Rapid loss of activity but not serum concentration in a passive infusion clinical trial of an HIV neutralizing antibody

作者：Sharana Mahomed, Nonhlanhla N. Mkhize, Leonid Serebryannyy, Tandile Hermanus, Prudence Kgagudi, Haajira Kaldine, Bronwen E. Lambson, Sandeep Narpala, Manjula Basappa, Mike Castro, Bob C. Lin, Kevin Carlton, J A Sands, Jason G. Gall, Richard A. Koup, Lynn Morris, Quarraisha Abdool Karim, Penny L. Moore, Salim S. Abdool Karim, Nicole A. Doria‐Rose · 发表于：medRxiv · 年份：2025 · DOI：10.1101/2025.09.04.25334949 · 被引用次数：1 · 研究领域：Monoclonal and Polyclonal Antibodies Research、Blood groups and transfusion、Biosimilars and Bioanalytical Methods

Monoclonal antibodies (mAbs) are a major class of drugs for treatment and prevention of disease. In early clinical trials, the pharmacokinetics (pK) of mAbs are usually assessed by measuring mAb concentration in serum. However, it is not a given that the mAbs will retain full functionality over time, emphasizing the need for integrated PK and functional assessments. In a re-analysis of data from the CAPRISA 012B trial, a previously published phase 1 study evaluating mAbs CAP256V2LS and VRC07-523LS in HIV-negative women, we report an unexpected disconnect between serum bNAb concentrations and HIV neutralization activity of CAP256V2LS, with implications for ongoing assessment of passive immunization trials.