SPECIAL NOTICE
A -- IMMUNE RESPONSE IN CHIMPANZEES FOLLOWING HEPATITIS C VIRUS T-CELL VACCINE
- Notice Date
- 9/5/2007
- Notice Type
- Special Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-07-1033394
- Response Due
- 9/12/2007
- Archive Date
- 9/27/2007
- Description
- The Food and Drug Administration intends to award a firm fixed price contract to the University of Louisiana at LaFayette - New Iberia Research Center . This is NOT a request for competitive quotes. The Purchase Order will be made on a sole source basis in accordance with FAR Part 13 - Simplified Acquisition Procedures and 13.501 (A)- Sole source acquisitions for the following, full time, services to be performed at University of Louisiana at LaFayette - New Iberia Research Center. Statement of Work: We have developed a chimpanzee model for HCV using a clonal virus that produces infections with highly reproducible viral kinetics. We have a large amount of immunologic, virologic, and pathologic data with this model and have developed a set of reagents specific for the study of infections with this HCV strain. 3 naive chimpanzees will be immunized i/v with our DNA prime/recombinant adenovirus boost vaccine that induces T cell responses to NS3 and NS5 and challenged with 100 CID50 of the clonal HCV inoculum which matches the sequence used to generate the vaccine. The vaccination series requires 3 months, animals will be challenged 3 months after the last dose of vaccine and the follow-up will be a further 6 months (1 year total). We will obtain weekly bleeds, alternating between 5ml of serum and 70mL of whole blood for T-cell isolation. We will also obtain liver biopsies every other week throughout the study. We will obtain 4 weeks of pre samples from all animals. The immune responses in the liver and the peripheral blood of all animals will be thoroughly studied using reagents that we have already developed or purchased. Liver biopsy samples will be obtained to isolate T-cells and for quantitative PCR determination of specific mRNA levels for immune response genes, IFN-gamma, TNF-alpha, and 2OAS to study innate immunity. HCV-specific T-cells will be analyzed by 12-color flow cytometry for surface markers (CD4+, CD8+, CD62L, CD27, CCR7, CD127) and intracellular cytokines (IFN-gamma, IL-2 and TNF-alpha) in order to determine the memory cell phenotype and perform qualitative comparisons between T-cells induced by vaccination versus those induced by natural infection. These analyses are currently being performed on chimpanzee T-cells from previous studies. Global micro array analyses or immune selected array panels will be performed on mRNA extracted from the liver biopsies. Inoculations: 0 and 4 weeks: DNA plasmids: ~4mg for each of 2 plasmids complexed with liposomes (8mg total) i/v. DNA concentration will be 2mg/ml in PBS. One plasmid expresses HCV antigens NS3-NS5B, the 2nd plasmid expresses human IL-12 as an adjuvant. Week 12: 3.1011 adenovirus particles, i.v. 1ml in PBS. The recombinant adenovirus vectored vaccine is non-replicating and administered at a dose of 1011 particles for each of 3 different constructs i.v. Both these vaccines have been used in previous chimpanzee experiments without difficulty. Week 24: 100 CID50 of HCV genotype 1a in the 4 animals, i.v. 3ml in Hanks buffer.This virus has been given in this dose to over 10 chimpanzees with a 100% take rate. Persistent infections have developed in about 60% of the chimps. The liver disease has been very mild. Blood withdrawal: 10 ml from the femoral vein every other week for plasma. 70 ml whole from the femoral vein every other week for isolation of PBMCs. These volume of blood removed per month will be well within allowable limits for animals of the weight and size to be used in this study. Procedures: Percutaneous liver biopsies at a maximum frequency of every 2 week by Klatskin. Menghini or Vimm-Silverman method according to protocols of NIRC. A maximum of 12 biopsies will be performed. The experiment will last a maximum of 1 years unless stopped earlier by PI. There may be an extension of up to 12 months depending on the availability of funding. Animals will be anesthetized for all bleedings and procedures. The University has worked extensively in these areas and thus possesses an understanding of the procedures, problems and timeliness aspect to these projects. Having the same University continue to do this will ensure that critical work is not interrupted and is completed in a manner that furthers the mission of FDA. The proposed source is for commercial services for which the Government intends to solicit and negotiate with only one source. This action is proposed on a sole source basis because it is a follow-on contract where the University has developed procedures that help expedite critical requests and there being a substantial duplication of cost to the government. Any Interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met, no later than September 10, 2007. A determination by the Government not to compete the proposed contract based on responses from this notice is solely within the discretion of the Government. Responses to this notice must be sent via email to Kimberly.davis@fda.hhs.gov. No phone calls will be accepted.
- Place of Performance
- Address: UNIVERSITY OF LOUISIANA, LAFAYETTE, NEW IBERIA RESEARCH CENTER
- Zip Code: 70504-1009
- Country: UNITED STATES
- Zip Code: 70504-1009
- Record
- SN01395065-W 20070907/070905220457 (fbodaily.com)
- Source
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