Cochrane South Africa, South African Medical Research Council, Tygerberg, South Africa.
Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Hum Vaccin Immunother. 2020 Apr 2;16(4):972-980. doi: 10.1080/21645515.2019.1693720. Epub 2019 Dec 12.
Clinical research is important in establishing the effects of health-care interventions. Vaccine clinical trials are to examine the effectiveness and safety of vaccines for the prevention of diseases. Africa has a high burden of infectious diseases such as malaria, tuberculosis, HIV/AIDS, and Ebola virus disease. Here we report a database surveillance study of vaccine-related clinical trials conducted in Africa. An objective is to address and profile vaccine clinical trials conducted in Africa. Data were extracted from the WHO International Clinical Trials Registry Platform on 22 July 2018 and updated on 05 September 2019. We found that 61% of the 377 clinical trials were registered prospectively and 35% registered retrospectively. About 72% of the trials were single-country studies and within the country, most trials (86%) were single-center studies. The proportion of trials involving multiple African countries was 11% and that of trials involving countries outside of Africa was 16%. The biggest funder of the vaccine trials (34%) was industry, followed by governments (25%) and universities (21%). The most studied diseases were malaria (20%), HIV/AIDS (15%), tuberculosis (7%), and Ebola virus disease (6%). Most of the vaccine trials were conducted in adults (42%). The trials ranged from phase I to phase IV, with most of the trials being in phase I (18%) and phase III (18%). The conduct of vaccine clinical trials in Africa seeks to address the disease epidemics faced by the continent. There is a need for more investments from governmental bodies toward vaccine research in Africa. Further, African country collaborations are needed in efforts to find African solutions to the current infectious disease threats faced by the continent.
临床研究对于确定医疗干预措施的效果非常重要。疫苗临床试验旨在检验疫苗预防疾病的有效性和安全性。非洲传染病负担沉重，如疟疾、结核病、艾滋病毒/艾滋病和埃博拉病毒病。在此，我们报告了一项针对在非洲进行的疫苗相关临床试验的数据库监测研究。目的是解决和介绍在非洲进行的疫苗临床试验。数据于 2018 年 7 月 22 日从世界卫生组织国际临床试验注册平台提取，并于 2019 年 9 月 5 日更新。我们发现，377 项临床试验中有 61%是前瞻性注册的，35%是回顾性注册的。约 72%的试验为单一国家研究，在国内，大多数试验（86%）为单一中心研究。涉及多个非洲国家的试验比例为 11%，涉及非洲以外国家的试验比例为 16%。疫苗试验的最大资助者（34%）是行业，其次是政府（25%）和大学（21%）。研究最多的疾病是疟疾（20%）、艾滋病毒/艾滋病（15%）、结核病（7%）和埃博拉病毒病（6%）。大多数疫苗试验在成年人中进行（42%）。试验范围从 I 期到 IV 期，其中大多数试验处于 I 期（18%）和 III 期（18%）。在非洲进行疫苗临床试验是为了应对该大陆面临的疾病流行。需要政府机构对非洲的疫苗研究进行更多投资。此外，需要非洲国家合作，努力为非洲大陆目前面临的传染病威胁找到非洲解决方案。
