利用受控人体感染模型（CHIM）支持疫苗开发：美国监管方面的考虑。
Use of controlled human infection models (CHIMs) to support vaccine development: US regulatory considerations.
机构信息
Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.
Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.
出版信息
Vaccine. 2019 Jul 18;37(31):4256-4261. doi: 10.1016/j.vaccine.2019.06.009. Epub 2019 Jun 21.
In 2016, the United States (U.S.) Food and Drug Administration (FDA) licensed Vaxchora® for active immunization against disease caused by Vibrio cholerae serogroup 01 in adults. Vaxchora was the first US-licensed vaccine for which the primary evidence supporting effectiveness was derived from human challenge studies. Following this precedent, FDA has received numerous inquiries from manufacturers, academic researchers, funders and other stakeholders regarding how controlled human infection models (CHIMs) can be used to support the development of safe and effective vaccines to address public health needs. The aims of this article are to discuss: (1) Chemistry, Manufacturing and Controls (CMC) for challenge inocula, (2) conduct of controlled human infection studies under US IND and (3) use of CHIMs to support vaccine development. General concepts and regulatory considerations for the safe conduct of CHIMs and use of CHIMs to evaluate vaccine effectiveness are discussed.
2016 年，美国食品和药物管理局（FDA）批准 Vaxchora®用于预防成人由霍乱弧菌血清群 01 引起的疾病的主动免疫。Vaxchora 是第一个获得美国许可的疫苗，其有效性的主要证据来自人体挑战研究。在此先例之后，FDA 收到了制造商、学术研究人员、资助者和其他利益相关者的大量询问，询问如何使用受控人体感染模型（CHIM）来支持开发安全有效的疫苗以满足公共卫生需求。本文的目的是讨论：（1）挑战接种物的化学、制造和控制（CMC），（2）在美国 IND 下进行受控人体感染研究，以及（3）使用 CHIM 支持疫苗开发。讨论了安全进行 CHIM 和使用 CHIM 评估疫苗有效性的一般概念和监管考虑因素。
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