The CAPRISA 012 SAMBA trial is a Phase I/II trial of subcutaneous administration of monoclonal broadly neutralising antibodies as an immunisation strategy for HIV prevention. The overall goal is to develop a combination of two anti-HIV monoclonal antibodies and a new, safe and effective long-acting HIV prevention technology, principally for women, in order to alter the course of the HIV epidemic in Africa.
The 012A trial (Phase I) that assessed the monoclonal antibodies VRC07-523LS and PGT121 has been completed. All 45 participants have successfully exited the study. There were no safety concerns. All safety data are finalised, and the manuscript is under review for publication. The 012B trial (Phase I) is evaluating the monoclonal antibodies CAP256V2LS and VRC07-523LS and has enrolled to date 42 HIV-negative participants. These participants have been followed up and have all successfully exited the study. There have been no safety concerns. Interim pharmacokinetics analysis demonstrated favourable antibody concentrations. Screening and enrolment into the HIV positive groups is ongoing.
The CAPRISA 012C (Phase II) study is currently evaluating CAP256V2LS and VRC07-523LS in administered in combination. The study protocol and all study-related documents were approved by the regulatory authorities and ethics committee earlier this year. The first participant was enrolled into the study on 19 November 2021. To date, 19 participants have been enrolled. Zambian partners, Centre for Infectious Disease Research in Zambia (CIDRZ), have started their regulatory submissions and implementation preparation is currently taking place in collaboration with CIDRZ. The Zambian trial is planned to start in the first quarter of 2022.
During this year, the study team faced multiple challenges due to the COVID-19 pandemic, however enrolment into the study safely continued with all precautions in place. Enrolment into the trial was continuously guided by the regulatory authorities.