Opportunity Information: Apply for RFA AI 16 019
Apply for RFA AI 16 019
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Advancing HIV Therapeutic Vaccine Science (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856,.
- This funding opportunity was created on Apr 07, 2016 and posted on Apr 07, 2016.
- Applicants must submit their applications by Jul 28, 2016. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The funding opportunity titled "Advancing HIV Therapeutic Vaccine Science (U01)" (Funding Opportunity Number RFA AI 16 019) is a National Institutes of Health (NIH) cooperative agreement program from the U.S. Department of Health and Human Services. It is aimed at moving therapeutic HIV vaccine research forward, specifically by improving scientific understanding of which vaccine regimens and vaccine-driven immune responses can lead to sustained suppression of HIV viral load in people who are already HIV-infected. Rather than focusing on prevention vaccines for uninfected individuals, this FOA is centered on therapeutic vaccination strategies intended to strengthen or redirect the immune system so it can better control HIV in the body over time.
A key feature of the announcement is its emphasis on clinical evidence that links immune responses to real virologic outcomes. Applicants are expected to design small, multi-arm, comparative clinical trials. In practical terms, this means proposals should include more than one study arm so different vaccine regimens (or combinations) can be compared side-by-side within the same trial framework. The trials are intended to generate interpretable comparisons that help identify correlations between the magnitude or quality of vaccine-induced immune responses and the degree of HIV virologic control achieved. The overall goal is not simply to show that a vaccine can trigger an immune response, but to determine which types and levels of immune responses are meaningfully associated with controlling the virus, and to use those findings to guide future therapeutic vaccine development.
The FOA also makes clear that therapeutic vaccines can be tested in combination with immune enhancers or other immunologic modifiers. This includes the use of adjuvants or other approaches designed to strengthen, broaden, or otherwise shape immune responses to HIV. The intent is to encourage regimens that are scientifically grounded and that can reveal how different immune-modulating components affect both immune readouts and viral load outcomes. This allows applicants to explore whether paired strategies can improve the durability or potency of HIV control compared with vaccine alone.
From an administrative standpoint, the award mechanism is a cooperative agreement (U01), which typically indicates substantial involvement from NIH program staff during the project. This structure is often used for complex, coordinated research activities such as clinical trials where ongoing collaboration, milestone-driven progress, and close communication with the agency are expected. The activity category is Health, and the relevant CFDA numbers listed are 93.855 and 93.856. The opportunity was posted and created on April 7, 2016, with an application closing date of July 28, 2016.
Eligibility is broad and includes many types of organizations that can conduct clinical research, such as public and private institutions of higher education, nonprofit organizations (including those with or without 501(c)(3) status), for-profit organizations (including small businesses), and various government entities (state, county, city/township, special districts), as well as Native American tribal governments and tribal organizations, and public housing authorities/Indian housing authorities. This wide eligibility reflects the fact that therapeutic vaccine clinical trials may be led by academic medical centers, research institutes, biotech or pharmaceutical groups, or other qualified clinical research organizations, often in collaboration with clinical sites capable of enrolling and monitoring HIV-infected participants.
In summary, this FOA is designed to generate actionable clinical trial data that connects therapeutic HIV vaccine regimens to measurable immune responses and, critically, to sustained control of HIV viral load. By supporting small but rigorously comparative, multi-arm studies, NIH is seeking to accelerate the identification of immune correlates of virologic control and to clarify which vaccine strategies, potentially enhanced by adjuvants or other immune modifiers, are most promising for longer-term HIV management.
FAQs: Advancing HIV Therapeutic Vaccine Science (U01) - RFA AI 16 019
What is the title of this funding opportunity?
The funding opportunity is titled "Advancing HIV Therapeutic Vaccine Science (U01)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA AI 16 019.
Which federal agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding opportunity under the U.S. Department of Health and Human Services.
What type of award mechanism is being used?
The award mechanism is a cooperative agreement (U01).
What does a U01 cooperative agreement imply for applicants?
A U01 cooperative agreement typically indicates substantial involvement from NIH program staff during the project. This structure is often used for complex and coordinated activities such as clinical trials, where ongoing collaboration, close communication, and milestone-driven progress are expected.
What is the main scientific purpose of this FOA?
The FOA is intended to move therapeutic HIV vaccine research forward by improving scientific understanding of which vaccine regimens and vaccine-driven immune responses can lead to sustained suppression of HIV viral load in people who are already HIV-infected.
Is this FOA focused on HIV prevention vaccines?
No. The FOA is centered on therapeutic vaccination strategies for people who are already HIV-infected, not prevention vaccines for uninfected individuals.
What kinds of studies are applicants expected to propose?
Applicants are expected to design small, multi-arm, comparative clinical trials. Proposals should include more than one study arm so that different vaccine regimens (or combinations) can be compared side-by-side within the same trial framework.
Why does the FOA emphasize multi-arm, comparative clinical trials?
The goal is to generate interpretable comparisons that help identify relationships between the magnitude or quality of vaccine-induced immune responses and the degree of HIV virologic control achieved.
What outcomes is NIH looking for in these trials?
The FOA emphasizes clinical evidence that links immune responses to real virologic outcomes, especially sustained suppression or control of HIV viral load.
Is it enough for a study to show that a vaccine triggers an immune response?
No. The intent is not simply to show that a vaccine can trigger an immune response, but to determine which types and levels of immune responses are meaningfully associated with controlling the virus, and to use those findings to guide future therapeutic vaccine development.
Can therapeutic vaccines be tested in combination with other immune-based components?
Yes. The FOA states that therapeutic vaccines can be tested in combination with immune enhancers or other immunologic modifiers, including adjuvants or other approaches designed to strengthen, broaden, or shape immune responses to HIV.
What is the purpose of allowing adjuvants or other immune modifiers?
The intent is to encourage scientifically grounded regimens that can reveal how different immune-modulating components affect both immune readouts and viral load outcomes, including whether paired strategies improve the durability or potency of HIV control compared with vaccine alone.
What is the activity category for this opportunity?
The activity category is Health.
What CFDA numbers are associated with this FOA?
The CFDA numbers listed are 93.855 and 93.856.
When was the opportunity posted and created?
The opportunity was posted and created on April 7, 2016.
What is the application closing date?
The application closing date is July 28, 2016.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations (including those with or without 501(c)(3) status); for-profit organizations (including small businesses); state, county, city/township, and special district governments; Native American tribal governments and tribal organizations; and public housing authorities/Indian housing authorities.
What types of organizations are well-suited to lead projects under this FOA?
Because the FOA supports therapeutic vaccine clinical trials in HIV-infected participants, likely applicants include academic medical centers, research institutes, biotech or pharmaceutical groups, and other qualified clinical research organizations, often working with clinical sites capable of enrolling and monitoring HIV-infected participants.
What is the overall goal of this FOA in practical terms?
The FOA is designed to generate actionable clinical trial data that connects therapeutic HIV vaccine regimens to measurable immune responses and, critically, to sustained control of HIV viral load. By supporting small but rigorously comparative, multi-arm studies, NIH aims to accelerate identification of immune correlates of virologic control and clarify which vaccine strategies, potentially enhanced by adjuvants or other immune modifiers, are most promising for longer-term HIV management.
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