A Multidisciplinary Approach to Study Vaccine-elicited Immunity and Efficacy against Malaria (U01 Clinical Trial Not Allowed) | RFA AI 20 064

Opportunity Information: Apply for RFA AI 20 064

The funding opportunity titled "A Multidisciplinary Approach to Study Vaccine-elicited Immunity and Efficacy against Malaria (U01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA AI 20 064) is a National Institutes of Health (NIH) discretionary grant initiative focused on improving the scientific understanding of why malaria vaccines work well in some people and settings, but show reduced protection (often described as hypo-responsiveness) in others, especially in malaria-endemic regions. The central emphasis is on uncovering the immune mechanisms and measurable biological patterns that correlate with protection or poor responsiveness after vaccination, with the practical aim of using those insights to improve how future malaria vaccines are designed, evaluated, and optimized for real-world use in endemic populations.

A key feature of this initiative is its explicit push toward a systems-level approach. Rather than relying only on traditional immunology readouts, applicants are encouraged to leverage advances in systems vaccinology and systems immunology, which typically integrate multiple layers of data (for example, cellular immune profiling, antibody features, transcriptomics, proteomics, metabolomics, and other high-dimensional measurements) to identify complex, multi-factor immune signatures associated with vaccine performance. The opportunity also highlights the growing role of data science and informatics, signaling that strong proposals may include advanced computational methods, robust data integration strategies, and analytic frameworks capable of handling large, heterogeneous datasets. The intent is to move beyond single biomarkers and toward more comprehensive "host signatures" and mechanistic explanations that can help predict or explain vaccine efficacy differences across individuals and populations.

Multidisciplinary collaboration is strongly encouraged. NIH is signaling that teams combining malaria vaccine expertise with other relevant specialties are especially welcome, such as systems biology, computational biology, immunoengineering, bioinformatics, statistics, machine learning, clinical immunology, genomics, and epidemiology. This reflects the complexity of malaria immunity and the reality that vaccine performance in endemic regions can be shaped by many interacting factors, including prior parasite exposure, co-infections, host genetics, age, nutritional status, microbiome influences, and environmental determinants. The broader goal is to identify mechanistic factors and immune patterns that influence vaccine performance in these contexts, so the field can make better-informed decisions about vaccine platforms, antigen design, adjuvants, dosing schedules, boosting strategies, and evaluation endpoints.

The award mechanism is a U01 cooperative agreement, meaning it is not a standard investigator-initiated grant in which the funder is hands-off. A cooperative agreement typically involves substantial NIH programmatic involvement during the project period, which can include coordination, steering input, milestone tracking, or participation in collaborative activities across funded projects. The funding instrument type listed is a Cooperative Agreement, the activity category is Health, and the CFDA number is 93.855. The notice also specifies "Clinical Trial Not Allowed," indicating that proposed work must not include a clinical trial as defined by NIH, though it may still involve clinical samples or observational studies depending on how the project is structured and classified. The opportunity was created on 2020-10-07, with an original closing date of 2021-02-08, and an award ceiling of 750,000 (as provided in the source data). The expected number of awards is not specified in the provided listing.

Eligibility is broad and includes many types of organizations, reflecting an interest in drawing talent and capacity from a wide range of institutions and regions. Eligible applicants include state, county, and local governments; 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; Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other unspecified entities. The announcement also explicitly lists additional eligible applicants such as 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, U.S. territories or possessions, regional organizations, Indian/Native American Tribal Governments (other than federally recognized), and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility, including foreign organizations, aligns with the scientific and public health reality that much of the critical work on malaria vaccine performance must be done in or in close partnership with malaria-endemic settings.

Overall, this opportunity is geared toward projects that can explain, at a mechanistic and systems level, what immune responses and host factors are linked to successful malaria vaccine protection in endemic regions, and what factors contribute to weaker-than-expected responses. By encouraging multidisciplinary teams and modern high-dimensional immunology paired with strong data science, the initiative aims to generate actionable knowledge that can directly inform next-generation malaria vaccine development and improve how vaccines are tested and deployed where malaria burden is highest.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "A Multidisciplinary Approach to Study Vaccine-elicited Immunity and Efficacy against Malaria (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 2020-10-07.
• Applicants must submit their applications by 2021-02-08. (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 $750,000.00 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.

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