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Designs for Vaccine Studies
1Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Annual Review of Statistics and Its Application
|May 19, 2025
Summary
Vaccine studies evaluate direct and indirect protection, alongside transmission reduction. Recent methods like target trial emulation and test-negative designs enhance vaccine impact assessment for public health.
Area of Science:
- Epidemiology
- Biostatistics
- Public Health
Background:
- Vaccine effectiveness can vary within populations due to direct and indirect effects.
- Vaccination impacts transmission dynamics, influencing both vaccinated and unvaccinated individuals.
- Emerging infectious diseases highlight the need for robust vaccine study designs.
Purpose of the Study:
- To review and discuss contemporary methodologies for vaccine study design.
- To explore recent advancements in evaluating vaccine effects, including indirect protection and transmission.
- To provide an overview of innovative trial designs for infectious disease outbreaks.
Main Methods:
- Focus on recent developments: target trial emulation, test-negative design, and regression discontinuity design.
- Discuss methods for evaluating vaccine effect durability, including placebo crossover studies.
- Highlight case-ascertained and ring vaccination trial designs for transmission assessment.
Main Results:
- Vaccine studies encompass direct protection, indirect effects, and transmission reduction.
- Innovative designs like target trial emulation and test-negative designs offer new approaches.
- Specific designs like case-ascertained and ring vaccination trials address transmission dynamics.
Conclusions:
- Modern vaccine study designs are crucial for understanding multifaceted vaccine impacts.
- Advanced methodologies are essential for evaluating vaccine effectiveness in diverse populations and outbreaks.
- The evolution of vaccine trial designs, including those for transmission, is vital for global health security.
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