Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants

J Pediatr. 2004 Feb;144(2):184-90. doi: 10.1016/j.jpeds.2003.10.054.

Abstract

Objectives: To investigate safety, efficacy, and immunogenicity of live quadrivalent rotavirus vaccine (QRV) containing human-bovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1a.

Study design: This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants approximately 2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8-week intervals.

Results: The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95% confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74.6% efficacious (95% CI: 49.5%, 88.3%) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100% efficacious (95% CI: 43.5%, 100%) in preventing severe rotavirus AGE through one rotavirus season. Serotype G1 was identified in most infants with rotavirus AGE. A >or=3-fold rise in serum neutralizing antibody to G1 was observed in 57% (45/79) of vaccinees. A >or=3-fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88% (162/185) and 65% (104/159) of vaccinees, respectively.

Conclusions: QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.

Publication types

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

MeSH terms

  • Animals
  • Antibodies, Viral / biosynthesis
  • Antibodies, Viral / blood
  • Cattle
  • Double-Blind Method
  • Drug Administration Schedule
  • Feces / virology
  • Female
  • Gastroenteritis / prevention & control
  • Gastroenteritis / virology
  • Humans
  • Immunoglobulin A / blood
  • Immunoglobulin A / immunology
  • Infant
  • Male
  • Reassortant Viruses / immunology*
  • Rotavirus / immunology*
  • Rotavirus Infections / immunology*
  • Rotavirus Infections / prevention & control
  • Rotavirus Vaccines / adverse effects
  • Rotavirus Vaccines / immunology*
  • Serotyping
  • Vaccines, Attenuated / immunology

Substances

  • Antibodies, Viral
  • Immunoglobulin A
  • Rotavirus Vaccines
  • Vaccines, Attenuated