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

CAPRISA0 个研究点目标入组 990 人开始时间: 2021年12月9日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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

发起方

CAPRISA