Sexually Transmitted Infections (STI) Cooperative Research Centers (CRC): Vaccine Development (U19 Clinical Trial Not Allowed) | RFA AI 18 005

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The Sexually Transmitted Infections (STI) Cooperative Research Centers (CRC): Vaccine Development funding opportunity (RFA-AI-18-005) is a National Institutes of Health (NIH) cooperative agreement (U19) designed to build coordinated research centers focused on advancing vaccines for major sexually transmitted infections where the vaccine pipeline is thin. The central goal is to bring together multidisciplinary teams in a collaborative center structure so that basic discovery, preclinical development, and translational planning can move forward in a more integrated and efficient way than individual projects typically allow. The FOA is explicitly aimed at vaccine development rather than treatment, and it uses the cooperative agreement mechanism, meaning NIH is expected to have substantial involvement in guiding and coordinating the program alongside the awardees.

Scientifically, the program prioritizes vaccines to prevent STIs caused by Neisseria gonorrhoeae (gonorrhea), Chlamydia trachomatis (chlamydia), and Treponema pallidum (syphilis), reflecting the public health burden of these infections and the limited number of strong vaccine candidates currently in development. In addition to those three bacterial pathogens, the FOA also supports the development of prophylactic (preventive) vaccines for herpes simplex virus (HSV). In practice, the center model is meant to promote synergistic collaborations across relevant disciplines such as microbiology, immunology, antigen discovery, adjuvant and formulation science, animal model development, correlates of protection, and other supporting capabilities needed to mature vaccine concepts toward readiness for later-stage testing.

From an administrative standpoint, the opportunity falls under the health category and is associated with CFDA 93.855. The eligible applicant pool is broad and includes a wide range of U.S.-based organizations and government entities, such as state, county, city or township governments, special district governments, and independent school districts; public and state-controlled institutions of higher education and private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; and for-profit organizations (other than small businesses) as well as small businesses. The FOA also highlights additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

The FOA draws an important boundary around international participation. Non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible to participate, and foreign components are allowed as defined by the NIH Grants Policy Statement. In other words, the primary award must go to an eligible U.S.-based applicant, but parts of the research effort can include foreign components when appropriately justified and structured under NIH policy.

The announcement is labeled "Clinical Trial Not Allowed," which signals that applications should not propose clinical trials within the scope of this U19. The intent is to support the research and development steps that build credible vaccine candidates and the evidence base needed to move forward, without conducting clinical trial activities under this specific award. The funding opportunity was created on March 16, 2018, and the original closing date listed is June 20, 2018.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Sexually Transmitted Infections (STI) Cooperative Research Centers (CRC): Vaccine Development (U19 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 2018-03-16.
• Applicants must submit their applications by 2018-06-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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