Centers for Disease Control and Prevention (CDC), Procurement & Grants Office, Contracts & Purchases Branch, 255 East Paces Ferry Rd., NE, Rm 419, Atlanta, GA 30305

B -- ASSAYS ON CLINICAL HERPES SIMPLEX VIRUS (HSV) ISOLATES SUPPORTING THE ACYCLOVIR-RESISTANT HSV SURVEILLANCE PROJECT SOL 98S095(Q) DUE 012398 POC Susan Cleveland, Contracting Officer, (404) 842-6715 The Centers for Disease Control and Prevention anticipates award of a noncompetitive order to Viromed. In October 1996, GlaxoWellcome was providing funding for a pilot project for this study. Viromed was the contractor to GlaxoWellcome for performing assays on clinical herpes simplex virus (HSV) isolates under this study. There were 22 collection sites established in Atlanta, Birmingham, Chicago, Columbus (OH), Denver, Ft. Lauderdale, Houston, Indianapolis, New York, San Francisco, and Seattle. Specific testing protocols and clearances for both virus isolation and sensitivity testing were established. Approximately 85% of the effort has been completed to date. In order to complete the study and maintain continuity of specific testing protocols, it is necessary that Viromed complete the remaining assays. The continuation of the project will be from date of the purchase order through December 31, 1998. Specimen collection kits will be provided by Viromed to the 22 sites for use in the study. There will be approximately 598 additional assays performed on specimens taken at the 22 sites under the original study. The specimens must be processed in accordance with protocol within 24 hours. Specimens cannot be frozen. HSV will be cultivated in a tube of rabbit kidney (RK) cells and observed for typical HSV produced Cytopathic effects (CPE). HSV1/HSV2 will be confirmed by staining with a mixture of HSV-specific monoclonal antibodies. All cells and media (Except M4-3 transport media) used in these studies must be obtained for Viromed's GMO manufacturing facility. Initial culture results must be reported to each site, and to CDC, within 10 days of receipt of the specimen. In addition, each positive HSV culture must be maintained and expanded to be used for viral titer determination and determination of acyclovir sensitivity by plaque reduction assay according to the original protocol. Acyclovir dose response curves must be generated for each isolate and the median effective concentration of acyclovir calculated for each isolate. Data is analyzed and maintained in a database which includes HSV isolate resistance profile and patient/site information. Monthly reports are provided to CDC. All positive cultures are kept in long term storage for later shipment to CDC. Contractor must have a IRB clearance prior to performing work under this project. See Numbered Note 22. (0012)

Loren Data Corp. http://www.ld.com (SYN# 0021 19980114\B-0003.SOL)