Human cytomegalovirus (HCMV) associated disease is responsible for over $10 billion in healthcare costs annually in the US. Mental retardation and hearing impairment caused by congenital CMV infection, and organ transplant rejection and MDS associated CMV retinitis and colitis are preventable diseases. However, no vaccine currently exists for prevention of HCMV disease and most inactivated or subunit approaches have failed. Aviron's objective is to develop a safe, live, attenuated HCMV vaccine for universal childhood immunization. Vaccination of seronegative persons prior to immunosuppression for organ transplantation or HIV infection may also prevent the morbidity and mortality of severe HCMV disease in the immunocompromised host. The goal of the research proposed in the Phase l SBIR application is to apply recent innovative advances in mucoaal vaccine delivery and virus detection to understand the human host's response to acute CMV infection and immunization. These data will be used to determine if a set of four specifically designed, reombinant, live HCMV vaccine candidates when delivered to the naso-, oral mucosal surface elicits humoral and cell-based responses that are likely to provide protection from the sequelae of HCMV infection. PROPOSED COMMERCIAL APPLICATIONS: An effective, live attenuated HCMV vaccine should prevent mental retardation and hearing impairment associated with HCMV congenital disease. There are no preventative or therapeutic regimens available to reduce HCMV congenital disease, therefore, the live HCMV vaccine addresses an unmet public health
