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Increasing efficiency and reducing bias when assessing HPV vaccination efficacy by using nontargeted HPV strains
Lola Etievant1, Joshua N Sampson1, Mitchell H Gail1
1Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA.
Biometrics
|March 29, 2022
Summary
Utilizing nontargeted virus strains as negative controls enhances vaccine efficacy estimates. This method improves precision in randomized trials and significantly reduces bias in observational studies for vaccine effectiveness.
Area of Science:
- Epidemiology
- Biostatistics
- Vaccinology
Background:
- Vaccine efficacy studies often collect data on both targeted and nontargeted virus strains.
- Standard analysis methods for vaccine efficacy typically exclude data from nontargeted strains, potentially leading to suboptimal estimates.
Purpose of the Study:
- To demonstrate how incorporating data from nontargeted virus strains (negative control outcomes) can improve vaccine efficacy estimation.
- To show the utility of this approach in both randomized controlled trials (RCTs) and observational studies.
Main Methods:
- Augmenting primary outcome estimating equations with unbiased functions of secondary (nontargeted) outcomes in RCTs.
- Jointly estimating treatment effects on primary and secondary outcomes in observational studies to correct for confounding bias.
Main Results:
- Using nontargeted strains modestly increased precision in randomized trials of HPV vaccines.
- This approach substantially reduced confounding bias in observational studies of HPV vaccines.
Conclusions:
- Negative control outcomes (nontargeted strains) offer a valuable, underutilized data source in vaccine efficacy research.
- This methodology enhances the reliability of vaccine effectiveness estimates, particularly in observational settings where confounding is a concern.
