NIAID is interested in working with vaccine developers with next generation SARS-CoV-2 vaccine candidates that will soon be ready to enter clinical trials. 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 particularly interested in novel vaccine candidates currently at a development stage ready to enter clinical trials or capable of entering clinical trials by mid-2024.
NIAID encourages interested vaccine developers to provide the following information outlined in items 1 – 7 below, so NIAID can determine if a vaccine aligns with our focus for next generation vaccines and to ensure NIAID supports a wide variety of approaches:
- Overview of existing next-generation candidate(s) in clinical development, or capable of entering clinical development within the next nine months, including:
- Vaccine platform
- Viral epitope targeted
- SARS-CoV-2 strain(s) used as antigen
- Adjuvant (if applicable)
- Vaccine vector (if applicable)
- Route of administration
- Number of doses and schedule proposed for an immunized population.
- Preclinical data including:
- Immunogenicity including cross reactive antibodies to variants of concern, assay used, and lab performing
- Summary of safety data (including Investigational New Drug (IND)-enabling toxicology studies if the candidate is in preclinical development)
- Summary of efficacy data
- Durability of protection
- Mucosal responses (if known) including assay used, lab performing, and development status of the assay
- Transmission blocking (if studies performed)
- Prior human studies (both US and ex-US) including:
- Highest phase trial
- Number of participants
- Comparator (if applicable)
- Summary of safety data
- Summary of immunogenicity data including cross reactive antibodies to variants of concern, assay used, and lab performing.
- Summary of mucosal assessments (if any) including samples collected (saliva, nasal secretions, cells, etc), method of sample collection, assay used, and lab performing.
- Regulatory path to licensure (if known) and whether or not a US IND is in place, to include proposed indication.
- Manufacturing
- Production capacity and status (i.e., where are you on the current Good Manufacturing Practice (cGMPs) scale).
- Demonstrated cGMP manufacturing to support inclusion in a Phase 1/2 clinical trial in the US by mid-2024.
- Status of contract manufacturing organization (CMOs) (API) and (FF), and whether or not any existing or proposed capacity is US based.
- Status of adjuvant supply (if applicable)
- Other non-COVID products using same manufacturing platform
- Current process yields
- Status of clinical trial material supply
- Estimated timeline to product release after new variant sequence is obtained
- Capability to add antigens (additional spike, receptor binding domain (RBD), other), if necessary
- Plans for ongoing and future clinical trials funded by company
- If support for clinical trials would help advance clinical development and licensure in the US, provide the following information:
- Phase of trial to be performed next (1, 2a, 2b/3)
- Target strain and dose
- Timeline for availability of clinical trial material that can be used in US
- Estimated time to first patient enrolled
- Ability to access comparator (i.e., licensed product) if needed
Responses should be sent electronically to NIAIDProjectNextGen@niaid.nih.gov.
Disclaimer
This submission is for information and planning purposes only and 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 information about a candidate does not guarantee support for current or future studies. NIAID does not provide feedback on submitted responses. Candidates of interest will be contacted by a NIAID representative.