Applied Immunization Research and Evaluation, Public Health Ontario, 480 University Avenue, Suite 300, Toronto, ON M5G 1V2, Canada; University of Toronto, 480 University Avenue, Suite 300, Toronto, ON M5G 1V2, Canada.
Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, United States.
Vaccine. 2018 Nov 19;36(48):7286-7293. doi: 10.1016/j.vaccine.2018.04.016. Epub 2018 Oct 26.
The need for a systematic approach to research on vaccine effectiveness (VE) is increasing with growing numbers of vaccines and complexity of immunization programs. The diverse scientific fields that investigate how vaccines work and why they fail continue to evolve, yet definitions related to such advances have not kept pace. Researchers in disciplines ranging from basic science through immunopathology, clinical and epidemiological research, and mathematical modelling need more precise definitions to promote communication and interdisciplinary VE research to ensure that studies are designed to appropriately address relevant questions. To meet these aims, we suggest standardized definitions, consider models of vaccine failure, and offer general approaches for incorporation into study design. We further propose a framework for conducting VE research that builds on the traditional epidemiological triad of host, pathogen and environment, and also includes additional elements such as characteristics of both the vaccine and vaccinee, the effect of time on likelihood of exposure and protection, and the impact of environment and pathogen, as well as how outcomes of interest and study design may impact observed vaccine effectiveness. The framework is relevant to researchers in all disciplines who investigate the effectiveness of vaccines and vaccination programs and why they may fail. Stronger research in this field will help policy makers optimise decision-making on vaccination programs, ensuring we maximize the health benefits of vaccines. It is also important for clinicians communicating the benefits of vaccines to the public.
随着疫苗数量的增加和免疫规划的复杂性，对疫苗有效性（VE）进行系统研究的需求不断增加。从基础科学到免疫病理学、临床和流行病学研究以及数学建模等各个科学领域都在不断探索疫苗的作用机制和失效原因，但相关定义却没有跟上步伐。从基础科学到免疫病理学、临床和流行病学研究以及数学建模等各个科学领域都在不断探索疫苗的作用机制和失效原因，但相关定义却没有跟上步伐。从基础科学到免疫病理学、临床和流行病学研究以及数学建模等各个科学领域的研究人员需要更精确的定义来促进沟通和跨学科的 VE 研究，以确保研究设计能够恰当地解决相关问题。为此，我们建议制定标准化定义、考虑疫苗失效模型，并提供一般方法，以便纳入研究设计。我们还提出了一个进行 VE 研究的框架，该框架建立在宿主、病原体和环境的传统流行病学三联体基础上，还包括疫苗和接种者的特征、时间对暴露和保护可能性的影响、环境和病原体的影响，以及关注的结果和研究设计如何影响观察到的疫苗有效性等额外要素。该框架适用于研究疫苗和接种计划有效性以及其失效原因的所有学科的研究人员。该领域的研究加强将有助于政策制定者优化疫苗接种计划的决策，确保我们最大限度地发挥疫苗的健康效益。这对于向公众传播疫苗益处的临床医生也很重要。
