Opportunity Information: Apply for PAR 14 122
Apply for PAR 14 122
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Feb 28, 2014 and posted on Feb 28, 2014.
- Applicants must submit their applications by Mar 13, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Special district governments County governments State governments City or township governments Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19) is a National Institutes of Health grant opportunity that supports teams working to move promising HIV/AIDS vaccine candidates out of advanced preclinical development and into early clinical testing. The central purpose of the program is translation: taking vaccine concepts that are already sufficiently mature and innovative, then pushing them through the practical, regulated, and resource-intensive steps required to reach first-in-human or other early-stage clinical evaluation. A key point in the announcement is that a proposal limited to preclinical research is not considered responsive; applicants are expected to present a plan that bridges preclinical work to clinical readiness and a path into clinical trials.
The program is structured to fund an integrated, multidisciplinary effort under a cooperative agreement mechanism (U19). That means projects are expected to involve coordinated components and expertise that typically span antigen or immunogen design, preclinical immunogenicity and safety assessments, process development and scale-up, formulation, assay development and validation, and the manufacturing and quality activities required for regulated clinical products. The FOA explicitly highlights support for the end-to-end sequence of activities from down-selection of a lead vaccine candidate through current Good Manufacturing Practice (cGMP) manufacture, required testing, and product release, culminating in readiness to enter a clinical trial.
The timeline expectations are unusually concrete: awards are intended to provide the critical resources needed so that vaccine concepts can be advanced to clinical trials within the first five years of the award, and investigators are expected to begin clinical studies no later than year five. At the same time, the FOA draws a clear boundary around what it will and will not pay for. While it supports the work needed to get a candidate ready for clinical evaluation, it does not provide funds to conduct the clinical studies themselves. Because of that, applicants are encouraged to plan early for how the clinical trial will actually be executed, including partnering with NIAID-supported clinical trial networks or building other relationships and arrangements that can support the clinical testing phase once the candidate is ready.
In practical terms, a competitive IPCAVD application would be expected to read like a development program rather than a basic research proposal. It would typically include a rational strategy for selecting or down-selecting the most promising candidate, a clear set of go/no-go milestones and decision points, a manufacturing and quality plan consistent with cGMP expectations, and a realistic pathway to an initial clinical protocol. Since clinical trial costs are not covered, the application would also need to show credible planning for clinical implementation, such as identified network partners, trial infrastructure, and a feasible transition plan that aligns with the five-year expectation to initiate clinical testing.
Administratively, this opportunity was issued as PAR-14-122, categorized as a discretionary funding opportunity and using the cooperative agreement funding instrument. It falls under the health activity category and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The announcement was posted February 28, 2014, with an original and current closing date of March 13, 2015, and an archive date of April 13, 2015. There is no cost sharing or matching requirement.
Eligibility is broad and includes for-profit organizations (other than small businesses), small businesses, nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, and a range of government entities (state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities). Tribal governments and tribal organizations are included, along with many institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and Asian American and Native American Pacific Islander-serving institutions. The FOA also allows non-U.S. entities (foreign organizations and foreign institutions) to apply, allows non-U.S. components of U.S. organizations, and allows foreign components as defined in NIH policy, which broadens opportunities for international or multinational development teams.
Overall, IPCAVD is aimed at closing the gap between strong vaccine concepts and the concrete deliverables required to enter human testing: a selected clinical candidate backed by robust preclinical justification, manufactured under cGMP with appropriate testing and release, and positioned to start clinical evaluation by the end of the award period through partnerships or networks that can conduct the trial work outside of this grant’s direct funding scope.
Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19) - FAQs
What is the IPCAVD (U19) funding opportunity?
The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) is a National Institutes of Health (NIH) grant opportunity that supports integrated teams working to advance promising HIV/AIDS vaccine candidates from advanced preclinical development into early clinical testing readiness. The emphasis is on translation, meaning moving mature and innovative vaccine concepts through the regulated and resource-intensive steps needed to reach first-in-human or other early-stage clinical evaluation.
What is the central purpose of this program?
The central purpose is to close the gap between strong vaccine concepts and the practical deliverables required to enter human testing. The program focuses on taking sufficiently mature vaccine concepts and pushing them through development activities so the candidate is ready to begin clinical evaluation by the end of the award period.
Are preclinical-only proposals responsive to this FOA?
No. The announcement states that a proposal limited to preclinical research is not considered responsive. Applicants are expected to present a plan that bridges preclinical work to clinical readiness and provides a path into clinical trials.
What type of funding mechanism does IPCAVD use?
IPCAVD uses a cooperative agreement mechanism (U19). This mechanism is intended to support integrated, multidisciplinary efforts with coordinated components and expertise.
What does it mean that this is a cooperative agreement (U19)?
Within this opportunity, a cooperative agreement implies an integrated program structure with coordinated components rather than isolated projects. The FOA describes expectations for a multidisciplinary development effort that spans multiple development functions needed to reach clinical trial readiness.
What kinds of activities and expertise are expected in an IPCAVD project?
The FOA describes an end-to-end development effort that can include coordinated work across areas such as antigen or immunogen design, preclinical immunogenicity and safety assessments, process development and scale-up, formulation, assay development and validation, and the manufacturing and quality activities required for regulated clinical products.
What development stages does the program explicitly support?
The FOA highlights support for the sequence of activities from down-selection of a lead vaccine candidate through current Good Manufacturing Practice (cGMP) manufacture, required testing, and product release, culminating in readiness to enter a clinical trial.
Does the program fund manufacturing under cGMP?
Yes. The FOA explicitly highlights support for cGMP manufacture and the associated required testing and product release activities needed to prepare a regulated clinical product for entry into a clinical trial.
Does IPCAVD fund the clinical trials themselves?
No. While IPCAVD supports the work needed to get a candidate ready for clinical evaluation, it does not provide funds to conduct the clinical studies themselves.
If clinical trial costs are not covered, what does the FOA expect applicants to do?
Applicants are encouraged to plan early for how the clinical trial will be executed once the candidate is ready. The FOA suggests partnering with NIAID-supported clinical trial networks or establishing other relationships and arrangements that can support the clinical testing phase outside the grant's direct funding scope.
What are the timeline expectations for reaching clinical testing?
The FOA states that awards are intended to provide critical resources so vaccine concepts can be advanced to clinical trials within the first five years of the award. Investigators are expected to begin clinical studies no later than year five.
How should an application be positioned to be competitive?
The FOA indicates that a competitive application should read like a development program rather than a basic research proposal. It should describe a practical pathway from a mature vaccine concept to clinical readiness, with concrete development steps and credible clinical implementation planning.
What planning elements are typically expected in a strong IPCAVD application?
Based on the FOA description, typical expectations include a rational strategy for selecting or down-selecting the most promising candidate, clearly defined go/no-go milestones and decision points, a manufacturing and quality plan consistent with cGMP expectations, and a realistic pathway to an initial clinical protocol.
Why are go/no-go milestones important in this program?
The FOA emphasizes translation and readiness for early clinical evaluation within a defined timeframe. Go/no-go milestones and decision points help demonstrate a disciplined development approach and a realistic plan to reach clinical readiness by the end of the award period.
What is meant by "down-selection" of a vaccine candidate?
In the context of this FOA, down-selection refers to a structured process for choosing a lead vaccine candidate from among options, leading to a single candidate that will be manufactured under cGMP and prepared for early clinical evaluation.
Is assay development and validation within scope?
Yes. The FOA describes assay development and validation as part of the integrated expertise that projects typically span, consistent with preparing a candidate for regulated clinical evaluation.
Is process development and scale-up within scope?
Yes. The FOA explicitly includes process development and scale-up among the expected coordinated components needed to reach cGMP manufacturing and clinical trial readiness.
What is the official FOA identifier for this opportunity?
The opportunity was issued as PAR-14-122.
How is this opportunity categorized?
It is categorized as a discretionary funding opportunity and uses the cooperative agreement funding instrument.
What is the activity category associated with this opportunity?
The FOA falls under the health activity category.
What CFDA numbers are associated with IPCAVD?
The FOA is associated with CFDA 93.855 (Allergy and Infectious Diseases Research) and CFDA 93.856 (Microbiology and Infectious Diseases Research).
When was the announcement posted?
The announcement was posted on February 28, 2014.
What were the closing and archive dates?
The original and current closing date was March 13, 2015. The archive date was April 13, 2015.
Is there a cost sharing or matching requirement?
No. The FOA states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes for-profit organizations (other than small businesses), small businesses, nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, and multiple types of government entities (state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities).
Are tribal governments and tribal organizations eligible?
Yes. Tribal governments and tribal organizations are included among eligible applicants.
Are minority-serving institutions eligible?
Yes. The FOA includes institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and Asian American and Native American Pacific Islander-serving institutions.
Can foreign organizations apply?
Yes. The FOA allows non-U.S. entities (foreign organizations and foreign institutions) to apply.
Can a U.S. organization include non-U.S. components in the application?
Yes. The FOA allows non-U.S. components of U.S. organizations and allows foreign components as defined in NIH policy.
What is the overall deliverable the program is aiming for by the end of the award period?
The program is aimed at delivering a selected clinical candidate backed by robust preclinical justification, manufactured under cGMP with appropriate testing and release, and positioned to start clinical evaluation by the end of the award period through partnerships or networks that can conduct the trial work outside the grant's direct funding scope.
What is the key boundary on what IPCAVD will pay for?
The FOA draws a clear boundary between supporting activities to reach clinical readiness and paying for the conduct of clinical studies. The grant supports the work needed to prepare a candidate for clinical evaluation but does not fund the clinical studies themselves.
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