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    • Application(array)
      • id868
      • user_id73
      • trial_status_id7
      • abstract_of_study<div>\n According to the Joint United Nations Programme on HIV/AIDS and the World Health Organization, as of the end of 2018, over 37.9 million people [32.7 – 44 million], were estimated to be living with HIV/AIDS. It is estimated that in 2018 alone, 1.7 million [1.6 – 2.3 million] were newly infected with HIV and 770,000 [570,000-1.1 million] people died of AIDS-related illnesses.The use of antiretroviral agents by HIV-uninfected individuals before potential sexual exposure to HIV-infected partners, known as pre-exposure prophylaxis (PrEP), is a new effective preventive approach against HIV-1. However, an important challenge to the success of such strategy is that its efficacy is highly dependent on adherence to a daily oral drug regimen.Therefore, the search for novel preventive and therapeutic interventions with a longer duration of action is of high priority. A new generation of highly potent broadly neutralizing antibodies (bNAbs) may represent a novel</div>\n<div>\n strategy to combat HIV-1 infection. Monoclonal antibodies, which are made in the laboratory but based upon natural human antibodies with high potency, are considered to be promising candidates for safe, long-acting preventive agents. In the past decade, a number of antibodies have been developed that have broad neutralizing ability, that is to say they neutralize a large number of HIV-1 isolates from different clades and geographic regions. Combinations of these antibodies have even broader activity. It will be important to have broad coverage, to protect against the wide variety of HIV-1 variants that are found in Africa and globally. In this study, we propose to study two such broadly neutralizing antibodies (bNAbs), in combination. Novel, Potent bNAbs: Selection and Preclinical characterization.The advent of single-cell cloning techniques allowed the identification of potent bNAbs that target multiple epitopes on the HIV-1 envelope. Some of the new bNAbs demonstrate in vitro neutralizing activity against over 90% of HIV-1 pseudoviruses derived from diverse clades, even at low concentrations. Broadly neutralizing antibodies are potential alternatives to standard antiretroviral drugs as they are likely to be safe and well tolerated, and to persist at neutralizing levels for longer periods of time. Below the characteristics of two novel bNAbs are described. Both antibodies have been evaluated in clinical studies, either alone or in combination. 3BNC117 and 10-1074 have shown favorable safety profiles in both HIV-infected and HIV-uninfected participants. Single infusions of 3BNC117</div>\n<div>\n or 10-1074 led to decline in plasma viremia of approximately 1.5 log10 copies/mL in viremic individuals, Experience with 3BNC117.</div>\n<div>\n  </div>\n<div>\n Neutralizing Activity</div>\n<div>\n 3BNC117 and 10-1074 are two of the most potent broadly neutralizing antibodies available. 3BNC117 targets the CD4 binding site, while 10-1074 targets the V3 loop of HIV-1 gp 120. They were chosen for clinical development for their neutralizing breadth and potency, and their antiretroviral activity when tested in humanized mice (hu-mice) and non-human primate (NHP) models. The neutralizing activities of 3BNC117 and 10-1074 were evaluated in vitro against large pseudovirus panels including diverse clades. 3BNC117 showed neutralizing activity against 82.5% of 399 pseudoviruses tested, while 10-1074 neutralized 61.7% of 295 pseudoviruses tested. The combination of these two antibodies, which target two nonoverlapping epitopes on HIV-1 gp 120 provides higher breadth and potency than either antibody alone. In vitro, the combination showed neutralizing activity against 96% of 125 viruses from multiple clades, with average IC80 0.15 μg/mL [15]. The 3BNC117 and 10-1074 combination neutralizing titers against a panel of 200 clade C viruses were predicted using the Bliss-Hill model. Against this panel, the 3BNC117 plus 10-1074 combination covered 87% of viral strains with IC80 of 0.16 μg/mL.</div>\n
      • study_title<div>\n Safety and Pharmacokinetics of the Combination Broadly Neutralizing  Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and</div>\n<div>\n African Adults (IAVI C100)</div>\n
      • laymans_summary<p style=\"margin-left:4.5pt;\">\n Anti-HIV neutralizing antibodies were first cloned from B cells of HIV-infected individuals. The antibodies selected for clinical testing showed the ability to neutralize (block infection of new cells) HIV strains of multiple clades at very low concentrations. These two antibodies are specific for two different regions of the HIV envelope protein, the outer layer of the virus. 3BNC117 binds to the CD4 binding site and 10-1074 to the V3 loop of HIV. The combination of both antibodies covers a larger number of viral strains than either antibody alone. When the antibodies were given to mice and non-human primates, the antibodies protected the animals from infection or lowered viral loads in infected animals.</p>\n<p style=\"margin-left:4.5pt;\">\n The antibodies that were originally found in two HIV-infected individuals were cloned and manufactured in the laboratory for clinical testing. In early clinical trials the antibodies have showed good safety profiles and half-lives of about 2 weeks. Both antibodies were able to lower viral loads in HIV-infected persons not taking antiretrovirals. The combination of antibodies was able to maintain undetectable viral loads during a period of ART interruption.</p>\n<p style=\"margin-left:4.5pt;\">\n 3BNC117 and 10-1074 were subsequently modified to improve their half-lives and also their stability as future drug products. The two changes made to improve half-life prolonged half-life of 3BNC117 from about 2 weeks to about 10 weeks, and of 10-1074 from about 3 weeks to about 13 weeks. These long-acting antibodies (3BNC117-LS and 10-1074-LS) are being testing in two clinical trials in the US. So far, the antibodies have shown very good safety profiles, similar to the original unmodified antibodies. The antibodies that will be used in this proposed study have additional modifications to improve the antibody chemical characteristics, but these modifications do interfere with the antibody activities.</p>\n<p>\n  </p>\n
      • short_titleIAVI C100
      • protocol_noECCT/20/11/02
      • version_no1.0
      • date_of_protocol26-11-2019
      • study_drugBroadly Neutralizing Antibodies (3BNC117-LS-J and 10-1074-LS-J) - IAVI C100
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • 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
      • comparatorYes
      • comparator_namePlacebo
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.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_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_applicantPeter Mogere
      • declaration_date110-11-2020
      • declaration_principal_investigatorDr. Nelly Mugo
      • declaration_date210-11-2020
      • placebo_presentYes
      • study_objectives<div>\n <strong>Primary:</strong></div>\n<div>\n 1. To evaluate the safety and tolerability of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, when given alone and in combination, intravenously (IV) or subcutaneously (SC) to healthy American and African adults.</div>\n<div>\n 2. To evaluate the pharmacokinetic profile of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, when given alone or in combination, IV or SC to healthy American and African adults.</div>\n<div>\n 3. To identify a regimen of the two antibodies that, when given SC every 3 months, will maintain a serum trough level of >10 μg/mL for each antibody in >80% of the study population.</div>\n<div>\n  </div>\n<div>\n <div>\n <strong>Secondary:</strong></div>\n <div>\n 1. To evaluate the effect of participant characteristics, e.g., sex, body weight or body mass index (BMI), on pharmacokinetic parameters.</div>\n <div>\n 2. To conduct pharmacokinetic modelling to assess the effect of dose, dose ratio, dosing frequency and loading dose on serum trough levels of each antibody.</div>\n <div>\n 3. To assess the incidence and titers of anti-drug antibodies (ADA) against each antibody.</div>\n <div>\n  </div>\n <div>\n <strong>Exploratory:</strong></div>\n <div>\n 1. To evaluate the effect of geographic region, immunoglobulin levels, and the subcutaneous site on injection (abdomen vs. arm) on pharmacokinetic parameters.</div>\n <div>\n 2. To characterize the bNAb neutralization potency in serum or plasma.</div>\n <div>\n 3. To investigate the effect of ADA on antibody concentration and neutralizing potency and the potential occurrence of ADA-related adverse events.</div>\n <div>\n 4. To characterize mucosal distribution of the bNAbs in a subset of participants enrolled in African sites.</div>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. Healthy male and female individuals, as assessed by a medical history, physical exam, and laboratory tests</div>\n<div>\n 2. At least 18 years of age on the day of screening and have not reached their 46th birthday on the day of the first administration</div>\n<div>\n 3. Willing to undergo HIV testing, risk reduction counseling and receive HIV test results; committed to maintaining low-risk behavior for the trial duration</div>\n<div>\n 4. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study;</div>\n<div>\n 5. In the opinion of the Principal Investigator or designee and based on Assessment of Understanding results, has understood the information provided and potential</div>\n<div>\n impact and/or risks linked to IP administration and participation in the trial; written informed consent will be obtained from the participant before any study-related</div>\n<div>\n procedures are performed;</div>\n<div>\n 6. All male and female participants of reproductive potential who are engaging in sexual activity that could lead to pregnancy must commit to use an effective</div>\n<div>\n method of contraception from enrollment until 9 months after the last administration, including a minimum of one of the following:</div>\n<div>\n  Condoms (male or female) with or without spermicide, Intrauterine device</div>\n<div>\n <div>\n  Contraceptive implant</div>\n <div>\n  Hormonal contraception</div>\n <div>\n  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)</div>\n <div>\n  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</div>\n <div>\n Note: More restrictive measures may be required by study sites.</div>\n <div>\n 7. All participants born female and of reproductive potential who are not heterosexually active at screening must agree to utilize an effective method of contraception if they become heterosexually active as outlined above.</div>\n <div>\n 8. All participants born female and of reproductive potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures.</div>\n <div>\n 9. Willing to forgo donations of blood, or any other tissues during the study following confirmation of study eligibility and, for those who test HIV-positive due to</div>\n <div>\n antibody-induced seropositivity, until the anti-HIV antibody titers become undetectable on HIV tests used in the community</div>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n 1. Confirmed HIV infection;</div>\n<div>\n 2. Reported risk for HIV infection within 6 months prior to investigational product administration, as defined by:</div>\n<div>\n  Unprotected sexual intercourse with a known HIV-infected person, a partner known to be at high risk for HIV infection and/or a casual partner (i.e. no continuing established relationship)</div>\n<div>\n  Engaged in sex work</div>\n<div>\n  Frequent excessive daily alcohol use or frequent binge drinking or any other use of illicit drugs</div>\n<div>\n  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 or hepatitis C;</div>\n<div>\n  Three or more sexual partners;</div>\n<div>\n 3. Any clinically relevant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the</div>\n<div>\n use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the investigator</div>\n<div>\n within the previous 6 months;</div>\n<div>\n  </div>\n<div>\n <div>\n The following exceptions are permitted and will not exclude study participation: </div>\n <div>\n 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</div>\n <div>\n single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks prior to enrollment in this study;</div>\n <div>\n  </div>\n <div>\n 4. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the participant unsuitable</div>\n <div>\n for participation in the study;</div>\n <div>\n 5. Asthma that is not well controlled;</div>\n <div>\n 6. If female, pregnant or planning a pregnancy during the period of enrollment until</div>\n <div>\n 9 months after the final IP administration; or lactating;</div>\n <div>\n 7. Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions) (Note: A participant who</div>\n <div>\n 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);</div>\n <div>\n 8. History of splenectomy;</div>\n <div>\n 9. Any of the following abnormal laboratory parameters listed below:</div>\n <div>\n  </div>\n <div>\n <strong>Hematology</strong></div>\n <div>\n  Hemoglobin – Africa participants: <9.5 g/dl in females; <11.0 g/dl in males</div>\n <div>\n  Hemoglobin – US participants: <10.5 g/dl in females; <11.0 g/dl in males</div>\n <div>\n  Absolute Neutrophil Count (ANC) – all participants: ≤1,000/mm3</div>\n <div>\n  Absolute Lymphocyte Count (ALC) – all participants: ≤650/mm3</div>\n <div>\n  Platelets – African participants: <100,000 cells/mm3</div>\n <div>\n  Platelets – US participants: <125,000 cells/mm3</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Chemistry</strong></div>\n <div>\n  Creatinine >1.1 x ULN and eGFR <60 mL/min/1.73m2</div>\n <div>\n  AST >1.25 x ULN</div>\n <div>\n  ALT >1.25 x ULN</div>\n <div>\n  </div>\n <div>\n <strong>Urinalysis</strong></div>\n <div>\n Clinically significant abnormal dipstick confirmed by microscopy:</div>\n <div>\n  Protein = 2+ or more</div>\n <div>\n  Blood = 2+ or more (not due to menses)</div>\n <div>\n  </div>\n <div>\n 10. Infectious disease diagnosis:</div>\n <div>\n  </div>\n <div>\n <div>\n 11. Receipt of blood transfusion or blood-derived products within the previous 3 months;</div>\n <div>\n 12. Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study (concurrent</div>\n <div>\n participation in an observational trial not requiring blood or tissue sample collection is not an exclusion);</div>\n <div>\n 13. Prior receipt of any investigational HIV vaccine candidate, or HIV monoclonal antibody. Note: receipt of placebo in a previous HIV vaccine or antibody trial will</div>\n <div>\n not exclude a participant from participation if documentation is available and the Medical Monitor gives approval;</div>\n <div>\n 14. History of severe local or systemic reactions to blood or immunoglobulin products or constituents of IPs (e.g., anaphylaxis, respiratory difficulties, angioedema);</div>\n <div>\n 15. Psychiatric condition that compromises the safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years;</div>\n <div>\n 16. Seizure disorder: A participant who has had a seizure in the last 3 years is excluded;</div>\n <div>\n 17. History of malignancy in the past 5 years or ongoing malignancy (A history of completely excised malignancy that is considered cured is not an exclusion);</div>\n <div>\n 18. Body mass index (BMI) >40;</div>\n <div>\n 19. Active tuberculosis;</div>\n <div>\n 20. If, in the opinion of the Principal Investigator, it is not in the best interest of the participant to participate in the trial.</div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<div>\n <strong>Safety and tolerability:</strong></div>\n<div>\n 1. Proportion of participants with solicited and IP-related unsolicited adverse events that are Grade 2 and above (including confirmed laboratory abnormalities) and their duration.</div>\n<div>\n 2. Proportion of participants with solicited and IP-related unsolicited adverse events that are Grade 3 and above (including confirmed laboratory abnormalities) and their duration.</div>\n<div>\n 3. Proportion of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and their duration.</div>\n<div>\n  </div>\n<div>\n <strong>Pharmacokinetics (PK):</strong></div>\n<div>\n 4. The ratio of 3BNC117-LS-J to 10-1074-LS-J that, when injected SC, will maintain similar levels of each bNAb at steady state.</div>\n<div>\n  </div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p 0px=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n KEMRI-CCR Partners in Health & Research Development - PHRD (Formerly Partners in Prevention) Thika Project, has 64 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc).</p>\n<p 0px=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p 0px=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Co-Principal Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p 0px=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n                                                 Dr. Elizabeth Irungu MBChB, MPH</p>\n<p 0px=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Lead Physician for the study: Dr. Stanley Ndwiga</p>\n<p 0px=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Coordinator: Dr. Catherine Kiptinness, BPharm, MPH</p>\n<p 0px=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Regulatory Lead: Peter Mogere</p>\n
      • other_details_explanation<p>\n The study will be conducted in both Kenya and the host country of the sponsor.</p>\n
      • other_details_regulatory_notapproved<p>\n Pan African Clinical Trials Registry - 18 April 2020</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute (SERU) - 25 March 2020</p>\n
      • other_details_regulatory_rejected<p>\n N/A</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_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyUnblinded study pharmacy staff at each site will be responsible for investigational product preparation and accountability. All other site staff and all trial participants will be blinded to treatment assignment (i.e., active versus placebo).
      • 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_states5
      • number_of_sites2
      • multi_country_list9 clinical trial sites, 3 located in the USA and 6 in Africa (Kenya, Uganda, Rwanda, and South Africa)
      • data_monitoring_committeeYes
      • total_enrolment_per_site28-35 participants
      • total_participants_worldwide225
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_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_nameDagna
      • investigator1_middle_name
      • investigator1_family_nameLaufer
      • investigator1_qualificationMD
      • investigator1_professional_addressInternational AIDS Vaccine Initiative 125 Broad Street, 9th Floor New York, New York 10004
      • investigator1_telephone+1 212-328-7459
      • investigator1_emaildlaufer@iavi.org
      • organisations_transferred_Yes
      • number_participantsThika Site will target to enroll 28-35 participants randomized to study groups 6-10
      • notification
      • approval_date03-03-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted10-06-2021
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-02-07 07:08:31
      • created2020-04-08 10:04:35
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id537
        • application_id868
        • given_nameNelly
        • middle_name
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressKEMRI - CCR Mbagathi way
        • telephone+254 (733) 629 665
        • emailrwamba@uw.edu
        • created2020-04-18 12:47:55
        • modified2021-06-10 11:11:18
    • SiteDetail(array)
      • 0(array)
        • id747
        • application_id868
        • county_id22
        • site_namePartners in Health Research and Development (PHRD) – CCR-KEMRI
        • physical_addressOAU Road, Thika Section 9
        • contact_details+254 (733) 629 665
        • contact_personDr. Nelly Mugo
        • site_capacity(null)
        • misc(null)
        • created2020-04-18 12:47:55
        • modified2021-06-10 11:11:18
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 1(array)
        • id748
        • application_id868
        • county_id47
        • site_nameKenya AIDS Vaccine Initiative- Institute of Clinical Research (KAVI-ICR)
        • physical_addressUniversity of Nairobi
        • contact_details+254 722207417
        • contact_personGaudensia Mutua
        • site_capacity(null)
        • misc(null)
        • created2020-04-18 16:22:37
        • modified2021-06-10 11:11:18
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id425
        • application_id868
        • sponsorInternational AIDS Vaccine Initiative (IAVI)
        • sponsor_typeOthers
        • contact_personDagna Laufer
        • address125 Broad Street, 9th Floor New York, New York 10004 USA
        • telephone_number+1 212-328-7459
        • fax_number
        • cell_number+1 215-852-6674
        • email_addressdlaufer@iavi.org
        • created2020-04-18 12:47:55
        • modified2021-06-10 11:11:18
  • 1(array)
    • Application(array)
      • id858
      • user_id71
      • trial_status_id7
      • abstract_of_study<p>\n This is a Phase 1/2 study to evaluate the safety and tolerability of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy American and African adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain trough serum levels >10 µg/ml at steady state. Primary Objectives 1.To evaluate the safety and tolerability of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, when given alone and in combination, intravenously (IV) or subcutaneously (SC) to healthy American and African adults. 2.To evaluate the pharmacokinetic profile of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, when given alone or in combination, IV or SC to healthy American and African adults. 3.To identify a regimen of the two antibodies that, when given SC every 3 months, will maintain a trough level of > 10 µg/ml for each antibody in >80% of study population. Secondary Objectives 1.To evaluate the effect of participant characteristics (e.g. sex, body weight or body mass index ) on pharmacokinetic parameters. 2.To conduct pharmacokinetic modelling to assess the effect of dose, dose ratio, dosing frequency and loading dose on serum trough levels of each antibody. 3.To assess the incidence and titers of anti-drug antibodies (ADA) against each antibody</p>\n
      • study_title<p>\n Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults</p>\n
      • laymans_summary<p>\n This is a clinical research study in which 2 experimental study products either given separately or together are being tested to see if they are safe, and to understand how long they stay in the human body. We hope to learn what kind of side effects one may experience after receiving the study product(s). The two study products being tested are called 3BNC117-LS-J and 10-1074-LS-J. They are human antibodies against HIV that have been made in a laboratory. HIV is the virus that causes Acquired Immunodeficiency Syndrome (AIDS). Scientists are hoping that one day, these antibodies can be used to help prevent HIV infection in people</p>\n
      • short_titleIAVI C100
      • protocol_noECCT/20/06/01
      • version_noVersion 2.0
      • date_of_protocol13-12-2019
      • study_drug3BNC117-LS-J and 10-1074-LS-J
      • 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_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantProf Walter Jaoko
      • declaration_date104-06-2020
      • declaration_principal_investigatorN/A
      • declaration_date204-06-2020
      • placebo_presentYes
      • study_objectives<p>\n Primary Objectives 1. To evaluate the safety and tolerability of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, when given alone and in combination, intravenously (IV) or subcutaneously (SC) to healthy American and African adults. 2. To evaluate the pharmacokinetic profile of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, when given alone or in combination, IV or SC to healthy American and African adults. 3. To identify a regimen of the two antibodies that, when given SC every 3 months, will maintain a trough level of > 10 µg/ml for each antibody in >80% of study population. Secondary Objectives 1. To evaluate the effect of participant characteristics (e.g. sex, body weight or body mass index ) on pharmacokinetic parameters. 2. To conduct pharmacokinetic modelling to assess the effect of dose, dose ratio, dosing frequency and loading dose on serum trough levels of each antibody. 3. To assess the incidence and titers of anti-drug antibodies (ADA) against each antibody</p>\n
      • principal_inclusion_criteria<p>\n INCLUSION CRITERIA 1. Healthy male and female 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 have not reached their 46th birthday on the day of the first administration 3. Willing to undergo HIV testing, risk reduction counseling and receive HIV test results; committed to maintaining low-risk behavior for the trial duration 4. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study; 5. In the opinion of the Principal Investigator or designee and based on Assessment of Understanding results, has understood the information provided and potential impact and/or risks linked to investigational product administration and participation in the trial; written informed consent will be obtained from the participant before any study-related procedures are performed; 6. All male and female participants of reproductive potential who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from enrolment until 9months after last administration. 7. All participants born female and of reproductive potential 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 participants born female and of reproductive potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures 9. Willing to forgo donations of blood, or any other tissues during the study and, for those who test HIV-positive due to antibody-induced seropositivity, until the anti-HIV antibody titers become undetectable on HIV tests used in the community</p>\n
      • principal_exclusion_criteria<p>\n EXCLUSION CRITERIA 1. Confirmed HIV infection 2. Reported risk for HIV infection within 6months prior to investigational product administration as specified by the protocol 3. Any clinically relevant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months. Limited exceptions are permitted and are described in detail in the protocol. 4. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study 5. Asthma that is not well controlled 6. If female, pregnant or planning a pregnancy during the study period of enrolment until 9months after final IP administration; or lactating 7. Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions) 8. History of splenectomy 9. Any of the following abnormal hematological, chemistry and urine laboratory parameters as detailed in the protocol 10. Infectious disease diagnosis: • Hepatitis B infection as measured by HbsAg and/or PCR • Hepatitis C infection Africa: HCV Ab positive and/or PCR; • Active syphilis (positive RPR confirmed by TPHA) 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 13. Prior receipt of any investigational HIV vaccine candidate, or HIV monoclonal antibody, 14. History of severe local or systemic reactions to blood or immunoglobulin products or constituents of investigational product (e.g., anaphylaxis, respiratory difficulties, angioedema) 15. Psychiatric condition that compromises safety of the participant and precludes compliance with the protocol. 16. Seizure disorder: A participant who has had a seizure in the last 3 years is excluded. 17. History of malignancy in the past 5 years or ongoing malignancy 18. Body mass index (BMI) >40 19. Active tuberculosis 20. If, in the opinion of the Principal Investigator, it is not in the best interest of the participant to participate in the trial</p>\n
      • primary_end_points<p>\n Primary:</p>\n<p>\n Safety and Tolerability: 1. Proportion of participants with solicited and IP-related unsolicited adverse events that are Grade 2 and above (including confirmed laboratory abnormalities) and their duration. 2. Proportion of participants with solicited and IP-related unsolicited adverse events that are Grade 3 and above (including confirmed laboratory abnormalities) and their duration. 3. Proportion of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and their duration. Pharmacokinetics (PK) 4. The ratio of 3BNC117-LS-J to 10-1074-LS-J that, when injected SC, will maintain similar levels of each bNAb at steady state.</p>\n<p>\n Secondary: 1. Serum concentration of the bNAb in each group at multiple timepoints along with participant characteristics (e.g. sex, weight, and BMI). 2. Serum concentration of 3BNC117-LS-J and 10-1074-LS-J in each group at multiple timepoints along with dose, dose ratio, dosing frequency and loading dose. 3. Serum concentration of anti-3BNC117-LS-J and anti-10-1074-LS-J antibodies in each group at multiple timepoints.</p>\n<p>\n Exploratory: 1. Serum concentration of the bNAb in each group at multiple timepoints along with geographical region, immunoglobulin levels and the subcutaneous site of injection (abdomen vs. arm). 2. Magnitude of serum neutralization of virus isolates sensitive to each antibody at 7 days and 12 weeks after SC administration in selected participants in America and Africa. 3. Proportion of participants with reduction in bNAb half-life concomitant with ADA. 4. Proportion of participants with reduction in bNAb neutralization potency concomitant with ADA. 5. Proportion of participants with pIMDs throughout the study period that are considered related to investigational product and their duration. 6. Relationship of solicited and unsolicited adverse events and pIMDs to ADA. 7. bNAb concentrations in mucosal secretions at selected sites.</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_pharmacology1
      • trial_administration_humans0
      • 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 <strong>Number of Staff:</strong> 1 physician, I pharmacist, 2 pharmacy staff, 2 trial clinicians, 3 nurse counselors, 2 community staff, 1 data IT/Data manager, 3 Data staff and 8 lab staff, I labaratory Manager</p>\n<p>\n <strong>Core Staff:</strong></p>\n<p>\n 1. Prof. Omu Anzala MBChB PhD, Co-Investigator,Virologist & Senior Research Scientist 2. Dr. Marianne Mureithi PhD, C100 Mucosal Study team leader 3. Dr Moses Masika MBChB MSc.Laboratory Manager 4.  Ms. Hilda Ogutu BsN, KPHN, KRM,KRN,Study Coordinator 6. Jacquelyn Nyange RN, BA, MSc. Clinical PSY Regulatory compliance</p>\n<p>\n <strong>Site Facities</strong>: Clinic, Labaratory, data and  Pharmacy  space available on site</p>\n<p>\n <strong>Emergency Facities:</strong> Well equiped Emergecy room in the clinic</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_duration24 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_comparatorPlacebo
      • design_controlled_other_medicinalYes
      • 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_states1
      • number_of_sites2
      • multi_country_listKenya \nUSA\nRwanda\nUganda\nSouth Africa
      • data_monitoring_committeeYes
      • total_enrolment_per_site24
      • total_participants_worldwide225 HIV-uninfected participants
      • 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_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_nameN/A
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailgmutua@kaviuon.org
      • organisations_transferred_No
      • number_participants24
      • notification
      • approval_date02-12-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-12-2021
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication approved by the expert committee
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-04-02 09:06:41
      • created2020-03-06 10:44:03
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id528
        • application_id858
        • given_nameProf Walter Jaoko
        • middle_nameGodfrey
        • family_nameJaoko
        • qualificationMBChB, MTropMed, PhD, PGD (Health Research Ethics)
        • professional_addressP.O Box 19676
        • telephone0727555254
        • emailwjaoko@kaviuon.org
        • created2020-03-06 11:27:32
        • modified2021-12-07 12:35:37
    • SiteDetail(array)
      • 0(array)
        • id703
        • application_id858
        • county_id47
        • site_nameKAVI-Insitute of Clinical Research, KNH site
        • physical_addressCollege of health Sciences, University of Nairobi, Kenyatta National Hospital
        • contact_detailsP.O Box 19676, 00202 KNH
        • contact_personDr Gaudensia Nzembi Mutua
        • site_capacity(null)
        • misc(null)
        • created2020-03-06 11:27:32
        • modified2021-12-07 12:35:37
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id415
        • application_id858
        • sponsorInternational AIDS Vaccine Initiative (IAVI)
        • sponsor_typeOthers
        • contact_personDagna Laufer, MD
        • address125 Broad Street, 9th Floor
        • telephone_number+1 212-328-7459
        • fax_numberN/A
        • cell_number+1 212-328-7459
        • email_addressdlaufer@iavi.org
        • created2020-03-06 11:27:32
        • modified2021-12-07 12:35:37
  • 2(array)
    • Application(array)
      • id834
      • user_id562
      • trial_status_id1
      • abstract_of_study<p>\n The East African Community (EAC) member states do not as a requirement conduct bioequivalent (BE) studies for generic medicines hence the quality of most of locally manufactured generic drugs is not fully established. This study aims to conduct a BE study of a locally-produced brand of enalapril 5mg tablets as an initial step of introduction of BE studies in EAC. The study will be an open-label, non-replicated, two-sequence, two-period crossover design with a seven-day washout period between each treatment phase. The study will enroll fourteen (14) healthy male adult volunteers aged 18 - 55 years with a body mass index of between 20and 30 kg/m<sup style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 8.26px;\"><font size=\"2\" style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 10.06px;\">2<strong style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 10.06px;\">.</strong></font></sup>Both drugs, brand and generic will be sourced from registered distributor. The reference pharmaceutical product will be Enam™ 5mg tablets while the local generic product will be Cardace™ 5mg tablets. One tablet of either the Cardace™ 5mg or Enam™ 5mg will be given orallyto the volunteers with 240 mL of water. A 5.0 mL blood sample for the enalapril assay will be drawn at time 0, 0.5, 1.0, 1.75, 2.25, 3,3.75, 5, 8, 12, and 24  hours dosing. The blood samples will be centrifuged at 1000 g for 10 minutes at room temperature and serum stored frozen at -35°C. After seven days, the study will be repeated in the same manner to complete the crossover design. Serum samples will be analyzed for enalapril plus its metabolite enaprilat, and the internal standard according to a validated Liquid chromatography-tandem mass spectrometry method.The following pharmacokinetic parameters will be calculated:elimination rate constant (Ke), maximum concentration (Cmax), time at maximum concentration (Tmax), elimination half-life (T<sub style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 8.26px;\"><font size=\"2\" style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 10.06px;\">1/2</font></sub>), area under the curve at time t (AUC0–t), and area under the curve extrapolated to infinity (AUC0–∞).Bioequivalence will be assessed by means of an analysis of variance (ANOVA) of the crossover design and estimating 90% confidence intervals for the ratio of the means of the test/reference products using log-transformed data. For AUC, the 90% confidence interval should be within the acceptance range 80-125%.</p>\n<p style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">\n  </p>\n<p>\n  </p>\n
      • study_title<p>\n <span style=\"margin: 0px; line-height: 107%; font-family: "Bookman Old Style",serif; font-size: 10pt;\">A bioequivalent pilot study of a locally-produced brand of enalapril tablets:<span style=\"margin: 0px;\">  </span>a key step towards implementation of bioequivalent study regulatory requirements in East Africa</span></p>\n
      • laymans_summary<p>\n <span style=\"font-size:12px;\"><span style=\"background: white; line-height: 200%; font-family: "Times New Roman",serif;\">Currently, East African Community (EAC) member states do not have capacity to carry out studies known as bioequivalent (BE) studies for generic (copy of the original brands) medicines. These studies are very important as they show whether generic medicines are basically the same with original brands. Due to lack of this capacity the quality of locally manufactured medicines may not be fully known. </span><span style=\"line-height: 200%; font-family: "Times New Roman",serif;\">This study intends to conduct a BE study of a locally produced medication called enalapril (which is a drug for treatment of high blood pressure) a key step towards enforcement of BE requirements in East Africa. The study will enroll fourteen (14) healthy adult volunteers aged 18-55 years^.<span style=\"background:white\">Both drugs, brand and generic will be sourced from a registered distributor. The reference pharmaceutical product (or the original product) will be Enam™ 5mg tablets while the local generic product will be </span>Cardace<span style=\"background:white\">™ 5mg. </span>One tablet of either the Cardace<span style=\"background:white\">™ 5mg</span> or Enam™ 5mg will be given by mouth to the volunteers with 240 mL of water. A 5.0 mL blood sample for the enalapril assay will be drawn into EDTA-K3 anticoagulant tubes before and after taking medication. The blood samples will be processed and kept frozen. After seven days, the study will be repeated in the same manner with the alternative medication being tested. Blood samples will be analyzed for enalapril using a machine known as LC MS/MS. The scientists will then carry out calculation to determine the similarity between the generic and original products of enalapril tablets.</span><span style=\"line-height: 200%; font-family: "Times New Roman",serif;\"> </span><span style=\"line-height: 200%; font-family: "Times New Roman",serif;\">The results of this study will be shared with the Pharmacy & Poisons Board (the national Drug Regulatory Authority) as part of policy enforcers, for their information. However, our results will not affect the drugs registration status.</span></span></p>\n
      • short_titleA Pilot BE study for Enalpril 5mg
      • protocol_noECCT/19/11/03
      • version_noVersion 3.0
      • date_of_protocol07-08-2019
      • study_drugEnalapril 5mg (Enam and Cardace)
      • disease_conditionHypertension
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameEnalapril
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameEnam
      • comparator_registeredYes
      • comparator_countriesIndia, Uganda, and South Africa
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjhkimotho@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_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_applicantDr. Simon Njoroge Njenga
      • declaration_date114-11-2019
      • declaration_principal_investigatorDr. James Hungo Kimotho, Study Coordinator
      • declaration_date214-11-2019
      • placebo_presentNo
      • study_objectives<h2>\n <span style=\"font-size:12px;\">Main Objective</span></h2>\n<p align=\"left\">\n To conduct a bioequivalent pilot study of a selected locally-produced brand of enalapril tablets on fasted subjects.</p>\n<p>\n <strong>Specific Objectives</strong></p>\n<ol>\n <li>\n  To demonstrate the feasibility of conducting bioequivalence studies in EAC</li>\n</ol>\n<ol>\n <li value=\"2\">\n To delineate challenges of implementing BE studies.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">Healthy males. The test to be done for someone to be a healthy volunteer will include HIV testing, malaria, random glucose, total blood count, renal profile, ECG, urinalysis.</font></span></p>\n<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">Aged between18 and 55 years</font></span></p>\n<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">BMI 20-30kg/m2</font></span></p>\n<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">Acceptance and sign informed consent </font></span></p>\n<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">Non-smokers and without a history of alcohol or drug abuse</font></span></p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ul style=\"margin-top:0in\" type=\"disc\">\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">HIV positive or other immunosuppressive status </span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Symptomatic infection</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Concomitant exposure to other investigational medicinal products</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">History of alcohol or drug abuse</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Smokers</span></li>\n</ul>\n<ul style=\"margin-top:0in\" type=\"disc\">\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Known hypersensitivity to ACE inhibitors</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Laboratory result abnormalities, including clinically significant abnormal ECG, liver function tests more than x3 upper limit of normal, abnormal renal function tests.</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition. </span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Aged below 18yrs or above 55 years</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Inability to give informed consent</span></li>\n</ul>\n
      • primary_end_points<p>\n  </p>\n<p style=\"margin: 0px 0px 10.66px 48px; line-height: 115%; text-indent: -0.25in;\">\n <font color=\"#000000\"><span bookman=\"\" lang=\"EN-GB\" old=\"\" style=\"margin: 0px; line-height: 115%; font-family: \"><span style=\"margin: 0px;\">1.<span new=\"\" style=\"font: 7pt \" times=\"\">    </span></span></span><span new=\"\" style=\"background: white; margin: 0px; line-height: 115%; font-family: \" times=\"\">Pharmacokinetic data and BE demonstration</span></font></p>\n<p style=\"margin: 0px 0px 10.66px 48px; line-height: 115%; text-indent: -0.25in;\">\n <font color=\"#000000\"><span new=\"\" style=\"background: white; margin: 0px; line-height: 115%; font-family: \" times=\"\">2.     </span></font><span new=\"\" style=\"background: white; margin: 0px; line-height: 107%; font-family: \" times=\"\"><font color=\"#000000\">Shared experience of conducting Bioequivalence studies in Kenya</font></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence1
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:158px;\">\n <p>\n <strong>            Names</strong></p>\n </td>\n <td style=\"width:144px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:144px;\">\n <p>\n <strong>Experience</strong></p>\n </td>\n <td style=\"width:159px;\">\n <p>\n <strong>Roles</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Simon N. Njenga</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n MBcHB, MMED</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Experienced in conducting clinical trial</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Project PI</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Fredrick Kirui</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n MBcHB, MMED</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Experienced in conducting clinical trial</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Co Project PI</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. James H. Kimotho</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n B. Pharm, PhD (Mol Med]</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Researcher/Scientist</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Study Co-ordinator</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Veronica Manduku</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n MBcHB, MMED</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Experienced in conducting clinical trial</p>\n </td>\n <td style=\"width:159px;\">\n <p align=\"left\">\n Will carry out, clinical implementation, and participate in manuscript writing</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Sabina Wachira</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n BSc Chem, PhD</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Chemical Analysis/LCMS and Pharmacokinetics</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Development and validation of methods of analysis for the drugs that will be used in the BE studies. She will also be in-charge of the pharmacokinetic studies.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr.Jane Ongong’a</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n MBcHB, MMED</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Experienced in conducting clinical trial</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Independent study Monitor</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Cecilia Wanjala</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n B.Pharm, MBA</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Commercialization of Pharma products</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Commercialization of the BE studies at KEMRI</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Ms. Jacqueline Thiga</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n BSc, MSc</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Research Scientist</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Documentation and other publication</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Ms. Lucy Muita</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n BSc.</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Assistant Research Scientist</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Internal Quality Assurance of the study</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Felix Skuta</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n B. Pharm</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Pharmacist</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Study Pharmacist</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Matthew H. Kwena</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n B. Pharm, MPharm</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n He work with the National Quality Control Laboratory - Analysis</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Development and validation of methods of analysis</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </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 None</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration6months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorEnam™ (enalapril)
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyCardace™(enalapril)
      • single_site_member_stateYes
      • location_of_areaKenya Medical Research Institute
      • single_site_physical_addressP. O. Box 54840 – 00200, NAIROBI, Kenya, Off Mbagathi Rd
      • single_site_contact_personDr. James H. Kimotho
      • single_site_telephone(254) (020 2722541, 2713349, 0722-205901, 0733-400003
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site14
      • total_participants_worldwide14
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • 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_nameJames
      • investigator1_middle_nameHungo
      • investigator1_family_nameKimotho
      • investigator1_qualificationB.Pharm, PhD
      • investigator1_professional_addressDr.
      • investigator1_telephone+254722243365
      • investigator1_emailjhkimotho@kemri.org
      • organisations_transferred_No
      • number_participants14
      • notification
      • approval_date09-04-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-03-2020
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy Approved although some documentation need to be provided when available
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-04-09 10:34:02
      • created2019-11-14 13:37:08
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id516
        • application_id834
        • given_nameSimon
        • middle_nameNjoroge
        • family_nameNjenga
        • qualificationMBChB, MMED
        • professional_addressDr
        • telephone+254722733213
        • emailsimon.n.njenga@gmail.com
        • created2019-11-14 13:57:57
        • modified2020-03-24 18:03:41
    • SiteDetail(array)
      • 0(array)
        • id678
        • application_id834
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-11-14 13:57:57
        • modified2020-03-24 18:03:41
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id404
        • application_id834
        • sponsorKEMRI/East Africa Community and Partners
        • sponsor_typeResearch Institution
        • contact_personDr. James H. Kimotho
        • addressKEMRI, P. O. Box 54840 00200 Nairobi
        • telephone_number(254) (020 2722541
        • fax_number(254) (020) 2720030
        • cell_number+254722243365
        • email_addressjhkimotho@kemri.org
        • created2019-11-14 13:57:57
        • modified2020-03-24 18:03:41
  • 3(array)
    • Application(array)
      • id816
      • user_id81
      • trial_status_id4
      • abstract_of_study<p>\n Malaria is a disease of major public health importance. The only vaccine available is partially effective and targets the pre-erythrocytic stages of the life cycle. Thus, there is a need to identify other potential vaccine targets as well as to develop models to test vaccine efficacy, especially that of transmission-blocking vaccines. Controlled human malaria infection (CHMI) has been shown to be an important tool for the assessment of the efficacy of novel malaria vaccines and drugs. CHMI also allows for the evaluation of immunity to malaria and monitoring of parasite growth rates <em>in vivo</em>. This is particularly useful in individuals from endemic areas with varying levels of exposure and immunity to malaria. Thus, CHMI in individuals with prior exposure to malaria has potential to accelerate malaria vaccine development. In this study, we aim to use CHMI in semi-immune adults to develop a model to assess transmissibility of malaria infection to mosquitoes, to study immune responses that are directed against sexual stages that might block transmission, and as a platform to test vaccines. To achieve this, the study will be carried out in two phases A (N=45 participants) and B (N=60 participants) over a period of 4-6months. We will vary the parasite dose in individuals enrolled for CHMI and use low-doses of anti-malarial drugs to promote the production of gametocytes <em>in vivo</em> (Phase A) and demonstrate transmissibility in mosquito feeding assays (Phase B). Thus, the main outcomes of the study will be: (1) optimisation of sporozoite dose for infections success in individuals with moderate-high malaria exposure; (2) use of sub-curative anti-malaria treatment for induction of gametocytes; and (3) infection of mosquitoes in mosquito feeding assays by induced gametocytes. To achieve this, we will screen up to 250 semi-immune adults who will be recruited from known areas of malaria endemicity in Kenya with varying exposure to malaria and enrol 105 individuals to conduct CHMI studies with serial quantitative polymerase chain reaction (PCR) to measure asexual parasite growth and induction of transmission stages <em>in vivo</em>. In addition, we will comprehensively characterize immunity and identify targets in relation to function assessed by various laboratory assays.</p>\n
      • study_title<p>\n Safety and feasibility of a malaria transmission model in semi-immune Kenyan adults using <em>Plasmodium falciparum</em> sporozoites</p>\n
      • laymans_summary<address>\n <strong>Formal Title: </strong>Safety and feasibility of a malaria transmission model in semi-immune Kenyan adults using <em>Plasmodium falciparum</em> sporozoites</address>\n<address>\n <strong>Lay Title: </strong>Use of malaria infection by injection to study malaria transmission</address>\n<address>\n <strong>What is the problem/background?</strong></address>\n<p>\n Malaria remains a major public health problem with up to half a billion-people infected with the parasite that causes the disease. In recent and ongoing studies, we have conducted controlled malaria infection in 189 Kenyan adults. By measuring malaria parasites in the blood, we have gained insights into the growth of parasites that will guide vaccine development. One other approach to vaccination is to target the transmitting stages of the malaria parasites such that mosquitoes feeding on the infected person would not become infected, thus breaking the life cycle of the parasite. There is a need to develop experimental methods to test the effect of candidate vaccines designed to interrupt transmission to mosquitoes so that vaccines showing evidence of efficacy can then be prioritized for large trials in the field. Furthermore, studying natural immunity in humans to the stages involved in malaria transmission will help characterize potential targets for new vaccines. </p>\n<address>\n <strong>What questions are we trying to answer?</strong></address>\n<p>\n We wish to develop a method to test the efficacy of vaccines and/or drugs designed to block transmission of malaria to mosquitoes and to identify the targets of transmission-blocking immunity to malaria.</p>\n<address>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></address>\n<p>\n The study will take place in Kilifi, Kenya. The study will involve the recruitment and screening of up to 250 individuals from Ahero and Kilifi to determine eligibility for participation and past exposure to malaria. This will be done after a programme of sensitisation and information giving about the study. The study will be conducted in two phases where individuals with moderate to high malaria exposure will be enrolled to participate in the following:</p>\n<ol>\n <li>\n Phase A (N = 45): “dose-finding” of the dose of sporozoites given and optimisation of the dose of anti-malarial drug that will be used to promote development of transmission stages without clearing the infection completely (i.e. a “sub-curative dose”);</li>\n <li>\n Phase B (N = 60): assessing infectivity of induced malaria transmission stages to mosquitoes.</li>\n</ol>\n<p>\n For each of these phases, selection will be based on level of past malaria exposure and health status. To determine these, blood samples will be taken at the point of screening for each individual participant.</p>\n<address>\n <strong>What does the study involve for those who are in it?</strong></address>\n<p>\n For screening, a blood sample of 21ml will be collected at the time of recruitment. A urine sample and medical history will also be obtained in addition to undergoing a clinical assessment and a test to check the functioning of the heart. For enrollment, a participant will need to have moderate to high malaria exposure and have no clinical disease. Those that meet this criteria, some will be enrolled into phase A and some into phase B (phase A will happen before phase B) for malaria infection studies and be required to stay at an in-patient facility in Kilifi near KEMRI-Kilifi. The participants will be asked to stay at the facility throughout the study so that they are closely monitored by the study staff. To transmit malaria to mosquitoes the human challenge model must first reliably induce infection and of a sufficient duration before being able to develop transmitting stages. We will:</p>\n<ol>\n <li>\n For Phase A: Assign individuals to one of three groups to be given different doses of malaria by injection. These individuals will be further assigned to receive two different anti-malarial drugs (sub-curative treatment)</li>\n <li>\n For Phase B: Based on results from Phase A, give individuals malaria infection by injection at the most successful dose and provide sub-curative treatment that promotes the most transmission stages. At peak time points of transmission stage induction (based on results from Phase A), mosquito feeding assays will be undertaken to determine infectivity to mosquitoes.</li>\n</ol>\n<p>\n Multiple blood samples will be taken for those enrolled for malaria infections (both Phase A and B). For both phases, blood samples will be drawn as follows: a day before infection (40ml); at five days after infection (8ml); twice daily every day from seven days after infection until the day they will receive a sub-curative treatment (cumulative total of 185ml); and then once daily afterwards to twenty-one days after infection (cumulative total of 70ml); then every other day from day twenty-one until day forty-two (cumulative total of 71ml); once daily during curative treatment (cumulative total of 18ml);  and on day fifty-six after infection (40ml). In addition, for participants enrolled into Phase B, direct skin mosquito feeding and blood samples for mosquito membrane feeding assays will also be taken to assess mosquito infectivity (cumulative total of 28ml). The specific days for assessing mosquito infectivity will be dependent on the results from Phase A of the study. For the entire duration of the study (4-6months), a total of 465ml per participant of blood will be drawn for those enrolled in Phase A and a total of 493mls for those in Phase B. This total volume of blood is less than the volume taken during a blood donation. In addition to blood sampling, clinical assessments will be repeated a day before infection including collection of a urine sample and measurements of weights and heights. Observed sub-curative treatment for malaria will be administered on the day the parasites reach a set threshold and a curative dose on day forty-two after infection.</p>\n<address>\n <strong>What are the benefits and risks/costs of the study for those involved?</strong></address>\n<p>\n Controlled human malaria infection has been conducted in one hundred and eighty-nine (189) healthy adults in Kenya (Hodgson et al Front Microbiol. 2014 (Nairobi, N=28 volunteers, 2013) and KEMRI/SERU/CGMR-C/029/3190 (Kilifi, N=161 volunteers, 2016-2018)) and has been proven safe in these individuals. The risks relate to the possibility of developing an allergic reaction upon administration of the malaria infection. In addition, participants may develop signs and symptoms of malaria after infection which are unpleasant, may result in development of severe malaria due to the higher doses of sporozoites being given and may develop some side effects to the drugs used for treatment (sub-curative and curative doses). There are no direct benefits to individuals participating in this study other than information about their health. However, all participants will have their transport costs reimbursed and compensated for all out of pocket expenses for the entire duration of the study.</p>\n<address>\n <strong>How will the study benefit society?</strong></address>\n<p>\n This work is necessary for enhancing our understanding of how malaria transmission stages develop, the immune targets involved and ability to test interventions such as vaccines in populations that have past exposure to malaria. The successful application of such interventions will benefit society by reducing malaria transmission, a major cause of illness, death and impediment to national development. An adaptation of the controlled human malaria infection provides a way of studying transmission of malaria in a very detailed way that is not possible using natural infections, and we believe that this step is now necessary to inform vaccine design and efficacy.</p>\n<address>\n <strong>When does the study start and finish?</strong></address>\n<p>\n The study will start upon receipt of ethical clearance. Data collection, analysis and write up will take place over three years.</p>\n
      • short_titleUse of malaria infection by injection to study malaria transmission
      • protocol_noECCT/19/08/01
      • version_noVersion 3.0
      • date_of_protocol27-03-2019
      • study_drugPfSPZ Challenge CHMI-Transmod
      • disease_conditionMalaria
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • 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_addressregulatory@kemri-wellcome.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_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_pi0
      • 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_applicantMelissa Kapulu
      • declaration_date105-08-2019
      • declaration_principal_investigatorMelissa Kapulu
      • declaration_date205-08-2019
      • placebo_presentNo
      • study_objectives<address>\n <strong>Primary objective</strong></address>\n<p>\n To adapt the Controlled Human Malaria Infection (CHMI) model using <em>P. falciparum</em> sporozoites to induce gametocytes and assess their infectivity to mosquitoes.</p>\n<p>\n <strong>Secondary objective(s)</strong></p>\n<address>\n 1. To determine the safety of varied increased doses of <em>P. falciparum</em> sporozoites in CHMI delivered by Direct Venous Inoculation (DVI) in semi-immune volunteers and optimise the dose of sporozoites that results in 100% infectivity in moderate to highly exposed adults;</address>\n<address>\n 2. To determine if the prevalence, peak density and peak time point of gametocytes is altered by drug-regimen and determine the area under the curve of density over time;</address>\n<address>\n 3. To determine the infectivity of drug-induced gametocytes in mosquito feeding assays;</address>\n<address>\n 4. To measure immunity to gametocyte antigens and determine associations between immunity and transmission-blocking activity in the CHMI model;</address>\n<address>\n 5. To explore the perceptions, attitudes, and experiences of research participants and other community and professional stakeholders involved in the CHMI study.</address>\n
      • principal_inclusion_criteria<ul>\n <li>\n Healthy adults aged 18 to 45 years.</li>\n <li>\n Able and willing (in the Investigator’s opinion) to comply with all study requirements.</li>\n <li>\n Informed consent.</li>\n <li>\n Use of effective method of contraception for duration of study (women only). We will ask the female volunteers to come with their family planning records to verify. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n Any of the following constitutes exclusion criterion:</p>\n<ul>\n <li>\n Body weight of less than 50kg or body mass index (BMI) less than 18 or greater than 25 kg/m² at screening.</li>\n <li>\n Use of systemic antibiotics with known antimalarial activity within 30 days of administration of PfSPZ Challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).</li>\n <li>\n Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.</li>\n <li>\n Current participation in another clinical trial or recent participation within 12 weeks of enrolment.</li>\n <li>\n Prior receipt of an investigational malaria vaccine.</li>\n <li>\n Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). This will also include Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) positivity.</li>\n <li>\n Use of immunoglobulins or blood products within 3 months prior to enrolment.</li>\n <li>\n Any serious medical condition reported or identified during screening that increases the risk of CHMI.</li>\n <li>\n Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.</li>\n <li>\n Women only; pregnancy, or an intention to become pregnant during the duration of the study.  </li>\n <li>\n Sickle cell trait or disease.</li>\n <li>\n History of drug or alcohol abuse.</li>\n <li>\n Known hypersensitivity to or contraindications for use of artemether-lumefantrine, chloroquine, piperaquine, primaquine, sulfadoxine-pyrimethamine, or history of severe (allergic) reactions to mosquito bites.</li>\n <li>\n Confirmed gametocyte positivity at screening and/or a day before challenge</li>\n <li>\n Confirmed parasite positive by PCR a day before challenge i.e. at C-1.</li>\n</ul>\n<p>\n <strong><em>Exclusion Criterion on Day of Challenge </em></strong></p>\n<ul>\n <li>\n Acute disease, defined as moderate or severe illness with or without fever (temperature >37.5^oC).</li>\n</ul>\n
      • primary_end_points<p>\n Not applicable. There are no primary endpoints.</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_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyHuman challenge study with deliberate infection of participants to induce transmission stages and understand immunogenicity.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Medical officer - 1<br />\n Clinical officer - 2<br />\n Nurses - 2<br />\n Fieldworkers - 5<br />\n Research and Assistant Research Officers - 2<br />\n Study Coordinator - 1<br />\n Pharmacisit - 1<br />\n Data Manager - 1<br />\n Data Clerk - 2<br />\n The inpatient facility is already staffed with 3 clincians, 1 paediatrician and 20 nurses.<br />\n All staff are trained in basic life support and resuscitation facilitaties are available.</p>\n
      • other_details_explanation<p>\n Not applicable.</p>\n
      • other_details_regulatory_notapproved<p>\n Submission is only to PPB.</p>\n
      • other_details_regulatory_approved<p>\n Not applicable.</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_duration3 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-Wellcome Trust Research Programme (KWTRP) Centre for Geographic Medical Research - Coast (CGMRC), Kilifi, Kenya.
      • single_site_physical_addressKEMRI-Wellcome Trust Research Programme, Off Bofa Road, Kilifi County Hospital, Kilifi, Kenya
      • single_site_contact_personMelissa Kapulu
      • single_site_telephone+254717501319
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site105
      • total_participants_worldwide105
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMelissa
      • investigator1_middle_name
      • investigator1_family_nameKapulu
      • investigator1_qualificationPhD
      • investigator1_professional_addressKEMRI-Wellcome Trust Research Programme, P. O. Box 230, Kilifi, Kenya 80108
      • investigator1_telephone+254709983463
      • investigator1_emailmkapulu@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants105
      • notification
      • approval_date15-11-2019
      • submitted1
      • deleted0
      • deleted_date2019-08-09 08:51:39
      • deactivated0
      • date_submitted27-02-2020
      • 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)
      • modified2024-07-29 09:25:54
      • created2019-07-18 14:56:05
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id506
        • application_id816
        • given_nameMelissa
        • middle_name
        • family_nameKapulu
        • qualificationPhd
        • professional_addressKEMRI-Wellcome Trust Research Programme, P. O. Box 230, Kilifi, Kenya 80108
        • telephone+254709983463
        • emailmkapulu@kemri-wellcome.org
        • created2019-07-18 15:09:17
        • modified2020-02-27 12:45:15
      • 1(array)
        • id507
        • application_id816
        • given_namePhilip
        • middle_name
        • family_nameBejon
        • qualificationBSc MBBS PhD
        • professional_addressKEMRI-Wellcome Trust Research Programme, P. O. Box 230, Kilifi, Kenya 80108
        • telephone+254709983549
        • emailpbejon@kemri-wellcome.org
        • created2019-07-18 15:10:33
        • modified2020-02-27 12:45:15
    • SiteDetail(array)
      • 0(array)
        • id664
        • application_id816
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-07-18 15:09:17
        • modified2020-02-27 12:45:15
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id395
        • application_id816
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_person
        • addressUniversity Offices, Wellington Square, Oxford, OX1 2JD, UK
        • telephone_number+44 1865 270000
        • fax_number
        • cell_number+44 1865 270000
        • email_addressresearch.services@admin.ox.ac.uk
        • created2019-07-18 15:09:17
        • modified2020-02-27 12:45:15
  • 4(array)
    • Application(array)
      • id767
      • user_id501
      • trial_status_id1
      • abstract_of_study<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">In many rural clinics providing women’s health services, paracervical block is impossible to perform due to the high cost of necessary tools (spinal needle, needle extender). In these situations, women undergo manual vacuum aspiration (MVA) and other gynecologic procedures without paracervical analgesia. We have developed a low-cost, reusable syringe extension device for the provision of paracervical analgesia during MVA. We propose to validate functionality of the device and collect user feedback from women’s health providers and patients at four sites in Kisumu, Kenya.</span></span></p>\n
      • study_title<p>\n <span style=\"font-size:12px;\"><span style=\"font-family: Helvetica;\">Validation of re-usable, low cost syringe extension device for the provision of paracervical analgesia during gynecological procedures</span></span></p>\n
      • laymans_summary<p>\n Women who are having a miscarriage, are usually treated by emptying the uterus. One of the ways to achieve this is a procedure that sucks out the non viable pregnancy called Manual Vacuum Aspiration (MVA) and many in Kenya refer to this procedure with the Kiswahili term "Kuoshwa tumbo".</p>\n<p>\n This procedure causes considerable pain, one way of avoiding pain includes the administration of a numbing injection (LA) to the cervix. However due to the position of the cervix in the birth canal, administration of this injection requires a super long needle that was designed for giving spinal anaesthesia. The unavailability and cost of the spinal needle has led to many women having this procedure with inadequate pain control.</p>\n<p>\n We have invented the Chloe Syringe Extension Device (SED), a low cost reusable gadget, that makes it possible to give a numbing injection to the cervix without needing a spinal needle.</p>\n<p>\n For the purpose of this study, the Chloe SED was manufactured in Nairobi by 3D printing.</p>\n<p>\n In this study we compared pain relief obtained by giving the numbing injection with the spinal needle, to that obtained with our invention.</p>\n<p>\n The results indicate that the pain relief obtained by Chloe SED is the same as that obtained by the spinal needle.</p>\n<p>\n We conclude that Chloe SED is a good substitute to the spinal needle in giving the numbing injection.</p>\n<p>\n We intend to use this results to design a bigger study to establish more information on the suitability of the gadget on giving the numbing injection</p>\n
      • short_titleValidation of syringe extension device
      • protocol_noECCT/19/03/01
      • version_no1.0
      • date_of_protocol01-01-2019
      • study_drugSyringe extension device (new device)
      • disease_conditionAnalgesia for paracervical block
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameSyringe extension device
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgwerso@yahoo.co.uk
      • 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_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantStephen Gwer
      • declaration_date111-04-2019
      • declaration_principal_investigatorStephen Gwer
      • declaration_date211-04-2019
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">1.  Health providers providing MVA services at the four study sites. </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">2.  Female patients receiving MVA at the four study sites </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">3.  Ability to consent and understand that participation in the study involves potential use of a new device during the planned MVA. </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">4.  Age greater than 18.</span></span></p>\n
      • principal_exclusion_criteria<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">1.  Males will be excluded from the patient population as men do not receive MVA services. </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">2.  Male MVA providers will not be excluded from the provider population.</span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">3.  There is no limitation based on race, tribe, or sexual orientation in the study for any patients or providers who meet inclusion criteria. </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">4.  There are no exclusions for patients based on language.</span></span></p>\n
      • primary_end_points<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">To validate the functionality of a newly developed, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a proof-of-concept study. Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.</span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The study population will include women’s health providers who perform MVA and patients requiring manual vacuum aspiration (MVA) at four clinical sites in Kisumu, Kenya: Jaramogi Oginga Odinga Teaching and Referral Hospital, Kisumu County Hospital, Marie Stopes Kenya, and God’s Will Clinic. The study team met with the regional directors at each of the four sites and confirmed willingness of each site to participate in the study (letters of support included). Clinical volume and number of MVA providers at each site were confirmed to ensure an adequate number of potential study participants for recruitment within the study period. Average clinical volume between the five sites is 400 MVA procedures per month with approximately 20 MVA providers available for potential study recruitment. </span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Jaramogi Oginga Odinga Teaching and Referral Hospital has a maternity complex with 60 beds. MVA providers at this facility include medical officers (MO) and clinical officers (CO). Other providers staffing the ward including Ob/Gyn physicians, residents, and nursing staff. There is a procedure room available for MVA procedures and an operating theatre also available. Kisumu County Hospital has a gyne ward with 6 beds. A procedure room is available for MVA procedures. MVA procedures are completed by nurses and COs. Marie Stopes International provides family planning services including post-abortion care in 37 countries worldwide. In Kenya, there are 23 centres, including the study site in Kisumu. At this site, MVA providers include nurses and COs in a procedure room. God’s Will Clinic in Kisumu provides MVA and post-abortion care. MVA procedures are conducted by nurses and CO in a procedure room.</span></span></p>\n
      • other_details_explanation<p>\n The trial is to be conducted in Kenya which is the host country of the applicant. The syringe extender has been developed in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n University of Illinois at Chicago Ethical Review Board: preliminary approval granted with one minor modification: February 27,2019</p>\n
      • other_details_regulatory_approved<p>\n Maseno University Ethical Review Board (MUERC): February 18, 2019</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration5 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorParacervical block admini
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites4
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrollment - minimum of zero and maximum of 60 at each site
      • total_participants_worldwide60
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameStephen
      • investigator1_middle_name
      • investigator1_family_nameGwer
      • investigator1_qualificationMedical Doctor - Obstetrics and Gynecology
      • investigator1_professional_addressPrivate Bag, Maseno University School of Medicine, Kisumu, Kenya
      • investigator1_telephone+254 77 2657163
      • investigator1_emailgwerso@gmail.com
      • organisations_transferred_No
      • number_participants60
      • notification<p>\n We look forward to your favourable response</p>\n
      • approval_date01-08-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-05-2019
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n <strong><em>Introduction:</em></strong> This was a pilot study that evaluated the efficacy of a novel, ultra-low-cost syringe extension device SED, which we have now decided to name the Chloe SED for provision of paracervical block (PCB) during manual vacuum aspiration (MVA). </p>\n<p>\n <strong><em>Method</em></strong>: A randomized, single-blinded non-inferiority trial of 61 patients was conducted at two facilities in Kisumu between September 2019 and January 2021 comparing PCB administered with Chloe-SED to a standard spinal needle.  The primary outcome was non-inferiority of pain score during uterine evacuation within a non-inferiority margin of 2 points on an 11-point visual assessment scale.  Secondary outcomes included non-inferiority of pain score at 4 other time points, patient satisfaction, and provider feedback on Chloe-SED.</p>\n<p>\n <strong><em>Results</em></strong>: Chloe-SED showed non-inferiority of the primary outcome with mean pain score during evacuation of 3.9 (3.2-4.7) compared with spinal needle at 4.1 (3.5-4.7).  Non-inferiority was shown at all time points. In one patient the syringe and device were incompatible.  The only adverse event was breakage of the finger-pad of the device after completion of PCB with no injury to patient or provider. Most patients and providers expressed desire for continued use of the device to administer PCB for MVA. </p>\n<p>\n <strong><em>Conclusion</em></strong>: The Chloe SED device appears effective and desirable for administration of PCB during MVA.</p>\n<p>\n <strong><em>Introduction:</em></strong> This was a pilot study that evaluated the efficacy of a novel, ultra-low-cost syringe extension device (Chloe-SED) for provision of paracervical block (PCB) during manual vacuum aspiration (MVA). </p>\n<p>\n <strong><em>Method</em></strong>: A randomized, single-blinded non-inferiority trial of 61 patients was conducted at two facilities in Kisumu between September 2019 and January 2021 comparing PCB administered with Chloe-SED to a standard spinal needle.  The primary outcome was non-inferiority of pain score during uterine evacuation within a non-inferiority margin of 2 points on an 10-point visual assessment scale.  Secondary outcomes included non-inferiority of pain score at 4 other time points, patient satisfaction, and provider feedback on Chloe-SED.</p>\n<p>\n <strong><em>Results</em></strong>: Chloe-SED showed non-inferiority of the primary outcome with mean pain score during evacuation of 3.9 (3.2-4.7) compared with spinal needle at 4.1 (3.5-4.7).  Non-inferiority was shown at all time points. In one patient the syringe and device were incompatible.  The only adverse event was breakage of the finger-pad of the device after completion of PCB with no injury to patient or provider. Most patients and providers expressed desire for continued use of the device to administer PCB for MVA. </p>\n<p>\n <strong><em>Conclusion</em></strong>: The Chloe SED device appears effective and desirable for administration of PCB during MVA.<strong><em> </em></strong>This results will be important in designing a larger more powered validation trial</p>\n
      • implication_results<p>\n These findings imply that Chloe SED is a suitable substitute to the spinal needle for provision of paracervical block. It therefore implies, that in situations where a spinal needle is not available it is possible to give adequate analgesia at no additional cost to the patient.</p>\n
      • quantity_importedNone all the syringe extension devices were manufactured in Nairobi
      • quantity_dispensedAll 30 devices were used and are available.
      • quantity_destroyednone was destroyed, but some broke and all are available.
      • quantity_exportednone
      • balance_site30
      • final_date0000-00-00
      • modified2021-06-08 23:22:45
      • created2019-02-27 09:02:06
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id476
        • application_id767
        • given_nameStephen
        • middle_name
        • family_nameGwer
        • qualificationMedical doctor - Obstetrics and Gynecology
        • professional_addressPrivate Bag, Maseno University School of Medicine, Kisumu, Kenya
        • telephone+254 77 2657163
        • emailgwerso@gmail.com
        • created2019-02-27 18:30:16
        • modified2019-05-02 23:32:03
      • 1(array)
        • id477
        • application_id767
        • given_nameAparna
        • middle_name
        • family_nameRamanathan
        • qualificationMedical Doctor - Obstetrics and Gynecology and Device Co-Inventor
        • professional_address820 S Wood Street, University of Illinois at Chicago School of Medicine, Chicago, IL, USA
        • telephone+1 617 388 8643
        • emailaparna.rajam@gmail.com
        • created2019-02-27 18:34:25
        • modified2019-05-02 23:32:03
    • SiteDetail(array)
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        • application_id767
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressKisumu-Kakamega Road
        • contact_details+254 057 2020801
        • contact_personDr. Okoth Peter, Dr. Stephen Gwer
        • site_capacity(null)
        • misc(null)
        • created2019-02-27 18:30:16
        • modified2019-05-02 23:32:03
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
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        • application_id767
        • county_id42
        • site_nameKisumu County Hospital
        • physical_addressOff Ang\'awa Avenue Box 1818
        • contact_details+254 057 2020171
        • contact_personDr. Massawa T.J., Dr. Stephen Gwer
        • site_capacity(null)
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        • created2019-02-27 18:59:04
        • modified2019-05-02 23:32:03
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
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        • application_id767
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        • site_nameGod\'s Will Clinic
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        • contact_details+254 0925248766
        • contact_personJanet A. Ogutu, Dr. Stephen Gwer
        • site_capacity(null)
        • misc(null)
        • created2019-02-27 18:59:04
        • modified2019-05-02 23:32:03
        • County(array)
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 3(array)
        • id616
        • application_id767
        • county_id42
        • site_nameMarie Stopes Kenya-Kisumu Clinic
        • physical_addressJomo-Kenyatta Highway
        • contact_details+254 800 720 005
        • contact_personDaisy Adalla, Dr. Stephen Gwer
        • site_capacity(null)
        • misc(null)
        • created2019-02-27 18:59:04
        • modified2019-05-02 23:32:03
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id372
        • application_id767
        • sponsorDepartment of Obstetrics and Gynecology
        • sponsor_type(null)
        • contact_personAparna Ramanathan
        • address820 S Wood Street, University of Illinois at Chicago School of Medicine, Chicago, IL, USA
        • telephone_number+1 617 388 8643
        • fax_number
        • cell_number+1 617 388 8643
        • email_addressaparna.rajam@gmail.com
        • created2019-02-27 18:30:16
        • modified2019-05-02 23:32:03
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_human_pharmacology1
• $this->validationErrors(array)
  • Permission(empty)
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  • InvestigatorContact(empty)
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  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4/usr/share/pear
• 5-> /var/www/html/ctr/lib/Cake/

Included Files

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• app(array)
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• plugins(array)
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