title: Field trial of rhesus rotavirus vaccine in infants.
abstract: Orally administered rhesus rotavirus vaccine (RRV) was evaluated in a placebo-controlled study in 176 infants (ages 2 to 4 months). Eighty-eight infants received a dose of 10(4) plaque-forming units of the vaccine, and 88 received the placebo. RRV was well-tolerated but mildly reactogenic in the 10 days after vaccination. There were mild febrile reactions (greater than or equal to 38 degrees C rectally) in 40% of the vaccinees and in 16% of the placebo recipients (P = 0.001). More of the vaccinees had loose stools than did the placebo recipients (P less than 0.05). RRV was immunogenic and induced a 4-fold or greater rise in serum neutralizing antibody responses in 67% of the vaccinees; however, breast-fed infants were less likely to develop a seroresponse than infants who were not breast-fed. Despite the good immunogenicity of RRV the overall incidence of rotavirus-associated illnesses was similar between the vaccine and placebo recipients. The failure of RRV in Rochester may be related to the fact that the circulating rotaviruses were predominantly serotype 1 and RRV is a serotype 3 rotavirus. Because the serotypes of rotavirus that predominate may vary from year to year, a polyvalent preparation may be necessary to provide effective vaccination against rotaviruses.
authors.affiliation: Department of Pediatric, University of Rochester School of Medicine and Dentistry, NY.
authors.forename: C
authors.initials: C
authors.lastname: Christy
authors.forename: H P
authors.initials: HP
authors.lastname: Madore
authors.forename: M E
authors.initials: ME
authors.lastname: Pichichero
authors.forename: C
authors.initials: C
authors.lastname: Gala
authors.forename: P
authors.initials: P
authors.lastname: Pincus
authors.forename: D
authors.initials: D
authors.lastname: Vosefski
authors.forename: Y
authors.initials: Y
authors.lastname: Hoshino
authors.forename: A
authors.initials: A
authors.lastname: Kapikian
authors.forename: R
authors.initials: R
authors.lastname: Dolin
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000914:Antibodies, Viral / Q000096:biosynthesis; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006801:Humans; D007223:Infant; D011897:Random Allocation; D012401:Rotavirus / Q000145:classification / Q000276:immunology*; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D012703:Serotyping; D014611:Vaccination; D014765:Viral Vaccines
chemical_list: D000914:Antibodies, Viral; D022243:Rotavirus Vaccines; D014765:Viral Vaccines; C052014:rhesus rotavirus vaccine