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      • id504
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      • abstract_of_study<p style=\"margin-left: 0.25in;\">\n The study titled “A Randomized Comparison of <strong>two</strong> Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings” is a phase III, open-label, prospective, <strong>2-arm</strong> randomized study stratified by CD4+ lymphocyte cell count and by country. This study will estimate the difference in event (KS progression, death, entry into an additional step, or loss to follow-up, prior to week 48) rates between two “experimental” regimens (ART initiation + BV   which are considered standard of care therapies in resource limited settings) and an active control (ART initiation + Paclitaxel - PTX: a standard treatment in the United States that is sometimes used as salvage therapy for relapsed/refractory KS in resource-limited settings) for the treatment of HIV-infected, ART-naive participants presenting with advanced KS.</p>\n<p style=\"margin-left: 0.25in;\">\n The target population includes males and females ³ 18 years of age with the following characteristics: documentation of HIV-1 infection, biopsy diagnostic of KS, current advanced  KS ( T1 stage KS), systemic chemotherapy for KS and radiation treatment naïve, and currently not receiving ART. A total of 706 participants, ≥18 years of age will be enrolled across all sites. Randomization will be stratified by screening peripheral blood CD4+ lymphocyte cell count (< 100 or  ³ 100 cells/mm³) and ART history (naïve or experienced). At study entry participants will be randomized in 1:1 fashion to one of the following <strong>2</strong> <strong>arms</strong> in Step 1: , arm 1B, co-formulated EFV/FTC/TDF with blemomycin/Vincristine(BV) and Arm 1C, Co-formulated EFV/FTC/TDF with PTX . In Step 2, at the discretion of the site investigator, after confirmation of disease progression by the IERC (Independent Endpoint Review Committee), participants who experience KS progression will receive second course of chemotherapy utilized in Step 1 (up to 6 cycles)  co-formulated EFV/FTC/TDF. In step 3, participants will receive randomly assigned chemotherapy co-formulated with EFV/FTC/TDF. In Step 4, following Clinical Management Committee (CMC) and IERC-confirmed KS progression on Step 3, or if there is dose-limiting toxicity after receiving less than 4 cycles of chemotherapy in Step 3, in the absence of a complete response (CR) or partial response (PR), participants will be assigned to the remaining study-provided chemotherapy not given in Step 1, Step 2, or Step 3. All participants will be followed for 5 years after randomization or assignment to the last step they enter.</p>\n<p style=\"margin-left: 0.25in;\">\n The primary endpoint incorporates lack of KS progression, death, entry into an additional step, or loss to follow-up<strong>, prior to week 48</strong>. The main interest of the study is the outcome at 48 weeks after the treatment initiation. The primary analyses will consist of the construction in the proportion of 48-week event rates between each experimental regimen and the active control (ART initiation with <strong>PTX</strong>).  </p>\n
      • study_title<p style=\"margin-left:.25in;\">\n <strong> A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings</strong></p>\n
      • laymans_summary(null)
      • short_titleA5263: A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings
      • protocol_noECCT/16/06/02
      • version_no2.0
      • date_of_protocol07-08-2012
      • study_drugPaclitaxel, Bleomycin,Vincristine and Etoposide
      • disease_conditionAdvanced AIDS-KS
      • 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_namePaclitaxel, Bleomycin,Vincristine and Etoposide
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressEokeyo@kemricdc.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)
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      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
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      • applicant_indemnity_pi(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr.Vincent Oliver otieno
      • declaration_date121-06-2016
      • declaration_principal_investigatorDr.Vincent Oliver otieno
      • declaration_date221-06-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n  Inclusion Criteria Step 1</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n a.         HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p>\n  </p>\n<p style=\"margin-left:1.45in;\">\n  </p>\n<p style=\"margin-left:1.0in;\">\n b.         Biopsy diagnostic of KS at any time prior to study entry.</p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n c.         Current KS stage T1 using ACTG criteria [29].</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n KS stage T1 is KS with any of the following:</p>\n<p style=\"margin-left:1.75in;\">\n ·         symptomatic tumor-associated edema</p>\n<p style=\"margin-left:1.75in;\">\n ·         tumor ulceration</p>\n<p style=\"margin-left:1.75in;\">\n ·         extensive oral KS (other than flat KS confined to the hard palate)</p>\n<p style=\"margin-left:1.75in;\">\n ·         gastrointestinal KS</p>\n<p style=\"margin-left:1.75in;\">\n ·         KS in any other non-nodal visceral organ (e.g., lung)</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.25in;\">\n d.          A minimum of five indicator KS cutaneous marker lesions plus an additional two lesions greater or equal to 4x4 mm that are accessible for punch biopsy.</p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n e.         CD4+ lymphocyte cell count obtained within 28 days prior to study entry at a DAIDS-approved laboratory.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n f.          The following laboratory values obtained within 14 days prior to study entry:</p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         Absolute neutrophil count (ANC) ³1000 cells/mm³</p>\n<p style=\"margin-left:1.75in;\">\n ·         Hemoglobin ³9 g/dL</p>\n<p style=\"margin-left:1.75in;\">\n ·         Platelet count ³100,000/mm³</p>\n<p style=\"margin-left:1.75in;\">\n ·         Estimated creatinine clearance of ≥60 mL/min using the formula:</p>\n<p>\n CrCl  = {[140 - age(yr)]x [weight(kg)]}÷ [72 x serum Cr(mg/dL)] (multiply the result x 0.85 for female participants)</p>\n<p>\n NOTE:  The Cockroft-Gault calculation program can be found on DMC website (<a href=\"http://www.fstrf.org/ACTG/index.html\">http://www.fstrf.org/ACTG/index.html</a>  </p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 ´ ULN</p>\n<p style=\"margin-left:1.75in;\">\n ·         Total bilirubin of <1.5 X ULN</p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n g.          Female study volunteers of reproductive potential (defined as girls who have reached menarche, women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy) must have a negative serum or urine pregnancy <strong>test with a sensitivity of 15-25 mIU/mL </strong>performed within 48 hours before initiating the protocol-specified medications.  </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n h.         All participants must agree <u>not</u> to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n i.          If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable forms of contraceptives will be used simultaneously while receiving protocol-specified medications, and for <strong>12</strong> weeks after stopping the medications.</p>\n<p style=\"margin-left:1.45in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n Study volunteers who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without the use of contraceptives. (Main protocol page 113).</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n j.          Men and women age ³18 years.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n k.         Ability to swallow oral medications and adequate venous access.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n l.          Karnofsky performance status ≥60 within 28 days prior to entry.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n m.        Ability and willingness of participant or legal guardian/representative to provide informed consent.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p>\n      <strong>Inclusion Criteria Step 2 </strong></p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n a.         Complete or partial response to the chemotherapy regimen used in <strong>S</strong>tep 1.</p>\n<p style=\"margin-left:1.5in;\">\n b.         KS progression at a time point greater than 12 weeks after the last dose of Step 1 chemotherapy.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n c.         Less than 72 weeks after Step 1 entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n d.         The following laboratory values obtained within 14 days prior to Step 2 entry:</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         ANC ≥1,000 cells/mm³</p>\n<p style=\"margin-left:1.75in;\">\n ·         Hemoglobin ≥9.0 g/dL</p>\n<p style=\"margin-left:1.75in;\">\n ·         Platelet count ≥100,000/mm³</p>\n<p style=\"margin-left:1.75in;\">\n ·         Estimated creatinine clearance of ≥60 mL/min using the formula: </p>\n<p style=\"margin-left:95.0pt;\">\n  CrCl  = {[140 - age(yr)]x [weight(kg)]}÷ [72 x serum Cr(mg/dL)] (multiply the result x 0.85 for female participants)</p>\n<p style=\"margin-left:95.0pt;\">\n NOTE:  The Cockroft-Gault calculation program can be found on DMC website (<a href=\"http://www.fstrf.org/ACTG/index.html\">http://www.fstrf.org/ACTG/index.html</a></p>\n<p>\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 ULN</p>\n<p style=\"margin-left:1.75in;\">\n ·         Total bilirubin of <u><</u>1.5 X ULN</p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n e.         For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to Step 2 entry. <strong>The urine test must have a sensitivity of 15-25 mIU/mL.</strong></p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n f.          Karnofsky performance status ≥ 50 within 28 days prior to Step 2.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n g.         All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p>\n    Inclusion Criteria Step 3</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n a.         Inability to continue on Step 1 or Step 2 due to KS progression OR lack of a CR or PR after receiving less than 4 cycles of chemotherapy in Step 1 or Step 2 because of the development of dose-limiting toxicity.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n b.         Less than 72 weeks after Step 1 entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n c.         The following laboratory values obtained within 14 days prior to Step 3 entry:</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         ANC ≥1,000 cells/mm³</p>\n<p style=\"margin-left:1.75in;\">\n ·         Hemoglobin ≥9.0 g/dL</p>\n<p style=\"margin-left:1.75in;\">\n ·         Platelet count ≥100,000/mm³</p>\n<p style=\"margin-left:1.75in;\">\n ·         Estimated creatinine clearance of ≥ 60 mL/min using the formula:  </p>\n<p style=\"margin-left:1.25in;\">\n CrCl  = {[140 - age(yr)]x [weight(kg)]}÷ [72 x serum Cr(mg/dL)]</p>\n<p style=\"margin-left:1.25in;\">\n  (multiply the result x 0.85 for female participants)</p>\n<p>\n                       NOTE:  The Cockroft-Gault calculation program can be found on DMC website (<a href=\"http://www.fstrf.org/ACTG/index.html\">http://www.fstrf.org/ACTG/index.html</a></p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 ULN</p>\n<p style=\"margin-left:1.75in;\">\n ·         Total bilirubin of <u><</u>1.5 X ULN</p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n d.         For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to Step 3 entry. <strong>The urine test must have a sensitivity of 15-25 mIU/mL.</strong></p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n e.         Karnofsky performance status ≥ 50 within 28 days prior to Step 3 entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n f.          All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p>\n  Inclusion Criteria Step 4</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n a.         Inability to continue on Step 3 due to KS progression OR lack of a CR or PR after receiving fewer than 4 cycles of chemotherapy in Step 3 because of the development of dose-limiting toxicity.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n b.         Less than 72 weeks after Step 1 entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n c.         The following laboratory values obtained within 14 days prior to Step 4 entry:</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         ANC ≥1,000 cells/mm³.</p>\n<p style=\"margin-left:1.75in;\">\n ·         Hemoglobin ≥9.0 g/dL.</p>\n<p style=\"margin-left:1.75in;\">\n ·         Platelet count ≥100,000/mm³.</p>\n<p style=\"margin-left:1.75in;\">\n ·         Estimated creatinine clearance of ≥ 60 mL/min using the formula:</p>\n<p style=\"margin-left:95.0pt;\">\n  CrCl  = {[140 - age(yr)]x [weight(kg)]}÷ [72 x serum Cr(mg/dL)] (multiply the result x 0.85 for female participants)</p>\n<p style=\"margin-left:95.0pt;\">\n NOTE:  The Cockroft-Gault calculation program can be found on DMC website (<a href=\"http://www.fstrf.org/ACTG/index.html\">http://www.fstrf.org/ACTG/index.html</a></p>\n<p>\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 ULN.</p>\n<p style=\"margin-left:1.75in;\">\n ·         Total bilirubin of <u><</u>1.5 X ULN.</p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n d.         For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to Step 4 entry. <strong>The urine test must have a sensitivity of 15-25 mIU/mL.</strong></p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n e.         Karnofsky performance status ≥ 50 within 28 days prior to Step 4 entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n f.          All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</p>\n
      • principal_exclusion_criteria<p>\n  </p>\n<p>\n       Exclusion Criteria step 1</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n a.         Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to study entry and/or is not clinically stable.  </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n b.         Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to entry.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n c.         Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial tomography (CAT), that in the opinion of the investigator would exclude bleomycin use.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n             d.       Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within 14 days prior to study enrollment. </p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n NOTE:  Exercise is defined as any activity that will increase a participant’s resting heart rate by at least 20 beats/minute.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n e.         Grade ≥3 peripheral neuropathy (PN) at entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n NOTE:  Severity of PN will be determined by the symptom severity scores from the Brief Peripheral Neuropathy Screen (BPNS), discussed in section 6.3.2<strong>0</strong>. </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n f.          Breastfeeding.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n g.         Receipt of ART for more than 28 days immediately prior to entry. ART is allowed within the 28-day window prior to study entry.</p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n NOTE:  The use of single-dose nevirapine (NVP) or zidovudine (ZDV) for any period of time during pregnancy to prevent mother to child transmission (MTCT) of HIV is allowed.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n NOTE:  Successful post-exposure prophylaxis is allowed. Unsuccessful post-exposure prophylaxis is not allowed.</p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:.75in;\">\n h.         Prior or current systemic or locally administered chemotherapy.</p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:.75in;\">\n i.          Prior or current radiation therapy.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n j.          Prior or current immunotherapy, e.g., interferon alfa.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n k.         Corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within the last 30 days prior to study entry. A tapering course of corticosteroids as acute therapy for <em>Pneumocystis carinii</em> pneumonia (PCP) or other conditions is an exception and is allowed.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n l.          Any immunomodulator, HIV vaccine, live attenuated vaccines, or other investigational therapy or investigational vaccine within 30 days prior to study entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n m         Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n n          Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n o.         Current or anticipated receipt of any of the prohibited medications listed in section 5.5.2.of the main protocol</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n p.         In the opinion of the investigator, any psychological or social condition, or addictive disorder that would preclude compliance with the protocol.</p>\n<p>\n Exclusion Criteria Step 2</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n a.         Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 2 entry and/or is not clinically stable. </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n b.         Severe toxicity to the chemotherapy regimen used in Step 1 requiring discontinuation of study chemotherapy.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n c.         Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 2 entry.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n d.         For patients who have not received bleomycin in Step 1:</p>\n<p style=\"margin-left:110.25pt;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         Development of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.</p>\n<p style=\"margin-left:1.75in;\">\n ·         Patients with an abnormal CXR or CT scan (which may indicate pulmonary KS) should undergo screening evaluations to rule out an infectious cause, per standard of care. If available, other diagnostic procedures such as bronchoscopy should be considered to confirm the presence or absence of pulmonary KS and/or an infectious agent. These procedures should be completed outside the study. These participants should be excluded if, in the opinion of the investigator, use of bleomycin in Step 2 would be detrimental.</p>\n<p style=\"margin-left:1.75in;\">\n ·         Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 2 entry. </p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.25in;\">\n d.    For patients who received vincristine or <strong>PTX</strong> in Step 1, Grade ≥3 PN at Step 2 entry. </p>\n<p style=\"margin-left:1.25in;\">\n NOTE: Severity of PN will be determined by the symptom severity scores from the BPNS, discussed in section 6.3.20 of the main protocol</p>\n<p style=\"margin-left:1.25in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n f.          Breastfeeding.</p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n g.         Other concurrent chemotherapy, immunotherapy, or radiotherapy.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n h.         Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 2 entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n NOTE:  A tapering course of corticosteroids as acute therapy for PCP or if required for management of IRIS is an exception.</p>\n<p>\n Exclusion Criteria Step 3</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n a.         Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 3 entry and/or is not clinically stable. </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n b.         Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 3 entry.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n c.         For patients who did NOT receive bleomycin in Step 1 or Step 2:</p>\n<p style=\"margin-left:110.25pt;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         Development of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.</p>\n<p style=\"margin-left:1.75in;\">\n ·         Patients with an abnormal CXR or CT scan (which may indicate pulmonary KS) should undergo screening evaluations to rule out an infectious cause, per standard of care. If available, other diagnostic procedures such as bronchoscopy should be considered to confirm the presence or absence of pulmonary KS and/or an infectious agent. These procedures should be completed outside the study. These participants should be excluded if, in the opinion of the investigator, use of bleomycin in Step 3 would be detrimental.</p>\n<p style=\"margin-left:1.75in;\">\n ·         Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 3 entry. </p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.25in;\">\n e.    For participants who did NOT receive vincristine or <strong>PTX</strong> in Step 1 or Step 2, Grade ≥3 PN at Step 3 entry. </p>\n<p style=\"margin-left:58.0pt;\">\n NOTE: Severity of PN will be determined by the symptom severity scores from the BPNS, discussed in section 6.3.20 of the main protocol</p>\n<p>\n  </p>\n<p>\n  </p>\n<p style=\"margin-left:1.25in;\">\n f.     Breastfeeding.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.25in;\">\n g.    Other concurrent chemotherapy, immunotherapy, or radiotherapy.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.25in;\">\n h.    Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 3 entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n NOTE:  A tapering course of corticosteroids as acute therapy for PCP or if required for management of IRIS is an exception.</p>\n<p>\n Exclusion Criteria Step 4</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n a.         Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 4 entry and/or is not clinically stable. </p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n b.         Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 4 entry.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n c.         For patients who did NOT receive bleomycin in Step 1, Step 2, or Step 3:</p>\n<p style=\"margin-left:110.25pt;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         Development of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         Patients with an abnormal CXR or CT scan (which may indicate pulmonary KS) should undergo screening evaluations to rule out an infectious cause, per standard of care. If available, other diagnostic procedures such as bronchoscopy should be considered to confirm the presence or absence of pulmonary KS and/or an infectious agent. These procedures should be completed outside the study. These participants should be excluded if, in the opinion of the investigator, use of bleomycin in Step 4 would be detrimental.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 4 entry. </p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n NOTE: Exercise is defined as any activity that will increase a participant’s resting heart rate by20 beats/minute.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n d.         For participants who did NOT receive vincristine or <strong>PTX</strong> in Step 1, Step 2, or Step 3:</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.75in;\">\n ·         Grade ≥3 PN at Step 4 entry. </p>\n<p style=\"margin-left:1.25in;\">\n NOTE: Severity of PN will be determined by the symptom severity scores from the BPNS, discussed in section 6.3.20 of the main protocol</p>\n<p>\n  </p>\n<p>\n  </p>\n<p style=\"margin-left:.5in;\">\n e.         Breastfeeding.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n f.          Other concurrent chemotherapy, immunotherapy, or radiotherapy.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n g.         Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 4 entry.</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p>\n NOTE:  A tapering course of corticosteroids as acute therapy for PCP or if required for management of IRIS is an exception</p>\n
      • primary_end_points<div>\n PFS defined as a lack of KS progression, death, entry into an additional step, or</div>\n<div>\n loss to follow-up, prior to week 48.</div>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n 1. Dr. Kevin Cain MD </p>\n<p>\n 2. Dr. Vincent Oliver Otieno MBcHB, MPH</p>\n<p>\n 3. Dr. Joan Cain MD, Oncology</p>\n<p>\n 3. Dr. Elisha Okeyo MBcHB</p>\n<p>\n 4. John Okanda BSc, Nutrition</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The study is designed for resource limited settings, a criteria that does not fit the host/sponsors country.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI Scientific and Ethics Review Unit, 26 May 2016.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationFive 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_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites3
      • multi_country_listKenya, Uganda, South Africa, Malawi, Peru and Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNone
      • total_participants_worldwide706
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVincent
      • investigator1_middle_nameOliver
      • investigator1_family_nameOtieno
      • investigator1_qualificationMD
      • investigator1_professional_addressP.O BOX 1578-40100 Kisumu
      • investigator1_telephone+254720798294
      • investigator1_emailvoliver@kemricdc.org
      • organisations_transferred_Yes
      • number_participants50
      • notification
      • approval_date28-07-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-06-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-05-08 15:58:07
      • created2016-06-17 13:22:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id330
        • application_id504
        • given_nameVincent
        • middle_nameOliver
        • family_nameOtieno
        • qualificationMD
        • professional_addressP.O BOX 1578-40100 Kisumu
        • telephone+254 720798294
        • emailvoliver@kemricdc.org
        • created2016-06-17 13:28:26
        • modified2016-06-23 12:56:29
    • SiteDetail(array)
      • 0(array)
        • id394
        • application_id504
        • county_id42
        • site_nameKisumu CRS
        • physical_address Kisumu
        • contact_detailsP.O BOX 1578-40100
        • contact_personDr. Vincent Oliver Otieno
        • site_capacity(null)
        • misc(null)
        • created2016-06-17 13:28:26
        • modified2016-06-23 12:56:29
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id262
        • application_id504
        • sponsorThe National Institute of Allergy and Infectious Diseases (NIAID) The National Cancer Institute (NCI) National Institute of Dental Craniofacial Research (NIDCR)
        • sponsor_type(null)
        • contact_personDr. Kevin Cain
        • addressP.O BOX 1578-40100 Kisumu
        • telephone_number+254710602786
        • fax_number
        • cell_number+254710602786
        • email_addressbvz1@cdc.gov
        • created2016-06-17 13:28:26
        • modified2016-06-23 12:56:29
  • 1(array)
    • Application(array)
      • id1390
      • user_id263
      • trial_status_id6
      • abstract_of_study<p style=\"margin-left:-.25pt;\">\n Early and accurate diagnosis of an infectious disease such as HIV, TB and malaria is very important in helping control the burden the such an infectious disease. Early and accurate diagnosis enables early initiation of treatment before the start of complications.</p>\n<p style=\"margin-left:-.25pt;\">\n The current mainstay of diagnosis in all these infectious diseases involve invasive techniques and which do not give real time results. The mainstay of malaria, HIV and TB diagnosis has been blood smear for malaria microscopy, HIV antibody testing and sputum for microscopy (acid fast bacilli) and culture or gene expert respectively. The need for waiting time to get the results makes the diagnostic tests above not very useful for screening, especially in the community.</p>\n<p>\n As a consequence of the unmet need for an ideal screening test for these highly prevalent diseases, EDE research institute is investigating a device, that has a potential to diagnose malaria, TB and HIV in both asymptomatic and symptomatic individuals.</p>\n<p>\n  </p>\n<p>\n This is a multinational, multicenter, cross-sectional observational study in which approximately 2320 eligible participants, male and female, aged 18 years and above will be recruited in 3 groups. We propose to recruit at about 500 participants, 18 years and above at the ACTU site. The duration of participation for each participant will be approximately 1 day, inclusive of recruitment and follow up of the participants until study conclusion.</p>\n<p>\n  </p>\n<p>\n All statistical analyses described in the main protocol will be applied based on the same methodology independently, unless otherwise specified.</p>\n<p>\n  </p>\n<p style=\"margin-left:4.3pt;\">\n The publication of the results of the trial will be done in peer reviewed scientific journals in accordance with the governing clinical trial agreement, presented at scientific conferences and findings communicated to the local community through the Community Health Volunteers, Ministries of Health. Individual participants may also be reached and provided with the information if they wish to receive it individually.</p>\n<p style=\"margin-left:-.25pt;\">\n The data obtained in this study will be used to validate the EDE scanner for the diagnosis of malaria, tuberculosis and HIV.</p>\n
      • study_title<p style=\"margin-left:-.25pt;\">\n A non-interventional clinical validation study of the Exponential Deep Examination (EDE) scanner in the detection of human immunodeficiency virus (HIV), tuberculosis (TB) and malaria.</p>\n
      • laymans_summary<p>\n Exponential Deep Examination (EDE) scanner is an innovative device designed to detect infectious diseases and antimicrobial resistance, developed by the parent company of Servizi EDE Research LLC, which has been carrying out research and scouting technology for more than 10 years, developing, among the others, a technology for non-invasive genome detection. Such technology can detect electromagnetic (EM) waves from individuals within a 2–5 meter radius. As EM waves differ among healthy (non-infected) versus infected individuals due to presence of pathogenic DNA/RNA sequences, the technology classifies these EM waves based on their spectral signatures and subsequently identifies the pathogen based on its corresponding sequence.</p>\n<p>\n The technology researched and fine-tuned by the parent company of Servizi EDE Research LLC comprises three main elements: (1) An EDE detector (sensor) to measure EM waves; (2) A portable targeting device: Android based device (smartphone) connected to the internet to transmit information and point to a certain individual and display information; and (3) A machine learning (ML) model to identify the spectral signature compatible with the specific pathogen.</p>\n<p>\n The same technology was used by the parent company of Servizi EDE Research LLC as a component to develop and fine-tune another type of scanner, which demonstrated high accuracy in detecting the Coronavirus Disease 2019 (COVID-19) (i.e., the COVID-19 EDE scanner). When tested in the Emirate of Abu Dhabi in the United Arab Emirates (UAE), the COVID-19 EDE scanner showed device sensitivity and specificity of 96.7% and 98.12%, respectively, against the gold standard COVID-19 polymerase chain reaction (PCR) test. Moreover, similar results were shown in a study conducted by the Abu Dhabi Health Services Company (SEHA) and Union 71 laboratory testing firm, whereby analysis of 1,093 patient samples yielded a sensitivity and specificity of 93.5% and 83.0%, respectively, in the detection of COVID-19 using the COVID-19 EDE scanner. Based on these data, the Health Department of Abu Dhabi approved the use of COVID-19 EDE scanner as a screening technology in the detection of COVID-19, whereby individuals screened positive for COVID-19 via the scanner would subsequently undergo RT-PCR testing to confirm the diagnosis of COVID-19. The COVID-19 EDE Scanner was widely used as a mandatory screening tool to detect COVID-19 at land/air entry points, shopping malls and residential areas in Abu Dhabi during the COVID-19 pandemic.</p>\n<p>\n The EDE scanner has the potential to detect other pathogens as well, including human immunodeficiency virus (HIV), tuberculosis (TB), and hepatitis C (HCV), as demonstrated through a preliminary study by Servizi EDE Research LLC (100% sensitivity and specificity in detection of HIV, TB, and HCV). This preliminary study was conducted among 74 patients from hospitals across the UAE that included patients suspected of HIV as well as confirmed cases of HCV and TB. The EDE scanner successfully detected all the suspected and symptomatic  patients with HIV, HCV, and TB, as confirmed against the standard diagnostic tests performed for each of these infections (HIV: HIV viral load and HIV antibody test; HCV: anti-HCV antibody test and nucleic acid test; TB: acid fast bacilli test). Furthermore, EDE scanner may be used to detect antimicrobial resistance. Thus, with prospects to detect a wide range of pathogens and antimicrobial resistance, the EDE scanner has the potential to be used in various settings, including visa screening centers, hospitals, clinics, laboratories, airports, malls, land/air entry points, as well as for other commercial purposes.</p>\n<p>\n Unique features of the EDE scanner include its ability to generate results in real-time (immediately), and its non-invasiveness (no direct contact is required). The device can be used as a screening tool to prompt further diagnostic testing. Such novel diagnostic screening technology is even more important in countries with limited resources and limited access to conventional diagnostic laboratory infrastructure. These technological advancements may reduce the existing gap between diagnostic needs and diagnostic access especially in the middle- and low- income countries (such as African countries), where despite the substantial burden of infectious diseases, only 19% of patients have access to appropriate diagnostics at the primary health care level.</p>\n<p>\n The African continent bears the largest burden of infectious diseases worldwide. Of the estimated 10 million deaths globally per year caused by infectious diseases, the majority occur in Africa. Key contributors to this excessive burden include widespread HIV, malaria, and TB infections, which together account for nearly over 1.2 million deaths per year on the continent. Within the continent, HIV and malaria are highly prevalent across South Africa and Kenya, which are also among the 30 countries worldwide with high burden of TB and MDR-TB.</p>\n
      • short_titleEDE Scanner Study
      • protocol_noECCT/24/06/06
      • version_no1.1
      • date_of_protocol17-07-2024
      • study_drugN/A
      • disease_conditionMalaria, TB and HIV
      • 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_nameEDE Scanner
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data0
      • 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_plan0
      • applicant_contractual_agreement1
      • declaration_applicantElizabeth Miron
      • declaration_date112-11-2024
      • declaration_principal_investigatorDr Bernhards Ogutu
      • declaration_date212-11-2024
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary objective</strong></p>\n<p>\n To assess the sensitivity, specificity, PPV, and NPV of EDE scanner in the detection of infectious diseases of interest (HIV, TB, malaria)</p>\n<p>\n <strong>Secondary objective</strong></p>\n<p>\n To determine the frequency of symptoms (at enrollment) among patients screened positive and screened negative via EDE scanner, for each infectious disease of interest (HIV, TB, malaria), among patients with confirmed disease*</p>\n<p>\n <strong>Exploratory objectives</strong></p>\n<p>\n To assess the sensitivity, specificity, PPV, and NPV of EDE scanner in the detection of MDR-TB.</p>\n<p>\n To assess the sensitivity, specificity, PPV, and NPV of EDE scanner in the detection of HCV.</p>\n
      • principal_inclusion_criteria<p>\n <strong>Inclusion criteria</strong></p>\n<p>\n <strong>For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):</strong></p>\n<p>\n • Male or female, aged ≥18 years</p>\n<p>\n • Asymptomatic/symptomatic patients suspected of HIV, or symptomatic patients suspected of TB, malaria, or HCV based on physician’s clinical evaluation, which may include laboratory (eg, liver function tests, CBC) or radiological (eg, chest X-ray) tests per routine clinical practice</p>\n<p>\n • Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for the respective infectious disease (HIV/TB/malaria/HCV) - per routine standard of care, in parallel</p>\n<p>\n • Provision of signed informed consent For Group 2 (healthy participants):</p>\n<p>\n • Male or female, aged ≥18 years</p>\n<p>\n • Healthy participant, as determined by physician’s judgment</p>\n<p>\n • Participant undergoing routine blood test as per standard of care</p>\n<p>\n • Participant agrees to undergo non-invasive EDE scanner test</p>\n<p>\n • Participant permits use of the routine blood sample to conduct a standard diagnostic test for HIV, malaria, or HCV; or, participant agrees to provide a sputum sample to conduct a standard diagnostic test for TB</p>\n<p>\n • No evidence of active infectious disease or any infectious disease in the past 8 weeks</p>\n<p>\n • No history of any of the following in the past 6 months (at minimum): close contact with infected patients or infectious disease department, open/unprotected relations, drug abuse, blood transfusions</p>\n<p>\n • Provision of signed informed consent</p>\n<p>\n <strong>For Group 3 (suspected MDR-TB patients):</strong></p>\n<p>\n • Male or female, aged ≥18 years </p>\n<p>\n • Patients with documented pulmonary TB due to strains of Mycobacterium tuberculosis, currently on TB treatment as per routine clinical practice and suspected of MDR-TB based on physician’s clinical evaluation (eg, lack of treatment response to both isoniazid and rifampicin)</p>\n<p>\n • Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for MDRTB (per routine standard of care), in parallel</p>\n<p>\n • Provision of signed informed consent</p>\n<p>\n • Male or female, aged ≥18 years</p>\n<p>\n • Asymptomatic/symptomatic patients suspected of HIV, or symptomatic patients suspected of TB, malaria, or HCV based on physician’s clinical evaluation, which may include laboratory (eg, liver function tests, CBC) or radiological (eg, chest X-ray) tests per routine clinical practice</p>\n<p>\n • Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for the respective infectious disease (HIV/TB/malaria/HCV) - per routine standard of care, in parallel</p>\n<p>\n • Provision of signed informed consent For Group 2 (healthy participants):</p>\n<p>\n • Male or female, aged ≥18 years</p>\n<p>\n • Healthy participant, as determined by physician’s judgment</p>\n<p>\n • Participant undergoing routine blood test as per standard of care</p>\n<p>\n • Participant agrees to undergo non-invasive EDE scanner test</p>\n<p>\n • Participant permits use of the routine blood sample to conduct a standard diagnostic test for HIV, malaria, or HCV; or, participant agrees to provide a sputum sample to conduct a standard diagnostic test for TB</p>\n<p>\n • No evidence of active infectious disease or any infectious disease in the past 8 weeks</p>\n<p>\n • No history of any of the following in the past 6 months (at minimum): close contact with infected patients or infectious disease department, open/unprotected relations, drug abuse, blood transfusions</p>\n<p>\n • Provision of signed informed consent</p>\n<p>\n <strong>For Group 3 (suspected MDR-TB patients):</strong></p>\n<p>\n • Male or female, aged ≥18 years </p>\n<p>\n • Patients with documented pulmonary TB due to strains of Mycobacterium tuberculosis, currently on TB treatment as per routine clinical practice and suspected of MDR-TB based on physician’s clinical evaluation (eg, lack of treatment response to both isoniazid and rifampicin)</p>\n<p>\n • Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for MDRTB (per routine standard of care), in parallel</p>\n<p>\n • Provision of signed informed consent</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria</p>\n<p>\n <strong>For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):</strong></p>\n<p>\n • Current or previous history of treatment for HIV, TB, malaria, or HCV</p>\n<p>\n • Patients suspected to be co-infected with more than one of the infectious diseases of interest (HIV/TB/malaria/HCV)</p>\n<p>\n • Current or previous participation in any investigational drug or medical device study in the past 3 months</p>\n<p>\n • Patients on any concomitant antibiotic or antiviral treatment</p>\n<p>\n <strong>For Group 2 (healthy participants):</strong></p>\n<p>\n • Current or previous participation in any investigational drug or medical device study in the past 3 months</p>\n<p>\n • Participants on any concomitant antibiotic or antiviral treatment For Group 3 (suspected MDR-TB patients):</p>\n<p>\n • Previous history of treatment for MDR-TB or extensive drug resistance TB (XDR-TB)</p>\n<p>\n • Current or previous participation in any investigational drug or medical device study in the past 3 months</p>\n<p>\n • Patients on any concomitant antibiotic or antiviral treatment</p>\n
      • primary_end_points<p>\n Sensitivity, specificity (with 95% CI), PPV, and NPV of EDE scanner compared with reference standard diagnostic tests in the detection of infectious diseases of interest (HIV, TB, malaria).</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyobservational study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n VIBRI Site</p>\n<p>\n 1. PI Dr. Lucas Otieno Tina, MBChB MSc. DLSHTM</p>\n<p>\n 2. Sub-Investigators- Dr. Walter Otieno, MBChB, MMED (Paeds), PhD</p>\n<p>\n Dr. Antony Oindo, MBChB</p>\n<p>\n Dr. Kenson Nyolmo Kipchumba, MBChB</p>\n<p>\n Dr. Diana Odhiambo, MBChB, MBA, MPH</p>\n<p>\n Dr. Grace Lanoi, MBChB, MMED (Paeds)</p>\n<div style=\"clear:both;\">\n 3. Pharmacist: Dr. Melanie Miruka, BPharm</div>\n<div style=\"clear:both;\">\n  </div>\n<div style=\"clear:both;\">\n Site Siaya Clinical Trials Annext</div>\n<div style=\"clear:both;\">\n 1. PI Prof. Videlis Nduba</div>\n<div style=\"clear:both;\">\n  </div>\n<div style=\"clear:both;\">\n 2. Sub-Investigators</div>\n<div style=\"clear:both;\">\n Dr Mercy Muderi Mwale - Medical Officer </div>\n<div style=\"clear:both;\">\n Dr. Mike Odoyo: Medical Officer</div>\n<div style=\"clear:both;\">\n  </div>\n<div style=\"clear:both;\">\n 3. Pharmacists</div>\n<div style=\"clear:both;\">\n Dr. Ian Mwangi </div>\n<div style=\"clear:both;\">\n Emily Naiserian </div>\n<div style=\"clear:both;\">\n  </div>\n<div style=\"clear:both;\">\n Ahero Clinical Trials Unit</div>\n<div style=\"clear:both;\">\n 1. PI Dr Bernhards Nduba</div>\n<div style=\"clear:both;\">\n  </div>\n<div style=\"clear:both;\">\n 2. Sub-Investigators.</div>\n<div style=\"clear:both;\">\n Dr. John Orimbo</div>\n<div style=\"clear:both;\">\n Dr. Fredrick Olewe</div>\n<div style=\"clear:both;\">\n Dr. Godfrey Allan Otieno</div>\n<div style=\"clear:both;\">\n Dr. John Michael Ong’echa</div>\n<div style=\"clear:both;\">\n  </div>\n<div style=\"clear:both;\">\n 3. Pharmacists</div>\n<div style=\"clear:both;\">\n Dr. Ruth Wasuna</div>\n<div style=\"clear:both;\">\n Dr. Simeon Onyango</div>\n<div style=\"clear:both;\">\n  </div>\n
      • other_details_explanation<p>\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">The Study Primary Objective is to assess the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of EDE scanner in the detection of infectious Sensitivity, specificity (with 95% CI), PPV, and NPV of EDE scanner compared with reference standard diseases of interest (HIV, TB, malaria). </span></p>\n<p>\n  </p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">The African continent bears the largest burden of infectious diseases worldwide. Of the estimated 10 million deaths globally per year caused by infectious diseases, the majority occur in Africa. Key contributors to this excessive burden include widespread HIV, malaria, and TB infections, which together account for nearly over 1.2 million deaths per year on the continent. Within the continent, HIV and malaria are highly prevalent across South Africa and Kenya, which are also among the 30 countries worldwide with high burden of TB and MDR-TB.</span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">There is no pool of patients in the host country UAE for HIV, Malaria and TB.</span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\"> </span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">A previous study on this device was done in UAE on COVID 19.  Protocol Synopsis of this study (protocol EDECOVID02) is included in this application. The study was designed for 5-7 sites and 1500 participants from UAE.</span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\"> </span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">Sponsor also  investigated the epidemiological status of tuberculosis (TB), hepatitis C</span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">(HCV), and human immunodeficiency virus (HIV), in different hospitals in</span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">UAE.</span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">The EDE machine was tested on:</span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">• 14 people who were quarantined in the hospitals and suspected of having HIV.</span></p>\n<p style=\"margin-bottom: 0px; margin-top: 8px;\">\n • 51 cases of Hepatitis C</p>\n<p>\n <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\"><span style=\"font-size: inherit;\">• 9 cases of TB infection</span></span></p>\n
      • other_details_regulatory_notapproved<p>\n South Africa Health Product Regulatory Authority submitted on 5th April</p>\n
      • other_details_regulatory_approved<p>\n None.</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration6-8 months
      • 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_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites3
      • multi_country_listSouth Africa
      • data_monitoring_committeeNo
      • total_enrolment_per_siteA proximately 387 participants will be enrolled per site
      • total_participants_worldwide2320
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBChB MPH
      • investigator1_professional_addressP.O BOX 54-40100 KISUMU
      • investigator1_telephone0733812613
      • investigator1_emailOgutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants1160
      • notification
      • approval_date20-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-06-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted26-06-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed adequately.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-08-05 12:14:47
      • created2024-03-21 15:01:10
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1050
        • application_id1390
        • given_nameBernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB MPH
        • professional_addressP.O BOX 54-40100 KISUMU
        • telephone0733812613
        • emailOgutu6@gmail.com
        • created2024-03-21 15:26:14
        • modified2024-11-12 14:46:12
      • 1(array)
        • id1055
        • application_id1390
        • given_nameLucas
        • middle_name
        • family_nameTina
        • qualificationMBChB MPH
        • professional_addressP.O BOX 7180-40100 KISUMU
        • telephone0720597654
        • emailltina@vibriafrica.org
        • created2024-04-08 11:54:26
        • modified2024-11-12 14:46:12
      • 2(array)
        • id1056
        • application_id1390
        • given_nameVIDELIS
        • middle_name
        • family_nameNDUBA
        • qualificationMBChB MPH PHD
        • professional_addressP.O BOX 254 NAIROBI
        • telephone0724522474
        • emailvnduba@kemri.go.ke
        • created2024-04-08 11:54:26
        • modified2024-11-12 14:46:12
    • SiteDetail(array)
      • 0(array)
        • id1687
        • application_id1390
        • county_id42
        • site_nameVICTORIA BIOMEDICAL RESEARCH INSTITUTE
        • physical_addressKisumu County Referral Hospital
        • contact_detailsP.O Box 2109, Kisumu, Kenya, Postal Code 40100
        • contact_personDr Lucas Tina
        • site_capacity(null)
        • misc(null)
        • created2024-03-21 15:26:14
        • modified2024-11-12 14:46:12
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1721
        • application_id1390
        • county_id41
        • site_nameKEMRI/CRDR Siaya Clinical Trials Annex
        • physical_addressSiaya Clinical trials annex Insite Siaya Country referral Hospital
        • contact_details0724522474
        • contact_personProf Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-06-12 12:28:45
        • modified2024-11-12 14:46:12
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 2(array)
        • id1722
        • application_id1390
        • county_id42
        • site_nameAhero Clinical Trials Unit
        • physical_addressAhero clinical trial Unit insite ahero Sub-County Hospital along Kisumu Nairobi highway
        • contact_details0733812613
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-06-12 12:32:56
        • modified2024-11-12 14:46:12
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id734
        • application_id1390
        • sponsorServizi EDE Research LLC
        • sponsor_typeIndustry
        • contact_person Salvatore Spagna
        • addressSharjah Media City, Sharjah, United Arab Emirates
        • telephone_number+971562240274
        • fax_number
        • cell_number+971562240274
        • email_addresssalvo.spagna@ede.ae
        • created2024-03-21 15:26:14
        • modified2024-11-12 14:46:12
  • 2(array)
    • Application(array)
      • id516
      • user_id38
      • trial_status_id7
      • abstract_of_study<p>\n This is a multi-country, prospective, long-term clinical safety study designed to extend the total follow-up period of vaccinated subjects up to 60 months (including the duration in the subject's original study), to allow collectio of serious adverse events and pregnancy outcomes (including spontaneous/elective abortion, intrauterine death/stillbirth, information on delivery) following administration of Ad26.ZEBOV and/or MVA-BN-Filo for theprevention of Ebola virus disease among subjects who participated in a Phase 1, 2 or 3 clinical study. In addition, offspring from vaccinated female subjects who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2 or 3 clinical study will be followed up to 60 months after birth. Up to approximately 5, 500 subjects may potentially be enrolled in this study, based on the number of exposed subjects in the contributing Phase 1, 2 or 3 clinical studies.</p>\n<p>\n This study will consist of an enrollment visit, a number of follow-up contacts and an end-of-study contact. These contacts are preferably conducted by phone; if not possible, a study site visit needs to be organized. Preferably, offspring from vaccinated female subjects will visit the study site for every study visit. If not possible, the child may be visited at home by study site staff or a qualified health care worker for data collection.</p>\n<p>\n Data collection can start when a signed informed consent from (ICF) is available for the current study. Preferably, signing of the ICF occurs at the last visit of the subject's original study (or at birth for offspring). If this is not possible, baseline data will be collected when a signed ICF is available and data need to be captured retrospectively up to the moment of enrollment in the current study.</p>\n
      • study_title<p style=\"margin-left: 40px;\">\n A Multi-country, prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines AD26.ZEBOV and or/ MVA-BN-Filo</p>\n
      • laymans_summary(null)
      • short_titleVAC52150EBL4001
      • protocol_noECCT/16/07/01
      • version_noversion date 25 Nov 2016
      • date_of_protocol25-11-2015
      • study_drugThis is a long term safety follow up study of subjects who received Ebola trial vaccine.
      • disease_conditionEbola
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_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_applicantVictorine Owira
      • declaration_date106-07-2016
      • declaration_principal_investigatorVictorine Owira
      • declaration_date206-07-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. male or female who participated in a phase 1, 2 or 3 clinical study with Ad26.ZEBOV and/or MVA-BN-Filo and has been exposed to Ad26.ZEBOV and/or MVA-BN-Filo( Cohort 1);</p>\n<p>\n or</p>\n<p>\n Female who participated in a phase 1, 2 or 3 clinical study with Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vacicnation with Ad26.ZEBOV (Cohort 2);</p>\n<p>\n or</p>\n<p>\n Child born to a female subject exposed to Ad26.ZEBOV and/or MVA-BN-Filo in a phase 1, 2 or 3 clinical study who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV (Cohort 3).</p>\n<p>\n 2. Must sign an ICF for the current study (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study (or let their child participate).</p>\n
      • principal_exclusion_criteria<p>\n No exclusions beyond those not meeting the inclusion criteria will be made for participation.</p>\n
      • primary_end_points<p>\n Incidence of serious adverse events in subjects exposed to Ad26.ZEBOV and/or MVA-BN-Filo in a phase 1, 2 or 3 clinical study, up to 60 months after prime vaccination.</p>\n<p>\n Incidence of pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV.</p>\n<p>\n Incidence of pregnancy by pregnancy outcome .</p>\n<p>\n Incidence of live-born children from a pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV.</p>\n<p>\n Incidence of serious adverse events in children born from a pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV up to 60 months after birth.</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_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n KAVI site has 5 investigators, I study cooedinator, study nurses, Laboratory technicians and technologist.</p>\n
      • other_details_explanation<p>\n This study is being conducted in countries where volunteers were previously (or currently) exposed to Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. This includes but not limited to, Kenya, Uganda, France, The United Kingdom, The United States, Sierra Leone, Burkina Faso, Ivory Coast, Tanzania, Nigeria, Rwanda and Mozambique.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n US submission was completed on 21 Jan 2016. The RA approval granted on 18 Feb 2016 - 7 sites</p>\n<p>\n UK submission done on 10 Jan 2016. The RA approval was granted on 19 Feb 2016 - 4 sites</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_durationSafety information will be collected by phone for up to 5 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_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states9
      • number_of_sites3
      • multi_country_listKenya, Uganda, Tanzania, Rwanda, Nigeria, Burkina Faso, Ivory Coast, Mozambique and Sierra Leone,
      • data_monitoring_committeeNo
      • total_enrolment_per_site150
      • total_participants_worldwide5500
      • 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_nameOmu
      • investigator1_middle_name
      • investigator1_family_nameAnzala
      • investigator1_qualificationMBChB. PhD
      • investigator1_professional_addressDirector, KAVI-Institute of Clinical Research (KAVI-ICR) School of Medicine, College of Health Sciences University of Nairobi. P.O. Box 19676-00202, Nairobi, Kenya
      • investigator1_telephone+254733-729965 or +254727-555279
      • investigator1_emailoanzala@kaviuon.org
      • organisations_transferred_Yes
      • number_participants150
      • notification
      • approval_date15-08-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-07-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-10-19 00:12:43
      • created2016-07-06 16:37:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id338
        • application_id516
        • given_nameOmu
        • middle_name
        • family_nameAnzala
        • qualificationMBChB. PhD
        • professional_addressDirector, KAVI-Institute of Clinical Research (KAVI-ICR) School of Medicine, College of Health Sciences University of Nairobi. P.O. Box 19676-00202, Nairobi, Kenya
        • telephone+254733-729965 or +254727-555279
        • emailoanzala@kaviuon.org
        • created2016-07-06 16:46:37
        • modified2016-07-08 15:10:31
    • SiteDetail(array)
      • 0(array)
        • id400
        • application_id516
        • county_id47
        • site_nameKAVI-Institute of Clinical Research
        • physical_addressKenyatta National Hospital, Nairobi-Kenya
        • contact_detailsP.O. Box 19676-00202, Nairobi, Kenya. +254733-729965/+254727-555279
        • contact_personProf. Omu Anzala
        • site_capacity(null)
        • misc(null)
        • created2016-07-06 16:46:37
        • modified2016-07-08 15:10:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id401
        • application_id516
        • county_id42
        • site_nameKenya medical Research Institute/Walter Reed Project Kombewa
        • physical_addressoff Kisumu-Bondo Road opposite Kombewa county Referal Hospital
        • contact_detailsP.O Box 54-40100, Kisumu, Kenya.
        • contact_personDr Janet Oyieko
        • site_capacity(null)
        • misc(null)
        • created2016-07-06 17:50:47
        • modified2016-07-08 15:10:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id402
        • application_id516
        • county_id35
        • site_nameKenya medical Research Institute/Walter Reed Project Kombewa
        • physical_addressAlong Kisumu-Nairobi Road
        • contact_detailsP.O Box 1357-20200 Kericho
        • contact_personDr Fredrick Sawe
        • site_capacity(null)
        • misc(null)
        • created2016-07-06 17:50:47
        • modified2016-07-08 15:10:31
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id268
        • application_id516
        • sponsorJanssen Pharmaceutical Companies of Johnson and Johnson
        • sponsor_type(null)
        • contact_personJoanna Pomorska
        • addressPAREXEL International Å»wirki i Wigury 18A 02-092 Warszawa, Poland
        • telephone_number+48 663 663 934
        • fax_number+48 22 452 13 00
        • cell_number+48 663 663 934
        • email_addressJoanna.Pomorska@parexel.com
        • created2016-07-06 16:46:37
        • modified2016-07-08 15:10:31
  • 3(array)
    • Application(array)
      • id914
      • user_id636
      • trial_status_id5
      • abstract_of_study<p style=\"direction: ltr; \">\n First in human study to demonstrate the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts.</p>\n<p style=\"direction: ltr;\">\n Feefteen subjects will be enrolled after screening by the participating clinical sites’ clinical team (physician and study staff) during a screening visit. Each subject will sign the ICF prior to any study activities and will be evaluated for inclusion and exclusion criteria. Only eligible subjects will be enrolled.</p>\n<p style=\"direction: ltr;\">\n Demographic data, medical history and concomitant medication use data will be collected from enrolled subjects. Subjects will be implanted with the CorNeat EverPatch and followed-up for ocular wall integrity at the implantation site (primary endpoint) and stability in patch dimensions - less than 10% change (length, projected width and thickness) measured by OCT on 6 months and 12 months. 9 clinic visits will be required: Screening, Implantation and 7 follow up visits. During follow-up visits safety data and use of concomitant medications will be documented. Subjects successfully completing 12 months of follow-up will be monitored for device retention and local tissue reaction every 6 months by a comprehensive ophthalmologist’s exam.</p>\n<p style=\"direction: ltr;\">\n Follow-up plan will include complete clinical exam and anterior segment OCT examining the EverPatch and measuring its dimensions. An alternative to OCT is Ultra Sound Bio-Microscopy (UBM)- high frequency US.</p>\n<p style=\"direction: ltr;\">\n  </p>\n
      • study_title<p dir=\"ltr\">\n <strong>The CorNeat EverPatch – A First-In-Human Clinical Study for Demonstrating the Safety of a Synthetic Tissue Substitute for Concealment of Artificial Implants and Glaucoma Tube Shunts</strong></p>\n<p>\n  </p>\n
      • laymans_summary<p style=\"direction: ltr; \">\n This is a First in human study aimed to demonstrate the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts.</p>\n<p style=\"direction: ltr;\">\n Each subject will sign an informed consent form prior to any study activities. Subjects will be screened by the participating clinical sites’ clinical team (physician and study staff) during a screening visit and will be evaluated for inclusion and exclusion criteria. Only eligible subjects will be enrolled.</p>\n<p style=\"direction: ltr;\">\n Demographic data, medical history and concomitant medication use data will be collected from enrolled subjects. Subjects will be implanted with the CorNeat EverPatch and followed-up for ocular wall integrity at the implantation site (primary endpoint) and stability in patch dimensions - less than 10% change (length, projected width and thickness) measured by OCT on 6 months and 12 months. 9 clinic visits will be required: Screening, Implantation and 7 follow up visits. During follow-up visits safety data and use of concomitant medications will be documented. Subjects successfully completing 12 months of follow-up will be monitored for device retention and local tissue reaction every 6 months by a comprehensive ophthalmologist’s exam.</p>\n<p style=\"direction: ltr;\">\n Follow-up plan will include complete clinical exam and anterior segment OCT examining the EverPatch and measuring its dimensions. An alternative to OCT is Ultra Sound Bio-Microscopy (UBM)- high frequency US.</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • short_titleCorNeat EverPatch
      • protocol_noECCT/20/08/01
      • version_no7.2
      • date_of_protocol11-06-2020
      • study_drugCorNeat EverPatch
      • disease_conditionConcealment of artificial implants and glaucoma tube shunts
      • 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_namePermanent ophthalmic implant
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressido@corneat.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantGerry Tal
      • declaration_date103-08-2020
      • declaration_principal_investigatorLily Nyamai
      • declaration_date203-08-2020
      • placebo_presentNo
      • study_objectives<p style=\"direction: ltr; \">\n This clinical trial will assess the safety of the CorNeat EverPatch device</p>\n
      • principal_inclusion_criteria<ol>\n <li style=\"direction: ltr; text-align: left;\">\n Male or female</li>\n <li style=\"direction: ltr; text-align: left;\">\n Aged ≥ 18 and ≤ 80 years on screening day</li>\n <li style=\"direction: ltr; text-align: left;\">\n Concealment of an artificial ophthalmic implant or a glaucoma tube shunt is indicated.</li>\n <li style=\"direction: ltr; text-align: left;\">\n Candidates must have the ability and willingness to attend all scheduled visits and   comply with all study procedures</li>\n <li style=\"direction: ltr; text-align: left;\">\n Adequate tear film and lid function </li>\n <li style=\"direction: ltr; text-align: left;\">\n Visual acuity of light perception or better</li>\n <li style=\"direction: ltr; text-align: left;\">\n Female patients of childbearing age must agree to use a method of contraception and have negative pregnancy test at screening. An effective method of contraception must be used throughout the study.</li>\n</ol>\n<p style=\"direction: ltr; \">\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li style=\"direction: ltr; text-align: left;\">\n Current retinal detachment</li>\n <li style=\"direction: ltr; text-align: left;\">\n Active ocular or orbital infection</li>\n <li style=\"direction: ltr; text-align: left;\">\n History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation</li>\n <li style=\"direction: ltr; text-align: left;\">\n History of ocular or periocular malignancy</li>\n <li style=\"direction: ltr; text-align: left;\">\n History of extensive keloid formation</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or         component of the device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Signs of current infection, including fever and current treatment with antibiotics</li>\n <li style=\"direction: ltr; text-align: left;\">\n Severe generalized disease that results in a life expectancy shorter than a year</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Currently pregnant or breastfeeding</li>\n <li style=\"direction: ltr; text-align: left;\">\n Participation in any study involving an investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Intraoperative complication that would preclude implantation of the study device.</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any traumatic perforation</li>\n <li style=\"direction: ltr; text-align: left;\">\n Tissue gaps/weaknesses, resulting either from traumatic, disease-related or iatrogenic damage</li>\n <li style=\"direction: ltr; text-align: left;\">\n Loss of scleral integrity where use of tissue or substitutes is indicated</li>\n</ol>\n<p style=\"direction: ltr; \">\n  </p>\n
      • primary_end_points<p style=\"direction: ltr;\">\n Primary Safety Endpoint:</p>\n<p style=\"direction: ltr;\">\n The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation of the CorNeat EverPatch device, and follow-up for up to 12 months will be 10% or less.</p>\n<p style=\"direction: ltr;\">\n Effectiveness Endpoints:</p>\n<p style=\"direction: ltr;\">\n Primary: Conjunctival integrity at the implantation site will be 90% or more.</p>\n<p style=\"direction: ltr;\">\n Secondary: Stability in patch dimensions, less than 10% change (length, projected width and thickness) measured by OCT after 1-week and follow-up for up to 12 months post-implantation in 90% of the implanted patients</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_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 dir=\"RTL\" style=\"direction: ltr; margin-right: 5.4pt;\">\n The proposed sites can ensure patient safety as they are centers of excellence. The centers are all well equipped to manage glaucoma cases and any complication if they occur; they all have well-equipped clinics, OR (operating room), pharmacies and lasers used in glaucoma (YAG, SLT). The PI will conduct enrollment, surgeries and follow-up in both centers. There is room for cross referral across disciplines in all centers.</p>\n<p style=\"direction: ltr;\">\n Additionally, EverPatch device replaces the use of artificial / tissue-based patches and does not require any specific change in the implantation procedure. Dr. Nyamai has successfully completed the Sponsor’s training during which the necessary information pertaining the specific protocol, the investigational product, data collection procedures and safety management was provided. This training was set to ensure that the clinical study will be conducted in accordance with the study protocol and Good Clinical Practice principles.</p>\n<p style=\"direction: ltr;\">\n <u>Description of Study Sites in Kenya:</u></p>\n<ol>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>Lions SightFirst Hospital</strong> -  is the largest eye hospital in Kenya. It is well equipped with subspecialty clinics, operating room (OR), diagnostic equipment (OCT and visual fields), pharmacies and lasers used in glaucoma (Argon, YAG). The glaucoma patients at the Lions SightFirst hospital are currently followed up by general ophthalmologists and clinical officers.  These ophthalmologists get referrals from outreach activities and other subspecialty clinics (cornea and retina). The clinic has an average of 20- 30 glaucoma patients visiting per week with 7-10 glaucoma surgeries performed per week. The PI will carry out a glaucoma clinic on two clinic days and one operating day for purposes of the study.</li>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>The Kenyatta National Hospital</strong> – is the oldest and largest hospital in the country. The PI also runs a general ophthalmology clinic in the KNH COC, with an average of 5 patients a month with a diagnosis of glaucoma. As the clinic in COC is relatively new and first line treatment for glaucoma is eye drops, only about 1 patient a month or less requires an Ahmed Glaucoma Valve (AGV) insertion. Ophthalmologists from the specialist clinics from the general eye clinic in the hospital will also be engaged by referring cases for AGV insertion.</li>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>The Kwale Eye institute</strong> - is a well-equipped center with clinics, OR, diagnostic equipment (OCT and visual fields) pharmacy, wet-lab and lasers used in glaucoma (SLT, YAG & Argon). The Kwale Eye Center has about 20 glaucoma patients per week seen at the general ophthalmology clinic. Glaucoma surgeries performed are about 3 per week. The PI will carry out clinic and OR for purposes of the study as deemed necessary.</li>\n</ol>\n<p style=\"direction: ltr;\">\n The PI assists with outreach activities at the Kwale Eye Center and was trained in cataract surgery and general ophthalmology in this center during her elective term as a resident in ophthalmology under the mentorship of Dr. Helen Roberts, a general ophthalmologist  and medical director of the hospital</p>\n<p style=\"direction: ltr;\">\n Kwale Eye Institute has conducted a clinical study on SLT laser in glaucoma among African eyes and was able to conclude the effectiveness of SLT laser in an African population; in addition, they acquired an SLT laser machine for the center through the study. The Kwale and Lions Sight first Eye centers have also been active in clinical research through residents in ophthalmology attending elective terms there, carrying out research for their dissertation.</p>\n<p style=\"direction: ltr;\">\n  </p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_explanation<p style=\"direction: ltr; \">\n Clinical sites have been chosen according to future markets planned for the devices</p>\n
      • other_details_regulatory_notapproved<p style=\"direction: ltr; \">\n ANSM - French National Agency for Medicines and Health Products Safety - Submitted on April 12th, 2020</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_regulatory_approved<p style=\"direction: ltr; \">\n Health Canada (Canada) - approved on December 16th, 2019; Two sites in Canada</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_regulatory_rejected<p style=\"direction: ltr; \">\n Not Applicable</p>\n
      • other_details_regulatory_halted<p style=\"direction: ltr; \">\n Not Applicable</p>\n
      • estimated_duration3 months recruitment + 12 months follow up = up to 15 months
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorHistorical Data
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites3
      • multi_country_listCanada, France, Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_siteLions SightFirst hospital will recruit 8 participants for the study, KNH (Kenyatta National Hospital) will recruit 2 participants and The Kwale center will recruit 5 participants
      • total_participants_worldwide40
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLily
      • investigator1_middle_nameAdhiambo
      • investigator1_family_nameNyamai
      • investigator1_qualificationCertified Ophthalmologist MBChB, MMed Ophth, FCOECSA, Fellowship Glaucoma
      • investigator1_professional_addressUniversity of Nairobi, P.O. BOX 19676, Nairobi, Kenya
      • investigator1_telephone+254721710027
      • investigator1_emaillilynyamai@gmail.com
      • organisations_transferred_No
      • number_participants15
      • notification
      • approval_date10-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication approved by the expert committee
      • final_report<p>\n <strong>Introduction:</strong> This executive summary presents the key findings from the CorNeat EverPatch FIH clinical trial, conducted at two clinical sites in Kenya: Lions SightFirst Hospital in Nairobi and Kwale Eye Center in Mombasa. The trial aimed to evaluate the safety and efficacy of the CorNeat EverPatch, a novel medical device for ocular applications.</p>\n<p>\n <strong>Clinical Site: Lions SightFirst Hospital – Nairobi, Kenya:</strong></p>\n<p>\n Of the 8 implanted patients, 4 patients successfully completed the 12-month follow-up without noteworthy device-related complications. It's important to note that a unique surgical technique was employed, with sutures placed on top of the implanted patch, which may have affected the outcomes due to potential migration and increased susceptibility to breakdown.</p>\n<p>\n A single patient experienced patch exposure and complications leading to implant removal, primarily due to recurrent conjunctival erosion and infection. Another patient had patch exposure, leading to implant removal and replacement with another CorNeat EverPatch. No significant damage to ocular structures was noted in either case.</p>\n<p>\n Two additional patients exhibited recurring patch exposure, which resolved without surgical intervention. No other abnormalities were observed.</p>\n<p>\n <strong>Clinical Site: Kwale Eye Center – Mombasa, Kenya:</strong></p>\n<p>\n Five patients were enrolled to the trial out of which, 2 patients completed the follow-up period without any adverse reactions, indicating the safety of the CorNeat EverPatch in these cases.</p>\n<p>\n A single patient experienced a large conjunctival defect and patch exposure at 2 months post-op, which recurred after a failed attempt to close the gap with sutures. At 9 months post-op, the patch was surgically removed, replaced with a scleral patch, and covered with conjunctiva graft. No infection or adverse reactions to ocular tissues were observed.</p>\n<p>\n The trial excluded the two remaining patients, with one being lost to follow-up, and the other passing away during the trial from natural causes unrelated to the device or the procedure.</p>\n<p>\n  </p>\n
      • implication_results<p>\n The CorNeat EverPatch FIH clinical trial in Kenya has yielded mixed results. While some patients experienced successful implantation without complications, others faced patch exposure and device-related complications, leading to explantation. The unique surgical technique employed may have influenced outcomes. Further evaluation and refinement of the device and surgical approach are warranted to enhance the safety and efficacy profile. These findings will contribute valuable insights for the ongoing development and regulatory evaluation of the CorNeat EverPatch in Kenya.</p>\n<p>\n  </p>\n
      • quantity_imported20
      • quantity_dispensed20
      • quantity_destroyed6
      • quantity_exportedNA
      • balance_site0
      • final_date0000-00-00
      • modified2023-09-06 10:47:39
      • created2020-06-23 08:29:27
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id565
        • application_id914
        • given_nameLily
        • middle_nameAdhiambo
        • family_nameNyamai
        • qualificationCertified Ophthalmologist MBChB, MMed Ophth, FCOECSA, Fellowship Glaucoma
        • professional_addressUniversity of Nairobi, P.O. BOX 19676, Nairobi, Kenya
        • telephone+254721710027
        • emaillilynyamai@gmail.com
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
    • SiteDetail(array)
      • 0(array)
        • id787
        • application_id914
        • county_id47
        • site_nameLions SightFirst Hospital
        • physical_addressKaptagat Rd, Nairobi, Kenya
        • contact_details+254721710027
        • contact_personDr. Lily Nyami
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id788
        • application_id914
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressHospital Rd, Nairobi, Kenya
        • contact_details+254722766233
        • contact_personDr. Owen Ogony
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:49:09
        • modified2020-08-05 16:05:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id789
        • application_id914
        • county_id2
        • site_nameKwale Eye Centre
        • physical_addressLikoni-Ukunda Rd, Mombasa, Kenya
        • contact_details+25472220287
        • contact_personDr. Helen Roberts
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:49:09
        • modified2020-08-05 16:05:31
        • County(array)
          • id2
          • county_nameKwale
          • created2012-05-31 16:15:21
          • modified2012-05-31 16:15:21
    • Sponsor(array)
      • 0(array)
        • id439
        • application_id914
        • sponsorCorNeat Vision
        • sponsor_typeIndustry
        • contact_personGerry Tal
        • addressHasheizaf 4, st Raanana, Israel
        • telephone_numberNA
        • fax_number
        • cell_number+972 52-356-2826
        • email_addressgerry@corneat.com
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
  • 4(array)
    • Application(array)
      • id1019
      • user_id73
      • trial_status_id5
      • abstract_of_study<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\"><strong>Background</strong></span></p>\n<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">SARS-CoV-2 is a novel coronavirus that emerged in the human population and has led to a pandemic of acute respiratory disease named COVID-19. The burden of SARS-CoV-2 morbidity and mortality has been catastrophic with greater than 2.8 million deaths recorded since first emerging in December 2019 among over 131.9 million confirmed cases (as of 06 April 2021) (2). In many locations, the rapid emergence of COVID-19 has overwhelmed the capacity of health systems to provide care for COVID-19-affected patients, let alone unaffected patients. Interventions to reduce transmission through reduction of population contact (also called social distancing) has had profound economic consequences. Safe and effective vaccines with sufficient supply would be vital to address the significant medical and societal burden caused by the pandemic. The CoV2 preS dTM-AS03 vaccines developed by Sanofi Pasteur utilize a recombinant protein approach in combination with an oil-in-water adjuvant, AS03 provided by GlaxoSmithKline (GSK). The CoV2 preS dTM-AS03 vaccines belong to the pharmacotherapeutic group of “covid19 vaccines”. The vaccines contain recombinant S protein, stabilized to maintain native prefusion trimer configuration as present on the viral envelope. The purpose of the study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) in adults 18 years of age and older in a multi-stage approach.</span></p>\n<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\"><strong>Methods</strong></span></p>\n<p class=\"p1\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; margin: 0px; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">This study is designed to maximize representation of the broader population by minimizing exclusionary eligibility criteria and allowing the participation of individuals with a broad range of medical conditions, including controlled HIV infection, Hepatitis B and Hepatitis C, and conditions associated with an increased risk of severe COVID-19. It is also designed to be inclusive of other subpopulations affected by COVID-19, including older adults as well as ethnic and racial minorities. Participants will be screened for eligibility criteria at the time of inclusion and then randomized to either the investigational vaccine or placebo in a 1:1 ratio in each stage. • Stage 1: eligible participants will be randomized to receive either 2 injections of CoV2 preS dTM-AS03 (D614) vaccine or Placebo 1 (participants who receive the placebo as part of Stage 1) administered 21 days apart • Stage 2: eligible participants will be randomized to receive 2 injections of either CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine or Placebo 2 (participants who receive placebo as part of Stage 2) administered 21 days apart. Randomization will be stratified by age groups (18-59 years of age and 60 years of age and older), baseline SARS-CoV-2 rapid serodiagnostic test positivity, and site. In the event that the enrollment in Stage 1 overlaps with enrollment of Stage 2, participants will continue to be randomly allocated to one of the investigational vaccine groups and their matched placebo group in a 1:1 ratio. Approximately 37 430 participants are planned to be enrolled (8000 per study intervention group in Stage 1 and 10 715 per study intervention group in Stage 2)The duration </span><span style=\"font-size: 11px;\">of the study for each participant will be 365 days post-last injection (ie, approximately 386 days total). The study includes 8 visits at D01, D22, D43, D78, D134, D202, D292, and D387. Participants will be contacted once a week over the entire duration of the study to inquire about the development of symptoms of COVID-19-like-illness and to remind participants to contact study staff if they experience symptoms of COVID-19-like illness. Additional visits and procedures are included for participants with verified COVID-19-like illness.</span></p>\n
      • study_title<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of ageand older</span></p>\n
      • laymans_summary<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-This is a Phase 3 study (efficacy study) of two experimental vaccines against SARS-CoV-2. The full names are:</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">1. Monovalent: SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, monovalent D614 (CoV2 preS dTMAS03 [D614])</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);margin-left: 40px;\">\n <span style=\"font-size:11px;\">2. Bivalent: SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, bivalent D614/B.1.351 (CoV2 preS dTM-AS03 [D614 + B.1.351])</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-This study is also known as “VAT00008” or “CoVPN 3005.”</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study vaccine is developed by Sanofi Pasteur, a company that produces vaccines against other diseases such as diphtheria, tetanus, pertussis, meningitis and</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">influenza.</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The vaccine will be manufactured using the same technology as is used to make an influenza vaccine that is licensed in the US for the prevention of influenza in</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">adults, marketed as Flublok .</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study will enroll about 37,500 participants globally.</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The purpose of the study is to learn if:</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study vaccines can prevent symptomatic COVID-19 illness</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The vaccines are safe</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The vaccines make people too uncomfortable</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study vaccines can prevent infection with SARS-CoV-2</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">-The study vaccines can prevent severe COVID-19 illness and hospitalization</span></p>\n<p class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n
      • short_titleVAT00008
      • protocol_noECCT/21/06/05
      • version_no3.0
      • date_of_protocol18-05-2021
      • study_drugSARS-CoV2 prefusion Spike delta TM (CoV2 preS dTM): antigen formulation at (placeholder: 5 μg or15 μg) AS03: CoV2 preS dTM-AS03, Squalene-based adjuvant 2.1%
      • disease_conditionCOVID-19
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_name0.9% normal saline
      • comparator_registeredyes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.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_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_applicantDr. Catherine Kiptinness
      • declaration_date111-06-2021
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date211-06-2021
      • placebo_presentYes
      • study_objectives<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Key Primary objectives</span></p>\n<ul>\n <li class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <p>\n <span style=\"font-size:11px;\">Primary Efficacy: To assess, in participants who are SARS</span><span style=\"font-size:11px;\">-CoV-2 na ve, the clinical efficacy of the CoV2 preS dTMAS03 </span><span style=\"font-size: 11px;\">vaccines for the prevention of symptomatic COVID-19 occurring ≥ 14 days after the second injection.<span style=\"font-size: 11px;\"><span style=\"font-size: 11px;\">​</span></span></span></p>\n </li>\n <li class=\"p1\" style=\"margin: 0px 0px 0px 40px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <p>\n <span style=\"font-size: 11px;\"><span style=\"font-size: 11px;\"><span style=\"font-size: 11px;\"><span style=\"font-size:11px;\">Primary Safety: To assess the safety of the CoV2 preS dTM-AS03 vaccines compared to placebo throughout the study</span></span></span></span></p>\n </li>\n</ul>\n
      • principal_inclusion_criteria<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Participants are eligible for the study only if all of the following criteria are met:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Age</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I01: Aged 18 years or older on the day of inclusion</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Type of participant and disease characteristics</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I02: For persons living with HIV, stable HIV infection determined by participant currently on antiretrovirals with CD4 count ></span><span style=\"font-size: 11px;\">200/mm3</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I03: SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I04: Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator to </span><span style=\"font-size: 11px;\">receive the authorized vaccine available to them at the time of enrollment</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Sex, contraceptive/barrier method and pregnancy testing requirements</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I05: A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions </span><span style=\"font-size: 11px;\">applies:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at </span><span style=\"font-size: 11px;\">least 1 year or surgically sterile</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">OR</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to </span><span style=\"font-size: 11px;\">the first study intervention administration until at least 12 weeks after the second study intervention administration. </span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size: 11px;\">A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by </span><span style=\"font-size: 11px;\">local regulation) within 25 hours before any dose of study intervention.</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Informed Consent</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I06: Informed consent form has been signed and dated</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Other Inclusions</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I07: Able to attend all visits and to comply with all study procedures</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">I08: Covered by health insurance, only if required by local, regional or national regulations</span></p>\n<p class=\"p2\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 112, 0);\">\n  </p>\n
      • principal_exclusion_criteria<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Participants are not eligible for the study if any of the following criteria are met:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Medical conditions</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E01: Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to a vaccine</span><span style=\"font-size: 11px;\">containing any of the same substances</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E02: Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on</span><span style=\"font-size: 11px;\">Investigator’s judgment</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E03: Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator’s judgment</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E04: Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, </span><span style=\"font-size: 11px;\">contraindicating IM vaccination based on Investigator’s judgment</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E05: Unstable acute or chronic illness that in the opinion of the Investigator or designee poses </span><span style=\"font-size: 11px;\">additional risk as a result of participation or that could interfere with the study procedures</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E06: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness </span><span style=\"font-size: 11px;\">(temperature ≥ 38.0 C [≥ 100.4 F]). A prospective</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">participant should not be included in the study until the condition has resolved or the </span><span style=\"font-size: 11px;\">febrile event has subsided </span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size: 11px;\">Prior/concomitant therapy</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E07: Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any </span><span style=\"font-size: 11px;\">vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza </span><span style=\"font-size: 11px;\">vaccination, which may be </span><span style=\"font-size: 11px;\">received at any time in relation to study intervention.</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E08: Prior administration of a coronavirus vaccine (severe acute respiratory syndrome </span><span style=\"font-size: 11px;\">coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERSCoV])</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E09: Receipt of solid-organ or bone marrow transplants in the past 180 days</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E10: Receipt of anti-cancer chemotherapy in the last 90 days </span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size: 11px;\">Prior/concurrent clinical study experience</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E11: Participation at the time of study enrollment (or in the 30 days preceding the first study </span><span style=\"font-size: 11px;\">vaccination) or planned participation during the present study period in another clinical</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">study investigating a vaccine, drug, medical device, or medical procedure</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Other exclusions</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E12: Deprived of freedom by an administrative or court order, or in an emergency setting, or </span><span style=\"font-size: 11px;\">hospitalized involuntarily</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">E13: Identified as an Investigator or employee of the Investigator or study center with direct </span><span style=\"font-size: 11px;\">involvement in the proposed study, or identified as an immediate family member (ie,</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">parent, spouse, natural or adopted child) of the Investigator or employee with direct </span><span style=\"font-size: 11px;\">involvement in the proposed study</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Depending on country regulations and feasibility, if the participant has a primary physician who is not the Investigator, the </span><span style=\"font-size: 11px;\">site may contact this physician with the participant’s consent to inform him / her of the participant’s participation in the </span><span style=\"font-size: 11px;\">study. In addition, the site may ask this primary physician to verify exclusion criteria including but not limited to previous</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">therapies, such as previous vaccines.</span></p>\n
      • primary_end_points<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <strong><span style=\"font-size:11px;\">Primary Efficacy Endpoints</span></strong></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Occurrences of symptomatic COVID-19</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <strong><span style=\"font-size:11px;\">Primary Safety Endpoints</span></strong></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">For participants in the Reactogenicity Subset:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of solicited (pre-listed in the participant’s diary card / electronic diary card [DC/eDC] and [electronic] Case Report </span><span style=\"font-size: 11px;\">Form [CRF]) injection site reactions and systemic reactions occurring up to 7 days after each vaccination</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of non-serious unsolicited adverse events (AEs) reported up to 21 days after the last vaccination</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n  </p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">For all participants in the study:</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of unsolicited injection site and systemic AEs reported in the 30 minutes after each </span><span style=\"font-size: 11px;\">vaccination</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of medically-attended adverse events (MAAEs) throughout the study</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of serious adverse events (SAEs) throughout the study</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of adverse events of special interest (AESIs) throughout the study</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">• Presence of virologically-confirmed SARS-CoV-2 infections and/or symptomatic COVID-19</span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyPhase III Vaccine study
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase III Vaccine study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">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).<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n  </p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Site Co-Principal Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">                                                Dr. Elizabeth Irungu MBChB, MPH<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Lead Physician for the study: Dr. Stanley Ndwiga<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Site Coordinator: Dr. Catherine Kiptinness, BPharm, MPH<o:p></o:p></span></p>\n<p style=\"margin: 0in; font-size: 12pt; font-family: Arial, sans-serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9pt; color: rgb(51, 51, 51);\">Regulatory Lead: Peter<span class=\"apple-converted-space\"> </span>Mogere<o:p></o:p></span></p>\n
      • other_details_explanation<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">N/A - trial is being conducted in the host country</span></p>\n
      • other_details_regulatory_notapproved<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Application to the CBER (USA) on 18 May 2021</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">India: HA submission (Central Drugs Standard Control Organization (CDSCO)) = 13-May-21</span></p>\n<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">Mexico: HA submission (Comisi n Federal para la Protecci n Contra Riesgos Sanitarios) = 24-May-21</span></p>\n
      • other_details_regulatory_approved<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">N/A - no approvals have been given yet</span></p>\n
      • other_details_regulatory_rejected<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">N/A - no rejections</span></p>\n
      • other_details_regulatory_halted<p class=\"p1\" style=\"margin: 0px; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 6px; line-height: normal; font-family: Helvetica; color: rgb(0, 0, 0);\">\n <span style=\"font-size:11px;\">N/A - study has not been halted</span></p>\n
      • estimated_duration386 days
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorSOLUTION FOR INJECTION
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-CCR-PHRD THIKA PROJECT
      • single_site_physical_addressOAU ROAD, SECTION 9 THIKA
      • single_site_contact_personDR. CATHERINE KIPTINNESS
      • single_site_telephone0721 323898
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states14
      • number_of_sites
      • multi_country_listUSA, Honduras, Dominican Rep, Mexico, Colombia, Japan, India, Pakistan, Sri Lanka, Egypt , Uganda, Kenya, Ghana, Nigeria
      • data_monitoring_committeeYes
      • total_enrolment_per_site250
      • total_participants_worldwide37430
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • 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_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMBchB,MPH,PHD
      • investigator1_professional_addressCentre for Respiratory Diseases Research, Kenya Medical Research Institute, P.O.Box 47855-00100G.P.O., Nairobi.
      • investigator1_telephone+254724522474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participants2000
      • notification<ol>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Provide time of commitment for submission of Phase II clinical study report:</span></span></p>\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Brief CSR (Day 01 – Day 43 Key Data): Already completed and submitted, report dated 16 May 2021)<span style=\"color:#0000cd;\"> </span><span style=\"color:#0000cd;\">We have <strong>Attached the brief CSR as well as Appendices (safety listings & Deaths/SAEs)</strong></span></span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><span style=\"color:#0000cd;\">Interim CSR (Day 01 – Day 43): 06 AUG 2021</span></span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><span style=\"color:#0000cd;\">Interim CSR (Day 202 Visit): 14 JAN 2022</span></span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><span style=\"color:#0000cd;\">Final CSR: 14 OCT 2022</span></span></span></p>\n </li>\n </ol>\n </li>\n <li>\n <p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><span lang=\"EN-US\" style=\"caret-color: rgb(0, 0, 0); color: rgb(0, 0, 0); text-size-adjust: auto;\">It has been noted that only section 2.4 of the dossier has been provided. Provide full IMPD dossier since this is a Phase III study<span class=\"Apple-converted-space\"> </span></span><span lang=\"en-KE\" style=\"text-size-adjust: auto; color: black;\">study:</span><span style=\"color:#0000ff;\"><span lang=\"EN-US\" style=\"text-size-adjust: auto;\"> </span></span><span style=\"color:#0000cd;\"><span lang=\"EN-US\" style=\"text-size-adjust: auto;\">In terms of format, we initially did not prepare an “IMPD” format for VAT08 but an IND/CTD format. I would like to highlight that the IND/CTD sections cover all the information usually included in the IMPD. Please add this to the response section</span></span></span></span></p>\n </li>\n</ol>\n
      • approval_date02-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-09-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:660px;\" width=\"660\">\n <tbody>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Study Title:</strong></p>\n </td>\n <td style=\"width:540px;\">\n <p>\n A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older as a primary series and open-label extension to assess immunogenicity, safety, and efficacy of a monovalent booster dose of the SARS-CoV2 Adjuvanted Recombinant Protein Vaccine.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Prtocol Number:</strong></p>\n </td>\n <td style=\"width:540px;\">\n <p>\n VAT00008</p>\n <p>\n <strong>ECCT REF</strong>: ECCT/21/06/05</p>\n <p>\n <strong>ERC REF:</strong> KEMRI/SERU/CCR/0228/4267</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Sponsor</strong></p>\n </td>\n <td style=\"width:540px;\">\n <p>\n Sanofi Pasteur Inc.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Study Objectives:</strong></p>\n <p>\n  </p>\n </td>\n <td style=\"width:540px;\">\n <ul>\n <li>\n <strong>The primary objectives:</strong></li>\n </ul>\n <ol>\n <li>\n To assess in SARS-CoV-2-naïve adults, the clinical efficacy of the CoV2 preS dTM – AS03 vaccines for the prevention of symptomatic COVID – 19 occurring <u>></u> 14 days after the second injection.</li>\n <li>\n To assess the safety profile of CoV2 preS dTM – AS03 vaccines compared to placebo throughout the study duration.</li>\n </ol>\n <ul>\n <li>\n <strong>Crossover/Booster objectives:</strong></li>\n </ul>\n <ol>\n <li>\n <strong>Secondary Immunogenicity: </strong>To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.</li>\n <li>\n <strong>Secondary Safety: </strong></li>\n </ol>\n <ul>\n <li>\n To assess the safety of the CoV2 preS dTM – AS03 vaccines after primary series or booster  vaccination.</li>\n <li>\n To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination.</li>\n <li>\n To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Study Design</strong></p>\n <p>\n  </p>\n </td>\n <td style=\"width:540px;\">\n <p>\n This Phase III study was a multi-country, multi-center, randomized, modified double-blind, placebo-controlled, multi-stage trial. It evaluated the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) in adults aged 18 years and older. The study consisted of two main stages:</p>\n <ul>\n <li>\n <strong>Stage 1:</strong> Assessment of the AS03 adjuvanted monovalent vaccine containing the prefusion S protein from the prototype (D614) variant against a placebo control.</li>\n <li>\n <strong>Stage 2:</strong> Evaluation of the AS03 adjuvanted bivalent vaccine containing prefusion S protein from the prototype (D614) and Beta (B.1.351) variants against a placebo control.</li>\n <li>\n <strong>Crossover/Booster Phase:</strong> Open-label extension to assess the safety, immunogenicity, and efficacy of a monovalent booster dose in participants who completed the primary study phase.</li>\n <li>\n The <strong>primary endpoint</strong> was the prevention of virologically confirmed symptomatic COVID-19 occurring <strong>≥14 days post-second dose</strong>.</li>\n <li>\n Safety and reactogenicity were also assessed.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Study Population</strong></p>\n <p>\n  </p>\n </td>\n <td style=\"width:540px;\">\n <p>\n Participants were categorized based on prior SARS-CoV-2 infection as:</p>\n <ul>\n <li>\n <strong>Naïve:</strong> No prior infection evidence at the time of enrollment.</li>\n <li>\n <strong>Non-naïve:</strong> Prior infection confirmed via serological or virological testing.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Key Findings</strong></p>\n <p>\n  </p>\n </td>\n <td style=\"width:540px;\">\n <p>\n <strong>Enrollment and Follow-Up:</strong></p>\n <ul>\n <li>\n <strong>10,114 participants</strong> received at least one dose.</li>\n <li>\n <strong>9,441 participants</strong> completed both doses.</li>\n <li>\n <strong>2,108 (20.8%) participants were SARS-CoV-2 naïve</strong> at the time of enrollment.</li>\n </ul>\n <p>\n <strong>Efficacy:</strong></p>\n <ul>\n <li>\n <strong>Overall vaccine efficacy (VE) against symptomatic COVID-19 was 15.3% (95% CI: -15.8 to 38.2)</strong> in SARS-CoV-2 naïve individuals, not meeting the predefined efficacy threshold.</li>\n <li>\n VE was <strong>52.7% (95% CI: 31.2 to 67.9) in non-naïve participants</strong> (previously infected individuals), indicating greater protection in previously exposed populations.</li>\n <li>\n VE against the <strong>Delta variant</strong> was <strong>64.2% (95% CI: 10.2 to 87.4) in naïve participants</strong>.</li>\n <li>\n VE against the <strong>Omicron variant</strong> was <strong>-44.5% (95% CI: -141.1 to 12.0),</strong> showing reduced protection against this highly immune-evasive strain.</li>\n </ul>\n <p>\n <strong>Safety and Tolerability:</strong></p>\n <ul>\n <li>\n The vaccine was <strong>well-tolerated</strong> with an <strong>acceptable safety profile</strong>.</li>\n <li>\n No significant increase in severe adverse events (SAEs), adverse events of special interest (AESIs), or medically attended adverse events (MAAEs) was observed compared to placebo.</li>\n <li>\n No cases of <strong>myocarditis, pericarditis, Guillain-Barré syndrome, or thrombosis with thrombocytopenia syndrome</strong> were reported.</li>\n <li>\n <strong>No deaths</strong> were observed in the vaccine group, while <strong>nine deaths</strong> were reported in the placebo group (none attributed to the vaccine).</li>\n </ul>\n <p>\n <strong>Immunogenicity:</strong></p>\n <ul>\n <li>\n The vaccine <strong>elicited strong neutralizing antibody responses</strong> in non-naïve participants.</li>\n <li>\n <strong>Geometric mean titer (GMT) of neutralizing antibodies</strong> was significantly higher in <strong>non-naïve participants (9109)</strong> compared to <strong>naïve participants (1409)</strong> at <strong>Day 43</strong>.</li>\n <li>\n Immune responses were comparable to other first-generation COVID-19 vaccines in terms of neutralizing activity against ancestral strains.</li>\n </ul>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:120px;\">\n <p>\n <strong>Conclusions and Implications</strong></p>\n </td>\n <td style=\"width:540px;\">\n <ul>\n <li>\n The study confirms that <strong>prior SARS-CoV-2 infection enhances vaccine-induced protection</strong>, with <strong>higher efficacy in non-naïve individuals</strong>.</li>\n <li>\n The <strong>D614 monovalent vaccine was less effective in SARS-CoV-2 naïve individuals</strong>, particularly against Omicron variants, highlighting the need for updated vaccine formulations targeting contemporary strains.</li>\n <li>\n These findings contribute to the evolving <strong>global COVID-19 vaccination strategy</strong>, reinforcing the need for <strong>variant-adapted vaccines</strong> and <strong>booster doses</strong>.</li>\n </ul>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • implication_results<p>\n There were no any implications from the study results as the sponsor has decided not to manufacture, supply, or further develop the vaccine due to decreased global public health demand for COVID-19 vaccines.</p>\n
      • quantity_imported570 kits
      • quantity_dispensed450
      • quantity_destroyedNone
      • quantity_exported120 kits
      • balance_siteNone
      • final_date0000-00-00
      • modified2025-02-27 14:25:38
      • created2021-06-11 02:57:47
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id665
        • application_id1019
        • given_nameNelly Rwamba
        • middle_name
        • family_nameMugo
        • qualificationMBCHB, MPH
        • professional_addressrwamba@uw.edu
        • telephone0733629665
        • emailrwamba@uw.edu
        • created2021-06-11 03:10:15
        • modified2021-09-20 13:48:02
    • SiteDetail(array)
      • 0(array)
        • id923
        • application_id1019
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-06-11 03:10:15
        • modified2021-09-20 13:48:02
        • County(empty)
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      • 0(array)
        • id509
        • application_id1019
        • sponsorSanofi Pasteur
        • sponsor_typeOthers
        • contact_personJames Okwach
        • addressDiscovery Drive, Swiftwater, PA 18370-0187, USA
        • telephone_number+254717721518
        • fax_number
        • cell_number+254717721518
        • email_addressOkwachJames@praintl.com
        • created2021-06-11 03:10:15
        • modified2021-09-20 13:48:02
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App Constants

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PHP Environment

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• 1/var/www/html/ctr/lib
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• 4-> /var/www/html/ctr/lib/Cake/

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    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php