontinuation (Shah, 2019) while L-glutamine provides a modest 25% reduction in annual VOC rates (Niihara, 2018). Crizanlizumab is a monoclonal antibody directed against human P-Selectin and is administered as an infusion every 4 weeks. This is potentially limiting in continued adherence to lifelong therapy as patients need to travel to an infusion centre in order to receive treatment. This extracts a cost on patient and caregiver productivity and frequent intravenous infusions generally attract extra costs to the patient. (Saini, 2009; Richter, 2003). Inclacumab has a similar mechanism of action as crizanlizumab. Previous studies on inhibition of pselectin through crizanlizumab, have demonstrated it to be efficacious and safe for use in SCD patients. Additionally, the dose selected is 30mg/kg every 12 weeks and from previous studies population PK simulations project that the inclacumab dose regimen of 30 mg/kg Q12W will maintain concentrations above 10 μg/mL throughout the 48- week study period in the majority of participants, thereby maximizing the pharmacology required for effective reduction of VOC in the SCD population. This study uses placebo as a comparator on the background of standard of care (SOC) treatment for a VOC. Placebo was chosen as the control because it is necessary to determine the safety and efficacy of inclacumab by allowing efficacy to be estimated controlling for background VOCs with SOC and safety signals to be distinguished from AEs occurring due to SCD. Treatments with stable standard of care are allowed except for crizanlizumab because it has a similar mechanism of action as the study drug and would confound the interpretation of this data In summary, despite the recent availability of new options to treat VOCs, an unmet medical need exists to further reduce the frequency of VOCs while reducing patient burden and enhancing patient adherence to therapy.</p>\n<p>\n <strong>NULL HYPOTHESIS</strong></p>\n<p>\n Inclacumab is non superior to placebo in reducing incidences of vaso occlusive crises</p>\n<p>\n <strong>OBJECTIVES</strong></p>\n<p>\n The primary objective of this study is:</p>\n<p>\n To evaluate the safety and efficacy of treatment every 12-weeks with inclacumab to reduce the incidence of VOCs in participants with SCD.</p>\n<p>\n Additional objectives of the study are: To evaluate the PK and PD of inclacumab, the presence of anti-drug antibodies (ADAs), and changes in quality of life (QOL).<strong> </strong></p>\n<p>\n <strong>STUDY DESIGN </strong></p>\n<p>\n This study will assess the safety and efficacy of inclacumab in reducing the frequency of VOCs in approximately 240 adult and adolescent participants (≥ 12 years of age) with SCD. Initial enrollment will include participants’ ≥ 16 years of age until the independent Data Monitoring Committee (DMC) determines that adequate safety and PK data support the enrollment of participants 12 to 15 years of age. Eligible participants will be randomized with a 1:1 ratio into one of two treatment arms as follows: • Inclacumab 30 mg/kg administered IV Q12W; or • Placebo administered IV Q12W. At the time of randomization, participants will be stratified by Baseline HU use (yes; no), number of VOCs (2 to 4; 5 to 10) in the preceding 12 months, and geographic region (North America; sub-Saharan Africa; Europe/rest of world). All participants will undergo safety, efficacy, and PK/PD assessments at Baseline and through Week 48. Visits to the clinical site for infusion of study drug will occur at Baseline (Day 1) and Q12W (Weeks 12, 24, and 36) for a total of 4 infusions. An additional visit at Week 6 will occur for safety, PK, and PD monitoring. The incidence of VOC events will be collected every 4 weeks, with participants contacted by phone at Weeks 4, 8, 16, 20, 28, 32, 40, and 44. Following completion of the Week 48 visit, eligible participants will be given the option to enroll in an open-label extension (OLE) study (under a separate protocol) to receive inclacumab. Participants will receive their first dose in the OLE study at the same Week 48 visit. Participants enrolling in the OLE study will not be required to return to clinic for the Week 60 visit. Safety, efficacy, and PK/PD assessments will occur at Week 60 for participants not enrolling on the OLE study. The DMC will regularly review the totality of accumulated safety data</p>\n
      • study_title<p>\n A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants with Sickle Cell Disease Experiencing Vasoocclusive Crises</p>\n
      • laymans_summary<p>\n Sickle cell disease is an inherited blood disorder that causes frequent pain episodes, and multiple organ complications. Currently, there is only one known cure for sickle cell disease which is bone marrow transplantation that is inaccessible for most Kenyans. Most patients however are usually on treatments that help control the disease e.g hydroxyurea and folic acid, or prevent infections e.g. palludrine and Penicillin V, or manage symptoms as they arise e.g. painkillers for pain episodes and blood transfusion for anemia. There is a need for new treatments that help improve the patients’ quality of life. Pain episodes are mainly caused by the blockage of blood flow to various parts of the body. One of the causes of this blockage includes formation of clots in the blood vessels. A molecule called p-selectin; produced by our bodies contributes to formation of this clots. This study drug prevents the function of p-selectin leading to the reduction of clots thus a decrease in pain episodes. A total of 240 participants will be enrolled across 75 site. They will randomly be assigned to either the treatment arm or the placebo arm.Kenya have 5 sites participating in this study.</p>\n
      • short_title131 Inclacumab Ph 3 Trial.
      • protocol_noECCT/21/12/05
      • version_noVersion 3.0
      • date_of_protocol21-01-2021
      • study_drugInclacumab_ Prof Ogutu GBT131
      • disease_conditionSickle cell
      • 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_addressPPDSubmissionsMembers.SM@ppd.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_applicantMillicent Aketch
      • declaration_date120-12-2021
      • declaration_principal_investigatorDr. Videlis N Nduba
      • declaration_date220-12-2021
      • placebo_presentYes
      • study_objectives<p>\n <strong>Objectives :</strong></p>\n<p>\n <strong>The primary objective of this study is</strong>:</p>\n<p>\n 1.To evaluate the safety and efficacy of treatment every 12-weeks with inclacumab to reduce the incidence of VOCs in participants with SCD.</p>\n<p>\n <strong>Additional objectives of the study are</strong>:</p>\n<p>\n To evaluate the PK and PD of inclacumab, the presence of anti-drug antibodies (ADAs), and changes in quality of life (QOL).</p>\n
      • principal_inclusion_criteria<p>\n 1. Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSβ0 thalassemia, or HbSβ+ thalassemia genotype). Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening.</p>\n<p>\n 2. Participant is male or female, ≥ 12 years of age at the time of informed consent. NOTE: Initial study enrollment will include participants ≥ 16 years of age until the DMC determines that adequate safety and PK data support the enrollment of participants 12 to 15 years of age. Sites will be informed by the Sponsor when participants 12 to 15 years of age may be enrolled.</p>\n<p>\n 3. Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain that:Has no medically determined cause other than a vaso-occlusive event, and  Requires parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics</p>\n<p>\n 4. Participants receiving erythropoiesis-stimulating agents (ESA, eg, EPO) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.</p>\n<p>\n 5. Participants receiving HU, L-glutamine, or voxelotor must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.</p>\n<p>\n 6. Participant has adequate venous access, in the opinion of the Investigator, to comply with study procedures.</p>\n<p>\n 7. Participant understands the study procedures and agrees to participate in the study by giving written informed consent or parental permission/written assent.</p>\n<p>\n 8. Women of childbearing potential (WOCBP) are required to have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy test on all subsequent clinic visits and must agree to use a highly effective method of contraception throughout the study period and for at least 165 days after dosing. See Section 6.2 for details on methods of contraception. Female participants will not be considered of childbearing potential if they are premenarchal, surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation, or bilateral oophorectomy) or postmenopausal (no menses for 12 months without an alternative medical cause, confirmed by follicle stimulating hormone test results).</p>\n
      • principal_exclusion_criteria<p>\n 1. Participant is receiving regularly scheduled RBC transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).</p>\n<p>\n 2. Participant is taking or has received crizanlizumab (ADAKVEO) within 90 days prior to the Screening Visit.</p>\n<p>\n 3. Participant weighs > 133 kg (292 lbs.).</p>\n<p>\n 4. Participant has a significant active and poorly controlled (unstable) hepatic disorder clearly unrelated to SCD.</p>\n<p>\n 5. Participant has any of the following laboratory values at screening: a. Absolute neutrophil count (ANC) < 1.0 × 109/L b. Platelet count < 80 × 109/L c. Hemoglobin < 4.0 g/dL for adults and < 5.0 g/dL for participants ages 12 to < 18 years of age d. Estimated glomerular filtration rate (eGFR) < 30 mL/min using Chronic Kidney Disease-Epidemiology Collaboration (CKDEPI) formula in adults, and Schwartz formula in adolescents</p>\n<p>\n 6. Participant has known active (symptomatic) COVID infection or tests positive for COVID-19 during Screening.</p>\n<p>\n 7. Participant has a history of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including severe or unstable pulmonary hypertension.</p>\n<p>\n 8. Participant has had treatment for a malignancy within the 12 months prior to the Screening Visit (except non-melanoma skin cancer and in situ cervical cancers). 9. Participant has had a stroke within the 2 years prior to the Screening Visit.</p>\n<p>\n 10. Participant has a positive test indicative of malaria infection at Screening. Testing to be conducted at local laboratories in malaria-endemic regions at the discretion of the Investigator.</p>\n<p>\n 11. Participant has any confirmed clinically significant drug allergy and/or known hypersensitivity to monoclonal antibody therapeutics or formulation components of the study drug or a related drug.</p>\n<p>\n 12. Participant has been in another investigational trial within 30 days or 5 half-lives of the investigational agent (whichever is greater) prior to the Screening Visit. 13. Participant has had a major surgery within 8 weeks prior to the Screening Visit.</p>\n<p>\n 14. Participant is pregnant, breastfeeding, or planning to become pregnant during the 48-week treatment period.</p>\n<p>\n 15. Participant, parent, or legal guardian are unlikely to comply with the study procedures.</p>\n<p>\n 16. Participant has other medical, psychological, or addictive condition that, in the opinion of the Investigator, would confound or interfere with evaluation of safety, efficacy, and/or PK of the investigational drug; prevent compliance with the study protocol; preclude informed consent; or render the participant, parent, or caretaker unable/unlikely to comply with the study procedures.</p>\n
      • primary_end_points<p>\n <strong>Primary Efficacy Endpoint </strong></p>\n<p>\n 1. The primary efficacy endpoint for the study is the rate of VOCs during the 48-week treatment period. A VOC is defined as an acute episode of pain that:</p>\n<ul>\n <li>\n Has no medically determined cause other than a vaso-occlusive event, and</li>\n <li>\n Results in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or results in a remote contact with a healthcare provider; and</li>\n <li>\n Requires parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. Complicated VOCs of acute chest syndrome (ACS), hepatic sequestration, splenic sequestration, and priapism that meet the requirements listed above will be included in the primary endpoint. To ensure consistency across study sites, all VOCs identified will be adjudicated by an independent, blinded panel comprised of experts in SCD. The primary efficacy analysis will be performed on adjudicated data.</li>\n</ul>\n<p>\n <strong>Safety Endpoints</strong></p>\n<p>\n Safety endpoints for the study are the following:</p>\n<ul>\n <li>\n Incidence of treatment-emergent adverse events (TEAEs).</li>\n <li>\n Change from Baseline in laboratory assessments (complete blood count, chemistry, and coagulation).</li>\n</ul>\n<p>\n <strong>Exploratory Endpoints</strong></p>\n<p>\n The exploratory endpoints for the study are the following:</p>\n<ul>\n <li>\n Rate of all SCD-related urgent care visits to clinic, emergency room, and hospital during the 48-week treatment period.</li>\n <li>\n Proportion of total days missed from school or work due to SCD during the 48-week treatment period.</li>\n <li>\n Rate of complicated VOCs (defined in Section 5.1) during the 48-week treatment period.</li>\n <li>\n Rate of red blood cell (RBC) transfusions during the 48-week treatment period.</li>\n <li>\n Rate of inpatient hospital admissions for any reason during the 48-week treatment period.</li>\n <li>\n Number of days of inpatient hospitalization for any reason during the 48-week treatment period.</li>\n <li>\n Proportion of participants rated as “very much improved” or “moderately improved” based on the Patients Global Impression of Change (PGI-C) at Weeks 12, 24, 36, and 48.</li>\n <li>\n Proportion of participants rated as “very much improved” or “moderately improved” based on the Clinician’s Global Impression of Change (CGI-C) at Weeks 12, 24, 36, and 48.</li>\n <li>\n Change from Baseline in the cumulative score for the Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Pain Impact – Short Form over time to Week 48.</li>\n</ul>\n<p>\n <strong>Exploratory Pharmacology Endpoints</strong></p>\n<p>\n The following exploratory pharmacology endpoints will be assessed:</p>\n<ul>\n <li>\n Plasma PK of inclacumab as assessed by population PK analysis using nonlinear mixed-effects modeling.</li>\n <li>\n The incidence of ADA to inclacumab. Pharmacodynamics including changes in non-activated and thrombin receptor activating peptide, (TRAP)-activated platelet leukocyte aggregates (PLA), platelet (PLT) P-selectin expression, serum P-selectin inhibition measured by surface plasmon resonance (SPR), and plasma total and free soluble P-selectin (sP-selectin) over time.</li>\n <li>\n Biomarkers including changes in red blood cell (RBC) adhesion (selected sites), genomic markers (optional), protein markers in the blood, urine markers of kidney function, and voxelotor plasma and whole blood concentrations (as applicable) Relationships between PK, PD, biomarkers, clinical labs, safety, and efficacy will be explored</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Strathmore University Medical Centre (SUMC) Site</strong></p>\n<p>\n The SUMC is designed for clinical trials and has a full clinical laboratory with bioanalytical capability. The Centre is managed by Strathmore University and the CREATES consortium. The Centre also has a dental unit.</p>\n<p>\n The medical centre is staffed by 2 pediatricians, 2 physicians, 1 medical officer, 1 clinical officer, 4 dental surgeons, 3 psychologists, 1 pharmacist, 1 visiting psychiatrist, 1 physician assistant, 4 nurses and 4 laboratory technologists. The facility supports healthcare to university students and staff and also general public. The centre currently runs a SCD clinic every Tuesday.</p>\n<p>\n Location The Sickle Cell study will be conducted at SUMC; recruitment will occur at the clinic. SUMC is located at Strathmore University in Madaraka Estate of Nairobi west, Nairobi County. SUMC will be staffed by qualified research personnel from KEMRI and SUMC. The site has a pharmacy, treatment area, clinical assessment area, data entry area, internal quality control and registration area and space where monitoring can be done. SUMC currently runs a SCD clinic with more than 200 patients on follow up comprising of both adults and children.</p>\n<p>\n Provision of medical care SUMC is an outpatient facility with a 2-bed holding unit and a separate emergency resuscitation area. The centre serves as a clinical trials facility for both paediatric and adult studies. The participants who will require inpatient care will be admitted to Coptic Hospital Ngong Road as SUMC already has an existing working arrangement. As for the Sickle cell disease, there is a database in place that has over 200 patients and we hope to base our recruitment on this list. The SUMC is also linked to other private, government, non-governmental and county health facilities, in Nairobi County that take care of patients with SCD. For the care of sickle cell patients, the SCD clinic will work closely with the study team.</p>\n<p>\n <strong>Kisumu/Siaya Site</strong></p>\n<p>\n Site activities are located in Kisumu/Siaya and Nairobi Counties. Kisumu hosts the main IP storage site, administrative offices of the PI and co-investigators, procurement and Human Resource functions are housed at the KEMRI Kisian Campus. Recruitment, follow-up of study participants will occur in Siaya.</p>\n<p>\n Recruitment, follow-up of study participants will occur in Siaya. KEMRI has a modern research annex at the Siaya county hospital with capacity to conduct phase I to Phase III studies. After community mobilization, screening and enrollment, IP dispensation will occur at the Siaya Clinical Research Annexe.</p>\n<p>\n Site investigators responsible for day to day running of the project include: Medical Officer 2, Pharmacist 1, Pharm tech 2, Nurses 5, Quality Assurance Officer 2, Quality Control 1, Clinical Officer 2, Community Interviewers 4.</p>\n<p>\n <strong>KEMRI/CRDR clinical research Site</strong></p>\n<p>\n Site activities will take place within the KEMRI/CRDR clinical research annex. This facility has several clinical rooms available for consenting, nursing procedures, clinical exams and dosing. There are also additional facilities that include an inpatient ward, staff work areas and a monitoring space, a pharmacy, laboratory and kitchen for preparing participant meals.</p>\n<p>\n Site staff include the principal investigator, 4 medical officers, 2 pharmacists, 1 pharmtech, 5 nurses, 5 quality assurance officers, 3 clinical officers and 6 community health workers.</p>\n<p>\n INVESTIGATOR ROLES</p>\n<p>\n Dr Videlis Nduba: Principal Investigator Roles: Has overall trial oversight, budgetary negotiations, sponsor communication, safety, ethical and regulatory communication. Oversight over clinical care provision</p>\n<p>\n Dr. Lilian Njagi, Dr. Jacqueline Mirera, Dr. Cheryl Kerama, Lucy Kijaro, Dr. Mercy Mwale and Dr. Don Brian (Medical Officers) Reviewing potential Study participants for eligibility, supervising Clinical Officers, reviewing laboratory results, adverse event surveillance and documentation, providing firsthand clinical care to participants. Data entry and reporting Serious Adverse Events.</p>\n<p>\n Dr. Ruth Njoroge, Dr. Julius Kiuri, Dr. Shamsa Haji and Dr. Ian Mwangi-Study Pharmacists Application of import license for Investigational Products, IMP accountability from receipt to storage, cold chain maintenance, preparation and dispensing and accountability logs, and IMP destruction. Supervising Pharmaceutical technologists at each site.</p>\n<p>\n <strong>International Cancer Institute-Eldoret</strong></p>\n<p>\n The Investigator (PI) has adequate staff and have the necessary time,capacity and availability to conduct the study, including site management, collection, processing and shipment of lab samples.</p>\n<p>\n Below is the list of the staff at the site:</p>\n<p>\n - Dr Fredrick Chite -PI - Joyce Chizi Kiti- Medical officer - Mercy Cherop-Biostatistician - Hildah Kaziga Chavera- Medical Officer - Collins Saina- Pharmacist - David Wambasi-Nurse - Stephen Karuru-Data manager - George Gitau Thumbi-Laboratory Technologist</p>\n<p>\n The site is in a spacious compound and has 5 building. The main clinic building, the Pharmacy, laboratory, an office for the study Coordinator and additional personnel (essential documents are stored in a locked cabinet in this office). The main administrative building has individual works pace, the Investigators office, a reception area, ablution blocks and individual works space cabins. The site has an access-controlled pharmacy, with shelving for storage of IP and non-IP products. There are consultation rooms, a nursing station with emergency equipment which also serves as a reception area and a procedure room.</p>\n<p>\n The clinic is fully equipped to handle emergencies and the site has a 5-bed addition bed capacity that can be used as a temporary inpatient facility. The clinic also has a counselling room which will be used for the consenting process. Each consultation room is equipped with a desk, computer which is video enabled, a lamp, an examination couch, a trolley, a wooden lockable cabinet for supplies, equipment required to perform examinations e.g. sphygmomanometer, stethoscopes and several other scopes, blood collection tools e.g tourniquets. The site will outsource Xray services and laboratory services that require an accredited laboratory to Lancet laboratories. The site has a high-speed internet</p>\n<p>\n <strong>Gertrude’s Children’s Hospital Site:</strong></p>\n<p>\n Gertrude’s Children’s Hospital (GCH) is one of the largest hospital in East and Central Africa dedicated exclusively to the care of children. For over 60 years, the hospital has provided high standards of paediatric care for children from birth to 21 years of age. The hospital is accredited by the Joint Commission International Accreditation and Safe Care, Netherlands following audits of the hospital facilities.</p>\n<p>\n GCH is a non-profit organization, chartered with the responsibility of provision of health services, fostering good health, carrying out research and teaching healthcare professionals. Based in Muthaiga, Nairobi, and spread out to various outpatient clinics all over Nairobi and in several other Counties, the hospital attends to over 300,000 children as outpatients and admits over 6,000 patients on average per year.</p>\n<p>\n The over 100-bed hospital offers comprehensive paediatric medical services and there are 21 specialist clinics that cover almost every aspect of paediatric healthcare from haematology, chest conditions, cardiology, dermatology, otorhinolaryngology, endocrinology, oncology and HIV/AIDS. Primary care services are also offered including a Well Baby and Immunization clinic.</p>\n<p>\n The laboratory is equipped with modern equipment and offers diagnostic laboratory testing in all areas of pathology and is headed by a pathologist supported by several other pathologists, laboratory manager and qualified medical laboratory technologists. The hospital laboratory and pharmacy cater for both children and adults. The laboratory is accredited by Kenya Accreditation Service as a medical testing laboratory (ISO15189:2012). Qualified pharmacists manage the hospital pharmacy. GCH has an up-to-date paediatric imaging facility that is managed by a team of radiologists and qualified radiographers. Most of the processes at the hospital are fully computerized and supported by a well-integrate Information Technology Department. The main hospital in Muthaiga is open 24/7 and offers 24-hour laboratory and pharmacy coverage. The Accident Is there a placebo? * and Emergency Department is well equipped to deal with all forms of paediatric emergencies and has a crash cart and crash team on call, 24 hours a day. There are registered nurses, medical officers and specialists specifically trained in Emergency Triage Assessment and Treatment. The Team is fully trained to handle emergencies, including but not limited to airway obstruction and other breathing problems; circulatory impairment or shock; severely altered central nervous system function (coma or convulsive seizures); and severe dehydration which require urgent appropriate care to prevent death. The Hospital runs an Institute of Child Health and Research based at the Muthaiga site which is approved by the Nursing Council of Kenya. The school offers courses in paediatric endocrinology, paediatric phlebotomy, emergency paediatric medicine and several specialised paediatric nursing courses. The Hospital has an Ethics Review Committee (ERC) that acts independently from the appointing authority, hosting institution, researchers, sponsors and any other stakeholders in its review and decision-making processes. The ERC is accredited by the National Commission for Science and Technology and Innovation (NACOSTI), an institution mandated to advise the Government on policies and matters relating to the scientific and technological activities and research required for the proper development of the country. The population served by the hospital is cosmopolitan and English and Kiswahili are the predominantly spoken languages.</p>\n<p>\n <strong>Site Study Staff Details.</strong></p>\n<p>\n The site has a multidisciplinary study team that comprises specialists and professionals in many fields of medicine including; medical officers, paediatricians, haematologists, oncologists, pathologists, nurses, pharmacists, medical laboratory technologists. The Team has members who have been trained on the job as study coordinators. The team members are experienced in clinical trials and have all been trained in Good Clinical Practice and most have successfully participated in several other clinical trials.</p>\n<p>\n <strong>Site personnel roles and responsibilities </strong></p>\n<p>\n Principal Investigator • Prof Jessie Githanga A qualified haematologist/clinical pathologist, registered by the Kenya Medical Practitioners and Dentists Council (KMPDC). She will be responsible for the overall conduct of the trial at the study site, budgetary negotiations, administrative actions and communication between Institutional Review Boards, and the sponsor and oversight of patient care. She will oversee the recruitment of the subjects and directly supervise study staff.</p>\n<p>\n Co-Investigator/main coordinator • Dr. Doreen Karimi Mutua A qualified paediatrician, with subspecialty training in paediatric haemato-oncology working at GCH and registered by the KMPDC. Dr Mutua will be responsible for clinical care provision of the patients, assist in supervision of study staff and will also participate in study recruitment. Dr Mutua supports PI and has roles that may be delegated such as ethical and sponsor communication and may be delegated related roles.</p>\n<p>\n Study Coordinator : • Dr Joy Githua A qualified medical officer, registered by the KMPDC working at GCH. She will be the main coordinator for the study and will be responsible for day to day management of trial aspects including participant recruitment, follows up, safety monitoring, data entry and maintaining the site files and other study records and may be delegated related roles.</p>\n<p>\n Pharmacist and assistant: • Dr Samuel Madere (pharmacist) • Crecencia Nekesa Makokha (pharmaceutical technologist) Qualified pharmacist, registered by the Pharmacy and Poison’s Board (PPB), will be delegated roles of the IP storage and related duties, dilution of IP and dispensing, processing of import permit for IP and may be delegated related roles. He will be assisted by a pharmaceutical technologist. Study nurses: • Hannah Wanjiku (assistant study coordinator) • Felicity Kamundi • Jane Nduati A registered nurse, registered by the Nursing Council of Kenya, will be responsible for co-ordinating the patient visits, taking patent vital signs and patient training. The assistant study coordinator will in addition be the assistant study coordinator.</p>\n<p>\n Laboratory Manager: Peninah Chege:Laboratory manager registered by the Kenya Medical Laboratory Technologists and Technicians Board (KMLTTB) will coordinate laboratory functions, process the import permits for laboratory items, equipment and may be delegated related roles. Laboratory technologist/phlebotomist • Charles Muia (technologist) • Herman Akumu(technologist) • Joseph Langat (phlebotomist) Trained laboratory technologists registered by the KMLTTB and trained in Good Clinical Practice (GCP) and phlebotomist who will obtain specimens from study participants. The technologists will perform any local laboratory testing where necessary and package specimens for shipping to Central or other local labs.</p>\n<p>\n Quality Assurance Officer • Winnie Abuto Quality Assurance Officer Nurse registered by the Nursing Council of Kenya, and GCP trained. She will be tasked with ensuring that study documents are quality controlled so that they are Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) in accordance GCP guidelines. She will ensure that staff are alerted to changes in standard operating procedures (SOPs) as necessary.</p>\n<p>\n Administrative assistant • Truphena Otinyo The Administrative assistant will coordinate and maintain the records of communications with the ERC, assist the main coordinator in patient visit coordination. She may be delegated related roles.</p>\n
      • other_details_explanation<p>\n N/A study is being done in USA</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n Regulatory Authority</td>\n <td>\n Date Submitted</td>\n <td>\n Status</td>\n </tr>\n <tr>\n <td>\n Zambia </td>\n <td>\n 22 Jun 2021</td>\n <td>\n Pending </td>\n </tr>\n <tr>\n <td>\n Nigeria</td>\n <td>\n 28 Apr 2021</td>\n <td>\n Pending</td>\n </tr>\n <tr>\n <td>\n Turkey </td>\n <td>\n 21 May 2021</td>\n <td>\n Pending</td>\n </tr>\n <tr>\n <td>\n Ghana</td>\n <td>\n 12 Jul 2021</td>\n <td>\n Pending</td>\n </tr>\n <tr>\n <td>\n Tanzania</td>\n <td>\n 03 Jul 2021</td>\n <td>\n Pending</td>\n </tr>\n <tr>\n <td>\n n/a</td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n <p>\n N/A</p>\n </td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n N/A</td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n N/A</td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n N/A</td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n Regulatory </td>\n <td>\n Approval date</td>\n <td>\n Number of sites</td>\n </tr>\n <tr>\n <td>\n United states of America </td>\n <td>\n 11Dec 2020</td>\n <td>\n 21</td>\n </tr>\n <tr>\n <td>\n Egypt</td>\n <td>\n 07Jul 2021</td>\n <td>\n 6</td>\n </tr>\n <tr>\n <td>\n Brazil</td>\n <td>\n 03 May 2021</td>\n <td>\n 7</td>\n </tr>\n <tr>\n <td>\n Italy</td>\n <td>\n 04 Aug 2021</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n Germany</td>\n <td>\n 10 Nov 2021</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n Lebanon</td>\n <td>\n  20 Apr 2021</td>\n <td>\n 1</td>\n </tr>\n <tr>\n <td>\n Kenya </td>\n <td>\n 06 Nov  2021 </td>\n <td>\n 1 of the 5 sites </td>\n </tr>\n <tr>\n <td>\n Colombia</td>\n <td>\n 29 Nov 2021</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n  France   </td>\n <td>\n 16 Nov 2021  </td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n Saudi arabia</td>\n <td>\n 02 Dec  2021 </td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n United Kingdom</td>\n <td>\n 24 Sep 2021</td>\n <td>\n 2</td>\n </tr>\n </tbody>\n</table>\n<p>\n                                                       </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n none </p>\n
      • other_details_regulatory_halted<p>\n The regulatory authority has not halted the conduct of the study in any country.</p>\n
      • estimated_duration2 years 4 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specify2-arm
      • design_controlled_comparatorplacebo-controlled.
      • 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_states17
      • number_of_sites5
      • multi_country_listRegion Country Africa Egypt Africa Ghana Africa Kenya Africa Nigeria Africa Tanzania Africa Zambia Europe France Europe\nGermany Europe Italy Europe UK LA Brazil LA Colombia Middle East Oman Middle East Saudi Arabia North America US Turkey\nLebanon\n
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment, however there is no min/max enrolment cap per site.\n
      • total_participants_worldwideApproximately 240 participants
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyAdolescent (between 12-17 years but will provide assent)
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_nameN
      • investigator1_family_nameNduba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKEMRI-CRDR , Kenyata National Hospital
      • investigator1_telephone+254724522474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsApproximately 50 participants at about 5 sites in Kenya\n
      • notification<p>\n Yes , the list of Competent Authorities dated 03 Dec 2021 </p>\n
      • approval_date22-03-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-02-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe queries raised have been responded to .
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-11-21 00:00:33
      • created2021-12-09 10:32:54
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id757
        • application_id1095
        • given_nameBernhards
        • middle_nameRagama
        • family_nameOgutu
        • qualificationMedical Doctor
        • professional_addressStrathmore University Medical Centre
        • telephone+254 733812613
        • emailogutu6@gmail.com
        • created2021-12-09 10:34:14
        • modified2022-02-08 07:20:43
      • 1(array)
        • id761
        • application_id1095
        • given_nameFredrick
        • middle_nameAsirwa
        • family_nameChite
        • qualification Internal Medicine Physician and Medical Oncologist & Hematologist
        • professional_addressDivision of Hematology and OncologyInternational Cancer Institute (ICI)
        • telephone +254 700 522 149
        • emailchiteasirwa@gmail.com, chite@intercancer.com
        • created2021-12-09 12:36:58
        • modified2022-02-08 07:20:43
      • 2(array)
        • id762
        • application_id1095
        • given_nameVidelis
        • middle_nameN
        • family_nameNduba
        • qualificationMedical Doctor
        • professional_addressSiaya Research Annex and KEMRI_CRDR KenyaTta National Hospital
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2021-12-09 12:36:58
        • modified2022-02-08 07:20:43
      • 3(array)
        • id763
        • application_id1095
        • given_nameProf. Jessie
        • middle_nameN
        • family_nameGithanga
        • qualificationHaematologist/clinical pathologist
        • professional_addressGertrude’s Children’s Hospital, 34 Muthaiga Road,
        • telephone+254721245721
        • emailjgithanga3@gmail.com
        • created2021-12-09 12:53:07
        • modified2022-02-08 07:20:43
    • SiteDetail(array)
      • 0(array)
        • id1195
        • application_id1095
        • county_id47
        • site_nameStrathmore University Medical Centre
        • physical_addressDr Bernhards Ogutu
        • contact_details Tel: +254733813613
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2021-12-09 10:34:14
        • modified2022-02-08 07:20:43
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          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1196
        • application_id1095
        • county_id47
        • site_nameKEMRI/CRDR
        • physical_addressKenyatta National Hospital Off Hospital Road, CRDR.
        • contact_detailsTel:+254790484654, P.O Box 47855-00100
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2021-12-09 12:37:58
        • modified2022-02-08 07:20:43
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          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
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        • site_nameKEMRI Siaya Clinical Research Annex
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        • contact_details Tel: +254722205901, P.O Box 144-40600,Siaya
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
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        • created2021-12-09 12:37:58
        • modified2022-02-08 07:20:43
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          • id41
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          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
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        • application_id1095
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        • site_nameGertrude’s Children’s Hospital.
        • physical_addressGertrude’s Children’s Hospital-Muthaiga
        • contact_detailsTel:+254 721245721,34 Muthaiga Road,
        • contact_personProf.Jessie Githanga
        • site_capacity(null)
        • misc(null)
        • created2021-12-09 12:37:58
        • modified2022-02-08 07:20:43
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id1199
        • application_id1095
        • county_id27
        • site_nameInternational Cancer Institute (ICI)-Eldorate
        • physical_addressInternational Cancer Institute, Nandi Road, Block 8/553
        • contact_detailsTel:+254700522149, P.O. Box 8088 – 30100, Eldoret – Kenya,
        • contact_personProf. Fredrick Chite Asirwa
        • site_capacity(null)
        • misc(null)
        • created2021-12-09 12:37:58
        • modified2022-02-08 07:20:43
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id561
        • application_id1095
        • sponsorGlobal Blood Therapeutics, Inc.
        • sponsor_typeIndustry
        • contact_personKalyan Obalampalli
        • address181 Oyster Point Blvd, South San Francisco, CA 94080 United States
        • telephone_number001 916 284 0777
        • fax_number
        • cell_number001 916 284 0777
        • email_addresskobalampalli@gbt.com
        • created2021-12-09 10:34:14
        • modified2022-02-08 07:20:43
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App Constants

CakePHP Constants

PHP Environment

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