Advancing Vaccine Science to Improve Tuberculosis Treatment Outcomes for People Living With or Without HIV (R01 Clinical Trial Not Allowed) | RFA AI 20 010

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The National Institutes of Health (NIH) released this discretionary grant opportunity, Funding Opportunity Announcement (FOA) RFA-AI-20-010, titled "Advancing Vaccine Science to Improve Tuberculosis Treatment Outcomes for People Living With or Without HIV (R01 Clinical Trial Not Allowed)." It uses the R01 grant mechanism and falls under the Health funding activity category (CFDA 93.855). The central goal is to support innovative research that advances therapeutic vaccine strategies aimed at improving treatment outcomes for people with active tuberculosis (TB), whether or not they are also living with HIV. In other words, the focus is not on preventing TB infection in the first place, but on vaccine approaches used alongside TB treatment to help patients clear disease more effectively, reduce relapse, shorten or strengthen treatment response, and improve overall outcomes, including in the complicated setting of TB/HIV co-infection.

The FOA emphasizes innovative clinical and preclinical/translational work. Preclinical and translational projects could include vaccine concept development, immune mechanism studies, identification of protective or treatment-response correlates, optimization of vaccine platforms or antigens, and translational studies that move promising therapeutic vaccine candidates toward human use. The inclusion of "clinical" research signals that studies involving human samples, immune profiling, observational or interventional work that is not categorized as a clinical trial, or other clinical research activities may be appropriate, as long as they fit the FOA rules. The phrase "Clinical Trial Not Allowed" is a key constraint: applications cannot propose NIH-defined clinical trials (for example, prospectively assigning human participants to an intervention to evaluate health-related biomedical or behavioral outcomes). Applicants therefore need to keep proposed human work within the boundaries of non-trial clinical research, such as immunologic studies using specimens, natural history or correlates studies, or other designs that do not meet NIH's clinical trial definition.

The scientific target is active TB treatment outcomes, with explicit attention to people living with HIV as well as those without HIV. This matters because HIV can alter immune function, TB disease presentation, and treatment response, and it can complicate the development and evaluation of therapeutic vaccines. The FOA is essentially asking investigators to push the science of therapeutic vaccination forward in ways that are relevant to real-world clinical needs: better treatment response, fewer failures or relapses, and strategies that remain effective across diverse patient populations, including immunocompromised groups.

Eligibility is broad and includes many types of domestic U.S. organizations as well as certain non-U.S. organizations. Eligible applicants listed include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities/foreign organizations. This breadth signals an intent to draw from a wide research ecosystem, including institutions that serve underrepresented communities and international partners, which can be particularly relevant for TB given its global burden.

Key administrative details from the source information include an original closing date of 2020-07-28, a creation date of 2020-03-06, and an award ceiling of $800,000. While the number of expected awards is not specified in the provided data, the ceiling indicates the FOA anticipated substantial budgets for projects that can involve complex immunology, vaccine development work, translational studies, and multi-disciplinary collaborations. Overall, this opportunity is designed to catalyze rigorous, non-clinical-trial R01 research that advances therapeutic vaccine science with the specific objective of improving outcomes for people undergoing treatment for active TB, including those with HIV co-infection.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Vaccine Science to Improve Tuberculosis Treatment Outcomes for People Living With or Without HIV (R01 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 2020-03-06.
• Applicants must submit their applications by 2020-07-28. (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 $800,000.00 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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