BY TIM BONFIELD
The Cincinnati Enquirer
A rotavirus vaccine developed in 1989 by researchers at Children's Hospital Medical Center has taken a big step closer to reaching widespread use.
Rotavirus is the leading cause of acute diarrhea in infants, which requires medical treatment for about 500,000 U.S. children a year and kills about 400,000 children a year worldwide.
"Phase II" clinical trials reveal that the Children's Hospital vaccine is 90 percent effective at preventing acute diarrhea in infants while causing mild side effects (low-grade fever) in about 20 percent of those vaccinated.
The vaccine, made by Virus Research Institute Inc. (VRI), of Cambridge, Mass., is one of three rotavirus vaccines under development. A product dubbed Rota-Shield, made by Philadelphia-based Wyeth-Ayerst Laboratories, could be licensed for widespread use within months. Merck & Co. also is working on a rotavirus vaccine that remains a few years from market.
"We are very impressed with the high level of protection provided by the vaccine as well as the very good safety profile," said Dr. David Bernstein, associate director of infectious diseases at Children's Hospital and lead investigator for the VRI clinical trial.
It will take about four years, researchers estimate, for the VRI vaccine to compete final, Phase III testing -- required for approval by the U.S. Food and Drug Administration. If successful, it would be the first major vaccine developed in many years at Children's Hospital, where the Sabin oral polio vaccine was created in the early 1950s.
Children's Hospital holds the patent for the VRI vaccine, a live, weakened strain of the rotavirus originally dubbed "89-12." It was developed by Dr. Bernstein and virologist Richard Ward. The hospital licensed VRI to do the Phase II clinical testing, which involved 210 infants at Children's Hospital and medical centers in Baltimore, Pittsburgh and Philadelphia.
However, in December, VRI sublicensed the vaccine rights to SB Biologicals, a unit of SmithKline Beecham to produce the vaccine for Phase III clinical trials and beyond.
