SOURCES SOUGHT
A -- DEVELOPMENT OF A THIRD GENERATION ANTHRAX VACCINE
- Notice Date
- 5/9/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- RFP-NIH-NIAID-DMID-07-05
- Response Due
- 5/23/2006
- Point of Contact
- Ross Kelley, Contracting Officer, Phone (301) 402-2234, Fax (301) 480-5253, - Barbara Shadrick, Acting Branch Chief, Phone 301-496-7288, Fax 301-402-0972,
- E-Mail Address
-
rk17a@nih.gov, bs92y@nih.gov
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED FROM THIS SOURCES SOUGHT THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious diseases. The NIAID, Division of Microbiology and Infectious Diseases (DMID), supports a comprehensive extramural research program focused on the prevention and control of diseases caused by virtually all infectious agents (with the exception of the Human Immunodeficiency Virus). This includes basic research, such as studies of microbial biology and physiology; applied research, including the development of vaccines, therapeutics and medical diagnostics; as well as clinical studies to evaluate experimental drugs and vaccines. Recent threats of the use of infectious agents as biological weapons have generated increased concern for the safety of the general American populace. Bacillus anthracis (B. anthracis) is the etiologic agent of anthrax. The ability to generate high titer anthrax spores using basic microbiological techniques combined with the ability of these agents to be disseminated by aerosolization, has made anthrax a primary bioterrorist and military threat. With the deliberate exposure of citizens of the United States to B. anthracis spores in 2001, there is an urgent need to stockpile appropriate and effective medical countermeasures to protect all U.S. citizens from the morbidity and mortality associated with infection from these instruments of terror. The NIAID is seeking capability statements from sources that are capable of advanced development and testing of anthrax vaccine candidates which build upon the second generation vaccine, and have properties desirable for a biodefense vaccine to be stored in the Strategic National Stockpile (SNS). These properties include long-term stability (i.e., three years or longer) at room temperature, the ability to generate a protective immune response in one or two doses, and the ability to be safely self-administered and/or rapidly inoculated into large numbers of people. Anthrax vaccine candidates eligible for support under this solicitation shall possess all or some of these properties while maintaining a superior safety profile to the currently U.S. licensed anthrax vaccine. Novel formulations/final vaccine presentation, new delivery platforms, adjuvants other than aluminum, and inclusion of antigens in addition to protective antigen (PA) may be components of candidate vaccines. The project involves: (1) manufacture and testing of anthrax vaccine candidates possessing some/all of the characteristics described above; (2) production of vaccine components and final product at pilot-lot scale; (3) characterization and testing including a stability program; (4) one or more pre-clinical safety studies required for the filing of an Investigational New Drug application (IND); (5) non-clinical aerosol spore challenge studies using rabbit and non-human primate models; (6) one option for the design and conduct of a Phase 1 dose escalating clinical trial in healthy subjects ages 18 to 40; and (7) one option for up to two Phase 2 clinical trials in healthy subjects ages 18 to 55. If a novel device for vaccine delivery is proposed, contract funds may be utilized to suitably formulate the candidate vaccine for the device; however, funds may not be used for developing a device. This RFP will require that a Premarket Approval Application (PMA) or a Premarket Notification Form 510K must be currently filed with the U.S. Food and Drug Administration (FDA) for such devices and documentation provided in the Technical Proposal. Capability statements submitted in response to this notice will be evaluated in accordance with each organizations demonstrated and documented capabilities as follows: (1) documentation that the proposed anthrax vaccine candidate has a purified Protective antigen (PA) that has been shown to be efficacious against B. anthracis spore challenge in animal models, the proposed vaccine must contain a PA component. The PA component may be proteinaceous or nucleotide-encoded; (2) documentation supporting the vaccine candidates development status relating to established Good Manufacturing Practices (cGMP) pilot-scale production of a clinical grade material suitable for use in Phase 1/2 clinical trials; (3) justification for further development of the proposed candidate vaccine as it relates to the objectives of this RFP (improved safety profile, rapid and robust titers in no more than two doses, elimination of cold chain/long-term stability, and ease of delivery for use in an emergency event) is warranted, while maintaining an improved safety/reactogenicity profile over the current licensed vaccine and at least equivalent efficacy; (4) demonstration of the availability and adequacy of facilities for cGMP drug substance (DS) and cGMP final drug product (FDP) manufacturing at pilot-lot manufacturing scale. For this effort, pilot-scale DS fermentation is defined as a minimum of 30 liter working volume and/or sufficient DS to fill 2,000 doses of FDP. FDP is defined as a minimum of 2,000 final doses per single lot run. Potential sources proposing methodology for DS production other than fermentation must provide documentation to indicate that current yield is of equivalent quantity as above requirements. Pilot-lot scale processes must be readily transferable to large scale manufacture; (5) documentation of previous experience in developing and conducting non-clinical development plans to evaluate safety and efficacy of vaccine candidates that includes the conduct of all FDA required Investigational New Drug application (IND) enabling studies; and (6) documentation of previous experience in developing and executing clinical development plans to evaluate safety and immunogenicity of vaccine candidates. It is estimated that the provision of FTEs will be approximately as follows: 13 FTE for Base Year 1 & 2; Reduced to 7.55 FTEs for Base Year 3; 2.1 FTEs for Year 3--Option 1; 2.1 FTEs for each Option 2—Years 4-7. The Option periods could increase the contract value and extend the contract by up to four years. Interested organizations should submit two copies of their capability statement addressing each of the areas cited above. Any proprietary information should be so marked. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status (i.e. educational institution, non-profit, large business, small business, 8(a), or other corporate or non-corporate entity). Written capability statements should be received by the Contracting Officer by May 23, 2006. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. See Government-Wide Numbered Note 25. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (09-MAY-2006). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 22-FEB-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NIAID/RFP-NIH-NIAID-DMID-07-05/listing.html)
- Record
- SN01237368-F 20070224/070222223528 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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