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 the discovery, characterization, and preclinical testing of new adjuvant candidates based upon triggering of the human innate immune system. High throughput screening of libraries of natural and/or synthetic compounds will be used to fulfill the requirement for novel adjuvant candidates. Funding under the prior RFPs is NOT required for the current solicitation; ALL qualified offerors are invited to apply.

Description: For the purpose of this BAA, adjuvants are defined as molecules that act via innate immune receptors to activate beneficial innate and/or adaptive (T and B cell-mediated) immune responses. The adjuvant products targeted in this program may be developed as components of antigen specific vaccines against infectious disease, or may serve as stand-alone agents that transiently prevent or treat infectious disease. Among the best characterized innate immune receptors are members of the Toll-like Receptor (TLR) family of proteins that participate in recognition of structures such as bacterial cell wall components, including lipoproteins and lipopolysaccharides; bacterial DNA sequences that contain unmethylated CpG motifs; and virus double stranded RNA. In addition to TLR, innate immune receptors include complement receptors; scavenger receptors such as CD36; C-type lectin-like receptors such as mannose-binding proteins, dectin-1, and DC-SIGN; and intracellular receptors such as the RIG-like helicases RIG-1 and MDA5, and NOD-like receptors such as NOD1/2, IPAF, and NALP3. To aid in designing safe and effective new adjuvants, this program will support the application and improvement of analytical tools for the discovery of new adjuvant candidates, the in-depth functional analysis of adjuvant-triggered responses on the cellular and molecular levels, in vitro testing with human cells or tissue, and in vivo testing in animals to assess efficacy and feasibility for further development that is beyond the scope of this program. Currently, only one adjuvant is licensed in the U.S. for general human use, aluminum hydroxide/aluminum phosphate, and it has failed to provide optimal immunostimulatory activity for a number of vaccine candidates. Therefore, new adjuvants are needed to induce robust immunity and to direct the most effective type of response, e.g., antibody production or cytotoxic T cell induction. No single adjuvant will be sufficient for all vaccine applications and it is expected that important new adjuvant candidates will emerge from adjuvant discovery research. Furthermore, in addition to their use for specific vaccine applications, adjuvants targeting innate immune receptors might be useful as stand-alone immunotherapeutic agents for the short term prevention or treatment of infectious disease.

It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a five-year period of performance beginning on or about July 2009. It is estimated that the provision of FTEs will be approximately as follows: 7.35 FTEs per annum per contract. Any responsible offeror may submit a proposal which will be considered by the Agency. This BAA will be available electronically on/about July 31, 2008, 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.