Study: New vaccine promises safer winter for infants
Gary S. Marshall, M.D., co-authored a study about the effectiveness of rotavirus vaccine. The clinical trial wss one of the largest ever conducted.
Rotavirus may soon join the list of deadly childhood diseases like measles, polio and smallpox that have sidelined by powerful 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, Penny Adcock Heaton, M.D. The University of Louisville was one of 130 clinical sites for the Rotavirus Efficacy and Safety Trial, recruiting 432 of the 70,000 infants who were studied. The study, one of the largest clinical trials ever conducted, demonstrated the safety and efficacy of a live, orally administered rotavirus vaccine. It led directly to FDA licensing under the trade name RotaTeq, which is marketed by Merck & Co. Inc. "Rotavirus season is about to start, but this time around we hope it will be different," said Gary S. Marshall, M.D., 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. No serious side effects were associated with the vaccine. 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 in January 2006 in the New England Journal of Medicine. Its findings were so significant that The Lancet identified 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.
