UofL vaccine research promises healthier winter for infants
October 15th, 2007
Measles, polio, smallpox — rotavirus infection may soon join the list of devastating childhood diseases sidelined by vaccines.
The pending demise for this leading cause of severe diarrhea comes largely because of a worldwide vaccine trial conducted partly in Louisville and led by a former University of Louisville Kosair Charities pediatric infectious disease fellow.
The Rotavirus Efficacy and Safety Trial was one of the largest clinical trials ever conducted, and UofL, one of 130 clinical sites for the study, recruited 432 of the 70,000 participating infants. Results demonstrated the safety and efficacy of a live, orally-administered rotavirus vaccine and led directly to FDA licensing under the trade name RotaTeq® (Merck & Co., Inc.).
“Rotavirus season is about to start but this time around we hope it will be different,” said Gary Marshall, UofL pediatric infectious disease specialist and a co-author of the study. “Rotateq®, which is now recommended for all infants in the U.S., has the potential to prevent tens of thousands of hospitalizations and countless emergency department visits. The impact on children’s health and pediatric practice could be significant.”
The vaccine was shown to be 98 percent effective against severe rotavirus disease, 96 percent effective at preventing hospitalization and 94 percent protective against emergency department visits. It has no serious side effects associated with it.
Rotavirus predictably appears every winter and affects almost every infant in the country. Symptoms include fever, vomiting and diarrhea. Hospitalizations occur because of dehydration. Worldwide, rotavirus causes more than 600,000 deaths annually, according to the Centers for Disease Control and Prevention.
The results of the study were published January 2006 in the New England Journal of Medicine. Its findings were so significant that The Lancet, a widely renowned British medical journal, singled the paper as one of two “papers of the year” from among 700,000 papers published worldwide. The journal stated that the article represented the best medical research of 2006.
“We are very proud of our former fellow, Dr. Penny Adcock Heaton, for spearheading this work and we’re proud to have participated in this landmark study,” Marshall said.
