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Mediation and instrumental variable analyses for vaccine-induced antibody titer against influenza B

机译：Mediation and instrumental variable analyses for vaccine-induced antibody titer against influenza B

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Objective: Immune correlate analyses for vaccine trials have been applied to investigate associations of vaccine efficacy and surrogate markers such as vaccine-induced antibodies. However, the role of antibody as a surrogate marker in predicting the outcome can vary by time, and surrogate-outcome confounding may have resulted in bias even in randomized trials. We provide a framework for surrogate marker assessment to address the aforementioned issues. Study Design and Setting: We reanalyzed the vaccine randomized trial for influenza B. We conducted a mediation analysis that enables estimation of vaccine efficacy, mediation effects and proportion of medi-ation on disease probabilities at various follow-up times. We proposed instrumental variable (IV) analy-ses with randomized vaccination as an IV accounting for potential unmeasured confounding. Results: The mediation effect of vaccine efficacy by hemagglutination inhibition (HAI) titer was signifi-cantly protective at 181 days after vaccination: 63.2% [95% confidence interval, (CI) = (39.9%, 82.0%)], and HAI titer explained 61.1% [95% CI = (36.7%, 96.2%)] of the protective effect of vaccination. Conclusions: Most of vaccine efficacy is mediated by HAI titer, particularly in children 10 years and older. Our contribution is to provide causal analytics for the role of surrogate marker with weaker assumptions regarding surrogate-disease causation. (c) 2023 The Author(s). Published by Elsevier Ltd.

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