Accelerating Discovery of Efficacious Pre-erythrocytic Stage Malaria Vaccines (U01 Clinical Trial Not Allowed) | RFA AI 19 059

Opportunity Information: Apply for RFA AI 19 059

Accelerating Discovery of Efficacious Pre-erythrocytic Stage Malaria Vaccines (U01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (RFA AI 19 059; CFDA 93.855) focused on moving the field toward more protective malaria vaccines that work before the parasite reaches the blood stage. The scientific emphasis is on pre-erythrocytic, sporozoite-based vaccine approaches, meaning strategies designed to stop infection early, at or shortly after the mosquito-transmitted sporozoite stage, before parasites establish liver infection and progress to symptomatic blood-stage disease. The overall intent is to push beyond what current sporozoite-based vaccine options can achieve and to produce one or more vaccine candidates with clearly superior performance that are realistic to advance into downstream development and, later, clinical evaluation.

This opportunity is aimed at stimulating a pipeline that starts with basic discovery and extends through early translational steps. Projects are expected to contribute to the generation of highly efficacious candidates by improving foundational understanding, enabling new vaccine concepts, or providing early-stage evidence that a candidate is promising and can be further engineered or produced for future testing. The announcement explicitly encourages cross-fertilization between malaria vaccine developers and researchers in complementary disciplines, particularly parasite biology, parasite genomics, malaria pathogenesis, and host immunology. In practice, that means NIH is looking for teams and concepts that blend expertise, such as pairing sporozoite vaccine platforms with new genomic insights into parasite vulnerabilities, or using modern immunology to define protective immune mechanisms that can be intentionally elicited by vaccination. Collaboration is not just allowed but actively encouraged as a way to speed up discovery and reduce the chance that vaccine design proceeds without the latest mechanistic insights.

The mechanism is a U01 cooperative agreement, which typically indicates substantial NIH programmatic involvement compared with a standard research project grant. While applicants still propose and lead the science, a cooperative agreement usually comes with expectations for coordination, milestone-driven progress, data sharing, and alignment with broader program goals. Importantly, the notice states "Clinical Trial Not Allowed," so the work supported under this announcement is not meant to include human clinical trials. Instead, the supported activities would generally fall into preclinical and early translational territory, such as antigen discovery and prioritization, sporozoite vaccine design and optimization, preclinical efficacy testing, characterization of immune correlates or mechanisms of protection, platform improvements, or other enabling studies that position a candidate for later process development and eventual clinical evaluation under separate funding and regulatory pathways.

From an applicant standpoint, eligibility is broad and includes many types of domestic U.S. organizations and government entities, such as state, county, city or township governments, special district governments, independent school districts, public and state-controlled universities, private institutions of higher education, and certain public housing authorities/Indian housing authorities. It also includes Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments). Nonprofit organizations are eligible whether or not they hold 501(c)(3) status (as long as they are not institutions of higher education in those categories), and both for-profit organizations (other than small businesses) and small businesses are listed as eligible. The opportunity also explicitly calls out additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, and non-U.S. entities (foreign organizations). That broad eligibility aligns with the stated goal of building interdisciplinary networks and bringing in expertise from multiple sectors and geographies relevant to malaria.

Key administrative details provided in the source include an original closing date of January 17, 2020, a creation date of October 11, 2019, and an award ceiling of $750,000. The listing also notes "ExpectedAwards:" but does not provide a number in the supplied text. Taken together, the program can be understood as NIH support for high-impact, preclinical and early translational malaria vaccine research that specifically targets the pre-erythrocytic stage with sporozoite-based strategies, prioritizes collaborations that merge vaccine development with deep parasite and immune biology, and aims to deliver candidate vaccines positioned for later-stage development rather than to fund clinical testing within this award.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Accelerating Discovery of Efficacious Pre-erythrocytic Stage Malaria Vaccines (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 2019-10-11.
• Applicants must submit their applications by 2020-01-17. (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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