A -- CGMP PRODUCTION OF VACCINIA CONSTRUCTS

Notice Date

December 17, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427 Room 12, Frederick, MD, 21702

ZIP Code

21702

Solicitation Number

VACCINIA-02

Response Due

January 17, 2002

Point of Contact

Annette Bishop, Lead Contract Specialist, Phone (301) 846 -- 5636, Fax (301) 846 -- 5414, Email abishop@mail.ncifcrf.gov

Description

Background: The National Cancer Institute's (NCI) Rapid Access to Intervention Development program (RAID) is designed to utilize NCI contract resources to assist extramural investigators with the preclinical and clinical development requirements for drugs and biologics that will be used in clinical trials. As part of these new initiative qualified sources is being sought who can produce clinical-grade vaccinia virus seeds for use in vaccine trials. Description of Work: To establish two (2) vaccinia viral seed stocks that encode tumor antigens that are expressed at sufficient levels for eventual cGMP production of candidate vaccines for the treatment of cervical carcinoma. Preclinical data have shown that both recombinant DNA and vaccinia constructs containing the gene/genes of interest can be used as vaccines to generate both specific helper and cytotoxic T-cells (CTLs) as well as anti-tumor effects in animal models. A synergistic effect is seen when using the DNA and vaccinia constructs in a prime-boost regimen. The manufacture of the DNA vaccines is already underway and will be used in separate clinical trials. Contractor must be able to create two (2) high titer recombinant vaccinia viral seed stocks in fully qualified cell lines that can be eventually used for the manufacture of recombinant vaccinia viruses expressing tumor antigens according to cGMP. These viruses will be utilized in Phase I /II clinical studies in cervical carcinoma. Specific Requirements Include: 1. Recombinant vaccinia shuttle vectors, harboring the genes encoding the tumor antigens of interest will be supplied to the contractor by SAIC/NCI. 2. The Wyeth Strain of vaccinia virus may be used for generating the recombinant vaccinia virus seed stocks. 3. The recombinant vaccinia virus may be created via initial transfection into qualified recipient cells. Recombination and plaque selection may be facilitated by thymidine kinase, -negative qualified HuTK-143B cells. These cells will be supplied to the contractor by the SAIC. 4. Subsequent to multiple rounds of plaque purification, confirmation of the expression (potency) and identity of the cervical tumor antigen(s) will be required. Identity testing should include, in addition to classical molecular analyses, nucleotide sequencing of the transgene and its flanking sequences. 5. Potency testing minimally should include immunoprecipitation and/or Western Blot analyses of the gene expression. Appropriate reagents will be obtained from the RAID Principal Investigator and provided to the Contractor by SAIC/NCI. 6. The purified plaque containing the correct gene sequence and expression profile will be amplified into qualified cells to produce the respective two (2) Master Viral Seed Stocks. Contractor Must be Able to Deliver: Two (2) vials of viral seed stock containing the respective vectors containing the specific genes of interest. All release criteria will be established in advance so that the Contractor will be aware of the exact requirements needed to produce acceptable products. Interested companies should describe their capabilities and experience and respond by January 17, 2002 to NCI-Frederick, P.O. Box B, Miller Drive, Building 244, Frederick, Maryland 21702.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/FCRF/VACCINIA-02/listing.html)

Record

Loren Data Corp. 20011219/ASOL009.HTM (D-351 SN515391)