Association between immunogenicity of a monovalent parenteral P2-VP8 subunit rotavirus vaccine and fecal shedding of rotavirus following Rotarix challenge during a randomized, double-blind, placebo-controlled trial

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Authors

Fellows, Tamika
Page, Nicola Anne
Fix, Alan
Flores, Jorge
Cryz, Stanley
McNeal, Monica
Iturriza-Gomara, Miren
Groome, Michelle J.

Journal Title

Journal ISSN

Volume Title

Publisher

MDPI

Abstract

A correlate of protection for rotavirus (RV) has not been consistently identified. Shedding of RV following an oral rotavirus vaccine (ORV) challenge has been investigated as a potential model to assess protection of parenteral RV vaccines. We previously showed that shedding of a challenge ORV dose was significantly reduced among recipients of a parenteral monovalent RV subunit vaccine (P2-VP8-P[8]) compared to placebo recipients. This secondary data analysis assessed the association between fecal shedding of RV, as determined by ELISA one week after receipt of a Rotarix challenge dose at 18 weeks of age, and serum RV-specific antibody responses, one and six months after vaccination with the third dose of the P2-VP8-P[8] vaccine or placebo. We did not find any association between serum RV-specific immune responses measured one month post-P2-VP8-P[8] vaccination and fecal shedding of RV post-challenge. At nine months of age, six months after the third P2-VP8-P[8] or placebo injection and having received three doses of Rotarix, infants shedding RV demonstrated higher immune responses than non-shedders, showing that RV shedding is reflective of vaccine response following ORV. Further evaluation is needed in a larger sample before fecal shedding of an ORV challenge can be used as a measure of field efficacy in RV vaccine trials.

Description

SUPPLEMENTARY MATERIALS : TABLE S1: Baseline demographic and clinical factors between rotavirus shedders and non-shedders, as determined by ELISA, stratified by vaccination status: three injections of P2-VP8-P[8] vaccine (30 g and 60 g doses; n = 91) or placebo (n = 44); FIGURE S1: Schedule of events for infants.
DATA AVAILABILITY STATEMENT : The data presented in this study are available on request from the corresponding author. The data are not publicly available due to a clinical trial agreement with PATH Vaccine Solutions.

Keywords

Rotavirus vaccine, Immune response, Pediatric, Fecal shedding, Oral rotavirus vaccine (ORV), SDG-03: Good health and well-being

Sustainable Development Goals

SDG-03:Good heatlh and well-being

Citation

Fellows, T.; Page, N.; Fix, A.; Flores, J.; Cryz, S.; McNeal, M.; Iturriza-Gomara, M.; Groome, M.J. Association between Immunogenicity of a Monovalent Parenteral P2-VP8 Subunit Rotavirus Vaccine and Fecal Shedding of Rotavirus following Rotarix Challenge during a Randomized, Double-Blind, Placebo-Controlled Trial. Viruses 2023, 15, 1809. https://DOI.org/10.3390/v15091809.