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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

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...

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Detalles Bibliográficos
Autores principales: Fellows, Tamika, Page, Nicola, Fix, Alan, Flores, Jorge, Cryz, Stanley, McNeal, Monica, Iturriza-Gomara, Miren, Groome, Michelle J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10536230/
https://www.ncbi.nlm.nih.gov/pubmed/37766217
http://dx.doi.org/10.3390/v15091809
Descripción
Sumario: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.