Maintaining Immunity after Immunization (U01 Clinical Trial Not Allowed) | RFA AI 22 055

Opportunity Information: Apply for RFA AI 22 055

Maintaining Immunity after Immunization (U01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity that supports research aimed at explaining why some vaccine-induced immune responses last for years while others fade more quickly. The central purpose is to strengthen scientific understanding of the immune system features and biological mechanisms that control the durability of protective immunity after vaccination against infectious agents. Rather than focusing on developing a new vaccine or running a clinical efficacy study, this opportunity is designed to fund mechanistic, immunology-focused projects that can pinpoint what drives long-lasting protection and what predicts waning immunity.

A defining requirement of this announcement is that proposed studies must use human cells and/or tissues to decode the human immune response produced by vaccination. In practice, this often means detailed analyses of immune memory after immunization, such as measuring and characterizing long-lived plasma cells, memory B cells, and vaccine-specific T cell populations; evaluating antibody quality (not just quantity), including breadth, affinity maturation, and functional activity; and identifying cellular and molecular signatures linked to durable protection. Studies may incorporate advanced laboratory and computational approaches, for example deep immune profiling, single-cell analyses, systems immunology, functional assays, and other methods that can reveal which immune components and pathways are responsible for maintaining protection over time.

Although the emphasis is on human-based research, the announcement allows animal studies when they are needed to test mechanistic pathways that cannot be easily or ethically evaluated using human samples alone. These animal components are intended to complement the human work by enabling targeted experimentation, causal testing, or tissue-level investigations that are not feasible in people. The overall expectation, however, remains that the project is anchored in deciphering vaccine-elicited immunity in humans.

The award mechanism is a U01 cooperative agreement, which typically indicates a collaborative relationship between the NIH and the funded research team, with substantial scientific or programmatic involvement from NIH staff compared with a standard research grant. The opportunity falls under the health research category and is associated with CFDA number 93.855. The listed award ceiling is $450,000, and the original application due date shown is January 13, 2023.

Eligibility is broad and includes many types of domestic organizations, such as state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and Native American tribal organizations that are not federally recognized tribal governments. It also includes nonprofits (with or without 501(c)(3) status), public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses. In addition, the announcement explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations).

Finally, the title and language of the announcement make clear that clinical trials are not allowed under this FOA. That generally means applicants should not propose prospective interventional studies in humans where participants are assigned to receive an intervention to evaluate health-related outcomes. Instead, the work should focus on mechanistic and observational analyses of vaccine responses using human specimens, potentially including samples from prior or ongoing vaccination contexts, provided the proposed project itself does not constitute a clinical trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Maintaining Immunity after Immunization (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2022-08-22.
• Applicants must submit their applications by 2023-01-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $450,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AI 22 055

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: