Comparison of 2 different regimens for reactogenicity, safety, and immunogenicity of the live attenuated oral rotavirus vaccine rix4414 coadministered with oral polio vaccine in south african infants

A. D. Steele, J. Reynders, F. Scholtz, P. Bos, M. C. De Beer, J. Tumbo, C. F. Van Der Merwe, A. Delem, B. De Vos

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33 Citations (Scopus)

Abstract

Background. A phase II, randomized, double-blind, placebo-controlled study was conducted in South Africa during 2003-2004 to evaluate the safety, reactogenicity, and immunogenicity of 2 regimens of the live attenuated oral human rotavirus vaccine RIX4414 when coadministered with the Expanded Program on Immunization childhood vaccines, including oral polio vaccine. Methods. Healthy infants were randomized (2:2:1) to receive either 2 doses of RIX4414 ( ; at np190 10 and 14 weeks, with placebo at 6 weeks), 3 doses of RIX4414 (np189; at 6, 10, and 14 weeks), or 3 doses of placebo (np96), all with concomitant routine vaccinations. The antirotavirus IgA seroconversion rate was assessed using enzyme-linked immunosorbent assay at 2 months after the last dose of RIX4414 or placebo. Antipolio types 1, 2, and 3 antibodies were measured using a virus neutralization assay. Solicited symptoms were recorded for 15 days after each dose. Results. The antirotavirus IgA seroconversion rates were similar in the RIX4414 2- and 3-dose groups (44.3% and 44.4%, respectively; Pp.544, by 1-sided Fisher exact test) and antirotavirus IgA geometric mean concentrations were also comparable. Seroprotection rates for antipolio types 1, 2, and 3 antibodies were high (93%-100%) and were not significantly different among groups. Solicited symptoms reported within 15 days after vaccination were similar in all groups. Conclusions. The immune seroconversion response to the RIX4414 vaccine with 3 doses was not superior to the 2-dose regimen. There was no interference by either regimen with antibody response to oral polio vaccine, and RIX4414 was well tolerated when given with routine vaccinations.

Original languageEnglish
Pages (from-to)S93-S100
JournalJournal of Infectious Diseases
Volume202
Issue numberSUPPL. 1
DOIs
Publication statusPublished - 1 Sep 2010
Externally publishedYes

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