Russell Nina D, Marovich Mary A
Bill & Melinda Gates Foundation; 440 5th Ave N, Seattle, WA 98109, USA.
Curr Opin HIV AIDS. 2016 Nov;11(6):614-619. doi: 10.1097/COH.0000000000000322.
The purpose of review is to provide an overview of the Pox-Protein Public Private Partnership (P5) and highlight the progress of the P5 program, including an upcoming HIV vaccine efficacy trial in South Africa.
The RV144 Thai vaccine efficacy trial was the first to demonstrate that an HIV-1 vaccine can prevent HIV acquisition. The P5 vaccine regimen uses an ALVAC prime and protein boost modeled after the RV144 vaccine and adapted for the subtype C virus predominant in the southern African region. This regimen was recently tested in the HIV Vaccine Trials Network 100 phase 1/2a study in South Africa. Based on prospectively defined immunogenicity thresholds, criteria were met to support the launch of an efficacy study in late 2016. The aim of this phase 2b/3 trial will be to improve upon the results of RV144, with increased and more durable vaccine efficacy, to accelerate the potential licensure of a preventive vaccine in southern Africa.
The planned P5 efficacy trial, HIV Vaccine Trials Network 702, is designed to test and prospectively define correlates of protection, if efficacious. A vaccine with modest efficacy, vaccine efficacy at least 50%, could have substantial public health impact and significantly decrease the incidence of new infections in heavily burdened areas of the world.
本综述旨在概述痘苗蛋白公私合作项目（P5），并重点介绍P5项目的进展，包括即将在南非开展的一项HIV疫苗疗效试验。
RV144泰国疫苗疗效试验首次证明HIV-1疫苗可预防HIV感染。P5疫苗方案采用以RV144疫苗为蓝本并针对非洲南部地区占主导地位的C亚型病毒进行调整的ALVAC初免和蛋白加强免疫。该方案最近在南非的HIV疫苗试验网络100 1/2a期研究中进行了测试。根据预先确定的免疫原性阈值，已满足支持在2016年末开展疗效研究的标准。这项2b/3期试验的目的是改进RV144的结果，提高疫苗效力并使其更持久，以加速在非洲南部预防性疫苗的潜在获批。
计划开展的P5疗效试验，即HIV疫苗试验网络702，旨在测试并前瞻性地确定保护的相关因素（如果有效）。一种效力适中（疫苗效力至少为50%）的疫苗可能会对公共卫生产生重大影响，并显著降低世界上负担沉重地区新感染的发生率。
