Accelerating Research and Development of Next Generation Vaccines against Malaria - a Model for Mosquito-Borne Diseases (R61/R33 Clinical Trial Not Allowed)

Mosquito-borne illnesses remain a major public health concern in the United States and worldwide. Malaria causes the greatest number of deaths globally and poses a significant risk for U.S. citizens abroad. The two first-generation malaria vaccines only offer partial, short-term protection in reducing disease in children over five months of age living in endemic areas. Better vaccines are needed to achieve higher efficacy against infection, severe disease, and/or transmission, offer longer lasting immunity, and protect across broader populations of all ages.

This notice of funding opportunity (NOFO) uses a R61/R33 Exploratory/Developmental Phased Award activity code to support discovery, proof-of concept, and/or preclinical development activities that are exploratory and developmental in nature, and to enable and accelerate the generation of highly efficacious malaria vaccines directed principally against two major human parasites, Plasmodium falciparum and Plasmodium vivax. The NOFO seeks product candidates or concepts that are highly effective in preventing infection, reducing disease burden, and/or blocking transmission of malaria and potentially other mosquito-borne diseases.

Specific Areas of Research Interest

The initiative will support activities that include, but are not limited to, the following topics: 

For discovery and proof of concept for vaccine candidate features:

• Design and/or construction of novel vaccine concepts utilizing improved immunogen design or new antigen(s), formulation, novel innovative or modern technology platforms [e.g., Artificial Intelligence (AI)-guided vaccine design] intended to lead to significant prevention of infection, reduction of disease, or blocking of transmission.
• Exploration of combination vaccine concepts:
• Combination of different vaccine platforms to elicit a broader range of protective immune responses,
• Combination of multiple protein subunit immunogens to target one or more functional biological pathways,
• Multi-stage vaccines targeting different life cycle stages of the parasites, for example, pre-erythrocytic, blood, and/or sexual stages of the parasite,
• Vaccine concepts that target mosquito vector products (e.g., salivary gland proteins) or processes that may help to reduce pathogen infection, transmission or disease.
• Demonstration of favorable vaccine features by confirming immunogenicity and efficacy of candidates using new approach methodologies (NAMs) or appropriate animal models [Note: for this NOFO, efficacy is defined as prevention of infection, disease, or relapse (e.g., for P. vivax)]. Examples of NAMs include novel functional assays, model systems, in vitro or ex vivo culture systems, or computational and AI-based approaches.

For preclinical development:

• Critical assay and process development,
• Formulation improvement,
• Current Good Manufacturing Practices (cGMP) pilot lot production and release,
• Investigational New Drug (IND)-enabling activities,
• Regulatory support required for initiation of Phase I trial (clinical protocol development or implementation of clinical trial excluded).

Application Instructions

Please submit as one combined pdf labeled with PI’s Lastname, Firstname:

1. A one‐page letter of intent with a description of proposed aims and approach.
2. If the final application requires a statement of broader impacts, please summarize your plans to address the specific requirements on an additional page.
3. CV (not biosketch) of the PI including past grant funding.

to limitedsubs@uw.edu by 5:00 PM Wednesday, December 16, 2026. Late pre-proposals will not be considered. Proposals are due to the sponsor 2/11/2027 so you will need to have your materials in to the Office of Sponsored Programs by 2/2/2027 if given the go‐ahead by the Limited Submissions review committee.