Advancing mAbs to Achieve a Drug-free Sustained HIV Virologic Remission (U01 Clinical Trial Required) | RFA AI 18 022

Opportunity Information: Apply for RFA AI 18 022

The National Institutes of Health (NIH) released this funding opportunity, RFA-AI-18-022, titled "Advancing mAbs to Achieve a Drug-free Sustained HIV Virologic Remission (U01 Clinical Trial Required)," to speed the launch of early-stage human clinical trials that test monoclonal antibodies (mAbs) as a strategy to reach sustained HIV virologic remission without ongoing antiretroviral therapy. In practical terms, the goal is to move promising native (naturally occurring) and/or engineered (modified for improved performance) antibodies into clinical testing quickly, with the explicit intention of seeing whether they can help people living with HIV maintain viral control after stopping standard HIV drugs. The emphasis on "drug-free sustained virologic remission" signals an interest in functional cure-like outcomes, where the virus remains suppressed without continuous medication, rather than simply improving suppression while antiretrovirals are still being taken.

The award uses a U01 cooperative agreement mechanism, meaning the project is expected to be a hands-on partnership with NIH rather than a fully investigator-directed grant with minimal federal involvement. Cooperative agreements typically involve substantial scientific or programmatic participation from the funding institute, which fits the stated intent to "rapidly implement" trials and to coordinate closely on trial design, execution, and milestones. The announcement also clearly states "Clinical Trial Required," so applications must include an actual clinical trial component rather than being limited to preclinical development or purely observational work. The overall activity category is health, and the listing is associated with CFDA number 93.855.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, and city or township 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; tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations (other than small businesses); and small businesses. The FOA additionally calls out a range of institution types as eligible, including 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), eligible federal government agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. This suggests NIH intended the program to be accessible to a wide array of clinical research-capable groups, including those serving populations that are often underrepresented in biomedical research.

Foreign eligibility is more limited and is spelled out in a nuanced way. Non-domestic (non-U.S.) entities (foreign organizations) and non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible to apply, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. In other words, a U.S.-based applicant can propose work that includes foreign sites or collaborators under NIH rules, but a fully foreign institution cannot serve as the primary applicant for this opportunity.

Key administrative details provided in the source include the original posting date (creation date) of June 28, 2018, and an original closing date of October 9, 2019. The funding instrument type is listed as a cooperative agreement, reinforcing that the program expects close coordination with NIH. Award ceiling and expected awards are not specified in the excerpt provided, so budget limits and the anticipated number of awards would need to be confirmed from the full FOA text if someone were planning to apply or compare this opportunity to similar NIH solicitations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing mAbs to Achieve a Drug-free Sustained HIV Virologic Remission (U01 Clinical Trial Required)" 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 2018-06-28.
• Applicants must submit their applications by 2019-10-09. (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.

Apply for RFA AI 18 022

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: