Conduct Research to Improve Protective Immunity Following Immunization

NIAID invites applications proposing research that improves our understanding of durable protective immunity following immunization against infectious agents through the funding opportunity announcement (FOA) Maintaining Immunity After Immunization (U01, Clinical Trial Not Allowed).

This initiative will support studies that define and characterize components and mechanisms of the immune system that lead to sustained immunity and identify common versus distinct durable immune mechanisms triggered by vaccines compared to natural infection. The research findings will contribute to a more complete understanding of the requirements for vaccine-induced durable protection.

NIAID has supported several programs to characterize the immune response to vaccination, including the Maintaining Immunity After Immunization initiative, where investigators have made important discoveries about how vaccination and infection engages and activates certain components of the immune response. However, we do not have a complete understanding of those immune components needed to sustain a protective immune response.

Research Objectives and Scope

With this opportunity, NIAID aims to extend this research and continue to identify the immune components and pathways needed to elicit and sustain a protective immune response following vaccination. Projects supported under this program will define and characterize the components of the immune response that are stimulated and how these components interact to induce an effective, durable immune response, such as that seen in vaccines against hepatitis B, varicella, or yellow fever.

NIAID is interested in research that can achieve the following:

• Identify the molecular components of innate and adaptive immune responses, such as immune receptors, metabolic changes, epigenetic modifications, or signaling molecules that must be activated to maintain durable protective immunity.
• Establish an understanding of the crosstalk between components that lead to protective immunity and are differentially elicited by natural infection versus by vaccination.
• Characterize immune mechanisms that contribute to reduction in durable immunity after vaccination in immunocompromised individuals (e.g., transplant recipients, thoses with autoimmune disorders).
• Determine the impact of race, ethnicity, or other factors that could be related to genetic determinants of durable immunity to vaccination.
• Elucidate the role of “trained” innate immunity as an initiator of durable protective immunity.
• Understand mechanisms regulating localization of immune cell types to tissues or organs, and how these mechanisms affect the formation of durable protective immunity, for example, the determination of the role of mucosal immune elements in durable immunity.
• Determine the effect of boosting (vaccines or natural infection/exposure) on maintenance/evolution of durable protective immune responses.
• Compare immune mechanisms that are engaged by vaccines that induce durable immunity versus those that induce short-term protective immunity.

Nonresponsive Areas of Research Interest

NIAID considers research applications in the following areas to be nonresponsive and will not review them:

• Projects that examine the efficacy of vaccine or adjuvant formulation without focusing on immune mechanisms triggered by these vaccines or adjuvants.
• Studies on AIDS, HIV, cancer, or SIV.
• Studies to perform clinical trials; however, studies proposing the use of human samples collected from independently funded clinical trials are responsive and will be reviewed.
• Projects that focus on vaccine or vaccine technology development.
• Projects that only study the immune response to infection, outside the context of vaccination.
• Projects that focus on adjuvant discovery or adjuvant development.
• Projects that do not propose the use of human cells or tissues.

Note that applicants submitting renewal applications may not propose clinical trials, nor can they use funds from this FOA, if awarded, to continue ongoing clinical trials from the previous award.

Budget and Submission Information

All applications are due by January 13, 2023, at 5 p.m. local time of the applicant organization.

Application budgets are not to exceed $450,000 in annual direct costs and should reflect the actual needs of the project. The scope of the proposed project should determine the project period which should not exceed the maximum period of 5 years.

Contact and Submission Information 

Direct inquiries to Dr. Conrad Mallia, NIAID’s scientific/research contact, at 240-627-3491 or cmallia@niaid.nih.gov. For peer review related questions, contact Dr. James Snyder at 240-669-5060 or James.Snyder@nih.gov.