SOLICITATION NOTICE
R -- PROFESSIONAL SERVICE INVOLVING VACCINE
- Notice Date
- 8/16/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NIH-NICHD-07-347
- Response Due
- 8/30/2007
- Archive Date
- 9/14/2007
- Description
- The National Institutes of health (NIH), The National Institute of Child Health and Human Development (NICHD), the Laboratory of Developmental and Molecular Immunity (LDMI) has developed a vaccine for anthrax. This is a continuation of a collaborative research study between Georgetown University and the NICHD for evaluation of immunogenicity and reactogenicity of a new recombinant rPA vaccine. This vaccine is composed of a purified recombinant protective antigen of Bacillus antracis. NICHD intends to procure the services of Georgetown University Medical School, 3800 Reservoir Road 2 PHC, Washington, DC 20007, under the authority of the Federal Acquisition Regulations (FAR) 6.302. The contractor shall provide the following services: Recruit, interview potential volunteers and have their blood analyzed for hepatitis B and C and liver functions. Female volunteers will be tested also for pregnancy. The Contractor shall choose 50 volunteers, based upon the interview and test results. The volunteers will be injected with one of 6 vaccine formulations according to random numbers provided. The subjects will be monitored for local reactions, fever and systemic reactions at 30 minutes and 72 hours. Diary cards will be collected on day 1, 2, and 4 through 7. The Contractor will examine the volunteers with severe reactions or upon their request, during that time. Blood samples will be taken for liver functions on day 7. The 2nd and 3rd injections (2 and 4 months after the first) will follow the same procedure; blood will be taken before each injection for PA antibodies and pregnancy test from female volunteers. The 4th injection will be given at 16 months with a blood sample for PA antibodies taken before and 2 weeks after the 4th injection. The last serum sample will be taken 1 year later (at 28 months). Between the 3rd and the 4th injections, the volunteers will be contacted by phone every 2 to 3 months to inquire about their health. Georgetown University is uniquely qualified and has experience in conducting clinical trials involving vaccines and has the required staffing, space and knowledge to provide this service. They have recruited, vaccinated and are following the first 50 volunteers. Georgetown University must continue this study to fulfill its purpose and in order to maintain uniformity. Interested vendors may identify, in writing, their interest with a capability statement to the Contracting Office prior to the closing date of this notice. This notice of intent is not a request for competitive proposals, however; all responses received, before the closing date, of this announcement will be considered by the Government. A determination by the Government not to compete this proposed acquisition is based upon responses to this notice and is solely within the discretion of the Government. It is anticipated that the Request for Quotation (RFQ) NIH-NICHD-07-347 will be available fifteen (15) days after the publication date of this synopsis. Receipt of quotations will be due ten (10) days after the release of the RFQ. Request for copies of the RFQ must be in writing to the National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd., Room 765C, Bethesda, MD 20817 Attention: Tina Robinson, or by email: robinsti@mail.nih.gov or fax to 301-480-4226. FAXED quotations must contain offerors name, address, telephone number and fax number. FAXED quotations will be accepted if dated and signed by an authorized company representative. All requests for quotations must have a valid email address. In order to receive an award from the NIDDK, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov.
- Record
- SN01374683-W 20070818/070816220626 (fbodaily.com)
- Source
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