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. 2017 Jan 3;35(1):184-190.
doi: 10.1016/j.vaccine.2016.10.077. Epub 2016 Nov 18.

Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design

Lauren M Schwartz  1 , M Elizabeth Halloran  2 , Ali Rowhani-Rahbar  3 , Kathleen M Neuzil  4 , John C Victor  5
Affiliations

Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design

Lauren M Schwartz et al. Vaccine. .

Abstract

Background: The test-negative design (TND), an epidemiologic method currently used to measure rotavirus vaccine (RV) effectiveness, compares the vaccination status of rotavirus-positive cases and rotavirus-negative controls meeting a pre-defined case definition for acute gastroenteritis. Despite the use of this study design in low-income settings, the TND has not been evaluated to measure rotavirus vaccine effectiveness.

Methods: This study builds upon prior methods to evaluate the use of the TND for influenza vaccine using a randomized controlled clinical trial database. Test-negative vaccine effectiveness (VE-TND) estimates were derived from three large randomized placebo-controlled trials (RCTs) of monovalent (RV1) and pentavalent (RV5) rotavirus vaccines in sub-Saharan Africa and Asia. Derived VE-TND estimates were compared to the original RCT vaccine efficacy estimates (VE-RCTs). The core assumption of the TND (i.e., rotavirus vaccine has no effect on rotavirus-negative diarrhea) was also assessed.

Results: TND vaccine effectiveness estimates were nearly equivalent to original RCT vaccine efficacy estimates. Neither RV had a substantial effect on rotavirus-negative diarrhea.

Conclusions: This study supports the TND as an appropriate epidemiologic study design to measure rotavirus vaccine effectiveness in low-income settings.

Keywords: Rotavirus; Test-negative design; Vaccine.

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Figures

Fig. 1
Fig. 1
VE-TND and VE-RCT estimates and 95% confidence intervals for each rotavirus vaccine RCT.
See this image and copyright information in PMC

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