Notice Number: NOT-AI-16-037
Key Dates
Release Date: March 3, 2016
This BAA will be available electronically on/about March 11, 2016
None
Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
Purpose
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 vaccine 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 initial 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- Implement stability program and pre-licensure activities (if applicable), drug product characterization, storage of production materials, and relevant manufacturing data. Preparation and filing of IND documents and updating 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.
NIAID plans to use a staged approach for performance of the work. Each contract will be initially awarded for a minimum of 1 year and up to a two year base period to support Stage I activities. Stages II and III will include options for completion of segments of work during Stages II and III. Options for Stage II and III awards will be exercised based on deliverables and Go/No Go decisions. Once Stage I milestones are met, the decision to fund the options for Stage II activities will depend upon the scientific priority, program balance, and the availability of funds. Options for segments of work to be completed during Stage II will be based on the offeror’s proposal and negotiated as needed. Likewise, the funding of the options for Stage III will depend on meeting Stage II milestones, as well as scientific priority, program balance, 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 September 1, 2017.
Below are the estimated cost (direct and indirect costs combined) and period of performance of each Stage:
- Stage I: Approximately $90,000 per year, for a maximum performance period of 2 years and a minimum period of 1 year (not to exceed $180,000 for Stage I, per award, for a maximum of 3 awards)
- Stage II: Approximately $15,000,000 total, for a maximum performance period of 3 years (not to exceed $15,000,000 for Stage II, per award, for a maximum of 2 awards)
- Stage III: Approximately $2,000,000 total, for a maximum performance period of 3 years (not to exceed $2,000,000 for Stage III, per award, for a maximum of 2 awards). Stage III activities may overlap with Stage II activities.
However, it is anticipated that the total cost for the award(s) may vary depending upon the vaccine candidate selected for manufacturing, 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. The period of performance proposed by an offeror should not exceed 7 years.
All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on or about 3/11/2016 and may be accessed through FedBizOpps at 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 online, via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.
For directions on using eCPS, go to the website https://ecps.nih.gov/NIAID 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.”
Inquiries
Please direct all inquiries to:
Robert Corno
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5151
Email: cornorj@niaid.nih.gov
John R. Manouelian
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5152
Email: manouelj@mail.nih.gov
and Human Services (HHS)
