Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II (LADDS II) (R61/R33 Clinical Trial Not Allowed) | RFA AI 23 061

Opportunity Information: Apply for RFA AI 23 061

The Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II (LADDS II) funding opportunity (RFA-AI-23-061) is an NIH discretionary grant program designed to speed up the creation and refinement of long-acting drug delivery approaches that could make HIV-1 treatment for children safer, simpler, and easier to maintain over time. The central goal is to push promising long-acting antiretroviral therapy (ART) delivery platforms forward so they are better suited for pediatric use, with an emphasis on improving real-world feasibility for children and caregivers by reducing dosing frequency and supporting sustained viral suppression. A key boundary of the program is that it is "Clinical Trial Not Allowed," meaning the supported work is focused on preclinical and translational-enabling efforts rather than testing interventions in human participants under a clinical trial framework.

This NOFO specifically targets teams that already have an existing long-acting platform in early development and need support to complete well-defined preclinical activities that de-risk and accelerate translation into pediatric HIV care. In practice, that means awards are intended to help applicants perform the kinds of studies and optimization steps that typically stand between a concept-stage technology and a development candidate that is ready for later-stage advancement. While the announcement language is broad, the intent is clearly oriented toward product-focused, milestone-driven development work that can address pediatric-relevant constraints, such as age-appropriate dosing, safety considerations unique to growth and development, long-term exposure concerns, and practical administration needs.

The mechanism is an R61/R33 phased award, which generally supports an initial stage focused on feasibility and accelerated development planning and execution (R61), followed by a second stage intended for expanded development and confirmation work (R33), contingent on meeting predefined milestones and programmatic expectations. The structure is meant to keep projects moving efficiently and to prioritize efforts that demonstrate concrete progress toward a pediatric-appropriate long-acting ART delivery product. The maximum award amount listed is $850,000 (award ceiling), and the original application closing date was March 13, 2024. The opportunity falls under NIH funding activity categories tied to health and social services, and it is associated with CFDA numbers 93.242, 93.855, and 93.865.

A defining feature of LADDS II is the requirement for collaborative research partnerships with industry. That requirement signals that NIH expects applicants to align their preclinical development plans with the realities of product development, manufacturing, scale-up, regulatory expectations, and eventual implementation. In other words, the program is not just supporting academic proof-of-concept work; it is supporting development steps that are more likely to translate into an actual deployable pediatric long-acting ART option. Industry collaboration can also help ensure the platform has a viable path for formulation development, quality systems, and longer-term commercialization or distribution planning once the preclinical package is mature.

Eligibility is broad and includes many common applicant types across government, academia, nonprofits, and the private sector. Eligible applicants listed include state, county, city, township, and 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 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. In addition, the NOFO explicitly highlights a range of other eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, non-U.S. entities (foreign organizations), regional organizations, Indian/Native American Tribal Governments other than federally recognized entities, and U.S. territories or possessions. This emphasis reflects an interest in inclusive participation across institutional types and geographies, including organizations that may be especially connected to communities affected by pediatric HIV.

Overall, LADDS II is best understood as a translational, product-acceleration program focused on pediatric HIV-1 treatment optimization through long-acting delivery technologies. It prioritizes preclinical optimization and development-enabling work for already-established long-acting platforms, expects active partnership with industry to keep projects aligned with real product development needs, and supports a wide range of applicant organizations capable of moving a pediatric-focused long-acting ART delivery candidate closer to future clinical readiness without conducting clinical trials under this award.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II (LADDS II) (R61/R33 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): 93.242, 93.855, 93.865.
• This funding opportunity was created on 2023-10-25.
• Applicants must submit their applications by 2024-03-13. (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 $850,000.00 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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