Innovation for HIV Vaccine Discovery (R01) | Apply Online

Frequently Asked Questions (FAQs): Innovation for HIV Vaccine Discovery (R01) (PAR-16-171)

What is the Innovation for HIV Vaccine Discovery (R01) funding opportunity?

Innovation for HIV Vaccine Discovery (R01) is a National Institutes of Health (NIH) grant funding opportunity (FOA: PAR-16-171) under the U.S. Department of Health and Human Services. It is intended to push HIV vaccinology into new territory by supporting innovative, high-risk, high-impact early discovery research that can meaningfully change how HIV vaccines are designed.

What is the main purpose of this FOA?

The purpose is to generate knowledge and test early discovery ideas that directly inform the design and development of an effective HIV vaccine immunogen. The FOA emphasizes discovery-driven work that clarifies mechanisms, reveals new vulnerable points in the virus, and leads to more rational immunogen design.

What kind of research is this program trying to support?

This program is built to support unconventional or cutting-edge HIV vaccine discovery research, including novel vaccine concepts, identification of new vaccine targets, and unconventional approaches. A key feature is that projects may not yet have extensive preliminary data, as long as they have strong potential to create major advances in HIV vaccine design.

Is this FOA focused on early-stage discovery or later-stage development?

It is focused on early-stage exploration and proof-of-concept testing of novel hypotheses in HIV vaccine discovery, with an emphasis on generating foundational insights that inform immunogen design.

What scientific questions does the FOA want projects to address?

Projects are expected to tackle key unanswered questions such as: which immune responses are truly protective against HIV, how to reliably induce those responses through vaccination, and how to do so safely and with durability.

Does the FOA emphasize durable or long-term protection?

Yes. The FOA emphasizes long-term, durable protection. This includes preventing HIV acquisition in uninfected individuals and may also include concepts aimed at improving immune control of ongoing infection, depending on the proposed approach.

What makes this opportunity different from a typical NIH R01?

A defining feature is the milestone-based structure with Go/No-Go criteria. While it uses the NIH R01 mechanism, continued support is explicitly tied to meeting clear, measurable milestones that are evaluated during the project.

What are milestones and Go/No-Go criteria in this FOA?

Applicants are expected to propose clear, measurable milestones that define what success looks like for early discovery and proof-of-concept work. Continued support is tied to whether the project meets negotiated Go/No-Go criteria, which are agreed upon prior to award.

When is progress formally evaluated for continuation decisions?

Progress toward the negotiated milestones is formally evaluated by the time of the year-2 progress report, and that evaluation helps determine whether the project should continue as funded.

What is the funding mechanism for this opportunity?

The funding mechanism is the NIH R01 research project grant.

Which agency and department sponsor this FOA?

This FOA is offered by the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services.

What are the CFDA numbers associated with this opportunity?

The FOA is identified with CFDA numbers 93.855 and 93.856.

When was this opportunity posted and created?

The opportunity was posted and created on April 7, 2016.

What was the application due date for this FOA?

The application due date (original and current closing date) was August 1, 2016.

Does the provided information list an award ceiling or the expected number of awards?

No. The source information does not list an award ceiling or the expected number of awards.

What is the overall intent of the funding based on the provided information?

The intent is to seed discovery programs that can justify continued investment based on early outcomes, using a milestone-driven approach to keep resources aligned with concepts that show real promise as data emerges.

Who is eligible to apply?

Eligibility is broad and includes many domestic organizations capable of biomedical research. 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
• Private institutions of higher education
• Federally recognized Native American tribal governments
• Other Native American tribal organizations
• Public housing authorities/Indian housing authorities
• Nonprofit organizations with 501(c)(3) status (excluding higher education institutions in those categories)
• Nonprofit organizations without 501(c)(3) status (excluding higher education institutions in those categories)
• For-profit organizations other than small businesses
• Small businesses
• Other entities as described in the FOA's additional eligibility language

Is the program limited to universities and research institutes?

No. The eligibility language is intentionally wide and includes universities, nonprofits, government entities, tribal organizations, and both for-profit organizations and small businesses, reflecting an intent to attract strong HIV vaccine discovery ideas wherever they can be performed.

What type of project fit is implied by the FOA description?

Projects that fit are those proposing innovative, potentially high-risk approaches with high potential impact on HIV vaccine immunogen design, supported by a clear plan for feasibility testing and objective milestone-based decision-making by the end of year 2.

What timeframe is emphasized for making objective continuation decisions?

The FOA emphasizes making objective Go/No-Go decisions by the end of the second year, based on the year-2 progress evaluation against pre-negotiated milestones.