A double-blinded, randomized, placebo-controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV negative women

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 β-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: * 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 jeopardises 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