Opportunity Information: Apply for PA 13 042
Apply for PA 13 042
- 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 Jan 16, 2014 and posted on Dec 14, 2012.
- Applicants must submit their applications by Jan 16, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County governments Small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities For profit organizations other than small businesses State governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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 Institute of Allergy and Infectious Diseases (NIAID), NIH cooperative agreement opportunity intended to push well developed, high potential HIV/AIDS vaccine candidates out of the purely research stage and into early clinical testing. The central purpose is translation: applicants are expected to bring forward vaccine concepts that are already sufficiently advanced and then execute the practical, regulated development work needed to reach a first in human or other early phase clinical study. The program is built around a coordinated, multidisciplinary team approach, recognizing that moving a vaccine candidate to the clinic requires expertise that spans immunology, virology, product development, manufacturing, quality, toxicology, and regulatory science rather than isolated preclinical experimentation.
A defining feature of the FOA is that it supports the full pipeline of activities from candidate down selection through clinical grade production and release, positioning the product to enter a clinical trial. That includes tasks such as selecting a lead vaccine candidate, completing required preclinical studies, developing and qualifying assays, planning and conducting cGMP manufacture, performing lot testing and quality control, and preparing materials needed for regulatory submissions. Importantly, the announcement makes clear that a proposal limited to preclinical research is not responsive; the expectation is an integrated development program that culminates in the ability to start a clinical study. In other words, the grant is meant to pay for the costly and operationally complex steps that frequently block promising vaccines from advancing, not simply to fund more exploratory laboratory work.
The funding structure is designed to accelerate clinical readiness within a defined timeline. Awards are intended to provide the critical resources needed to advance vaccine concepts into clinical trials within the first five years of the project period. After that, the FOA anticipates reduced support for up to two additional years, aimed at practical follow through needs such as continued stability studies, updates to regulatory filings, and refinements based on information emerging from the clinical experience. This reflects a development mindset: the program emphasizes generating a product and data package that can stand up to regulatory expectations and real world clinical testing, and then maintaining and improving that package as early clinical insights come in.
At the same time, applicants need to understand a key boundary: the FOA does not provide funds to conduct the clinical trials themselves. Instead, awardees are encouraged to collaborate with NIAID supported clinical trial networks or build other partnerships and funding arrangements to run the actual clinical studies. Because of that constraint, the application must include a credible clinical development plan that explains how a clinical study will be initiated during the first five years of the award, including the relationships, infrastructure, and pathway that will make trial launch feasible even though trial execution dollars are not coming from this mechanism. That clinical development plan is not optional; it is an explicit requirement and is central to demonstrating that the project is truly translational and time bound.
Mechanistically, this is a cooperative agreement (U19), which typically means substantial programmatic involvement by NIH staff compared to a standard research project grant. While the specific terms are in the full announcement, applicants should generally expect active coordination, milestones, and potentially NIH input on prioritization and progress as the project moves through manufacturing, regulatory preparation, and clinical readiness steps. The activity category is health, and the relevant CFDA programs listed are 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The total estimated funding listed in the source snapshot is $4,000,000, and there is no cost sharing or matching requirement.
Eligibility is broad and includes many types of U.S. and non U.S. organizations. Eligible applicants include public and private institutions of higher education, nonprofit organizations with and without 501(c)(3) status, for profit entities (including small businesses and other for profit organizations), state and local governments, tribal governments and tribal organizations, school districts, public housing authorities/Indian housing authorities, and various mission focused institutions such as HBCUs, Hispanic serving institutions, tribally controlled colleges and universities, and AANAPISI institutions. Foreign organizations and foreign institutions are also eligible, and non U.S. components of U.S. organizations can apply; foreign components are allowed consistent with NIH policy. Practically, this broad eligibility aligns with the program goal of assembling the strongest development teams, which may include academic labs, biotech or manufacturing partners, and clinical network collaborators, sometimes across borders.
The specific opportunity referenced is Funding Opportunity Number PA-13-042, posted December 14, 2012, with administrative dates indicating creation on January 16, 2014 and an archive date of February 16, 2014; the snapshot lists an original closing date of March 13, 2015 and a current closing date of January 16, 2014, reflecting the historical record for this announcement. The full text of the FOA is available through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PA-13-042.html, and NIH Office of Extramural Research support contacts are provided for access or linking issues.
In plain terms, IPCAVD is aimed at teams that already have a serious AIDS vaccine candidate and need an integrated, milestone driven push through late preclinical development, cGMP production, and regulatory preparation so that a clinical trial can begin quickly, while relying on external partnerships or networks to pay for and run the trial itself.
Frequently Asked Questions (FAQs)
What is the Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19)?
IPCAVD is a National Institute of Allergy and Infectious Diseases (NIAID), NIH cooperative agreement opportunity designed to move well developed, high potential HIV/AIDS vaccine candidates out of the research-only stage and into early clinical testing readiness. The program is focused on translation: taking an advanced vaccine concept and completing the practical development work needed to reach a first-in-human or other early phase clinical study.
What is the main goal of this funding opportunity?
The central goal is to support an integrated, end-to-end development program that advances a vaccine candidate through late preclinical development, clinical-grade manufacturing, and regulatory preparation so that a clinical study can be initiated within the first five years of the award.
What does "integrated preclinical/clinical" mean in this FOA?
It means the project is expected to cover the full development pipeline needed to reach clinical readiness, not just laboratory research. Applicants should propose a coordinated plan that connects preclinical work, product development, manufacturing, quality activities, and regulatory preparation to a clear clinical development pathway.
Is a proposal limited to preclinical research responsive to this FOA?
No. The announcement explicitly states that a proposal limited to preclinical research is not responsive. The expectation is an integrated development program that culminates in the ability to start a clinical study (for example, first-in-human or another early phase clinical study).
What kinds of activities does IPCAVD support across the development pipeline?
Based on the description provided, supported activities can include selecting a lead vaccine candidate, completing required preclinical studies, developing and qualifying assays, planning and conducting cGMP manufacturing, producing and releasing clinical-grade product, performing lot testing and quality control, and preparing materials needed for regulatory submissions.
Does the program support clinical-grade manufacturing and release activities?
Yes. A defining feature of this FOA is support for activities that position the vaccine product to enter a clinical trial, including clinical-grade production and release, lot testing, and quality control under cGMP-relevant planning and execution.
Does IPCAVD pay for the clinical trials themselves?
No. The FOA does not provide funds to conduct the clinical trials. Awardees are encouraged to work with NIAID-supported clinical trial networks or establish other partnerships and funding arrangements to run the actual clinical studies.
If the grant does not fund the trial, what is required regarding clinical plans?
The application must include a credible clinical development plan explaining how a clinical study will be initiated during the first five years of the award. This plan should describe the pathway, relationships, and infrastructure that will make trial launch feasible even though trial execution costs are not funded by this mechanism.
How long is the project support timeline described in the FOA?
The FOA describes a structure in which awards are intended to provide critical resources to enable clinical trial initiation within the first five years of the project period, followed by anticipated reduced support for up to two additional years for practical follow-through needs.
What is meant by "reduced support" after the first five years?
The FOA anticipates that after the initial push toward clinical readiness and trial initiation, support may be reduced for up to two more years to cover follow-through needs such as continued stability studies, updates to regulatory filings, and refinements informed by early clinical experience.
Why does the program emphasize multidisciplinary teams?
Moving a vaccine candidate into the clinic requires coordinated expertise across immunology, virology, product development, manufacturing, quality, toxicology, and regulatory science. The FOA is designed around a coordinated, multidisciplinary team approach rather than isolated preclinical experimentation.
What makes this mechanism a cooperative agreement (U19), and why does that matter?
This opportunity uses a cooperative agreement (U19) mechanism, which typically involves substantial NIH staff programmatic involvement compared to a standard research grant. Applicants should generally expect active coordination, milestones, and potential NIH input on prioritization and progress as the project advances through manufacturing, regulatory preparation, and clinical readiness steps.
What is the activity category for this opportunity?
The activity category listed is health.
Which CFDA programs are associated with this funding opportunity?
The CFDA programs listed are 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
What is the estimated total funding amount shown in the snapshot?
The source snapshot lists total estimated funding of $4,000,000.
Is cost sharing or matching required?
No. The snapshot states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes many U.S. and non-U.S. organizations. Eligible applicants include public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), for-profit entities (including small businesses), state and local governments, tribal governments and tribal organizations, school districts, public housing authorities/Indian housing authorities, and mission-focused institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and AANAPISI institutions.
Are foreign organizations or foreign components allowed?
Yes. Foreign organizations and foreign institutions are eligible. Non-U.S. components of U.S. organizations can apply, and foreign components are allowed consistent with NIH policy.
What kinds of partnerships are implied or encouraged by this FOA?
The FOA is aligned with building strong development teams that may include academic labs, biotech or manufacturing partners, and clinical network collaborators. Because clinical trials are not funded by the mechanism, partnerships with NIAID-supported clinical trial networks or other trial-funding arrangements are specifically encouraged to enable study initiation.
What is the funding opportunity number and where can the full FOA be found?
The funding opportunity number is PA-13-042. The full FOA is available through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PA-13-042.html.
What are the key posted and archive dates listed for this opportunity?
The opportunity was posted on December 14, 2012. Administrative dates shown include creation on January 16, 2014 and an archive date of February 16, 2014.
What closing dates are shown in the snapshot, and what do they imply?
The snapshot lists an original closing date of March 13, 2015 and a current closing date of January 16, 2014, indicating the record is historical and reflects the archived status of the announcement.
What should an applicant emphasize to align with the "translation" focus?
An aligned application should emphasize that the vaccine concept is already sufficiently advanced, and then present a practical, regulated development plan covering late preclinical requirements, assay development/qualification, cGMP manufacturing and release, quality activities, and regulatory preparation, paired with a credible plan to initiate a clinical study within five years.
What types of barriers is this program intended to address?
The FOA is intended to fund the costly and operationally complex steps that often block promising vaccines from advancing, such as regulated product development, cGMP manufacture, quality testing, and regulatory preparation, rather than funding additional exploratory laboratory work alone.
Who provides support contacts for access or linking issues related to the FOA?
NIH Office of Extramural Research support contacts are provided for access or linking issues, as referenced in the opportunity information.
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