From the World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
WHO Collaborating Centre for Reference and Research on Influenza, Royal Melbourne Hospital, Doherty Department, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.
Epidemiology. 2022 May 1;33(3):334-345. doi: 10.1097/EDE.0000000000001473.
When new vaccine components or platforms are developed, they will typically need to demonstrate noninferiority or superiority over existing products, resulting in the assessment of relative vaccine effectiveness (rVE). This review aims to identify how rVE evaluation is being performed in studies of influenza to inform a more standardized approach.
We conducted a systematic search on PubMed, Google Scholar, and Web of Science for studies reporting rVE comparing vaccine components, dose, or vaccination schedules. We screened titles, abstracts, full texts, and references to identify relevant articles. We extracted information on the study design, relative comparison made, and the definition and statistical approach used to estimate rVE in each study.
We identified 63 articles assessing rVE in influenza virus. Studies compared multiple vaccine components (n = 38), two or more doses of the same vaccine (n = 17), or vaccination timing or history (n = 9). One study compared a range of vaccine components and doses. Nearly two-thirds of all studies controlled for age, and nearly half for comorbidities, region, and sex. Assessment of 12 studies presenting both absolute and relative effect estimates suggested proportionality in the effects, resulting in implications for the interpretation of rVE effects.
Approaches to rVE evaluation in practice is highly varied, with improvements in reporting required in many cases. Extensive consideration of methodologic issues relating to rVE is needed, including the stability of estimates and the impact of confounding structure on the validity of rVE estimates.
当开发新的疫苗成分或平台时，通常需要证明它们在非劣效性或优效性方面优于现有产品，从而评估相对疫苗效力（rVE）。本综述旨在确定在流感研究中如何进行 rVE 评估，以提供更标准化的方法。
我们在 PubMed、Google Scholar 和 Web of Science 上进行了系统检索，以查找比较疫苗成分、剂量或接种时间表的 rVE 评估研究。我们筛选了标题、摘要、全文和参考文献，以确定相关文章。我们提取了关于研究设计、进行的相对比较以及用于估计 rVE 的定义和统计方法的信息。
我们确定了 63 篇评估流感病毒 rVE 的文章。研究比较了多种疫苗成分（n=38）、同一疫苗的两种或更多剂量（n=17）或接种时间或接种史（n=9）。一项研究比较了一系列疫苗成分和剂量。几乎所有研究都控制了年龄，近一半研究控制了合并症、地区和性别。对 12 篇同时呈现绝对和相对效果估计的研究进行评估表明，效果具有比例性，这对 rVE 效果的解释产生了影响。
实践中 rVE 评估的方法多种多样，在许多情况下需要改进报告。需要充分考虑与 rVE 相关的方法学问题，包括估计的稳定性以及混杂结构对 rVE 估计有效性的影响。
