G
This contract would be a follow-on to the existing contract (#N01-AI-30063) in which Southern Research Institute is the incumbent contractor. The anticipated period of performance for the new contract is from September 30, 2011 through September 29, 2014. The anticipated contract will consist of a base period.
Background
Since 2003, a growing number of human avian influenza (H5N1) cases have been reported in Asia. More than half of the people infected with H5N1 virus have died. Because there is little natural immunity to a pandemic influenza strain, the disease has the potential to spread from person to person and could be a major world-wide health threat. In the past few years, the government has significantly expanded its influenza research programs in order to provide the knowledge base necessary for the development of antivirals and vaccines and new and improved diagnostics for both seasonal and pandemic influenza. As part of the pandemic preparedness program of the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response, DHHS, the Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), NIH, is currently conducting several phase 1 clinical trials evaluating an H5N1 avian influenza vaccine with and without adjuvant provided by two separate manufacturers, in the NIAID Vaccine and Treatment Evaluation Units (VTEUs). NIAID needs to acquire serological evaluation of the samples collected from these trials.
Purpose and Objectives
The contract is to evaluate the immunological responses of human samples collected from two phase 1 clinical trials of H5N1 influenza vaccine with and without adjuvant being conducted in the NIAID VTEUs as part of the government's pandemic preparedness program:
1. A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without MF59 Adjuvant. (DMID Protocol # 100016)
2. A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without AS03 Adjuvant (DMID Protocol # 100017)
Project Requirements
A. Perform approximately 12,500 qualified Hemagglutinin Inhibition (HI) and approximately 12,500 qualified Microneutralization (MN) assays on clinical specimens collected from subjects in clinical trials of H5N1 influenza vaccines with and without adjuvant:
1. A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without MF59 Adjuvant. (DMID Protocol # 100016)
2. A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without AS03 Adjuvant (DMID Protocol # 100017)
B. The clinical specimens in B.1, above will be supplied in batches by the DMID Clinical Agent and Specimen Repository Contractor.
C. Perform control assays and trend analysis to monitor assay performance.
D. All assays shall be conducted in accordance with the qualified acceptance standards as evaluated and accepted by the US FDA. The Contractor shall perform quality control on all assay results and submit the qualification data as part of the final report.
E. Submit results from assays performed in B.1, above electronically into Global Trace, the DMID clinical specimen tracking and data management web site maintained by the DMID Statistical and Data Coordinating Center.
Other Considerations
The work requires a BSL3 facility and trained staff in place with the necessary permits from CDC and USDA to work with Select Agents, including H5N1. The registration process to obtain a permit to work with live influenza viruses with pandemic potential can take up to a year to obtain which would result in unexpected delays, duplication of effort, and substantial increase in costs.
The contractor is the only independent organization in the United States that utilizes assays to measure immunogenicity of avian influenza vaccines that were evaluated by the FDA to be qualified.
The "qualification" of the contractor's hemagglutination inhibition (HI) and microneutralization (MN) assays allows for comparability with all test results from previous H5N1 avian influenza vaccine clinical trials. Even if another vendor could perform the mentioned HI and MN assays, the results by another vendor would compromise the scientific validity of the data from the ongoing clinical trials.