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VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES

Solicitation Number: NIAID-DMID-NIHAI2010104
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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NIAID-DMID-NIHAI2010104
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Added: Sep 15, 2011 10:15 am
PRESOLICITATION NOTICE

VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES
BROAD AGENCY ANNOUNCEMENT NUMBER NIAID-DMID-NIHAI2010104



Presolicitation Notice Information


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 Microbiology and Infectious Diseases, has a requirement to advance the development of new medical countermeasures against the biological agents that are most likely to be used in a terror attack on civilian populations.
Description
The primary objective of this solicitation is to support the advanced development of candidate products which consist of a vaccine component and a technology that accelerates the immune response for use in post-event settings following the intentional release of the NIAID Category A Priority Pathogen B. anthracis or in response to naturally occurring outbreaks of infectious diseases caused by the NIAID Category A Priority Pathogen B. anthracis. In these settings, simplicity and efficiency of delivery of vaccine to, and the effectiveness in large numbers of patients are key considerations.


Candidate products that increase vaccine stability and/or reduce logistical requirements are important secondary objectives and would further enhance the capabilities of a candidate product that accelerates the immune response. Anticipated benefits may include: decreased manpower and time required to prepare and administer the vaccine, maximum compliance of the vaccine recipients, and production of a protective immune response with 1-2 doses of vaccine.



Vaccine components at the Product Technology Readiness Level (TRL) 6 (https://www.medicalcountermeasures.gov/Integrated_TRLs.aspx), which have demonstrated completion of current Good Manufacturing Practices (cGMP) manufacturing and undergone a Phase 1 clinical trial; TRL 5 in which advanced characterization of the vaccine component is demonstrated and cGMP process development is initiated; or TRL 4, in which the vaccine component is optimized and activity and efficiency are also demonstrated in a non-GLP setting may be proposed.


NOTE: When using these criteria, a vaccine component should be rated at a particular level only after all activities listed in that level have been completed (e.g., a product is rated at TRL 4 once it completes all of the activities listed in TRL 4).


Organizations responding to this Broad Agency Announcement should have documented expertise in product development, including regulatory submissions, to advance the development and evaluation of candidate products, against biological threats identified as the NIAID Category A and B Priority Pathogens (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx¬) or Top Priority Biological Threats in the HHS, 2007 PHEMCE Implementation Plan (https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx).


Eligible candidate products include those for the NIAID Category A Priority Pathogen B. anthracis.


Additional technologies, when applicable, that increase vaccine stability and/or reduce logistical requirements, will be supported as components of the candidate product. Novel delivery platforms may be components of the candidate product to be developed. Cross-cutting platform delivery technologies applicable to more than one vaccine are also of interest. Candidate products include:


1. Vaccine Component - The vaccine component of a proposed candidate product should be at least at the TRL 4 in which the vaccine component is optimized and activity and efficiency are also demonstrated in a non-GLP setting.


2. Technology Component


a. The technology components used in the proposed candidate product may consist of a new adjuvant, an immune modulator, a formulation technology or a delivery platform designed to enhance the immune response onset for the NIAID Category A Priority Pathogen B. anthracis vaccine candidates. Simply changing a vaccine formulation, for example taking a liquid to a stable lyophilized vaccine formulation, would not be sufficient to meet the objectives.


b. Technology components should address reduced time to establish immunity with proof of concept efficacy data in animal models that demonstrate efficacy with the proposed vaccine- component and the feasibility of attaining a safety profile that meets all existing U.S. Food and Drug Administration (FDA) requirements.



It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a 5 year period of performance beginning on or about September 27, 2012.


The NIAID estimates that one or more contracts may be issued for a total cost (direct and indirect costs combined) of up to $9.0 million per year. Importantly, contract activities will be divided into manageable time frames with initial funding of only the Base Period. Funding of subsequent timeframes will be funded by Options. Each Option will be fully funded when exercised and will be dependent on successful completion of critical predecessor activities, including USG acceptance of associated deliverables when applicable. The critical predecessor activities should constitute Go/No Go criteria for successor activities. The contract budget will be aligned with the Base Period, Options and associated tasks identified in the Product Development Plan and associated Gantt Chart.


Moreover, 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 five years.


All responsible sources may submit a proposal which shall be considered by the Agency. This Broad Agency Announcement will be available electronically on/about September 26, 2011, and may be accessed through FedBizOpps http://www.fbo.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.


 

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PRESOLICITATION

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
PRESOLICITATION
Posted Date:
September 15, 2011
Description: VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES

Amendment 1

Type:
Mod/Amendment
Posted Date:
September 20, 2011
Description: “VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES”

Solicitation 1

Type:
Solicitation
Posted Date:
September 26, 2011
Description: VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES

Amendment 2

Type:
Mod/Amendment
Posted Date:
October 20, 2011
Description: “VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES”

Amendment 3

Type:
Mod/Amendment
Posted Date:
October 20, 2011
Description: "VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES"

Amendment 4

Type:
Mod/Amendment
Posted Date:
November 3, 2011
Description: BAA-NIAID-DMID-NIHAI2010104
Amendment #4

“VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES”
Description: Attachment 10 - Technical Proposal Cost Summary
Description: Attachment 11 - SUMMARY OF RELATED AND PROPOSED ACTIVITIES
Description: Attachment 15 - Proposal Summary and Data Record, NIH-2043
Description: Attachment 18 - Offeror's Points of Contact
Description: Attachment 24 - Procurement of Certain Equipment
Description: Attachment 25 - Research Patient Care Costs, NIH(RC)-11
Description: Attachment 28 - Commitment to Protect Non-Public
Description: Attachment 29 - Roster of Employees Requiring Suitability
Description: Attachment 30 - Employee Separation Checklist

Amendment 5

Type:
Mod/Amendment
Posted Date:
December 13, 2011
Description: VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES
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