Broad Agency Announcement (BAA): Adjuvant Discovery Program, BAA-NIAID-DAIT-NIH-AI-2013168

Notice Number: NOT-AI-13-044

Release Date: May 1, 2013

National Institute of Allergy and Infectious Diseases (NIAID)

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. Through this solicitation, the NIAID Division of Allergy, Immunology and Transplantation plans to support the early stage discovery and initial characterization of novel adjuvant candidates. Thus, research solicited under this acquisition will contribute to the pipeline of new adjuvant leads that either (a) exploit the natural capacity of the innate immune system to initiate and sustain effective T and B cell responses and to induce long term immune memory or (b) act directly on lymphocytes to enhance their response to pathogen-derived antigens.

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 Discovery Program to identify and characterize novel, effective and safe vaccine adjuvants. The design of new adjuvants in this program must include each of the following areas of research:

• Identification of novel adjuvant candidates through high throughput (HTS) approaches and validation that lead compounds stimulate human cells;
• Determination of the mechanism of action of select lead compounds, including the identification of the receptor(s) the adjuvant candidates work through and the cellular signaling pathways they activate;
• Optimization of lead adjuvant candidates through formulation and medicinal chemistry, guided by structure-activity relationship (SAR) studies; and
• Verification of the efficacy of lead compounds as vaccine adjuvants in vivo in an animal model.
  

Proposals will be evaluated based on the following technical evaluation criteria:

• Technical Plan,
• Scientific and Technical Personnel,
• Project Management, and
• Facilities, Equipment and Other Resources.

It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a 12 month period of performance beginning on or about 08/01/2014. The NIAID estimates that the average annual total cost (direct and indirect costs combined) is $2M. In addition, $500,000/award for one year will be available for an elective HIV envelope immunogen study. 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 or about 05/10/2013 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.

For this solicitation, the NIAID requires proposals to be submitted via two methods:

• Disc (CD or DVD) and
• Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."

To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 4 weeks. For more information, please see http://era.nih.gov/applicants/how-to_steps.cfm#register.

Please direct all inquiries to:

Maribel Miranda
National Institute of Allergy & Infectious Diseases (NIAID)
6700-B Rockledge Drive, Room 3236
Bethesda, MD 20892-7612
For Express Mail, change zip code to 20817-7612
Direct Phone: 301-451-7457
Main Phone: 301-496-0612
Fax: 301-402-0972
Email: Maribel.Miranda@nih.gov