Details

Capability: Capabilities

Project Timeline: 7/13/2006

Each year in the US, approximately 400 children die from congenital CMV infection, and more than 8000 others suffer serious, permanent disabilities. Determining whether a future CMV vaccine is effective will require robust estimates of congenital CMV rates prior to vaccine licensure. Sequoia Foundation designed and carried out study of congenital CMV incidence in an ethnically diverse, population-based sample of infants, resulting in data that can aid in the calculation of sample sizes for future vaccine efficacy trials.

For this study, 5,000 randomly selected dried blood spots were tested for evidence of CMV DNA using the most sensitive PCR method developed. Rates of congenital CMV were compared in different racial/ethnic groups, which allowed measurement of incidence in diverse racial/ethnic groups and identify risk factors for congenital infection. These data will aid in the calculation of sample sizes for future vaccine efficacy trials and, when a CMV vaccine becomes available, post-vaccine rates of congenital CMV in California can be calculated and directly compared with rates from this study.