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. Description: The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is committed to the development of efficacious preventive vaccines against HIV-1 for worldwide use to end the AIDS epidemic. While industry, government, and academia have contributed considerable resources to this effort over the past 30 years, no fully effective vaccine has emerged. A wide assortment of candidate HIV-1 vaccines have reached Phase I clinical trials but only three vaccine regimens have advanced to efficacy testing. One of these 3 trials, designated RV144, has shown modest efficacy in humans and this result coupled with promising results from nonhuman primate (NHP) studies has now stimulated the field to continue to test more advanced vaccine candidates in humans. Thus, the discovery and development, of preventive HIV/AIDS vaccines may be within reach. To augment the development portion of the process for identifying and ultimately testing an improved HIV vaccine, NIAID will be using a staged development approach to allow the rapid advancement of promising HIV vaccine platforms to CGMP manufacturing for subsequent clinical testing. The primary intent of this BAA solicitation is to provide support to multifunctional teams for advanced development and manufacture of HIV vaccines candidates that have demonstrated success in NHP challenge studies, equivalent preclinical animal models or early human clinical trials, and have demonstrated manufacturing feasibility. The activities supported through this Broad Agency Announcement (BAA) will allow the further development of the current leading HIV vaccine platforms. The platforms listed below are the primary areas of interest, but offerors are not limited exclusively to these areas when submitting proposals. Separate proposals must be submitted for each vaccine platform. NIAID's primary areas of interest are: - Recombinant HIV protein including HIV envelopes, envelope derivatives, Virus Like Particles, as well as formulations of HIV proteins with immune enhancers such as adjuvants and immune modulators. - POX virus (e.g. Fowlpox, NYVAC, ALVAC, Modified Vaccinia Ankara (MVA) vector-based vaccine candidates. - DNA vaccines, including DNA delivery device technologies and DNA expressed immune modulators. - Replication defective adenovirus vectors with low sero-prevalence and low T-cell reactivity in the relevant human populations. - Replication competent viral vectors (e.g., Paramyxoviruses, Morbilliviruses, Herpesviruses.). - Adeno-associated virus (AAV) vectors for the delivery of broadly neutralizing antibodies. Awards will be based on evaluation of the potential to advance the vaccine platforms forward through a staged approach. This staged approach will allow NIAID flexibility to quickly advance vaccine candidates into milestone drive CGMP manufacturing for testing in clinical trials. Briefly, the 3 stages are as follows: - Stage I- refinement and implementation of the product development plan and the initiation of limited activities to prepare for the CGMP production of the vaccine candidate; - Stage II- manufacture, formulation, and release of the product for phase I/II/III clinical trials; and - Stage III- continuation of ongoing stability program, pre-licensure activities, continued product characterization studies, and updated regulatory submissions that would allow the product to remain in regulatory compliance and acceptable for future clinical trials. 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 7 years. Each contract will be awarded for up to a two year base period to support Stage I activities and will include options for Stage II and Stage III activities. Options for Stage II and III awards will be exercised based on Go/No Go decisions. Once Stage I milestones are met the decision to fund the option for Stage II will depend upon the scientific priority, importance to agency programs, and the availability of funds. Likewise, the funding of the option for Stage III will depend on meeting Stage II milestones, as well as scientific priority, importance to agency programs, and the availability of funds. All activities must be performed in strict adherence to FDA regulations and guidance, including requirements for manufacturing of the vaccine candidate under CGMP (21 CFR 11, 210, 211, 600-680, and 820) and the conduct of animal studies and assays under GLP (21 CFR 58). It is anticipated that 2 to 3 cost reimbursement, completion type contracts will be awarded for a 7-year period of performance beginning on or about November 1, 2016. NIAID plans to use a staged approach for performance of the work. The contract will be awarded for up to a 2 year base period to support Stage I activities and will include options for Stage II and Stage III activities. Below are the estimated cost and period of performance of each Stage: Stage I: Approximately $100,000 per year for a maximum performance period of 2 years (not to exceed $200,000 for Stage I) Stage II: Approximately $5,000,000 per year for a maximum performance period of 3 years (not to exceed $15,000,000 for Stage II) Stage III: Approximately $2,000,000 total for a maximum performance period of 3 years (not to exceed $2,000,000 for Stage III) All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about June 3, 2015 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, NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) 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."
