Notice ID
473158fc5aca7e32c54e80331f8e9ecf
BackgroundThe National Cancer Institutes 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 clinicalgrade 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 genegenes of interest can be used as vaccines to generate both specific helper and cytotoxic Tcells CTLs as well as antitumor effects in animal models A synergistic effect is seen when using the DNA and vaccinia constructs in a primeboost 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 SAICNCI 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 HuTK143B 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 antigens 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 andor Western Blot analyses of the gene expression Appropriate reagents will be obtained from the RAID Principal Investigator and provided to the Contractor by SAICNCI 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 NCIFrederick PO Box B Miller Drive Building 244 Frederick Maryland 21702
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