Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
Vaccine. 2012 Nov 6;30(48):6859-63. doi: 10.1016/j.vaccine.2012.09.008. Epub 2012 Sep 16.
Group A Neisseria meningitidis epidemics have been an important and unresolved public health problem in sub-Saharan Africa for over a century. The Meningitis Vaccine Project (MVP) was established in 2001 with the goal of developing, testing, licensing, and introducing an affordable group A meningococcal conjugate vaccine for Africa. A monovalent group A conjugate vaccine, MenAfriVac™, was developed at the Serum Institute of India Ltd. and tested in clinical trials at multiple trial sites in sub-Saharan African countries. The setup and successful conduct of ICH-GCP standard vaccine trials across multiple trial sites located in low-resource settings are challenging. We describe the main operational issues encountered in three randomized, observer-blind, active controlled studies to evaluate the safety and immunogenicity of MenAfriVac™. The studies were conducted in parallel among 2700 subjects aged between 2 months and 29 years of age enrolled across four trial sites located in Mali, The Gambia, Senegal, and Ghana between September 2006 and August 2009. Many important lessons were learned during the preparation, setup, and implementation of the Meningitis Vaccine Project clinical program. They are summarized here to help vaccine development programs identify efficient pathways for successful implementation of clinical trials in low-resource settings.
A 群脑膜炎奈瑟菌流行在撒哈拉以南非洲地区已持续一个多世纪，是一个重要且尚未解决的公共卫生问题。脑膜炎疫苗项目（MVP）成立于 2001 年，旨在开发、测试、许可并向非洲推出一种负担得起的 A 群脑膜炎球菌结合疫苗。单价 A 群结合疫苗 MenAfriVac™由印度血清研究所开发，并在撒哈拉以南非洲国家的多个试验点进行临床试验测试。在资源匮乏的环境中，在多个试验点建立和成功开展符合 ICH-GCP 标准的疫苗试验具有挑战性。我们描述了在三项评估 MenAfriVac™安全性和免疫原性的随机、观察者盲、主动对照研究中遇到的主要操作问题。这些研究于 2006 年 9 月至 2009 年 8 月在马里、冈比亚、塞内加尔和加纳的四个试验点同时对 2700 名年龄在 2 个月至 29 岁之间的受试者进行。在脑膜炎疫苗项目临床计划的准备、建立和实施过程中吸取了许多重要经验。现总结如下，以帮助疫苗开发项目确定在资源匮乏环境中成功实施临床试验的有效途径。
