About this item:

56 Views | 26 Downloads

Author Notes:

Julia M. Baker, PhD, Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322. Email: julia.baker@emory.edu

The authors acknowledge www.clinicalstudydatarequest.com and GlaxoSmithKline for enabling access to the data.

B. A. L. has received a research grant and personal fees from Takeda Pharmaceuticals for service outside the submitted work. V. E. P. is a member of the WHO Immunization and Vaccine-related Implementation Research Advisory Committee and has received reimbursement from Merck for travel expenses unrelated to rotavirus vaccines. All other authors report no potential conflicts.


Research Funding:

This work was supported by the Emory University Laney Graduate School (to J. M. B.); and National Institutes of Health National Institute of Allergy and Infectious Diseases (grant number R01AI112970 to B. A. L. and V. E. P.).


  • Science & Technology
  • Life Sciences & Biomedicine
  • Immunology
  • Infectious Diseases
  • Microbiology
  • rotavirus
  • vaccination
  • correlate of protection
  • gastroenteritis
  • immunoglobulin A
  • 1ST 2 YEARS
  • LIVE
  • RIX4414

Postvaccination Serum Antirotavirus Immunoglobulin A as a Correlate of Protection Against Rotavirus Gastroenteritis Across Settings

Journal Title:



Volume 222, Number 2


, Pages 309-318

Type of Work:

Article | Final Publisher PDF


Background: A correlate of protection for rotavirus gastroenteritis would facilitate rapid assessment of vaccination strategies and the next generation of rotavirus vaccines. We aimed to quantify a threshold of postvaccine serum antirotavirus immunoglobulin A (IgA) as an individual-level immune correlate of protection against rotavirus gastroenteritis. Methods: Individual-level data on 5074 infants in 9 GlaxoSmithKline Rotarix Phase 2/3 clinical trials from 16 countries were pooled. Cox proportional hazard models were fit to estimate hazard ratios (HRs) describing the relationship between IgA thresholds and occurrence of rotavirus gastroenteritis. Results: Seroconversion (IgA≥20 U/mL) conferred substantial protection against any and severe rotavirus gastroenteritis to age 1 year. In low child mortality settings, seroconversion provided near perfect protection against severe rotavirus gastroenteritis (HR,0.04; 95% confidence interval [CI],. 01-.31). In high child mortality settings, seroconversion dramatically reduced the risk of severe rotavirus gastroenteritis (HR, 0.46; 95% CI,. 25-.86). As IgA threshold increased, risk of rotavirus gastroenteritis generally decreased. A given IgA threshold provided better protection in low compared to high child mortality settings. Discussion: Postvaccination antirotavirus IgA is a valuable correlate of protection against rotavirus gastroenteritis to age 1 year. Seroconversion provides an informative threshold for assessing rotavirus vaccine performance.

Copyright information:

Published by Oxford University Press for the Infectious Diseases Society of America 2020.

This is an Open Access work distributed under the terms of the Creative Commons Universal : Public Domain Dedication License (https://creativecommons.org/publicdomain/zero/1.0/rdf).
Export to EndNote