Opportunity Information: Apply for RFA AI 18 016
The Targeted In Vivo Delivery of Gene Therapeutics for HIV Cure opportunity (RFA AI 18 016) is a National Institutes of Health (NIH) research grant solicitation that aims to push forward practical, evidence-based methods for getting anti-HIV gene therapies into the right cells inside the body. The core problem this FOA is trying to solve is delivery: even when a gene-based strategy looks strong in a dish or in isolated cells, it often fails to translate because the therapeutic payload cannot be delivered efficiently, selectively, and safely to the relevant HIV target cells in vivo. This announcement is therefore focused on developing and validating innovative delivery approaches that can home to specific target cells and achieve meaningful gene modification where it matters for an HIV cure strategy.
The scientific emphasis is on in vivo targeting and efficiency. In plain terms, NIH is looking for projects that can demonstrate a credible path to delivering gene therapeutics (such as gene editing systems, engineered nucleases, antiviral genes, or other genetic payloads) directly to key HIV-relevant cell populations within living systems, rather than relying on ex vivo manipulation and reinfusion. The work is expected to go beyond concept sketches and into rigorous validation, meaning applicants should be prepared to show measurable delivery performance (for example, the fraction of target cells reached, levels of gene transfer or editing, durability of expression or modification, and impacts on HIV-related outcomes where appropriate), along with a clear strategy for assessing specificity and limiting off-target distribution.
The mechanism is an R01, which generally supports substantial, multi-year research programs with well-developed aims, strong preliminary rationale, and robust experimental plans. This specific R01 is labeled "Clinical Trial Not Allowed," which signals that the funded studies must not be clinical trials in human participants. In practice, that usually means the work should be preclinical or translational in nature, potentially involving lab studies, animal models, and development/optimization of delivery platforms, but stopping short of interventional studies that meet the NIH definition of a clinical trial. Applicants still need to design their research so it produces decision-quality data that could eventually support later-stage translation, but without crossing into clinical trial territory under this FOA.
From an administrative standpoint, this is a discretionary grant program in the health category, offered under NIH CFDA numbers 93.242 and 93.855. The original closing date listed for this opportunity was July 31, 2018, and the creation date was April 20, 2018. An award ceiling is not specified in the provided source data, and the expected number of awards is not listed, which often means applicants should consult the full FOA text and NIH budget guidance to understand typical award sizes and any institute-specific constraints. Even when a formal ceiling is absent, R01 budgets are commonly evaluated for reasonableness relative to the proposed scope of work.
Eligibility is broad and includes many types of U.S. organizations and some non-U.S. entities. Eligible applicants include state, county, 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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 foreign (non-U.S.) entities. Taken together, this reflects NIH's intent to encourage a wide range of capable research performers, including institutions that serve underrepresented populations and organizations outside the continental United States.
Overall, the opportunity is best understood as a targeted push to overcome one of the biggest bottlenecks in HIV gene therapy approaches: getting the therapeutic genetic tool to the right cells in the body with enough efficiency and precision to matter. Competitive applications would be expected to present a delivery concept that is clearly innovative, paired with a realistic and well-validated plan to demonstrate targeted in vivo delivery, quantify performance, and address safety and specificity in a way that moves the field toward workable gene-based HIV cure strategies, all within a non-clinical-trial research framework.Apply for RFA AI 18 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Targeted In Vivo Delivery of Gene Therapeutics for HIV Cure (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): 93.242, 93.855.
- This funding opportunity was created on 2018-04-20.
- Applicants must submit their applications by 2018-07-31. (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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FAQs: Targeted In Vivo Delivery of Gene Therapeutics for HIV Cure (RFA AI 18 016)
What is this funding opportunity?
This is a National Institutes of Health (NIH) research grant solicitation titled "Targeted In Vivo Delivery of Gene Therapeutics for HIV Cure" (RFA AI 18 016). It supports research aimed at improving practical, evidence-based ways to deliver anti-HIV gene therapeutics to the right cells inside the body.
What is the main problem NIH wants to solve with this FOA?
The central bottleneck is delivery. Many gene-based HIV strategies perform well in a dish or in isolated cells but fail to translate because the therapeutic payload cannot be delivered efficiently, selectively, and safely to relevant HIV target cells in vivo. This FOA is focused on solving that delivery challenge.
What is the overall goal of projects funded under this announcement?
The goal is to develop and validate innovative in vivo delivery approaches that can home to specific HIV-relevant target cell populations and achieve meaningful gene modification where it matters for HIV cure strategies.
What does "in vivo targeting and efficiency" mean in this context?
It means the proposed delivery approach should work inside living systems and show credible potential to reach the intended HIV-relevant cells with meaningful efficiency. Applicants are expected to quantify how well the delivery system reaches the target cells and how effectively it transfers or edits genes in those cells.
What kinds of gene therapeutic payloads are relevant to this FOA?
The scientific focus includes delivering gene therapeutics such as gene editing systems, engineered nucleases, antiviral genes, and other genetic payloads intended to support HIV cure strategies.
Is this FOA focused on ex vivo approaches (modify cells outside the body and reinfuse them)?
No. The emphasis is on delivering gene therapeutics directly to key HIV-relevant cell populations within living systems (in vivo), rather than relying on ex vivo manipulation and reinfusion.
What level of evidence is NIH expecting from applicants?
The work is expected to go beyond early concept sketches and into rigorous validation. Applicants should be prepared to generate measurable, decision-quality data demonstrating delivery performance and targeting in vivo.
What types of performance measurements does NIH expect?
Examples of measurable delivery performance described in the opportunity include the fraction of target cells reached, levels of gene transfer or editing, durability of expression or modification, and impacts on HIV-related outcomes where appropriate.
Does the FOA address safety and off-target effects?
Yes. Applicants are expected to include a clear strategy for assessing specificity and limiting off-target distribution, alongside plans to demonstrate efficient and selective delivery to the intended cell types.
What grant mechanism is used for this opportunity?
The mechanism is an NIH R01, which generally supports substantial, multi-year research programs with well-developed aims, a strong preliminary rationale, and robust experimental plans.
Are clinical trials allowed under this R01?
No. This specific R01 is labeled "Clinical Trial Not Allowed," meaning funded studies must not be clinical trials in human participants.
If clinical trials are not allowed, what kinds of studies fit?
Based on the description, the work is intended to be preclinical or translational in nature. This may include laboratory studies, animal models, and development or optimization of delivery platforms, as long as it does not cross into an NIH-defined clinical trial in human participants.
Does NIH still expect translation-relevant data even though clinical trials are not allowed?
Yes. The research should produce decision-quality data that could support later-stage translation, while staying within a non-clinical-trial research framework.
What is the funding category and agency associated with this opportunity?
It is a discretionary grant program in the health category offered by the National Institutes of Health (NIH).
What CFDA numbers are associated with this FOA?
The opportunity is listed under NIH CFDA numbers 93.242 and 93.855.
When was this opportunity created and what was the original closing date?
The creation date listed is April 20, 2018, and the original closing date listed is July 31, 2018.
Is there an award ceiling listed?
No award ceiling is specified in the provided information. Applicants may need to consult the full FOA text and NIH budget guidance for typical award sizes and any constraints.
Is the expected number of awards provided?
No. The expected number of awards is not listed in the provided information.
How are R01 budgets typically handled if no ceiling is stated?
Even when a formal ceiling is absent, R01 budgets are commonly evaluated for reasonableness relative to the proposed scope of work.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include many types of U.S. organizations and some non-U.S. entities, including governments, higher education institutions (public and private), nonprofits (with or without 501(c)(3) status, other than institutions of higher education), for-profit organizations (including small businesses and other than small businesses), tribal governments and tribal organizations, public housing authorities/Indian housing authorities, and other organizations.
Are state and local government entities eligible?
Yes. Eligibility includes state governments, county governments, city or township governments, and special district governments.
Are schools and universities eligible?
Yes. Eligibility includes independent school districts and both public/state-controlled and private institutions of higher education.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments are eligible.
Are nonprofits and for-profits eligible?
Yes. Nonprofits with or without 501(c)(3) status (other than institutions of higher education) are eligible, and for-profit organizations are eligible, including small businesses and for-profits other than small businesses.
Does the FOA encourage applications from institutions serving underrepresented populations?
Yes. The FOA explicitly highlights additional eligible applicant categories such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed among eligible applicant categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed among eligible applicant categories.
Are foreign (non-U.S.) entities eligible to apply?
Yes. Foreign (non-U.S.) entities are explicitly listed as eligible.
What types of projects are likely to be competitive under this FOA?
Competitive projects would typically pair an innovative delivery concept with a realistic, well-validated plan to demonstrate targeted in vivo delivery, quantify performance (such as targeting fraction and editing or transfer levels), and address specificity and off-target distribution, all aligned with HIV cure strategy needs and within a non-clinical-trial framework.
How should applicants think about "target cells" for HIV in this FOA?
The FOA emphasizes delivery to key HIV-relevant cell populations in vivo. Applications should clearly identify the intended target cell population(s) and justify how the delivery approach will selectively home to those cells.
Is the FOA primarily about inventing a gene therapy or about delivering it?
The stated emphasis is on delivery: creating and validating approaches that can deliver anti-HIV gene therapeutics to the right cells in vivo with enough efficiency, selectivity, and safety to support HIV cure strategies.
What is the big-picture purpose of this program?
It is a targeted push to overcome one of the biggest bottlenecks in HIV gene therapy approaches: getting the therapeutic genetic tool to the right cells in the body with enough efficiency and precision to matter.
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