CAPRISA 012C
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202112683307570
- Lead Sponsor
- CAPRISA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 990
•18 to 30 years of age
• Persons born Female (assigned female sex at birth) and identifying as female.
• Able and willing to complete the informed consent process
• Able to understand the information provided including the potential impact and/or risks linked to SC administration of the study product, willing to comply with protocol procedures, has access to the clinical research site and is available for follow-up for the study duration
• Based on clinical assessment, participant must be in good general health as per opinion of the Principal Investigator (PI) or designee
• Haemoglobin > 10g/dl
• Creatinine = 1.25 x ULN
• ALT < 1.25 x ULN
• HIV negative
• Negative ß-HCG (human chorionic gonadotropin) pregnancy test on day of enrolment
• If of reproductive potential, has evidence of effective contraceptive use and is willing to adhere to effective contraceptive use during the study period
• Sexually active in the last 3 months
• Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardizes the safety or rights of the participant
• If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding
• A history of alcohol or substance use judged by the PI to potentially interfere with participant study compliance
• Prior participation in an investigational HIV vaccine trial, except if proof of allocation to the placebo arm is available.
• Receipt of any vaccines within 28 days prior to enrolment
• Administration of a monoclonal antibody or polyclonal immunoglobulin within 6 months prior to enrolment
• Investigational HIV-related products received within 6 months prior to enrolment
• Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema
• Evidence of autoimmune disease or currently receiving immunosuppressive therapy
• Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety of CAP256V2LS and VRC07-523LS in HIV-negative women
- Secondary Outcome Measures
Name Time Method • To evaluate the tolerability of CAP256V2LS and VRC07-523LS<br>• To assess the PK profile of study products administered 16 weekly (4 monthly) in comparison to 24 weekly (6 monthly) administration<br>• To compare HIV incidence rates in antibody and placebo recipients<br>• To assess CAP256V2LS and VRC07-523LS systemic and mucosal concentrations in relation to breakthrough infections<br>• To determine the prevalence of autoantibody induction<br>• To assess participant acceptability of the subcutaneous injections