Efficacy and safety of high-dose rhesus-human reassortant rotavirus vaccine in Native American populations

Mathuram Santosham, Lawrence Hale Moulton, Raymond Reid, J. Croll, R. Weatherholt, R. Ward, J. Forro, E. Zito, M. Mack, G. Brenneman, B. L. Davidson

Research output: Contribution to journalArticle


Objectives: We compared the efficacy, safety, and immunogenicity of a rhesus rotavirus tetravalent vaccine (RRV-TV), a rhesus rotavirus monovalent (serotype 1) vaccine (RRV-S1), and placebo in healthy American Indian infants for two rotavirus seasons. Study design: Infants aged 6 to 24 weeks were enrolled in a randomized, double-blind efficacy study. Infants were orally administered RRV-TV (4 x 105 plaque-forming units per dose), RRV-S1 (4 x 105 plaque-forming units per dose), or placebo at 2, 4, and 6 months of age. Stools collected during episodes of gastroenteritis were tested for detection of rotavirus antigen. A total of 1185 infants received at least one dose of a study vaccine or placebo, and 1051 received all three doses according to the protocol. Results: During the first year of surveillance, the estimates of vaccine efficacy (with 95% confidence interval) for preventing rotaviral gastroenteritis were 50% (26, 67) for RRV-TV and 29% (-1, 50) for RRV-S1. In this population only 6% of rotaviral gastroenteritis episodes among placebo recipients were associated with type G1 disease. For severe disease the estimates of vaccine efficacy were higher: 69% (29, 88) for RRV-TV and 48% (- 4, 75) for RRV-S1. Conclusions: These data indicate that RRV-TV is moderately efficacious in preventing all episodes of gastroenteritis caused by rotavirus and is most efficacious against the severe disease characteristic of rotaviral illness.

Original languageEnglish (US)
Pages (from-to)632-638
Number of pages7
JournalJournal of Pediatrics
Issue number4
Publication statusPublished - 1997


ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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