A field study of the safety and efficacy of two candidate rotavirus vaccines in a native american population

Mathuram Santosham, G. William Letson, Mark Wolff, Raymond Reid, Sheila Gahagan, Roberta Adams, Charles Callahan, R. Bradley Sack, Albert Z. Kapikian

Research output: Contribution to journalArticlepeer-review

Abstract

A double-blind, randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of a rhesus rotavirus vaccine and RIT 4237, a bovine rotavirus vaccine, in a Navajo population. Infants aged 2-5 months were randomized to receive one dose of either 104 pfu of the rhesus rotavirus vaccine or 108 pfu of the RIT 4237 vaccine or placebo. Eleven (10.2%) of 108 infants in the rhesus vaccine group, 11 (10.4%) of 106 in the RIT 4237 group, and 9 (8.4%) of 107 in the placebo group experienced rotavirus diarrhea during the follow-up period of 17 months. Thus, in this population, neither vaccine was efficacious in preventing rotavirus diarrhea.

Original languageEnglish (US)
Pages (from-to)483-487
Number of pages5
JournalJournal of Infectious Diseases
Volume163
Issue number3
DOIs
StatePublished - Mar 1991

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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