Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in Lima, Peru

Claudio F. Lanata, Karen Midthun, Robert E. Black, Betzabe Butron, Ana Huapaya, Mary E. Penny, Gladis Ventura, Ana Gil, Mary Jett-Goheen, Bruce L. Davidson

Research output: Contribution to journalArticlepeer-review

Abstract

An oral rhesus-human rotavirus tetravalent (RRV-TV) vaccine (104 pfu of rhesus rotavirus [type G3] and of 3 human-rhesus reassortants [G1, G2, and G4]) was evaluated in a field trial in Lima, Peru. At 2, 3, and 4 months of age, infants received either a dose of RRV-TV, an initial dose of vaccine followed by a dose of placebo at 3 and 4 months, or a dose of placebo. Rotavirus-specific IgA responses were detected by ELISA in 75% of the three- dose vaccine group, 59% of the one-dose vaccine group (p = .05), and 24% of the placebo group (P < .001): 64%, 48%, and 12% of each group, respectively, had a neutralizing antibody response to at least 1 serotype. Both one and three doses of vaccine failed to induce a significant level of protection against rotavirus diarrhea; however, they did provide some protection (range, 35%-66%) against more severe rotavirus diarrhea, especially for episodes caused by type G1.

Original languageEnglish (US)
Pages (from-to)268-275
Number of pages8
JournalJournal of Infectious Diseases
Volume174
Issue number2
DOIs
StatePublished - 1996
Externally publishedYes

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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