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Adjuvant Development Program

Solicitation Number: BAA-NIAID-DAIT-NIHAI2012146
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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BAA-NIAID-DAIT-NIHAI2012146
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Solicitation
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Added: Aug 02, 2012 9:45 am

Introduction.  The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  The NIAID Division of Allergy, Immunology and Transplantation has a requirement for establishing an Adjuvant Development Program to advance a novel class of vaccine adjuvants towards licensure for human use.


Description.  The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and other agencies in the Department of Health and Human Services (DHHS) support extramural research to develop new products to protect the public from the health consequences of biological agents that might be used in acts of bioterrorism and from emerging and re-emerging diseases, such as West Nile Virus, multi-drug resistant Tuberculosis and Dengue Fever.  The biological agents deemed to pose the greatest threat to civilian populations are prioritized in the NIAID Emerging and Re-emerging Infectious Diseases list, which is available at: http://www.niaid.nih.gov/topics/emerging/pages/list.aspx. NIAID also contributes to meeting the goals for host defense described in the NIAID Strategic Plan for Biodefense (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Documents/biosp2007.pdf)  by supporting the development of new vaccine adjuvants that stimulate stronger, more protective immune responses against NIAID Emerging and Re-emerging Infectious Diseases.  In addition, NIAID supports research to develop vaccines against infection by the HIV-1 virus and against the development of AIDS including the study of adjuvants that might potentiate the induction of protective immunity.


The purpose of this solicitation is to renew the Adjuvant Development Program to advance novel adjuvants towards licensure for human use.  Adjuvants will be studied and developed for human licensure with currently licensed or new investigational vaccines to protect against NIAID Emerging and Re-emerging Infectious Disease Pathogens or against HIV/AIDS. This initiative supports the development of adjuvants through immunological characterization studies and lead compound optimization, up to and including IND-enabling studies, for a period not to exceed five years. 


Candidate vaccine adjuvants eligible for support must meet the following requirements: (1) the adjuvant has been previously identified as minimally reactogenic and characterized as safe after administration in an animal model; (2) there is documented evidence that demonstrates a mechanism of action for the adjuvant; (3) the adjuvant has been shown to safely augment the ability of a vaccine to protect against pathogen challenge in an in vivo animal model; (4) the adjuvant has immune-enhancing activity with human primary cells or tissues; and (5) the proposed Product Development Plan will significantly advance the development of candidate vaccine adjuvants within the five year period of contract performance.


Technical proposals will be evaluated based on the following technical evaluation criteria: (1) Technical Approach, (2) Scientific and Technical Personnel, (3) Project Management, and (4) Facilities, Equipment and Other Resources.


It is anticipated that multiple cost reimbursement, completion type contracts with options will be awarded beginning on or about August 30, 2013.   


The NIAID estimates that the average annual total cost (direct and indirect costs combined) is $2M.  In addition, $500K per award for a one year elective HIV envelope immunogen study may be included as an option. However, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s).  The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research.  In no event shall the period of performance proposed by an offeror exceed five years.


All responsible sources may submit a proposal which shall be considered by the Agency.   This BAA will be available electronically on/about August 17, 2012 and may be accessed through FedBizOpps http://www.fedbizopps.gov/.  This notice does not commit the Government to award a contract.  No collect calls will be accepted.  No facsimile transmissions will be accepted.

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Solicitation 1

Type:
Solicitation
Posted Date:
August 17, 2012
Description: Adjuvant Development Program

Amendment 1

Type:
Mod/Amendment
Posted Date:
November 20, 2012
Description: AMENDMENT 1

The purpose of this amendment is to 1) clarify language in the BAA and 2) provide responses to questions which may be useful to all potential offerors.
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Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
:
George Ralis,
Contract Specialist
Phone: 3014960194
Fax: 3014802248
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David T Lisle,
Contracting Officer
Phone: 301-451-2617
Fax: 301-402-0972