Vaccine – Volume 35, Issue 1, Pages 1-200 (3 January 2017)

Vaccine
Volume 35, Issue 1, Pages 1-200 (3 January 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/1

Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design
Original Research Article
Pages 184-190
Lauren M. Schwartz, M. Elizabeth Halloran, Ali Rowhani-Rahbar, Kathleen M. Neuzil, John C. Victor
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