HIV/AIDS
Conditions
Interventions
Group 1 A
Group 1B
Group 1C
Sponsors
CAPRISA
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives •To evaluate the safety of subcutaneously administered CAP256V2LS and VRC07-523LS among young HIV-negative women Primary Endpoints •Proportion of participants with any grade 3 or higher solicited reactogenicity events within the first 3 days after administration of CAP256V2LS in combination with VRC07-523LS versus placebo •Proportion of participants with any grade 3 or higher unsolicited adverse events (AE) related to the administration of CAP256V2LS in combination with VRC07-523LS versus placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives • To assess the plasma PK profile of study products administered at a fixed dose every 24 weeks • To compare HIV incidence rates in participants who receive antibodies against those receiving placebo • To assess CAP256V2LS and VRC07-523LS systemic and mucosal concentrations in relation to breakthrough HIV infections • To assess participant acceptability of the subcutaneous injections Secondary Endpoints • Differences in the PK profile of study products administered as weight-based dosing compared to fixed dosing • Documented HIV-1 infections after product administration during study follow-up • Differences in the systemic and mucosal concentrations of CAP256V2LS and VRC07-523LS titres among participants with breakthrough infection versus those without breakthrough infection • Proportion of participants reporting subcutaneous injections to be acceptable as per the study acceptability questionnaire | — |
Countries
South Africa
Contacts
Public ContactNqobile ;Revina Myeni;Munsamy
CAPRISA;CAPRISA
Outcome results
None listed