The National Institute of Allergy and Infectious Disease recently awarded the University of Alabama at Birmingham Department of Pediatrics contracts totaling $11.5 million under its Broad Agency Announcement mechanism to support two studies to be conducted at UAB and its partner academic sites.
The studies will assess treatment of babies born with congenital cytomegalovirus without symptoms, and frequency of neonatal herpes infections in the United States and Peru.
Almost 1 percent of babies born in the United States will have CMV, the largest nongenetic cause of sensory loss and mental disabilities. Ninety percent of these babies will be asymptomatic, or show no visible or laboratory evidence of the disease, at the time of birth. Early detection and close follow-up can lessen the effects of congenital CMV in infants. The new study, supported by a $10 million contract, will explore whether treating babies with four months of an oral drug — valganciclovir — that targets the virus can improve outcomes.
“UAB has been the world leader in studying congenital viral infections for the past 50 years,” said David Kimberlin, M.D., who holds the Sergio Stagno, M.D., Endowed Chair in Pediatric Infectious Disease at UAB. “Our team of researchers and physicians has been instrumental in learning more about CMV and treating the disease. The next step is being able to identify and treat CMV in babies who are asymptomatic at birth.”
Studies conducted by UAB researchers Suresh Boppana, M.D., and Karen Fowler, Dr.P.H., under a $15 million contract with the National Institute on Deafness and Other Communication Disorders found diagnostic tools to screen for congenital CMV. In 2011, Boppana and Fowler developed a saliva test that can identify the silent virus in newborns with 97 percent accuracy. This has directly led to increasing testing of babies for CMV.
“Now that there is a targeted screening program for identifying CMV, we will see more babies with CMV who are asymptomatic,” said Kimberlin, principal investigator of the study and co-director of the UAB Division of Pediatric Infectious Diseases. “Under this new contract, we will be able to build upon the previous studies to observe and identify proper treatment plans for the asymptomatic population of infants.”
The five-year study across nine sites will look at male and female infants under 1 month of age with asymptomatic congenital CMV infection. Four months of oral valganciclovir, an antiviral treatment for infections caused by viruses, will be administered to babies without baseline sensorineural hearing loss. Those with baseline SNHL also will be enrolled if they are receiving oral valganciclovir prescribed by their physician.
A $1.5 million contract will support a study to assess the incidence of neonatal herpes infections in the United States and Peru using large databases in both countries to see how common the infection is. Knowledge gained from these investigations will inform future therapeutic studies aimed to decrease mother-to-infant transmission of herpes simplex virus. A prospective trial also will be conducted in Peru under this contract.