Research Project
6140372
DESCRIPTION (Adapted from Applicant's Abstract): A replication defective HSV-2 strain has been constructed for use as a vaccine for genital herpes. The vaccine strain contains defined deletions in two genes essential for viral replication (UL29 and UL5). The virus is grown on complementing cells that express the deleted proteins. When the replication defective virus infects normal cells, many of the viral proteins are expressed. However, the replication cycle is not completed due to the lack of viral DNA synthesis. The objective of Phase 1 of this project is to demonstrate feasibility of this virus as a candidate vaccine for humans. A Research Cell Bank of the production cell line and a viral seed stock of the virus will be prepared and characterized. Process development studies will be performed to optimize a production/purification process that will consistently yield the amount of infectious virus required to produce clinical lots of the vaccine. Vaccine stability studies will be performed to select the formulation to be used in the preparation of clinical lots of the vaccine. Materials will be prepared and a production process devised for use in the manufacture clinical lots of the HSV-2 vaccine (Phase 2 of the project.) PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE
