Safety and immunogenicity of bovine rotavirus vaccine RIT 4237 in 3-month-old infants

Y. Maldonado, L. Hestvik, M. Wilson, T. Townsend, J. O'Hare, S. Wee, R. Yolken

Research output: Contribution to journalArticle

Abstract

To assess the safety and immunogenicity of bovine rotavirus vaccine, we administered attenuated strain RIT 4237 to 54 inner-city infants randomized to one of three groups in a double-blind fashion to receive a dose at 3 and 5 months of age of either placebo, vaccine virus at 107 TCID50/ml, or vaccine virus at 108 TCID50/ml. Vaccination began in early fall 1984, and continued through spring 1985. Forty-nine infants received one dose of vaccine or placebo; 43 received both doses of vaccine or placebo. At 2 and 3 months after vaccination, homologous geometric mean neutralizing antibody titers were significantly higher in children who received either dose of vaccine compared with placebo recipients. Cumulative seroconversion to bovine rotavirus after either dose of vaccine virus was 87% at 6 months of age. Seroconversion was significantly higher (P<0.01) in both vaccine groups compared with the placebo group. No ill effects were associated with vaccine administration. RIT 4237 vaccine appears to be safe and immunogenic when administered to young infants living in the United States.

Original languageEnglish (US)
Pages (from-to)931-935
Number of pages5
JournalThe Journal of pediatrics
Volume109
Issue number6
DOIs
StatePublished - Dec 1986

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ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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