Received 30 May 2002; revised 17 July 2002; electronically
published 22 October 2002.
Rotavirus vaccine development isa high priority. Theassociation between the tetravalentrhesus-human
reassortant rotavirus vaccineand intussusception has increasedthe need to developnew vaccines. In asmall
efficacy trial, thehuman rotavirus vaccine 89-12
recently has been shownto be safe andeffective; 184
of the215 healthy infants initiallyenrolled in this
trialwere followed for asecond year. Vaccine
efficacyduring the second yearwas 59% (P =.047). For the 2years of observation, vaccine
efficacy was 76% againstrotavirus gastroenteritis, 83% againstsevere rotavirus gastroenteritis, and100% against
rotavirus illnessesrequiring medical intervention (P< .001 for each).These encouraging results have
led to continued evaluation,in several countries, of
a vaccine candidate derivedfrom strain 89-12.
Presented inpart: Infectious Diseases
Societyof America meeting, NewOrleans, 710
September 2000.
Informedconsent was obtained fromthe parents or
guardiansof participating children. Humanexperimentation
guidelines of theUS Department of Healthand Human
Services and/orthose of the authors'institutions were
followed inthe conduct this research.
Financialsupport: Avant Therapeutics; SmithKline
Biologicals (now Glaxo SmithKline).
Commercialand other associations: D.I.B.and R.L.W.
are inventorsof human rotavirus vaccine89-12 (patent
"Human Rotaviruses,Vaccines and Methods" [issued12
December 1995]) andwere consultants to AvantTherapeutics
and SmithKline Biologicals.
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
10
September 2000.