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

J Infect Dis. 1996 Aug;174(2):268-75. doi: 10.1093/infdis/174.2.268.

Abstract

An oral rhesus-human rotavirus tetravalent (RRV-TV) vaccine (10(4) 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antibodies, Viral / blood
  • Developing Countries
  • Diarrhea, Infantile / epidemiology
  • Diarrhea, Infantile / prevention & control*
  • Diarrhea, Infantile / virology
  • Dose-Response Relationship, Drug
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Humans
  • Immunoglobulin A / blood
  • Infant
  • Macaca mulatta / virology
  • Male
  • Neutralization Tests
  • Peru / epidemiology
  • Placebos
  • Rotavirus Infections / blood
  • Rotavirus Infections / epidemiology
  • Rotavirus Infections / prevention & control*
  • Suburban Population
  • Viral Plaque Assay
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology
  • Viral Vaccines / therapeutic use*

Substances

  • Antibodies, Viral
  • Immunoglobulin A
  • Placebos
  • Viral Vaccines