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Annual Review of Statistics and Its Application

Volume 12, 2025

Designs for Vaccine Studies

  • M. Elizabeth Halloran1,2
  • 1Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA; email: [email protected] 2Department of Biostatistics, University of Washington, Seattle, Washington, USA
  • Vol. 12:1-18 (Volume publication date March 2025)
  • First published as a Review in Advance on October 30, 2024
  • Copyright © 2025 by the author(s).
    This work is licensed under a Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See credit lines of images or other third-party material in this article for license information.

Abstract

Due to dependent happenings, vaccines can have different effects in populations. In addition to direct protective effects in the vaccinated, vaccination in a population can have indirect effects in the unvaccinated individuals. Vaccination can also reduce person-to-person transmission to vaccinated individuals or from vaccinated individuals compared with unvaccinated individuals. Design of vaccine studies has a history extending back over a century. Emerging infectious diseases, such as the SARS-CoV-2 pandemic and the Ebola outbreak in West Africa, have stimulated new interest in vaccine studies. We focus on some recent developments, such as target trial emulation, test-negative design, and regression discontinuity design. Methods for evaluating durability of vaccine effects were developed in the context of both blinded and unblinded placebo crossover studies. The case-ascertained design is used to assess the transmission effects of vaccines. The novel ring vaccination trial design was first used in the Ebola outbreak in West Africa.

Keyword(s): causal inference, cluster-randomized trial, immune correlates, observational study, regression discontinuity design, ring vaccination, target trial emulation, test-negative design, vaccines
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2025-03-07
2025-06-18
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