PEDIATRICS Vol. 96 No. 6 December 1995, pp. 1132-1136
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Comparison of Immunogenicity and Efficacy of Rhesus Rotavirus Reassortant Vaccines in Breastfed and Nonbreastfed Children

Margaret B. Rennels MD1, Steven S. Wasserman PhD2, Roger I. Glass MD, PhD3, Virginia A. Keane MD4, and US Rotavirus Vaccine Efficacy Group

1 Departments of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore
2 Departments of Medicine, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore
3 The Viral Gastroenteritis Section, Respiratory and Enteric Viruses Branch, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
4 Departments of Pediatrics, University of Maryland School of Medicine, Baltimore

Objective. To evaluate whether breastfeeding affected the immunogenicity and/or efficacy of candidate rhesus-human rotavirus reassortant vaccines.

Methods. A total of 989 healthy infants between 4 and 26 weeks of age were enrolled into a 23-center, prospective, randomized, double-masked, controlled study of the safety, immunogenicity, and efficacy of three doses (4 x 104 plaque-forming units) of monovalent rhesushuman viral protein 7, or G, serotype 1 reassortant vaccine, (RRV-S1) or tetravalent vaccine (RRV-TV) consisting of rhesus-human reassortant G serotypes 1, 2, and 4, and the parent RRV G serotype 3. Vaccine efficacy was compared in the breastfed and nonbreastfed children as well as seroconversion rates and postvaccination geometric mean titers (GMTs) of neutralizing antibodies to human serotypes 1, 2, 3, and 4, RRV, and immunoglobulin A to RRV. GMTs in the two feeding groups were compared with and without adjustment for age at initiation of vaccination, prevaccination antibody titers, and the age and prevaccination titer interaction.

Results. The seroconversion rates to both vaccines by one or more assays were similar for the breastfed and the nonbreastfed groups (RRV-S1, 84% and 85%, respectively; RRV-TV, 94% and 93%, respectively). There were no significant differences in postvaccination GMTs to either vaccine, measured by any serologic assay, in the two feeding groups. The efficacy of the RRV-S1 vaccine was not significantly lower among the breastfed children than the nonbreastfed children (28% and 39%, respectively). RRV-TV, which is the vaccine being further evaluated for licensure, was equally protective in breastfed and nonbreastfed infants (50% and 51%, respectively). Logistic regression analysis, taking into account differences in age at vaccination and day 1 titer, revealed no evidence of differential vaccine efficacy in the two feeding groups for either vaccine.

Conclusions. These results indicate that the RRV-TV vaccine, given as three doses of 4 x 104 plaque-forming units, induces similar seroresponses and protection in breastfed and nonbreastfed US children.

Submitted on October 19, 1994
Accepted on December 19, 1994




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