A Phase I Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of a Human Monoclonal Antibody, CAP256V2LS (VRC-HIVMAB0102-00-AB) administered intravenously to HIV-negative and HIV-positive women or subcutaneously alone and in combination with VRC07- 523LS and /or PGT121 to HIV-negative women in South Africa

CAPRISA0 个研究点目标入组 76 人开始时间: 2020年2月5日最近更新: 2023年5月29日

适应症

试验速览

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•18 to 45 years of age
•Born 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 IV and 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
•Neutrophil count within institutional normal range/accompanied by the PI/designee approval
•Platelets within institutional normal range/ accompanied by the PI/designee approval
•Creatinine < 1.1 x ULN
•ALT < 1.25 x ULN
•HIV negative as per FFDA-approved method of detection in last 30 days (for Groups with HIV negative participants only)
•Negative ß-HCG (human chorionic gonadotropin) pregnancy test
•If of reproductive potential, has evidence of effective contraceptive use and is willing to adhere to effective contraceptive use during the study period
•Willing to have blood samples collected, stored, and used for research purposes.
•Willing to adhere to reduced risk sexual behaviour during study participation.

•Any clinically significant acute or chronic medical condition 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
•Exceeding the weight of 95 kilograms
•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
•Administration of a mAb or polyclonal immunoglobulin within 28 days 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
•Participants in the study may not take part in other concurrent 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