Fellows, TamikaPage, Nicola AnneFix, AlanFlores, JorgeCryz, StanleyMcNeal, MonicaIturriza-Gomara, MirenGroome, Michelle J.2023-11-302023-11-302023-08-25Fellows, 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/v15091809.1999-4915 (online)10.3390/v15091809http://hdl.handle.net/2263/93564SUPPLEMENTARY 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.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.en© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.Rotavirus vaccineImmune responsePediatricFecal sheddingOral rotavirus vaccine (ORV)SDG-03: Good health and well-beingArticle