Request for Information (RFI): Development of Multivalent Vaccine Candidates For Filovirus and Lassa Fever

Notice Number: NOT-AI-15-049

Key Dates
Release Date: July 29, 2015
Response Date: September 4, 2015

Related Announcements
None

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

Purpose

NIAID is seeking information from pharmaceutical and biopharmaceutical product developers on multivalent vaccines and rapidly adaptable vaccine platform technologies against filoviruses (Ebola, Sudan, and Marburg); candidate vaccines may also include a component that confers protection against Lassa Fever. The primary focus of this Request for Information (RFI) is to gather information about multivalent filovirus vaccine candidates (with a Lassa Fever vaccine component if feasible) that at a minimum have shown efficacy in nonhuman primate disease models for at least one of the filovirus components. NIAID is also seeking information about any multivalent filovirus vaccine candidates that incorporates technological enhancements. Examples of technological enhancements include but are not limited to any of the following: vaccine presentations or formulations that are stable without the need for cold chain; rapid onset of protective immunity that will permit a prophylaxis indication in a post-event scenario; minimal doses to achieve protection; reasonable complexity of vaccine components (e.g., fewer individual viral constructs are preferable); non-parenteral routes of delivery; needle-free delivery; addressing issues such as anti-vector immunity and vaccine interference often seen with multivalent vaccines; comorbidities (e.g., pathogen burdens) and immunological attributes of individuals in Viral Hemorrhagic Fever endemic areas; and maturity of immune assays that may be used to identify correlates of protection.

The emphasis of this RFI is to gather information on multivalent filovirus vaccines, preferably ones that include technological enhancements. Multivalent filovirus vaccine candidates that also incorporate a component to confer protection against Lassa Fever are of interest.

Background

Development of countermeasures (vaccines, therapeutics, diagnostics and platform technologies) against NIAID Category A-C agents (http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx), including influenza, continues to be a high priority for the NIAID Biodefense and Emerging Infectious Diseases program. Development of filovirus vaccines reflects priorities outlined in the NIAID Strategic Plan for Biodefense Research, HHS Public Health Emergency Medical Countermeasures Enterprise Implementation Plan, the HHS 2010 Medical Countermeasure Review, and Homeland Security Presidential Directive 18: Medical Countermeasures against Weapons of Mass Destruction. NIAID’s plan supports the national biodefense strategy and reflects the Institute’s partnerships to develop countermeasures in tandem with HHS’ 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 multivalent filovirus vaccine products including those that incorporate technological enhancements and may also include a Lassa fever vaccine component.

Information Requested

Organizations are invited to describe their research efforts involving multivalent filovirus vaccines. Your comments may include but are not limited to: a) vaccine platform and antigen components, such as the development status, manufacturing capabilities, results of proof of concept studies in nonhuman primate models, and the design and the results of any completed Phase 1 clinical trial(s); b) adjuvant component, if applicable, including development status, i.e. evaluation in nonhuman primate studies, clinical trial(s), and manufacturing capabilities; c) status of the legal rights to the intellectual property or agreements associated with the vaccine product, including any technological enhancements, as applicable; d) the overall stage of product development for the multivalent filovirus vaccine, including the current status of preclinical and clinical safety and efficacy studies, including proof of concept data from nonhuman primate models and other studies, if applicable; and e) the planned indication(s) for use.

The government is also interested in the manufacturing status of potential vaccine candidates and likelihood that a Phase 1 or Phase 2 trial could be completed within 7 years. Organizations are invited to describe the status of manufacturing processes including Good Manufacturing Practice (GMP), scalability and ability to complete and submit an IND.

Submitting a Response

This is an 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.

Responses should be limited to 5 pages for any given multivalent filovirus vaccine product, not including cover page, cover letter and table of contents. Responses where multiple filovirus vaccine candidates are described should 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 are encouraged to 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 September 4, 2015. A companion RFI is posted in FedBizOpps.gov.

Inquiries

Inquiries should be directed to the NIAID Division of Microbiology and Infectious Diseases, Office of Acquisitions, Primary Point of Contact (POC): Michael Finn, at finnm@niaid.nih.gov.

RFI responses should be directed to the NIAID Division of Microbiology and Infectious Diseases, Office of Acquisitions, Primary POC: Shane Ryan, at ryanes@niaid.nih.gov. Alternate POCs for RFI responses are Aileene Mitchell Ford at aileene.mitchellford@nih.gov and Michael Finn at finnm@niaid.nih.gov.