Burden-of-illness vaccine efficacy

Area of Science:

• Vaccinology
• Biostatistics
• Epidemiology

Background:

• Vaccines primarily prevent disease but can also mitigate severity in breakthrough cases.
• Observed mitigation of breakthrough illness reported for Herpes Zoster, Influenza, Rotavirus, and Pertussis.
• The burden-of-illness (BOI) score quantifies disease incidence, severity, and duration.

Purpose of the Study:

• To derive a vaccine efficacy statistic based on BOI scores.
• To extend this method for adjusting for baseline covariates.
• To illustrate the application using Herpes Zoster vaccine trial data.

Main Methods:

• Derivation of vaccine efficacy statistic from BOI scores.
• Extension of the method to incorporate adjustments for baseline covariates.
• Application and illustration using a Herpes Zoster vaccine clinical trial dataset.

Main Results:

• A novel vaccine efficacy statistic derived from BOI scores.
• The method allows for covariate adjustment in efficacy calculations.
• Demonstrated utility in evaluating Herpes Zoster vaccine efficacy.

Conclusions:

• BOI scores provide a comprehensive measure for vaccine efficacy.
• The derived statistic and methodology enhance vaccine effectiveness evaluation.
• This approach offers a robust framework for analyzing vaccine trial data.