Led by NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), Project NextGen is a coordinated effort where the federal government works with the private sector to advance the pipeline of new, innovative vaccines and therapeutics from labs into clinical trials with the intent to transition to the private sector later stage development and potential U.S. Food and Drug Administration (FDA) authorization, approval, and commercial availability.
How Is NIAID Addressing This Topic?
Through Project NextGen, NIAID aims to accelerate the development of the next generation of COVID-19 vaccines that are ready for clinical evaluation. NIAID plans to leverage existing infrastructure and network sites to implement a structured program evaluating up to 10 next generation COVID-19 vaccines in Phase 1 and Phase 2 clinical trials. The studies will be sponsored by NIAID using common protocols and centralized assays of multiple immune parameters including humoral, cellular, and mucosal responses. These studies will help advance products as well as advance science in the field by evaluating how immunologic parameters correlate with protection from infection and disease.
Next generation vaccines include those with enhanced breadth of protection to variants, improved durability, and those with an enhanced ability to block infection/transmission including mucosal vaccines, relative to currently approved vaccines. NIAID is interested in working with vaccine manufacturers with next generation novel vaccine candidates currently at a development stage ready to enter clinical trials or capable of entering clinical trials by mid-2024.
NIAID requests that vaccine developers that have novel next generation vaccine candidates and are interested in working with NIAID, submit the product information to NIAIDProjectNextGen@niaid.nih.gov. The required information can be found at Project NextGen. NIAID has received responses that were submitted to a recent BARDA Request for Information related to Project NextGen and is currently determining if projects align with NIAID’s area of focus. Thus, NIAID requests that any new or updates on previous submissions be provided directly to the email address above. This is not a funding opportunity, but rather a collaboration between NIAID and vaccine developers to advance next generation vaccines.
- For more information about BARDA’s efforts, please visit Project NextGen: Next Generation Medical Countermeasures.
- For specific questions about NIAID’s planned clinical trials, please contact: NIAIDProjectNextGen@niaid.nih.gov.
Preclinical Development of Next Generation COVID-19 Vaccines
For COVID-19 vaccine candidates in the preclinical stage of development, NIAID recommends the following options:
- Submit an application in response to one of these NIH Notices of Funding Opportunity (NOFOs) or any re-issues of these NOFOs.
- NIH Research Project Grant (Parent R01, Clinical Trial Not Allowed)
- NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Not Allowed)
- NIAID Investigator-Initiated Program Project Application (PAR-22-225, Clinical Trial Not Allowed)
- PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
- PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
- Explore options for accessing NIAID’s suite of Preclinical Services, including: