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. 2020 Jun 29;222(2):309-318.
doi: 10.1093/infdis/jiaa068.

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

Julia M Baker  1   2 , Jacqueline E Tate  2 , Juan Leon  3 , Michael J Haber  4 , Virginia E Pitzer  5 , Benjamin A Lopman  1   2
Affiliations

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

Julia M Baker et al. J Infect Dis. .

Abstract

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.

Keywords: correlate of protection; gastroenteritis; immunoglobulin A; rotavirus; vaccination.

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Figures

Figure 1.
Figure 1.
A–D, Cumulative proportion of infants experiencing any or severe rotavirus gastroenteritis during the entire follow-up period, by antirotavirus IgA antibody (U/mL), severity of rotavirus gastroenteritis, and child mortality setting. Abbreviations: IgA, immunoglobulin A; RVGE, rotavirus gastroenteritis.
See this image and copyright information in PMC

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