September 15, 2023
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National Institute of Allergy and Infectious Diseases (NIAID)
This Notice from the National Institute of Allergy and Infectious Diseases (NIAID) is to inform the influenza research community of the limited availability of cGMP material for use in controlled human influenza virus infection model (CHIVIM) clinical studies and trials.
As background, in 2018 NIAID participated in a meeting organized by the Bill & Melinda Gates Foundation, PATH, and the Global Funders Consortium for Universal Influenza Vaccine to discuss the role of a standardized CHIVIM in the development of a broadly protective ‘‘universal” influenza vaccine capable of producing immunity to multiple influenza type A and B viruses and providing long lasting protection against both seasonal and pandemic influenza (https://doi.org/10.1016/j.vaccine.2019.06.080 and https://doi.org/10.1016/j.vaccine.2019.06.053). During the meeting, participants agreed that the production of appropriate challenge viruses is a critical component for CHIVIM studies and to that end, NIAID agreed to assist with the development of well-characterized influenza virus challenge materials. NIAID has produced RG-A/Texas/71/2017 (H3N2; clade 3c3a) cGMP material and is currently funding the production of an H1N1 challenge strain. This is not a funding opportunity, but rather an invitation for investigators to request CHIVIM material for research purposes.
NIAID considers these materials to be an extremely valuable resource that may lead to significant advances toward the development of a more broadly protective influenza vaccine. Accordingly due to the limited supply of challenge virus material, investigators interested in requesting access to the currently available H3N2 material referenced above for their CHIVIM studies will need to provide detailed information about the proposed use of this material that will be evaluated by NIAID staff. For example, investigators must provide a description of how the requested material will be utilized (e.g., for vaccine efficacy studies, for natural history studies) and the timeframe when the cGMP material would be needed. In addition, investigators must submit a high-level 1-2 page protocol synopsis that summarizes the clinical trial/study design and endpoints, route of administration, age groups, and inclusion/ exclusion criteria. Investigators should also demonstrate funding support for their proposed CHIVIM clinical study or trial, but the study does not necessarily need to be funded by NIAID. Requests for access will be evaluated by NIAID twice a year, and request forms and material will be due to NIAID by March 15th and October 15th.
NIAID will provide a comprehensive evaluation form that will include these and other questions that must be completed and submitted for evaluation and approval. Investigators interested in submitting a formal request for these materials should send an email to NIAIDCHIVIMreagentrequests@mail.nih.gov to indicate their interest and initiate the process.
Following evaluation of the submitted evaluation form, investigators approved to receive these materials will be contacted by NIAID staff and must submit documentation of IRB approval before shipment of material. Approved requests will be subject to a formal Clinical Material Supply Agreement and NIAID will require these investigators to share relevant study data (e.g., safety). It should be noted that challenge strains produced in the U.S. could be used in other countries.
Disclaimer: This Notice shall not be construed as a solicitation or funding opportunity; a contract, grant, cooperative agreement, or other transaction; or as an obligation on the part of the Federal Government and the NIH to provide support for any ideas identified in response to it. Submitting a request for these materials does not guarantee support for current or future studies. NIAID does not provide feedback on submitted responses. Studies of interest will be contacted by a NIAID representative.
and Human Services (HHS)
