https://www.fbo.gov/index?s=opportunity&mode=form&id=a3ff6667d37edf1b8e35320de68af194&tab=core&_cview=1
Staged Vaccine Development
Solicitation Number: BAA-NIAID-DAIDS-NIHAI2012151
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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:
BAA-NIAID-DAIDS-NIHAI2012151
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Award
:
September 17, 2014
:
HHSN272201400042C
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$12,596,832 (with all options)
:
Children's Hospital of Philadelphia Research Institute
:
073757627
:
3615 Civic Center Boulevard
Philadelphia, Pennsylvania 19104-4318 United States
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Added: Jan 22, 2013 11:18 am
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 candidates to CGMP manufacturing for subsequent clinical
testing.The primary intent of this Broad Agency Announcement (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 BAA will allow the further development of the current leading HIV vaccine candidates, based on existing data are defined below (the areas listed below are the primary areas of interest of this BAA, but not limited exclusively to these areas when submitting proposals): • 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-prevelence in the relevant human population. • Replication competent viral vectors (e.g. Flaviviridae, Adenoviridae, Alphaherpesvirinae, Rhabdoviridae.) Awards will be based on evaluation of the potential to advance the vaccine candidates 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. Each contract will be awarded for up to a two year base period to support Stage I activities and will include two 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 contracts will be awarded beginning on or about July 1, 2014. NIAID plans to use a staged funding approach. The contract will be awarded for up to a 2 year base period to support Stage I activities and will include two 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/year for a maximum performance period of up to 2 years Stage II: Approximately $5,000,000/year for a maximum performance period of 3 years Stage III: Approximately $1,000,000/year for a maximum performance period of 2 years All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about February 5, 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.
Added: Feb 05, 2013 9:46 am
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Solicitation 1
Type:
Solicitation
Posted Date:
February 5, 2013
Description: Staged Vaccine Development
Amendment 1
Type:
Mod/Amendment
Posted Date:
April 11, 2013
Amendment_1.pdf (142.49 Kb)
Description: Please see the Attached
Amendment 1 which serves to revise Attachment 1: Packaging and Delivery
of the Proposal to require electronic proposal submission and answer
questions from potential offers.
Amendment 2
Type:
Mod/Amendment
Posted Date:
April 26, 2013
NIAID_DAIDS_NIHAI2012151_Amendment_2.pdf (101.02 Kb)
Description: The purpose of this
amendment is to correct several broken website links related to
Information and Physical Access Security and Electronic and Information
Technology Accessibility (Section 508).
Amendment 3
Type:
Mod/Amendment
Posted Date:
May 16, 2013
SVD_Amendment_3_FINAL.pdf (22.49 Kb)
Description: Amendment 3 - Response to two questions.
Amendment 4
Type:
Mod/Amendment
Posted Date:
June 11, 2013
20130611_SVD_Amendment_4.pdf (22.76 Kb)
Description: Responses to questions
submitted concerning deadline clarification, possible future
solicitations in the area of "staged vaccine development", and period of
time proposal expected to be valid for once submitted to the
Government.
HHSN272201400043C Award Info
Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Posted Date:
September 5, 2014
FBO_Synopsis_-_1400043C_FINAL.pdf (12.06 Kb)
Description: HHSN272201400043C Award Info
Synopsis of Award
Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Posted Date:
September 17, 2014
FBO_Synopsis_-_1400042C.pdf (12.04 Kb)
Description: Synopsis of an award for Staged Vaccine Development
:
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612 Bethesda, Maryland 20892-7612
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