Engineering Immunity to HIV-1 Through Next Generation Vaccines (R61/R33 Clinical Trial Not Allowed) | RFA AI 20 015

Opportunity Information: Apply for RFA AI 20 015

Engineering Immunity to HIV-1 Through Next Generation Vaccines (R61/R33 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number RFA-AI-20-015; CFDA 93.855) focused on accelerating the design and early development of new HIV-1 vaccine concepts. The central aim is to deliberately bring together bioengineers and immunologists and have them work as an integrated team, using newer ideas and tools from physical sciences and computational sciences to create vaccine strategies that can elicit stronger, more protective, and more precisely targeted immune responses against HIV-1. In practice, the FOA is trying to push the field beyond incremental improvements by encouraging vaccine development approaches that are informed by engineering principles (such as quantitative design, modeling, controlled delivery, and structured antigen presentation) and by modern computation (such as simulation, algorithmic design, and data-driven immune profiling), all grounded in immunology.

The award mechanism is the NIH R61/R33 phased innovation structure. That format typically supports a milestone-driven project where the first phase (R61) emphasizes high-impact, early-stage innovation and proof-of-concept work, and the second phase (R33) supports expansion and further development once predefined milestones are met. While the detailed milestone requirements are specified in the full FOA, the intent of this mechanism is to fund ideas that are ambitious but still disciplined, with clear go/no-go decision points. The title explicitly states "Clinical Trial Not Allowed," meaning funded activities must stay on the preclinical or non-clinical side of vaccine R and D. Projects may involve vaccine concept design, immunogen engineering, platform development, delivery strategies, advanced measurement of immune responses, and computational modeling, but they cannot include a clinical trial as part of the proposed research.

This opportunity sits in the NIH health research category and is designed to support the engineering of immunity, not just the creation of vaccine components. That framing highlights that applicants are expected to think about how vaccine design choices translate into immune system programming: what kinds of antibody or T cell responses are desired, how to guide their development, and how to measure whether the immune responses produced by a candidate vaccine are moving toward protective profiles against HIV-1. The FOA encourages leveraging emerging innovative knowledge in physical and computational science, which signals strong interest in multidisciplinary methods such as rational antigen design, nanoparticle or biomaterial-enabled delivery, systems immunology, machine learning approaches to immune response prediction, and other quantitative strategies that can shorten iteration cycles and improve the odds of achieving broadly effective immunity against a highly variable virus.

Eligibility is broad, reflecting NIH's goal of drawing in both traditional biomedical research groups and organizations that can contribute engineering, computational, or translational capabilities. Eligible applicants include a wide range of U.S. government entities (state, county, city or township governments, and special district governments), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, and public housing authorities/Indian housing authorities. The FOA also allows Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments), along with nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses. In addition, the announcement explicitly calls out eligibility for several mission- and community-focused institution types and organizations, including 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 (AANAPISISs). 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) are also included, signaling NIH openness to international or cross-sector collaboration when it strengthens the scientific approach.

From an administrative standpoint, the opportunity was created on March 9, 2020, with an original closing date of July 28, 2020. The listing does not provide an award ceiling or expected number of awards in the supplied source data, so applicants would have needed to consult the full FOA text for budget limits, project period expectations, and the anticipated funding level. Overall, the program is best understood as a targeted NIH effort to stimulate cross-disciplinary, milestone-based research teams that can apply engineering and computational innovation to one of the hardest problems in vaccinology: reliably inducing effective immunity to HIV-1 without moving into clinical trial execution under this specific funding mechanism.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Engineering Immunity to HIV-1 Through Next Generation Vaccines (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): 93.855.
• This funding opportunity was created on 2020-03-09.
• 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.)
• 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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