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- Title
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.
- Authors
Fellows, Tamika; Page, Nicola; Fix, Alan; Flores, Jorge; Cryz, Stanley; McNeal, Monica; Iturriza-Gomara, Miren; Groome, Michelle J.
- 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.
- Subjects
ROTAVIRUSES; ROTAVIRUS vaccines; IMMUNE response; IMMUNOGLOBULINS; VACCINE effectiveness; ORAL vaccines; SERUM; VACCINE trials
- Publication
Viruses (1999-4915), 2023, Vol 15, Issue 9, p1809
- ISSN
1999-4915
- Publication type
Article
- DOI
10.3390/v15091809