SPECIAL NOTICE
B -- Seeking Medical Centers to Conduct Influenza Research Utilizing Hyper Immune Plasma
- Notice Date
- 5/24/2013
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, Maryland, 20817
- ZIP Code
- 20817
- Solicitation Number
- HHSN
- Archive Date
- 8/30/2013
- Point of Contact
- John Tierney,
- E-Mail Address
-
jtierney@niaid.nih.gov
(jtierney@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Allergy and infectious Diseases (NIAID), Division of Clinical Research (DCR) has a project with Medical Centers Conducting Influenza Research Utilizing Hyper Immune Plasma. This is a Request for Information (RFI) only and does not constitute a commitment, implied or otherwise, that HHS/NIH/NIAID will take procurement action in this matter. This is NOT a solicitation for proposals, applications, proposal abstracts or quotations. The purpose of this RFI is to find potential clinical sites for participation in a clinical research study for influenza. Further, neither HHS/NIH/NIAID nor the government will be responsible for any cost incurred in furnishing this information. Background Information and Scientific Rationale Despite treatment with current antivirals, considerable morbidity and mortality results from influenza infections. The use of hyper-immune plasma is a treatment modality often tried for emerging diseases (SARS, avian influenza). A meta-analysis of studies using convalescent blood products during the Spanish Influenza pandemic of 1918 concluded the approach may have been beneficial in the treatment of influenza pneumonia and ARDS. A cohort study conducted in Hong Kong on 93 patients with severe influenza H1N1 2009 infection demonstrated a 30% improvement in mortality. However, no definitive studies have been conducted. The NIAID, DCR is currently sponsoring a study under an Investigational New Drug application (IND) that utilizes H1N1 and H3N2 hyperimmune plasma collected from subjects who have either convalesced from these influenza strains or who have been vaccinated against such influenza strains. Subjects who are hospitalized and are at risk of developing severe disease as defined in the clinical protocol are eligible to receive the plasma. This is a randomized study with a 1:1 randomization scheme and subjects are randomized to receive either standard of care for influenza or standard of care plus hyperimmune plasma. This study is currently taking place at approximately 20 sites in the US. The NIAID is interested in adding additional sites/medical centers to participate in this clinical research study. The minimum requirements of treatment sites would include: •1. The Investigator of Record (IoR) has been or is currently an investigator/sub-investigator in a clinical trial sponsored by NIAID or another division of NIH, government institution/network, or pharmaceutical Sponsor. •2. The site must have sufficient time and study staff to support this study. •3. The study site must be able to utilize privately licensed software for electronic data capture. •4. The site must have the ability to perform rapid influenza testing (PCR or rapid antigen - whichever the site prefers and has established) •5. The site must be affiliated with a registered blood bank that is capable of storing up to 12 bags of investigational plasma at -20°C. •6. The site must be able to process serum and virology specimens and store them at minus 70°C or colder. •7. The site must have staff with the capability to ship Category B samples on dry ice. •8. During peak influenza season, the site and the blood bank must have the resources to conduct weekend subject visits. •9. Sites must have or be able to obtain a Federal Wide Assurance (FWA) prior to the initiation of the clinical protocol. Selected sites must be experienced with and comply with all federal regulation covering human subject research and IND regulations. Sites will be supplied with appropriate levels of plasma (study agent) to store at their sites in the event an eligible subject is randomized to receive plasma. Sites will randomize subjects through the study data coordinating center. Sites will be trained on study conduct and procedure by NIAID or a NIAID contractor prior to study initiation. Sites will be responsible for filling out all case report forms and reporting all safety issues, if any, per the clinical protocol. Sites expressing interest may be asked to complete a more detailed site feasibility questionnaire prior to final selection. Through an existing NIAID contract, selected sites will receive study start-up costs and a contract specified amount per subject enrolled. Please submit in writing (e-mail is acceptable) the following information for consideration as a study site: •1. Expression of Interest •2. Site contact person along with their contact information •3. General description of potential clinical site resources All information or questions should be submitted to John Tierney at 301-451-5136 or jtierney@niaid.nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/HHSN/listing.html)
- Record
- SN03071571-W 20130526/130524234214-b4d5ad2ea18e406a76758b5b8de225b7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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