Results of a study of long-acting anti-HIV bNAbs - CAP256V2LS & VRC07l523LS in women in South Africa
In this phase 1 dose-escalation, randomised controlled trial clinical trial, Mahomed et al evaluated the safety and pharmacokinetic profile of the broadly neutralising monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS in young HIV-negative women in Durban, South Africa. The results of the CAPRISA 012B trial found that CAP256V2LS and VRC07-523LS with or without ENHANZE, a recombinant human hyaluronidase, was safe and well tolerated, with detectable antibody concentrations 6 months after product administration.
The trial published in the journal The Lancet HIV was the first trial to evaluate the engineered CAP256V2LS as a PrEP concept. This trial also evaluated for the first time the use of ENHANZE with a bNAb as a concept for HIV prevention, potentially allowing for increased volumes of bNAbs to be administered subcutaneously. The study design consisted of three groups. Groups 1 and 2 were open label with CAP256V2LS administered at 5 mg/kg and 10 mg/kg intravenously and 5 mg/kg, 10 mg/kg, and 20 mg/kg subcutaneously. In group 3, participants were randomly allocated to receive a combination of CAP256V2LS and VRC07-523LS at 10 mg/kg and 20 mg/kg subcutaneously comixed with ENHANZE.
From July 13, 2020, to Jan 13, 2021, 42 HIV-negative women, aged 18–45 years, were enrolled and completed the trial. There were no serious adverse events or dose-limiting toxicities. Data from this trial supports further assessment of CAP256V2LS and VRC07-523LS as a long-acting 6-monthly administered PrEP agent in larger clinical studies.
