title: Efficacy of two doses of RIT 4237 bovine rotavirus vaccine for prevention of rotavirus diarrhoea.
abstract: Candidate oral bovine rotavirus vaccine RIT 4237 or placebo was given to 252 Finnish infants at birth and at 7 months of age. No vaccine-associated reactions were observed. Primary rotavirus ELISA IgM responses were detected in 36% of the infants after the first vaccination; after the second dose 68% of the vaccinees were seropositive for rotavirus ELISA IgG antibody. The infants remained in clinical follow-up over two rotavirus epidemic seasons (total 28 months). Counted from child years in follow-up the overall vaccine protection rate was 43%. The clinical severity of rotavirus episodes was assessed using a numerical score 0-20. Vaccine protection rate for cases with a score greater than or equal to 7 was 57% and for cases with a score greater than or equal to 11 it was 89%. It is concluded that vaccination with a bovine rotavirus vaccine at birth and at 7 months of age, with the second dose given shortly before rotavirus epidemic season, protects infants against moderately severe and severe rotavirus diarrhoea in the first 2 years of life.
authors.affiliation: Department of Clinical Sciences, University of Tampere, Finland.
authors.forename: T
authors.initials: T
authors.lastname: Vesikari
authors.forename: T
authors.initials: T
authors.lastname: Ruuska
authors.forename: A
authors.initials: A
authors.lastname: Delem
authors.forename: F E
authors.initials: FE
authors.lastname: André
authors.forename: G M
authors.initials: GM
authors.lastname: Beards
authors.forename: T H
authors.initials: TH
authors.lastname: Flewett
mesh_terms: D000888:Antibodies, Anti-Idiotypic / Q000097:blood; D003968:Diarrhea, Infantile / Q000382:microbiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology; D007075:Immunoglobulin M / Q000276:immunology; D007231:Infant, Newborn; D012401:Rotavirus / Q000276:immunology*; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated / Q000008:administration & dosage*; D014765:Viral Vaccines / Q000008:administration & dosage*
chemical_list: D000888:Antibodies, Anti-Idiotypic; D007074:Immunoglobulin G; D007075:Immunoglobulin M; C041165:RIT 4237 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; D014765:Viral Vaccines