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Definitive Contract HHSN272201600010C
Award Date
2/23/16
Potential Completion Date
5/14/23
Potential Value
$4.2M
Overview
AI Insights
Buyer Personas
Industry Personas
Buyer Personas In this Market
Activity
4
Transactions
4
Subawards
Opportunity Stack
1
Federal Agency
National Institute of Allergy and Infectious Diseases
Awardee
Profectus Biosciences, Inc.
Ultimate Awardee
Not listed
NAICS Category
541712 - Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
PSC Category
AN81 - R&D- Medical: Aids Research (Basic Research)
Federal Contract Vehicle
Not listed
Set-Aside Type
No Set-Aside Used
Extent Competed
Full and Open Competition
Major Defense Program
Not listed
Pricing Type
Cost Plus Fixed Fee
Place of Performance
Baltimore, MD 21224, USA
Solicitation Procedures
Negotiated Proposal / Quote
Number Of Offers Received
4
Legislative Mandate
Not listed
National Interest Action
Not listed
Research Type
Not listed
Primary Consortia Member
Not listed
Description
Update #1
Update #2
Update #3
PRODUCTION OF PDNA VACCINE EXPRESSING FLSC
Posted 2/23/16, 12:00 AM
Name
Description
Solicitation Number
Federal Agency
Type
Posted Date
(Click to sort descending)
Staged Vaccine Development
Added: Aug 19, 2014 3:05 pm 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 implementation of the produce 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. 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, program balance, 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, 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 4 to 6 cost reimbursement, completion type contracts will be awarded for a 7-year period of performance beginning on or about December 1, 2015.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 $200,000 for a maximum performance period of up to 2 yearsStage II: Approximately $15,000,000 for a maximum performance period of 3 yearsStage III: Approximately $1,000,000 for a maximum performance period of 3 yearsAll responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about September 3, 2014 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."
BAA-NIAID-DAIDS-NIHAI2014014
Department of Health and Human Services National Institutes of Health
Award Notice 1/1
8/19/14, 3:05 PM
Mod #
Description
Reason For Modification
Federal Obligation
(Click to sort descending)
Date
(Click to sort ascending)
3
PRODUCTION OF PDNA VACCINE EXPRESSING FLSC
Close Out
($1k)
2/4/19
2
PRODUCTION OF PDNA VACCINE EXPRESSING FLSC
Other Administrative Action
$0
4/26/17
1
PRODUCTION OF PDNA VACCINE EXPRESSING FLSC
Other Administrative Action
$0
11/1/16
Not listed
PRODUCTION OF PDNA VACCINE EXPRESSING FLSC
Not listed
$75.3k
2/23/16