A Phase II Trial to Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS in HIV- Negative Women

Prior treatment

• 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
• Evidence of autoimmune disease or currently receiving immunosuppressive therapy

Other illness

• 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
• A history of alcohol or substance use judged by the PI to potentially interfere with participant study compliance
• Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema

Other

• If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding
• 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

• 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