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2
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Human immune responses to vaccines in the first year of life: biological, socio-economic and ethical issues - a viewpoint.人类在生命第一年对疫苗的免疫反应:生物学、社会经济和伦理问题——观点。
Vaccine. 2013 May 17;31(21):2483-8. doi: 10.1016/j.vaccine.2012.06.018. Epub 2012 Jun 19.
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Development and technology transfer of Haemophilus influenzae type b conjugate vaccines for developing countries.发展中国家流感嗜血杆菌 b 型结合疫苗的开发和技术转让。
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Adaptive trial design: could we use this approach to improve clinical trials in the field of global health?适应性试验设计:我们能否采用这种方法来改进全球卫生领域的临床试验?
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Pediatric clinical trials in Latin America and Guyana: present views of local practitioners and ways to embrace the future.拉丁美洲和圭亚那的儿科临床试验:当地从业者的现状观点和拥抱未来的方式。
Paediatr Drugs. 2011 Aug 1;13(4):257-65. doi: 10.2165/11590350-000000000-00000.
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Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans.在非洲人中,脑膜炎球菌 A 结合疫苗的免疫原性和安全性。
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Blood sample volumes in child health research: review of safe limits.儿童健康研究中的血液样本量:安全限度综述。
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Small(pox) success?(天花)成功了?
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非洲疫苗试验的影响、挑战和未来预测。

Impact, challenges, and future projections of vaccine trials in Africa.

机构信息

Vaccinology Theme, Medical Research Council Unit, Banjul, The Gambia.

出版信息

Am J Trop Med Hyg. 2013 Mar;88(3):414-9. doi: 10.4269/ajtmh.12-0576.

DOI:10.4269/ajtmh.12-0576
PMID:23468356
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3592518/
Abstract

Immunization remains the most cost effective method for the control of infectious diseases. Therefore, there is a global effort to deploy new vaccines for disease control and eradication. These new vaccines must be tested in the settings in which they will be used. This necessity has required the conduct of many vaccine trials in Africa, where several infectious diseases with significant public health impact are prevalent. However, these areas have peculiarities and are just beginning to gain expertise in the conduct of such trials. The vaccine developers and sponsors of these trials may also not be conversant with some issues unique to the trial site. The understanding gap from both partners can result in challenges if not addressed during the planning phase of the trial. This review seeks to highlight the issues surrounding the conduct of clinical trials in resource-constrained settings and suggests some ways of circumventing them.

摘要

免疫接种仍然是控制传染病的最具成本效益的方法。因此,全球正在努力部署新的疫苗来控制和消灭疾病。这些新疫苗必须在将要使用的环境中进行测试。这一必要性要求在非洲进行许多疫苗试验,因为那里有几种具有重大公共卫生影响的传染病流行。然而,这些地区具有特殊性,刚刚开始在进行此类试验方面获得专业知识。这些试验的疫苗开发商和赞助商也可能不熟悉试验现场特有的一些问题。如果在试验规划阶段不解决这两个合作伙伴之间的理解差距,可能会导致挑战。本综述旨在强调在资源有限的环境中进行临床试验所面临的问题,并提出一些解决方法。