title: 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.
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.
authors.affiliation: Department of Adult and Pediatric Infectious Diseases, University of Rochester School of Medicine and Dentistry, New York.
authors.forename: H P
authors.initials: HP
authors.lastname: Madore
authors.forename: C
authors.initials: C
authors.lastname: Christy
authors.forename: M
authors.initials: M
authors.lastname: Pichichero
authors.forename: C
authors.initials: C
authors.lastname: Long
authors.forename: P
authors.initials: P
authors.lastname: Pincus
authors.forename: D
authors.initials: D
authors.lastname: Vosefsky
authors.forename: A Z
authors.initials: AZ
authors.lastname: Kapikian
authors.forename: R
authors.initials: R
authors.lastname: Dolin
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000914:Antibodies, Viral / Q000096:biosynthesis / Q000097:blood; D004361:Drug Tolerance; D006801:Humans; D007070:Immunoglobulin A / Q000096:biosynthesis / Q000097:blood; D007223:Infant; D008253:Macaca mulatta; D012401:Rotavirus / Q000145:classification / Q000276:immunology*; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D012703:Serotyping; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D022243:Rotavirus Vaccines; D014614:Vaccines, Synthetic; D014765:Viral Vaccines; C052014:rhesus rotavirus vaccine