More Effective Rotavirus Vaccine Demonstrated in National Study Published in the Lancet
CINCINNATI -- A rotavirus vaccine developed by Avant Immunotherapeutics Inc., is 89 percent effective in preventing rotavirus disease in infants, according to a Phase II study published in the July 24, 1999, edition of the Lancet.
The effectiveness reported in the multi-center study, coordinated at Children's Hospital Medical Center of Cincinnati, is higher than that of the currently approved rotavirus vaccine, whose effectiveness ranges in studies from 49 to 68 percent.
The Avant vaccine was discovered at The Children's Hospital Research Foundation, patented at Children's Hospital Medical Center of Cincinnati, and licensed to Avant, which licensed the vaccine to Smithkline Beecham Biologics.
Rotavirus is the most common cause of severe vomiting and diarrhea requiring hospitalization in the United States. It is also the most important cause of death due to dehydrating diarrhea in infants and children throughout the world.
Each year, more than 50,000 children are hospitalized in the United States for rotavirus infection, and up to 50 die. The virus is estimated to lead to 600,000 child deaths throughout the world each year.
There is only one approved vaccine to prevent rotavirus infection. It combines human and monkey rotavirus genes.
"The rotavirus vaccine evaluated here may have advantages over those tested previously," says David Bernstein, M.D., associate director of Cincinnati Children's Division of Infectious Diseases and the study's lead investigator. Dr. Bernstein was co-discoverer of the vaccine, along with Richard Ward, Ph.D., also of Children's Hospital Medical Center of Cincinnati Division of Infectious Diseases.
"The use of an attenuated (weakened) human strain compared to animal rotaviruses may induce better protection because it is more closely related to human rotavirus strains," adds Dr. Bernstein.
"Further development of this vaccine is warranted." The study, involving 215 infants with rotavirus, was conducted at Children's Hospital Medical Center of Cincinnati, the Johns Hopkins University Medical School, Pittsburgh Pediatric Research, and Pennridge Pediatric Associates in Philadelphia.
About half the infants received the live, attenuated human vaccine, known as 89-12, and about half received a placebo.
Of those families reporting vomiting or diarrhea, rotavirus was detected in 20 infants. Only two of those 20 were in the group that received the vaccine, for an overall efficacy of 89 percent. In addition, all 10 infants who required medical attention were in the placebo group.
The vaccine, given in two doses, was safe and generally well-tolerated, according to Dr. Bernstein. Nineteen percent developed a mild fever in the week following the first dose -- similar to rates in Finnish and American studies. Larger trials will be necessary to confirm a lack of other symptoms, according to Dr. Bernstein.
Contact Information
Jim Feuer,
jfeuer@chmcc.org
