Field trial of rhesus rotavirus or human-rhesus rotavirus reassortant vaccine of VP7 serotype 3 or 1 specificity in infants. The Elmwood, Panorama, and Westfall Pediatric Groups

J Infect Dis. 1992 Aug;166(2):235-43. doi: 10.1093/infdis/166.2.235.

Abstract

Orally administered live rhesus monkey rotavirus vaccine (RRV, VP7 serotype 3) and human-rhesus reassortant rotavirus vaccine (DxRRV, VP7 serotype 1) were evaluated in a placebo-controlled field trial of 223 infants 2-4 months old. Both vaccines were mildly reactogenic but were generally well tolerated in the 10 days after vaccination. RRV and DxRRV were immunogenic, inducing serum antibody responses in 78% and 71% of the vaccines, respectively. Efficacy of RRV vaccine was 66% (P = .01) and of DxRRV vaccine 77% (P = .002) against rotavirus-associated illness in the first season after vaccination. Efficacy of RRV vaccine against rotavirus-associated illness over three rotavirus seasons was 51.2% (P = .045) and of DxRRV vaccine was 67.3% (P = .006). RRV vaccine provided heterotypic protection of 58.5% (P = .041) and DxRRV vaccine provided homotypic protection of 72.8% (P = .005) over three seasons against the predominant serotype 1 rotavirus.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Administration, Oral
  • Animals
  • Antibodies, Viral / biosynthesis
  • Antibodies, Viral / blood
  • Drug Tolerance
  • Humans
  • Immunoglobulin A / biosynthesis
  • Immunoglobulin A / blood
  • Infant
  • Macaca mulatta
  • Rotavirus / classification
  • Rotavirus / immunology*
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines*
  • Serotyping
  • Vaccines, Synthetic / administration & dosage
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology
  • Viral Vaccines* / administration & dosage
  • Viral Vaccines* / adverse effects
  • Viral Vaccines* / immunology

Substances

  • Antibodies, Viral
  • Immunoglobulin A
  • Rotavirus Vaccines
  • Vaccines, Synthetic
  • Viral Vaccines
  • rhesus rotavirus vaccine