Notice Number: NOT-AI-12-058

Update: The following update relating to this announcement has been issued:

• December 5, 2012 - See Notice NOT-AI-13-017. Notice of Response Date Extension for Request for Information.

Key Dates
Release Date: October 11, 2012
Responses Due by: (Extended to December 7, 2012 per NOT-AI-13-017), Originally November 30, 2012

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This is a Request for Information (RFI) only and does not constitute a commitment, implied or otherwise, that the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), will take procurement action in this matter. This is NOT a solicitation for proposals, applications, proposal abstracts or quotations. The purpose of this RFI is to obtain knowledge and information to assess the current state of the science. Further, neither DHHS/NIH/NIAID nor the government will be responsible for any cost incurred in furnishing this information.

NIAID is seeking information from pharmaceutical and biopharmaceutical product developers on vaccine formulation technologies to develop dry vaccine formulations against NIAID Category A, B and C priority pathogens (http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx). The primary focus of this RFI is to gather information about the available dry formulation technologies (also referred to as solid vaccine formulations) that increase duration of stability, eliminate cold chain and minimize the need for preservatives, and their use in Biodefense vaccine development. Technologies may include but are not limited to lyophilization, spray drying, foam drying, nanoparticles and other emerging drying technologies. NIAID is seeking information on dry vaccine formulations that rapidly achieve protective efficacy in animal models and/or high levels of immune response in humans with a single vaccination. Dry vaccine formulation technologies that are effective with one administration are of greatest interest, although information on dry vaccine formulations that require multiple administrations to be effective may be submitted. Dry vaccine formulations may contain adjuvants to achieve a rapid immune response. The emphasis of this RFI is to gather information on solid formulation technologies; dry formulation technologies that are combined with cGMP clinical grade antigen and/or adjuvant that have completed Phase 1 clinical trials is of greatest interest.

Background

The NIAID has been conducting and supporting research and development for biodefense with a defined research priority against select Category A, B, and C bio-threat agents. The NIAID’s Strategic Plan for Biodefense Research establishes a broad-spectrum strategy to develop new and improved medical countermeasures that are effective against an array of biological threats, and emerging and re-emerging infectious diseases. NIAID’s plan supports the national biodefense strategy and reflects the Institute’s partnerships to develop countermeasures in tandem with HHS’s Biomedical Advanced Research and Development Authority (BARDA) via the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and Department of Homeland Security. This request for information focuses on examining the state of the science in the field of biodefense vaccine products with dry formulation technologies.

Information requested:

Organizations are invited to submit a white paper describing their research efforts involving dry vaccine formulation against NIAID Category A, B and C priority pathogens. The paper can include but is not limited to a description of the product in terms of: a) dry formulation technology; b) vaccine antigen component, including the development status, manufacturing capabilities, results of proof of concept studies in animal models, and the design and the results of any completed Phase 1 clinical trial(s); c) adjuvant component, if applicable, including development status, i.e. evaluation in animal studies; clinical trial(s); and manufacturing capabilities; d) status of the legal rights to the intellectual property or agreements associated with the vaccine product, including the dry formulation technology, antigen and adjuvant, as applicable; e) the overall stage of product development for the dry vaccine formulation, including the current status of preclinical and clinical safety and efficacy studies, including proof of concept data from animal model and other studies, if applicable; and f) the planned indication(s) for use.

We request that the responses be limited to 5 pages for any given dry formulation vaccine product, not including cover page, cover letter and table of contents. We also request that the responses where multiple dry formulations are described be limited to 10 pages. Any proprietary information should be clearly identified as such and will be kept confidential as allowed by relevant federal law. Submitted data and information will not be returned.

RFI response must include: 1) Name and title of the primary point of contact for the response; 2) Name and address of the Institution or Company; 3) Email address and phone number of the primary point of contact. Responses are due by November 30, 2012.

Inquiries

Inquiries and RFI responses should be directed to the NIAID Division of Microbiology and Infectious Diseases, Office of Biodefense Research Affairs at: [email protected].