Opportunity Information: Apply for PA 06 519
Apply for PA 06 519
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Phased Innovation Awards in AIDS Vaccine Research (R21/R33)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Dec 5, 2008 and posted on Aug 10, 2006.
- Applicants must submit their applications by Multiple Receipt Dates See Link to Full Announcement for details.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Private institutions of higher education For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) State governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Foreign institutions are not eligible to apply. Eligible agencies of the Federal Government can apply. Faith based or community based organizations can apply. Applicants may submit more than one application, provided each application is scientifically distinct. Clinical trials or first time in human studies will not be supported under this FOA. (See . http://grants.nih.gov/grants/guide/notice files/NOT AI 05 021.html). Clinical research, including research that uses clinical specimens, is within the scope of this announcement.
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Opportunity Summary:
The Phased Innovation Awards in AIDS Vaccine Research (R21/R33) funding opportunity (PA-06-519) is an NIH grant program aimed at pushing forward the development of a preventive, or prophylactic, HIV/AIDS vaccine. The emphasis is on research ideas that are genuinely innovative and novel, including projects that may be considered high risk but could yield high impact if successful. NIH signals that it is interested in supporting work that can meaningfully improve how candidate AIDS vaccines are designed or evaluated, and it leaves the scientific scope intentionally broad: any line of investigation that contributes to an effective HIV vaccine is considered responsive.
A defining feature of this opportunity is what it does not fund. Clinical trials and first-in-human studies are explicitly out of scope, meaning applicants should not propose human efficacy or safety trials under this FOA. At the same time, NIH makes clear that certain kinds of clinical research can still fit, such as studies using clinical specimens. In other words, the program welcomes human-sourced materials and clinical data-driven research when it supports vaccine discovery or evaluation, but it draws the line at interventional clinical trials.
The program uses the NIH phased innovation mechanism that combines an R21 Phase I (exploratory) award with an R33 Phase II (developmental) award. This structure is designed to fund early proof-of-concept work first, then allow a faster transition into a larger, more developed project if the initial phase hits clearly defined milestones. The R21 phase supports milestone-driven feasibility or exploratory studies for up to two years. Investigators are expected to propose measurable milestones up front, and performance against those milestones is central to whether a project is eligible to transition. Projects that successfully complete the R21 phase milestones can be considered for the R33 phase, which supports expanded development for roughly an additional two to three years. Progression is not automatic: the R21 results are evaluated, and only projects that meet the expectations and remain programmatically aligned move forward.
Funding levels are also clearly defined and tied to each phase. For the R21 portion, direct costs are capped at $275,000 total across the two-year R21 period. For the R33 portion, direct costs are capped at $300,000 per year. NIH also indicates that advancement from R21 to R33 will be competitive and limited, anticipating that no more than about 50% of funded R21 awards will ultimately transition to the R33 phase. As with most NIH programs, final funding decisions depend on scientific and technical merit, program priorities, and the availability of funds.
In terms of who can apply, the eligibility pool is broad across U.S.-based organizations. Eligible applicants include public and private institutions of higher education, nonprofits (including both 501(c)(3) organizations and certain nonprofits without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, state governments, and certain other organizations as clarified in the full announcement. Faith-based and community-based organizations are eligible, and eligible federal agencies may apply. Foreign institutions are not eligible to apply under this FOA. Applicants may submit more than one application as long as each submission is scientifically distinct, which allows institutions or investigators with multiple vaccine concepts or platforms to pursue separate, non-overlapping ideas.
Administratively, the opportunity is categorized as discretionary grant funding in the health area, aligned with CFDA programs 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research). It does not require cost sharing or matching. The announcement listed multiple receipt dates (rather than a single deadline), with applicants directed to the full FOA text for the specific schedule and instructions. The complete announcement was posted by NIH and is accessible via the NIH Grants Guide page for PA-06-519.
Frequently Asked Questions (FAQs): Phased Innovation Awards in AIDS Vaccine Research (R21/R33) (PA-06-519)
What is the purpose of the Phased Innovation Awards in AIDS Vaccine Research (R21/R33) program (PA-06-519)?
This NIH funding opportunity supports research intended to advance the development of a preventive (prophylactic) HIV/AIDS vaccine. The program is geared toward projects that could meaningfully improve how candidate AIDS vaccines are designed or evaluated, and it is open to any line of investigation that contributes to an effective HIV vaccine.
What types of projects does NIH want to support under this FOA?
NIH emphasizes genuinely innovative and novel ideas, including high-risk concepts that could have high impact if they succeed. The scientific scope is intentionally broad, as long as the work contributes to HIV vaccine discovery, design, or evaluation.
Is the scientific scope narrow or limited to specific research topics?
The scope is intentionally broad. Any research that contributes to an effective HIV vaccine is considered responsive, particularly if it improves approaches for designing or evaluating candidate AIDS vaccines.
Are clinical trials allowed under PA-06-519?
No. Clinical trials and first-in-human studies are explicitly out of scope for this funding opportunity. Applicants should not propose human efficacy or safety trials under this FOA.
Is any type of clinical research allowed?
Yes, certain clinical research activities can fit, such as studies using clinical specimens. The program allows work that uses human-sourced materials and clinical data-driven research when it supports vaccine discovery or evaluation, but it does not support interventional clinical trials.
What does the R21/R33 "phased innovation" mechanism mean?
This FOA uses a two-phase structure: an R21 Phase I (exploratory) award followed by an R33 Phase II (developmental) award. The structure supports early proof-of-concept work first and then allows a faster transition into a more developed project if the Phase I milestones are met.
How long can the R21 (Phase I) portion last?
The R21 phase supports milestone-driven feasibility or exploratory studies for up to two years.
How long can the R33 (Phase II) portion last?
The R33 phase supports expanded development for roughly an additional two to three years, following a successful R21 phase.
Do applicants need to propose milestones?
Yes. Investigators are expected to propose measurable milestones up front, and performance against those milestones is central to determining whether the project is eligible to transition from R21 to R33.
Does an R21 award automatically transition into an R33 award?
No. Progression is not automatic. R21 results are evaluated, and only projects that meet expectations and remain programmatically aligned can be considered for the R33 phase.
How competitive is the transition from R21 to R33?
NIH anticipates that advancement from R21 to R33 will be competitive and limited, with no more than about 50% of funded R21 awards expected to transition to the R33 phase.
What is the maximum budget for the R21 phase?
For the R21 portion, direct costs are capped at $275,000 total across the two-year R21 period.
What is the maximum budget for the R33 phase?
For the R33 portion, direct costs are capped at $300,000 per year.
What factors affect whether an application is funded?
Final funding decisions depend on scientific and technical merit, program priorities, and the availability of funds.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations. Eligible applicants include public and private institutions of higher education, nonprofits (including 501(c)(3) organizations and certain nonprofits without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, state governments, and certain other organizations as described in the full announcement. Faith-based and community-based organizations are eligible, and eligible federal agencies may apply.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply under this FOA.
Can an organization or investigator submit more than one application?
Yes. Applicants may submit more than one application as long as each submission is scientifically distinct (for example, separate non-overlapping vaccine concepts or platforms).
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
What is the funding type and program area for this opportunity?
This is discretionary grant funding in the health area. It is aligned with CFDA programs 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
When are applications due?
The announcement listed multiple receipt dates rather than a single deadline. Applicants are directed to the full FOA text for the specific schedule and submission instructions.
Where can applicants find the official announcement and instructions?
The complete announcement was posted by NIH and is available via the NIH Grants Guide page for PA-06-519.
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