title: Second-year follow-up evaluation of live, attenuated human rotavirus vaccine 89-12 in healthy infants.
abstract: Rotavirus vaccine development is a high priority. The association between the tetravalent rhesus-human reassortant rotavirus vaccine and intussusception has increased the need to develop new vaccines. In a small efficacy trial, the human rotavirus vaccine 89-12 recently has been shown to be safe and effective; 184 of the 215 healthy infants initially enrolled in this trial were followed for a second year. Vaccine efficacy during the second year was 59% (P=.047). For the 2 years of observation, vaccine efficacy was 76% against rotavirus gastroenteritis, 83% against severe rotavirus gastroenteritis, and 100% against rotavirus illnesses requiring medical intervention (P<.001 for each). These encouraging results have led to continued evaluation, in several countries, of a vaccine candidate derived from strain 89-12.
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, USA. david.bernstein@cchmc.org
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: David A
authors.initials: DA
authors.lastname: Sack
authors.forename: Keith
authors.initials: K
authors.lastname: Reisinger
authors.forename: Edward
authors.initials: E
authors.lastname: Rothstein
authors.forename: Richard L
authors.initials: RL
authors.lastname: Ward
mesh_terms: D004311:Double-Blind Method; D005500:Follow-Up Studies; D005759:Gastroenteritis / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016865:Reassortant Viruses / Q000187:drug effects; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D016896:Treatment Outcome; D014613:Vaccines, Attenuated / Q000008:administration & dosage*
chemical_list: D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; C113153:rotavirus vaccine 89-12