Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design. Issue 1 (3rd January 2017)

• Record Type: Journal Article
• Authors: Schwartz, Lauren M.; Halloran, M. Elizabeth; Rowhani-Rahbar, Ali; Neuzil, Kathleen M.; Victor, John C.
• Is Part Of: Vaccine. Volume 35:Issue 1(2017)
• Page Start: 184
• Page End: 190
• Publication Date: 2017-01-03
• Subjects: Rotavirus -- Vaccine -- Test-negative design; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2016.10.077
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Rotavirus vaccines (RVs) have been recently introduced in low-income settings. Accurate post-introduction monitoring of RV effectiveness is important. The test-negative design (TND) is used to measure RV effectiveness. The TND was evaluated using randomized trials of RV in sub-Saharan Africa and Asia. The TND is an appropriate method to measure RV effectiveness in low-income settings. 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.