Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, or solicitations for Council’s input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.
Note: Council approval does not guarantee that a concept will become an initiative.
Table of Contents
Fiscal Year (FY) 2026 Division of Microbiology and Infectious Diseases (DMID) Concepts
- Broad Spectrum Products Against Multiple Neurotoxin Botulinum Serotypes
- Rational Design of Vaccines Against Hepatitis C Virus
- In Vitro Assessments for Antimicrobial Activity
- Impact of Initial Influenza Exposure on Immunity in Infants
- Collaborative Influenza Vaccine Innovation Centers (CIVICs)
- Clinical Research Operations Core
- Notice of Special Interest (NOSI)—Advancing Research Needed to Develop a Universal Influenza Vaccine
Broad Spectrum Products Against Multiple Neurotoxin Botulinum Serotypes
For the published request for applications, check the December 11, 2024 Guide announcement, Broad Spectrum Products Against Multiple Neurotoxin Botulinum Serotypes (R61/R33, Clinical Trial Not Allowed).
Rational Design of Vaccines Against Hepatitis C Virus
Request for Applications—proposed FY 2026 initiative
Contact:
Kaitlyn Morabito
kaitlyn.dambach@nih.gov
Objective: To optimize broadly protective vaccines for hepatitis C virus (HCV), assess immunogenicity, and perform investigational new drug (IND)-enabling studies to enable the advancement of vaccine candidates into clinical evaluation.
Description: This initiative will support translational research including the discovery and optimization of broadly protective vaccines for HCV, evaluation of immunogenicity in animal models, and other IND-enabling studies to support advancement of vaccine candidates into clinical development. This initiative will also support basic research including structural biology, virology, and immunology to characterize viral proteins, diversity, pathogenesis, and correlates/mechanisms of protection in natural infection and animal models.
In Vitro Assessments for Antimicrobial Activity
For the published request for proposals, check the December 30, 2024 solicitation, In Vitro Assessments of Antimicrobial Activity.
Impact of Initial Influenza Exposure on Immunity in Infants
Request for Applications—proposed FY 2026 initiative
Contact:
Michelle Arnold
michelle.arnold@nih.gov
Objective: To determine how immunity generated by initial and subsequent influenza infections and/or vaccinations shapes protective immunity to future influenza exposures in longitudinal human infant cohorts, which will help inform the design of durable, broadly protective influenza vaccines.
Description: This initiative will establish, follow, and characterize longitudinal cohorts of infants and/or mother-infant dyads to determine how initial and repeated natural influenza infections and/or vaccinations shape infant and childhood immunity to future influenza exposures. Research supported under this program will define and characterize immunity acquired upon initial exposure to influenza antigens from natural infections and/or vaccinations and examine how these exposures influence immune responses to subsequent influenza infections and/or vaccines. Projects that include mother-infant dyads will also be able to assess the role of maternal influenza immune status on neonatal responses to influenza infection and/or vaccination. The overall goal of this research is to provide key information to facilitate design of durable, broadly protective influenza vaccines.
Collaborative Influenza Vaccine Innovation Centers (CIVICs)
Broad Agency Announcement—proposed FY 2026 initiative
Contact:
Stacey Esters
stacey.esters@nih.gov
Objective: This renewal initiative will continue to support a consortium of collaborative centers to apply innovative approaches to the development of influenza vaccines that provide robust, durable, broadly protective mucosal and systemic immunity, as well as the improvement of the immunogenicity, breadth, and enhanced durability of licensed seasonal influenza vaccines.
Description: The Vaccine Centers will be required to form integrated product teams that cover the entirety of the vaccine development pipeline from vaccine design to preclinical testing, process development, toxicology testing, regulatory support, and cGMP manufacturing. The Vaccine Centers will be required to have at least one vaccine candidate with an established target product profile and GMP partner that will allow GMP product release within 9 to 12 months of award, consistent with a technology readiness level of 5 or 6. As preclinical and process development data from Vaccine Center products becomes available, key Go/No-Go decisions will be made by the External Advisory Group and NIAID leadership, which will determine whether Options may be executed to allow for further product development, such as pilot runs and cGMP manufacturing. By forming these integrated product teams within the Vaccine Centers, the intent is to allow for more streamlined communication between the vaccine developers and process development experts, as well as more streamlined intellectual property among the team. The following activities will be supported under the Vaccine Centers:
- Rational design and preclinical evaluation of influenza vaccine immunogens, antigen/adjuvant combinations, and delivery platforms.
- Conduct comprehensive immunological analyses to support the design and testing of influenza vaccine candidates including analysis of systemic and mucosal immune responses and identification of correlates of protection.
- Test novel combinations of vaccine approaches and conduct head-to-head comparisons to down-select and identify the most promising influenza vaccine candidates for further development.
- Design, develop, qualify, and validate protocols, reagents, and assays for preclinical and clinical evaluation of influenza vaccine immunogenicity and efficacy.
- Optimize, formulate, and manufacture influenza vaccines and vaccine components.
This next iteration of the program will utilize existing NIAID clinical trial infrastructure for clinical trials.
Clinical Research Operations Core
Request for Proposals—proposed FY 2026 initiative
Contact:
Chase Sullivan
chase.sullivan@nih.gov
Objective: To enable DMID to develop and execute clinical trials across all the Division’s scientific objectives by streamlining trial activities and operationalizing scientific concepts originated from the Division.
Description:
- DMID’s Clinical Research Operations Core (OpsCore) will provide operational support, management, and oversight for DMID clinical research activities.
- The OpsCore will manage and oversee a range of activities to advance clinical research priorities for DMID, including:
- Protocol development.
- Site selection from across DMID’s clinical infrastructure.
- Budget development and oversight.
- Management of end-to-end processes for study implementation.
- Oversight of laboratory services and specimen management.
- Coordination among stakeholders to ensure timely dissemination of results.
Notice of Special Interest (NOSI)—Advancing Research Needed to Develop a Universal Influenza Vaccine
For the published notice of special interest, check the November 21, 2024 Guide notice, Notice of Special Interest (NOSI): Advancing Research Needed to Develop a Universal Influenza Vaccine.