College of Medicine conducts rotavirus clinical trial
The University of Illinois College of Medicine at Rockford has been selected as a site for a three-year study of the Safety and Efficacy of Pentavalent Human-Bovine Rotavirus Vaccine in Healthy Infants.
Principal investigator for the clinical trial is Lawrence Frenkel, M.D., chair of the Department of Pediatrics and professor of Pediatrics at the College of Medicine. Sponsor of the international trial of the oral bovine-human reassortant rotavirus vaccine is Merck and Company of Whitehouse Station, N.J. Approximately 60,000 patients will be enrolled in the United States and Finland.
Rotavirus, identified in 1973, infects the bowel or intestine. It is the most common cause of severe diarrhea in infants and young children in the United States and worldwide. In the U.S., more than 2 million children have the disease each year. Children between six and 24 months of age are at the highest risk. Children may have mild diarrhea, but can have more serious symptoms, including fever, vomiting, abdominal (stomach) pain and dehydration (loss of body water.)
Rotavirus infections are very common. Virtually every child in the U.S. will be infected at least once in the first three to five years of life. Up to 90 percent of all rotavirus infections in the U.S. occur during the winter months. The disease is very easily spread from one child to another by contaminated hands or objects. It can also be spread through ingestion of contaminated water or food and contact with contaminated surfaces.
Most children recover from the illness by being treated with extra fluids at home. In very young children, especially those younger than two years, rotavirus disease can be very serious. For healthy infants with normal immune systems, the illness is usually mild, lasting from three to eight days. Children with more severe cases may become dehydrated and have to be treated with fluids given through the veins at a hospital. If children with severe diarrhea are not properly treated, they may die from dehydration.
In developing countries, rotavirus is associated with significant mortality in children under the age of two years. It may be responsible for 600,000 to 850,000 deaths annually. In contrast, in developed countries, the mortality is low: 20-40 deaths per year in the U.S. (1985-1999) and 2-5 total deaths in Finland (1985-1995). Worldwide, rotavirus infection is responsible for approximately 25 percent of all deaths associated with diarrhea and 6 percent of all deaths in children less than five years old.
The goal of immunization against rotavirus is to protect infants against rotavirus-associated disease, especially severe disease which may cause hospitalization or even death. Prevention of the most serious rotavirus-associated disease requires development of immune protection within the first months of birth. In clinical trials to date, there is evidence to suggest that the WC3 bovine-human reassortant rotavirus vaccine is safe and well tolerated and provides good protective efficacy against all rotavirus disease.
The study will have a continuous monitoring system for intussusception (a blockage of the bowel) and will be stopped early if there is evidence of an association between the vaccine and intussusception at any point during the study. It should be noted that intussusception is also seen in some normal children with viruses and intestinal infections who have not received any vaccine.