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

VRC已经生产了抗hiv抗体VRC01、VRC01LS、VRC07-523LS、N6LS和10E8VLS，还有其他几种bnAbs正在开发中，同时正在进行多项I期临床试验。VRC01目前正在美国、南美和非洲进行II期临床试验(抗体介导预防（AMP）试验（http://www.hvtn.org/en/science/HVTN- studies/AMPstudy.html）。该bnmAb的一部分是前几年生产的，但由于临床试验受试者数量和临床试验计划的扩大，不足以完成AMP试验和其他HIV单抗临床试验。因此，需要额外的VRC01、VRC01LS、VRC07-523LS和10E8VLS DS批号用于I期和II期试验。根据该任务订单生产的DS将使未来的药品填充能够用于临床试验。

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.