Sexually Transmitted Infections (STI) Cooperative Research Centers (CRC): Vaccine Development (U01 Clinical Trial Not Allowed)

Background
The purpose of this Funding Opportunity Announcement (FOA) is to advance vaccine candidates for gonorrhea, chlamydia and syphilis by supporting IND-enabling activities. The FOA aims to combat antimicrobial resistance, eliminate adverse neonatal outcomes, reduce HIV transmission, prevent cancer, decrease the burden of infertility and improve the health of young people.

Grant Details
The FOA will focus on advanced vaccine development for STI pathogens that have limited candidates in the product development pipeline: Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum. Applicants are required to provide a Product Development Strategy (PDS) that includes a Product Development Plan and Timelines and Milestones. The proposed activities include toxicology, clinical assay development, formulation, process development and control assays, and Good Manufacturing Practice (GMP) manufacture. Applications proposing vaccine development for pathogens other than Neisseria gonorrhoeae, Chlamydia trachomatis and Treponema pallidum or focusing on HIV/SIV/AIDS or clinical trials will not be reviewed.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, federal agencies, U.S. territories or possessions, Native American tribal organizations, faith-based or community-based organizations, and foreign institutions. Foreign entities are also eligible to apply.

Period of Performance
The maximum project period is five years with an earliest start date of June 14, 2023.

Grant Value
NIAID intends to commit $8.4M in FY 2024 to fund 2 to 3 awards. Application budgets are not expected to exceed $1.4M in direct costs per year.