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Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design
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Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design
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Journal Article
Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design
2017
Overview
•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.
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.
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.
TND vaccine effectiveness estimates were nearly equivalent to original RCT vaccine efficacy estimates. Neither RV had a substantial effect on rotavirus-negative diarrhea.
This study supports the TND as an appropriate epidemiologic study design to measure rotavirus vaccine effectiveness in low-income settings.
Publisher
Elsevier Ltd,Elsevier Limited,Elsevier Science
Subject
Africa South of the Sahara - epidemiology
/ Age
/ Asia
/ Bias
/ Design
/ Diarrhea
/ Female
/ Gastroenteritis - epidemiology
/ Gastroenteritis - prevention & control
/ Humans
/ Income
/ Infant
/ Male
/ Randomized Controlled Trials as Topic
/ Rotavirus Infections - epidemiology
/ Rotavirus Infections - prevention & control
/ Rotavirus Vaccines - administration & dosage
/ Rotavirus Vaccines - immunology
/ Studies
/ Vaccine
/ Vaccines
/ Viruses
