Ibanga Hannah B, Brookes Roger H, Hill Philip C, Owiafe Patrick K, Fletcher Helen A, Lienhardt Christian, Hill Adrian V S, Adegbola Richard A, McShane Helen
MRC Laboratories, Fajara, The Gambia.
Lancet Infect Dis. 2006 Aug;6(8):522-8. doi: 10.1016/S1473-3099(06)70552-7.
Tuberculosis remains a substantial global health problem despite effective drug treatments. The efficacy of BCG, the only available vaccine, is variable, especially in tuberculosis-endemic regions. Recent advances in the development of new vaccines against tuberculosis mean that the first of these are now entering into early clinical trials. A recombinant modified vaccinia virus Ankara expressing a major secreted antigen from Mycobacterium tuberculosis, antigen 85A, was the first new tuberculosis vaccine to enter into clinical trials in September 2002. This vaccine is known as MVA85A. In a series of phase I clinical trials in the UK, MVA85A had an excellent safety profile and was highly immunogenic. MVA85A was subsequently evaluated in a series of phase I trials in The Gambia, a tuberculosis-endemic area in west Africa. This vaccine is the only new subunit tuberculosis vaccine to enter into clinical trials in Africa to date. Here, we discuss some of the issues that were considered in the protocol design of these studies including recruitment, inclusion and exclusion criteria, reimbursement of study participants, and HIV testing. These issues are highly relevant to early clinical trials with all new tuberculosis vaccines in the developing world.
尽管有有效的药物治疗方法，但结核病仍然是一个严重的全球健康问题。卡介苗（BCG）作为唯一可用的疫苗，其效果存在差异，尤其是在结核病流行地区。新型抗结核疫苗研发的最新进展意味着其中一些疫苗现已进入早期临床试验阶段。一种表达结核分枝杆菌主要分泌抗原85A抗原的重组改良安卡拉痘苗病毒，是2002年9月首个进入临床试验的新型结核疫苗。这种疫苗被称为MVA85A。在英国进行的一系列I期临床试验中，MVA85A具有良好的安全性，且免疫原性很强。随后，MVA85A在西非结核病流行地区冈比亚进行了一系列I期试验。该疫苗是迄今为止在非洲进入临床试验的唯一新型亚单位结核疫苗。在此，我们讨论这些研究方案设计中考虑的一些问题，包括招募、纳入和排除标准、研究参与者的补偿以及HIV检测。这些问题与发展中国家所有新型结核疫苗的早期临床试验高度相关。
