Second-year follow-up evaluation of live, attenuated human rotavirus vaccine 89-12 in healthy infants.
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.
Bernstein
David I
DI
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, USA. david.bernstein@cchmc.org
Sack
David A
DA
Reisinger
Keith
K
Rothstein
Edward
E
Ward
Richard L
RL
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*
D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; C113153:rotavirus vaccine 89-12