Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009737295685 Date of Registration: 02/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Adjuvant Study for Env-C DNA and Protein Vaccines in Kenya
Official scientific title A Randomized, Double-Blind Phase 1 Trial to Evaluate the Safety and Immunogenicity of Priming with Env-C Plasmid DNA Vaccine Alone, with Different Adjuvants, or with an Adjuvanted HIV Env gp145 C.6980 Protein Vaccine and Boosting with the Adjuvanted HIV Env gp145 C.6980 Protein Vaccine with or without the Env-C Plasmid DNA Vaccine in Healthy HIV Uninfected Adults in Kenya
Brief summary describing the background and objectives of the trial Primary Exploratory study to assess the safety and tolerability (including reactogenicity) of Env-C Plasmid DNA given IM alone, admixed with ALF43 adjuvant, topically applied with dmLT adjuvant, or given with an adjuvanted HIV Env gp145 C.6980 protein and followed by adjuvanted HIV Env gp145 C.6980 boost IM vaccinations, with or without Env-C Plasmid DNA. Secondary Assess the immunogenicity of the various study vaccine combinations: 1. Determine whether the adjuvants under study improve the immunogenicity of the Env-C Plasmid DNA priming. 2. Determine whether the addition of ALF43 to the Rehydragel® –HIV Env gp145 C.6980 protein boost further improves the immune response to HIV Env gp145 C.6980 protein. 3. Determine whether adjuvants improve humoral responses across vaccination regimens. 4. To evaluate the influence of various adjuvants on cellular immune responses. 5. Describe mucosal humoral responses across vaccination regimens in cervicovaginal and rectal secretions and semen.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RV 460
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 27/11/2020
Actual trial start date 27/11/2020
Anticipated date of last follow up 26/06/2023
Actual Last follow-up date 26/06/2023
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 126
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Env C Plasmid DNA Group N V/P Prime at weeks 0, 4, 12 Boost at weeks 20, 32, 56 1 15/3 Env-C Plasmid DNA (2 mg, IM) HIV Env gp145 C.6980 (100 μg, IM)/Rehydragel® (500 μg, IM) 2 15/3 Env-C Plasmid DNA (2 mg, IM) HIV Env gp145 C.6980 (100 μg, IM)/Rehydragel® (500 μg, IM) / ALF43 (200 μg, IM) 3 15/3 Env-C Plasmid DNA (2 mg, IM) + dmLT (50 μg, TCI) HIV Env gp145 C.6980 (100 μg, IM)/Rehydragel® (500 μg, IM) 4 15/3 Env-C Plasmid DNA (2 mg, IM) + dmLT (50 μg, TCI) HIV Env gp145 C.6980 (100 μg, IM)/Rehydragel® (500 μg, IM) / ALF43 (200 μg, IM) 5 15/3 Env-C Plasmid DNA (2 mg, IM) / ALF43 (200 μg, IM) HIV Env gp145 C.6980 (100 μg, IM)/Rehydragel® (500 μg, IM) 6 15/3 Env-C Plasmid DNA (2 mg, IM) / ALF43 (200 μg, IM) HIV Env gp145 C.6980 (100 μg, IM)/Rehydragel® (500 μg, IM) / ALF43 (200 μg, IM) 7 15/3 Env-C Plasmid DNA (2 mg, IM) /HIV Env gp145 C.6980 (100 μg, IM)/ALF43 (200 μg, IM) Env-C Plasmid DNA (2 mg, IM) /HIV Env gp145 C.6980 (100 μg, IM)/ALF43 (200 μg, IM)/Rehydragel® 500 μg, IM) 26 months Experimental HIV vaccines with/without adjuvants 63
Control Group HIV Env gp145 C.6980 100 μg 26 months Boost vaccine 63 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
INCLUSION CRITERIA 1. Healthy, male and female participant aged 18 to 40 years and available for 26 months 2. Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool. 3. Must be able to understand and complete the informed consent process. 4. Must be capable of reading English or Kiswahili. 5. Must agree to a home visit. 6. Must complete a Test of Understanding (TOU) before enrollment. Must answer 9 out of 10 questions correctly, with a maximum of three attempts. 7. Must be in good general health without a clinically significant medical history. 8. HIV-uninfected per diagnostic algorithm within 45 days of enrollment. 9. Laboratory values: • Hemoglobin: 12.5-18.1 g/dL men 11.0-16.1 g/dL women • White Cell Count: 2.7-7.7 x 103 cells/μL men 3.0-9.1 x 103 cells/μL women • Platelets: 125-370 103 cells/μL men 125-444 103 cells/μL women • ALT and AST: ≤1.25 institutional upper limit of the reference range Creatinine: ≤1.25 institutional upper limit of the reference range • Urinalysis: (dipstick) for blood and protein less than 1+ and negative glucose Female-Specific Criteria: 10. Negative urine pregnancy test for women at screening, the day of each vaccination, and before any invasive procedure. 11. Already using and commits to continued use of an adequate birth control method for 45 days before to the first vaccine/placebo vaccination and for at least 90 days after the final vaccine/placebo vaccination. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms with spermicide, diaphragms, intrauterine device (IUD 1. Three or more sexual partners in the previous 24 weeks 2. Commercial sex work 3. Non-adherence to condom use in the absence of a long-term monogamous relationship 4. Intravenous drug use in the previous year. 5. A sexually transmitted infection in the previous 24 weeks 6. Asplenia: any condition resulting in the absence of a functional spleen 7. Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) 8. Breastfeeding or pregnant (positive pregnancy test) women or planning to become pregnant during the window between study enrollment and three months after the last vaccination visit. 9. Any past, ongoing, or in remission history of treated or untreated autoimmune disease. 10. Has known active Hepatitis B virus infection (or positive HBsAg). 11. History of anaphylaxis or other serious adverse reaction to vaccines or allergies or reactions likely to be exacerbated by any component of the vaccine and placebo, including antibiotics or excipients 12. Absolute Neutrophil Count (ANC): <1.0 x 103 cells/μL 13. Participant has received any of the following substances: • Chronic use of therapies that may modify immune response, such as intravenous (IV) immune globulin and systemic corticosteroids (in doses of >20 mg/day prednisone equivalent for periods exceeding 10 days) • The following exceptions are permitted and will not exclude study participation: o use of corticosteroid nasal spray for rhinitis, o topical corticosteroids for an acute uncomplicated dermatitis; or o A short course (10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks before enrollme Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2020 KEMRI
Ethics Committee Address
Street address City Postal code Country
MBAGATHI ROAD NAIROBI 0100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reactogenicities systemic and local 7 days
Secondary Outcome Immunogenicity 14 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI WRP KERICHO HOSPITAL ROAD KERICHO 20200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
The US National Institute of Allergy and Infectious Diseases and the Division of AIDS BETHESDA MARYLAND United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NIAID BETHESDA MARYLAND United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
U.S. Military HIV Research Program 6720A Rockledge Drive Bethesda Maryland 20817 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Josphat Kosgei josphat.kosgei@usamru-k.org +254729110122 Hospital Road
City Postal code Country Position/Affiliation
Kericho 20200 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Rael Bor rael.bor@usamru-k.org +254729110121 Hospital Road
City Postal code Country Position/Affiliation
Kericho 20200 Kenya Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Michael Obonyo michael.obonyo@usamru-k.org +254705251656 Hospital Road
City Postal code Country Position/Affiliation
Kericho 20200 Kenya Regulatory Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study has not generated any data yet as the enrollment has not yet began. The data will be provided once the study has began analysis. Informed Consent Form,Study Protocol On completion of primary analysis. No data yet. To be provided once analysis has been done.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information