SOURCES SOUGHT
R -- Laboratory Support for AIDS Vaccine and Other Prevention Clinical Trials
- Notice Date
- 10/22/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700 B Rockledge Room 2230 MSC7612, Bethesda, MD, 20892-7605
- ZIP Code
- 20892-7605
- Solicitation Number
- N01AI85341
- Response Due
- 12/8/2003
- Archive Date
- 12/23/2003
- Point of Contact
- Glynis Fisher, Contract Specialist, Phone 301-496-3699, Fax 301-402-0972, - Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-480-5253,
- E-Mail Address
-
gfisher@niaid.nih.gov, bs92y@nih.gov
- Description
- The Vaccine Clinical Research Branch (VCRB), Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), intends to negotiate, under the authority of 41 U.S.C. 253(c) (1), and FAR 6.302-1, a modification to increase the volume of activity under its seven (7) year contract N01- AI-85341 with BBI Biotech Research Laboratories. This contract was awarded under full-and-open competition under SIC Code 8733; Size Standard $5 million, for the period July 1, 1998 through June 30, 2005. The project currently provides support to all DAIDS vaccine and prevention clinical trials. This contract was originally designed to collect and store clinical specimens and perform virological, immunological, and molecular biological assays to detect HIV infection as well as measure immune responses in support of the DAIDS vaccine and prevention clinical trial networks. The contract requires expansion to support the growing HIV vaccine pipeline that extends beyond the current HIV vaccine trial network (HVTN) central laboratory capabilities. The planned negotiated modification will expand current tasks and provide for a level of increased effort over a period of two years (within contract?s current period). BBI is in a unique position to perform the work because of its previous experience and continuous support to HVTN laboratories during the preceding five years in the following areas: 1. HIV-1 serum validation assays for ELISA and Western blot analysis 2. Developed an ELISA for IgA and IgM antibodies for comparison to Western blot analysis 3. Validated a cell line based neutralization assay and validation of HIV isolation and culture procedures 4. Developed and standardized ELISPOT protocols utilizing CMV, EBV and Influenza (CEF) standard peptides against cells from uninfected HIV negative volunteers 5. Evaluated cell recovery, viability, and apoptosis of PBMC after cryo preservation and long term storage To support DAIDS sponsored vaccine trials, BBI will: 1) process, store and ship sera/PBMCs to HVTN central immunology laboratories; 2) periodically perform tests to assess the viability of patient?s PBMCs; 3) serve as central repository for ELISPOT proficiency test panels; 4) acquire, assemble and ship reagents for ELISPOT proficiency panels to participating sites; 5) manufacture and provide standardized ELISPOT kits to central immunology laboratories; 6) validate and provide SOP for sample freezing and shipping, especially as related to international sites without liquid N2 capabilities; 7) develop capacity to audit and train laboratories performing immunological assays. If there are responsible sources who feel that they are able to perform the requirement, they must submit a capability statement within 45 days from the posting date of this announcement. Organizations that submit capability statements in response to this announcement must demonstrate their ability to assume the work without unnecessary delay and duplication of cost and effort. See Government wide Numbered Notes 22 and 26. No collect calls will be accepted.
- Place of Performance
- Address: Gaithersburg, Maryland
- Record
- SN00457813-W 20031024/031023061004 (fbodaily.com)
- Source
-
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