title: Immune protection of infants against rotavirus gastroenteritis by a serotype 1 reassortant of bovine rotavirus WC3.
abstract: The safety and protective efficacy of a serotype 1 reassortant of bovine rotavirus WC3, disignated strain WI79-9, was evaluated in a double-blind placebo-controlled trial. Rotavirus reassortant WI79-9 contains a gene segment 9 coding for the surface structural protein vp7 of a human serotype 1 rotavirus, with all other gene segments derived from WC3 rotavirus, which had previously been shown to be safe and immunogenic in infants. Infants 2-11 months of age were given two doses of vaccine (10(7.3) plaque-forming units/dose) or of placebo 28 days apart. Adverse reactions to the vaccine were not detected. The incidence of serum plaque reduction neutralization antibody responses to two doses of vaccine was serotype 6, 97%; serotype 3, 68%; and serotype 1, 22%. Active surveillance during the subsequent rotavirus season revealed 8 cases of rotavirus gastroenteritis in 39 placebo control infants and no cases in 38 WI79-9 vaccine recipients (protection = 100%, P = .003). Six cases of rotavirus gastroenteritis were caused by type 1 and two by type 3 virus. Although vaccination with WI79-9 affected only the incidence of rotavirus gastroenteritis, the vaccinated infants exhibited a significantly reduced incidence of total days of diarrhea, fever, and illness associated with gastroenteritis in general.
authors.affiliation: Joseph Stokes, Jr., Research Institute, Children's Hospital, Philadelphia, PA 19104.
authors.forename: H F
authors.initials: HF
authors.lastname: Clark
authors.forename: F E
authors.initials: FE
authors.lastname: Borian
authors.forename: S A
authors.initials: SA
authors.lastname: Plotkin
mesh_terms: D000914:Antibodies, Viral / Q000096:biosynthesis; D015331:Cohort Studies; D003967:Diarrhea / Q000517:prevention & control*; D004311:Double-Blind Method; D005243:Feces / Q000032:analysis; D005759:Gastroenteritis / Q000517:prevention & control*; D006801:Humans; D007070:Immunoglobulin A / Q000032:analysis; D007223:Infant; D009500:Neutralization Tests; D016032:Randomized Controlled Trials as Topic; D012401:Rotavirus / Q000145:classification / Q000276:immunology*; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D014765:Viral Vaccines / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D022243:Rotavirus Vaccines; D014765:Viral Vaccines; C058442:WC3 rotavirus vaccine