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

The National Institutes of Health, under the Department of Health and Human Services, is soliciting applications for RFA-AI-28-024 to support the research and preclinical development of highly efficacious malaria vaccines. The initiative focuses on utilizing structure-based immunogen design, improved formulations, and combination vaccines to create long-lasting protection that can serve as a model for other mosquito-borne diseases. This funding opportunity is structured as a phased award, consisting of an R61 exploratory phase for up to three years with annual direct costs up to 400,000 dollars, and an R33 development phase for up to two years with annual direct costs up to 750,000 dollars. The maximum total project period is five years, and clinical trials are strictly prohibited. Applications will be evaluated through the NIH peer review system based on the importance of the research, rigor and feasibility of the approach, and the expertise of the investigators and their environment. Key requirements include the establishment of quantifiable R61 transition milestones and clear translational Go/No-go criteria for vaccine candidates. Applicants must maintain active SAM registration and provide a Data Management and Sharing Plan. Additionally, recipients must adhere to strict cybersecurity protocols modeled after the NIST framework, including multifactor authentication and a 48-hour incident notification requirement, and ensure all research involving human subjects or vertebrate animals complies with federal regulations and ethical guidelines.