title: Safety and immunogenicity of live, attenuated human rotavirus vaccine 89-12.
abstract: The safety and immunogenicity of an orally administered live human rotavirus vaccine candidate (89-12), attenuated by 33 passages in monkey kidney cells, were evaluated in placebo-controlled trials in adults, children and infants. This strain was selected because natural infections with 89-12-like rotaviruses provided 100% protection over two years. The initial evaluations in adults, seropositive children and nine infants indicated that the vaccine was safe. Two doses of vaccine (10(5) p.f.u. dose-1) or placebo were then given to 42 infants, aged from 6 to 26 weeks. No significant difference in side effects was seen. Seroconversion was demonstrated in 19 of 20 previously uninfected vaccine recipients, but > or = 4-fold rises in 89-12 neutralizing antibody titers were detected in only seven subjects. Intestinal IgA responses were detected in 15 subjects. This attenuated human rotavirus was safe and immunogenic and should be further evaluated as a vaccine candidate.
authors.affiliation: Gamble Program for Clinical Studies, Division of Infectious Diseases, Children's Hospital Medical Center, Cincinnati, OH 45229-3039, USA.
authors.forename: D I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: V E
authors.initials: VE
authors.lastname: Smith
authors.forename: J R
authors.initials: JR
authors.lastname: Sherwood
authors.forename: G M
authors.initials: GM
authors.lastname: Schiff
authors.forename: D S
authors.initials: DS
authors.lastname: Sander
authors.forename: D
authors.initials: D
authors.lastname: DeFeudis
authors.forename: D R
authors.initials: DR
authors.lastname: Spriggs
authors.forename: R L
authors.initials: RL
authors.lastname: Ward
mesh_terms: D000328:Adult; D000956:Antigens, Viral / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000209:etiology; D004311:Double-Blind Method; D006801:Humans; D007223:Infant; D012401:Rotavirus / Q000276:immunology*; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D014765:Viral Vaccines / Q000276:immunology* / Q000627:therapeutic use*
chemical_list: D000956:Antigens, Viral; D022243:Rotavirus Vaccines; D014765:Viral Vaccines; C113153:rotavirus vaccine 89-12