Potential test-negative design study bias in outbreak settings: application to Ebola vaccination in Democratic Republic of Congo.

ABSTRACT:

Background

Infectious disease outbreaks present unique challenges to study designs for vaccine evaluation. Test-negative design (TND) studies have previously been used to estimate vaccine effectiveness and have been proposed for Ebola virus disease (EVD) vaccines. However, there are key differences in how cases and controls are recruited during outbreaks and pandemics of novel pathogens, whcih have implications for the reliability of effectiveness estimates using this design.

Methods

We use a modelling approach to quantify TND bias for a prophylactic vaccine under varying study and epidemiological scenarios. Our model accounts for heterogeneity in vaccine distribution and for two potential routes to testing and recruitment into the study: self-reporting and contact-tracing.

SUBMITTER: Pearson CAB 

PROVIDER: S-EPMC8855996 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature