sharon sanders
Editor-in-Chief & President
Solicitation Number:
HHS-NIH-NIAID_AI-SS-11-130
Notice Type:
Sources Sought
Synopsis:
Added: Jul 15, 2011 4:12 pm
SEROLOGICAL ASSAYS FOR PANDEMIC INFLUENZA VACCINES
Sources Sought (non-R&D) Notice
Solicitation Number: NIH-AI-2011130
Introduction
This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.
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 Important 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.
• Potential Offerors must possess FDA evaluated and qualified assays to measure immunogenicity of avian influenza vaccines.
Anticipated Period of Performance
Base: September 30, 2011 - September 29, 2014
Capability Statement /Information Sought
Offerors must demonstrate related experience, describe available facilities, list the staff qualified to support this effort, has appropriate financial resources and the ability to complete the work by the designated contract completion date.
more...
https://www.fbo.gov/index?s=opportu...d5000e75d4458c4ff58619ec4e4&tab=core&_cview=0
HHS-NIH-NIAID_AI-SS-11-130
Notice Type:
Sources Sought
Synopsis:
Added: Jul 15, 2011 4:12 pm
SEROLOGICAL ASSAYS FOR PANDEMIC INFLUENZA VACCINES
Sources Sought (non-R&D) Notice
Solicitation Number: NIH-AI-2011130
Introduction
This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.
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 Important 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.
• Potential Offerors must possess FDA evaluated and qualified assays to measure immunogenicity of avian influenza vaccines.
Anticipated Period of Performance
Base: September 30, 2011 - September 29, 2014
Capability Statement /Information Sought
Offerors must demonstrate related experience, describe available facilities, list the staff qualified to support this effort, has appropriate financial resources and the ability to complete the work by the designated contract completion date.
more...
https://www.fbo.gov/index?s=opportu...d5000e75d4458c4ff58619ec4e4&tab=core&_cview=0