SOURCES SOUGHT
B -- Study on Pandemic H5N1/H1N1 Flu-infected Ferrets
- Notice Date
- 3/1/2012
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1100599
- Archive Date
- 3/23/2012
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." The associated North American Industry Classification System (NAICS) Code is 541712- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) Small Business Size Standard is 500 employees. Background Human infections with avian influenza A (H5N1) are associated with high mortality. As of July 5, 2010 there had been 500 cases and 296 fatalities. The influenza virus readily undergoes mutation and re-assortment, and there are concerns that an H5N1 variant could be responsible for a future pandemic. The influenza neuraminidase inhibitors Zanamivir and Oseltamivir are approved for the treatment and prophylaxis of influenza. Oseltamivir is being used to treat H5N1 infections and a case has been made supporting the use of Zanamivir also; however, there are no reports for the latter. Despite treatments with early use of oseltamivir combined with supportive care as suggested by WHO, 30% to 80% of hospitalized patients with H5N1 influenza have died, and an oseltamivir-resistant virus has developed in some patients. Although the majority of patients infected by pandemic influenza A (H1N1) 2009 virus had a mild illness, severe diseases and mortality occurred in those with extremes of age, immunosuppression, obesity, pregnancy, and other underlying illnesses. Patients with mild illness fared well with the early use of neuraminidase inhibitors. However, the usefulness of these antiviral agents in treating patients with severe illness is uncertain. Despite the use of double-dose oseltamivir and inhaled zanamivir, patients with severe illness had delayed clearance of viral load in respiratory secretions, associated with persistent elevation of cytokines in their serum samples. Thus, there is an urgent need to find alternative therapeutic regimens for managing this subgroup of patients. Robust protection from lethality for at least 72 hours after infection was demonstrated for monoclonal antibodies with neutralizing activity produced by immortalized B lymphocytes of convalescent patients recovering from influenza A (H5N1) virus infection in a murine model challenged by the hypervirulent influenza A (H5N1) virus. Furthermore, meta-analysis on studies using convalescent blood products in the 1918 influenza pandemic suggested that such an approach could reduce the mortality rate of severe cases by > 50%. Scope of Work The study deals with measuring the neutralizing ability of neutralized antibody in plasma. Based on published reports, plasma from patients can neutralize influenza. LMV plans to verify this using ferrets infected with influenza virus, H5N1 and H1N1. To understand the duration of viremia and whether / how convalescent plasma treatment reduces mortality and improve the recovery of patients infected with H5N1 or pandemic H1N1 influenza virus, LMV plans to study viremia and disease pathogenesis of H5N1 virus and pandemic H1N1 virus infection in the susceptible ferret animal model. To examine blood safety and virus neutralization by convalescent plasma, ferrets will be inoculated intranasally with one ml of H5N1 virus containing 500 µl to each nare with one times of EID50. Plasma, which will be collected from the ferrets by the contractor on day0, day30, day60, day120, or day180 post-infection, will be given to ferrets separately, on day 2 post-infection. Clinical signs of infection, weight, and temperatures are to be recorded daily by the contractor. In addition, virus load in lung, brain, ileum, nasal turbinate, nasal wash and blood, and cytokines in blood will be tested that at the contractor's BSL3 facility. The contractor will also measure viral RNA in blood one or two days before death. Technical Requirements • All research much be conducted within a Biosafety Level 3 (BSL-3) containment laboratory. STUDY I: • Culture and titer A/VN/1203/04 (H5N1); • 36 male healthy 4-month old ferrets without infection of flu shall be challenged (infected) with A/VN/1203/04 (H5N1) through nares; • during inoculation (6 donor animals for 180 days; 30 recipient animals for12 days) of infected animals will be caged in BL3 lab of contractor and clinical presentations will be observed by contractor; • Collect blood from donors day0, day30, day60, day120, day180; • Perform plasma transfusion secondarily to ferrets (recipients). Collect nasal wash, blood from recipients at day0, day2, day4, day6, day8. • Isolate virus culture and RNA isolation from lung, brain, nasal turbinate, nasal wash and blood of recipients STUDY II: • Culture and titer A/California/04/2009 (H1N1); • 36 male healthy 4-month old ferrets without infection of flu shall be challenged (infected) with A/VN/1203/04 (H5N1) through nares; • during inoculation (6 donor animals for 180 days; 30 recipient animals for12 days) of infected animals will be caged in BL3 lab of contractor and clinical presentations will be observed by contractor; • Collect blood from donors day0, day30, day60, day120, day180; • Perform plasma transfusion secondarily to ferrets (recipients). Collect nasal wash, blood from recipients at day0, day2, day4, day6, day8. • Isolate virus culture and RNA isolation from lung, brain, nasal turbinate, nasal wash and blood of recipients Deliverables Collected data in Excel format containing temperatures, weights, survival time, culture results and a total of 360 samples of RNA isolated from lung, brain, ileum, nasal turbinate, and blood of 30 ferries, and 360 samples of nasal wash at Day0, Day2, Day4, Day6, Day8, and Day12. Period of Performance: Seven (7) months Special Considerations This work involves experiments with a highly dangerous pathogen, A/VN/1203/04 (H5N1), which requires a Biosafety Level 3 (BSL-3) containment laboratory. We currently do not have access to such a facility in the Center for Biologics Evaluation and Research, and therefore would like to conduct the study in an outside facility due to the urgent need of the research. Interested Contractors must respond with capability statements to include information regarding the following: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. References provided should be within the last three (3) years. Potential contractors must indicate DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code. Capability statements are due in person, by postal mail or email to the point of contact listed below on or before March 8, 2012, by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, Office of Acquisitions & Grants Services, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1100599. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1100599/listing.html)
- Place of Performance
- Address: Contractor's Location, United States
- Record
- SN02687114-W 20120303/120301235337-b2cc82446c463eb9bbc444b14f1c093d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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