Anti-HIV Broadly Neutralizing Monoclonal Antibody (bnAbs) Drug Substance (DS) Clinical Trial Material Production and Release

点击翻译按钮获取中文摘要

The VRC has produced the anti-HIV bnAbs VRC01, VRC01LS, VRC07-523LS, N6LS, and 10E8VLS and has several other bnAbs in development, while initiating multiple Phase I clinical trials. VRC01 is currently in a Phase II clinical trial (the Antibody-Mediated Prevention (AMP) Trial (http://www.hvtn.org/en/science/HVTN- studies/AMPstudy.html) in the U.S., South America and Africa. A portion of this bnmAb was produced in prior years, but is not sufficient for completion of the AMP trial and other HIV mab clinical trials due to expansion of clinical trial subject numbers and expanded clinical trial plans. Therefore, additional DS lots of VRC01, VRC01LS, VRC07-523LS, and 10E8VLS for Phase I and Phase II trials is needed. The DS produced under this task order will enable future drug product fills to be used in the clinical trials.