%0 Randomized Controlled Trial
%T 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 Fellows T
%A Page N
%A Fix A
%A Flores J
%A Cryz S
%A McNeal M
%A Iturriza-Gomara M
%A Groome MJ
%J Viruses
%V 15
%N 9
%D 2023 08 25
%M 37766217
%F 5.818
%R 10.3390/v15091809
%X 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.