Opportunity Information: Apply for PAR 10 161
Apply for PAR 10 161
- 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, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Apr 19, 2011 and posted on Mar 30, 2010.
- Applicants must submit their applications by Nov 8, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,200,000.00 to eligible and selected applicants.
- Eligible applicants include: County governments City or township governments Small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities 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 State governments Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Independent school districts Nonprofits having 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 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.
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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) cooperative agreement funding opportunity designed to move promising, basic-science-driven prophylactic HIV vaccine ideas out of the lab and into first-in-human testing. The central aim is translation: taking innovative vaccine concepts supported by strong scientific rationale and helping investigators generate the preclinical, manufacturing, regulatory, and early clinical evidence needed to decide whether a candidate is ready for initial clinical trials. The program is specifically framed around the idea that some of the most important questions in HIV vaccine research can only be answered in humans, so the award is structured to support an integrated pathway that culminates in an early clinical study.
A key feature of IPCAVD is that it is not meant to fund stand-alone preclinical work. Applications are expected to cover an end-to-end development plan that includes both preclinical and clinical components, with clear scientific questions that will ultimately be addressed through human research. In practice, the award supports three tightly linked areas. First, it supports hypothesis-driven basic and translational work that advances a vaccine concept toward a viable lead, including non-human primate (NHP) proof-of-concept studies and a down-selection process to identify the strongest candidate(s). Second, it provides access to the kinds of development resources that determine whether the concept is clinically feasible, including activities aimed at meeting U.S. Food and Drug Administration (FDA) expectations for clinical testing, assessing whether the vaccine can be manufactured as clinical-grade material under current Good Manufacturing Practice (cGMP) conditions, and completing the required toxicology and pharmacology studies that establish a preliminary safety profile. Third, it supports the initial human clinical study that is central to testing the proposed question, effectively bridging the final step from late preclinical readiness into early clinical evaluation.
The funding mechanism is a multi-project cooperative agreement (U19), which typically implies a substantial level of programmatic involvement by the NIH compared with a standard research grant. The intent is to support coordinated, milestone-driven projects where scientific progress, development decisions, and readiness for clinical evaluation are actively managed and aligned with the program goals. For this specific opportunity (Funding Opportunity Number PAR-10-161), NIAID anticipated roughly $3.2 million in total costs available in FY2011, with an expected 1 to 2 awards (new or renewal), indicating a relatively selective competition focused on highly developed, competitive vaccine concepts.
Eligibility is broad and includes many types of domestic applicants such as state, local, and tribal governments; public and private institutions of higher education; nonprofits (including those with and without 501(c)(3) status); for-profit organizations (including small businesses); independent school districts; public housing authorities; and special district governments. The eligibility list also explicitly includes a range of mission-focused institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations), as well as eligible federal agencies. The opportunity does not require cost sharing or matching.
Administratively, this is an NIH discretionary grant opportunity in the health area, associated with CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research). The announcement was posted March 30, 2010, and the record indicates a current closing date of November 8, 2011, with archiving in December 2011 (reflecting that this was a time-bounded FOA cycle). The full announcement was hosted on the NIH grants site under the PAR-10-161 listing.
Frequently Asked Questions (FAQs)
What is the IPCAVD (U19) funding opportunity?
The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) is a National Institute of Allergy and Infectious Diseases (NIAID) cooperative agreement program designed to move promising, basic-science-driven prophylactic HIV vaccine ideas from the laboratory into first-in-human testing.
What is the main goal of this program?
The central aim is translation. The program supports an integrated pathway that helps investigators generate the preclinical, manufacturing, regulatory, and early clinical evidence needed to decide whether a vaccine candidate is ready for initial clinical trials, culminating in an early human clinical study.
What makes IPCAVD different from a typical preclinical-only vaccine grant?
IPCAVD is explicitly not meant to fund stand-alone preclinical work. Applications are expected to propose an end-to-end development plan that includes both preclinical and clinical components, with scientific questions that will ultimately be addressed through human research.
What types of research activities does IPCAVD support?
The program supports three tightly linked areas: (1) hypothesis-driven basic and translational work advancing a vaccine concept toward a viable lead (including non-human primate proof-of-concept studies and down-selection to the strongest candidate or candidates), (2) development resources needed for clinical feasibility such as FDA-aligned preparations, assessing manufacturability under cGMP conditions, and completing required toxicology and pharmacology studies to establish a preliminary safety profile, and (3) the initial human clinical study that bridges late preclinical readiness to early clinical evaluation.
Does the program require human clinical testing as part of the application plan?
Yes. The award is structured to support an integrated pathway that culminates in an early clinical study, reflecting the program framing that some of the most important HIV vaccine research questions can only be answered in humans.
Are non-human primate (NHP) studies included in the scope of work?
Yes. The supported activities include non-human primate proof-of-concept studies as part of advancing a vaccine concept and conducting a down-selection process to identify the strongest candidate(s).
Does IPCAVD support manufacturing and regulatory readiness work?
Yes. The program includes activities aimed at meeting U.S. Food and Drug Administration (FDA) expectations for clinical testing, assessing whether the vaccine can be manufactured as clinical-grade material under current Good Manufacturing Practice (cGMP) conditions, and completing toxicology and pharmacology studies needed for an initial safety profile.
What funding mechanism is used for this opportunity?
This opportunity uses a multi-project cooperative agreement mechanism (U19).
What does it mean that IPCAVD is a cooperative agreement (U19)?
A U19 cooperative agreement typically implies a substantial level of NIH programmatic involvement compared with a standard research grant. The intent is to support coordinated, milestone-driven projects where progress, development decisions, and readiness for clinical evaluation are actively managed and aligned with program goals.
What is the Funding Opportunity Number (FOA) for IPCAVD?
The Funding Opportunity Number is PAR-10-161.
How much funding was anticipated and how many awards were expected?
For this specific opportunity, NIAID anticipated roughly $3.2 million in total costs available in FY2011, with an expected 1 to 2 awards (new or renewal), indicating a selective competition.
Which agency and institute sponsor this opportunity?
The opportunity is sponsored by the National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID).
What types of applicants are eligible to apply?
Eligibility is broad and includes many domestic applicants such as state, local, and tribal governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (including small businesses); independent school districts; public housing authorities; and special district governments.
Are mission-focused and minority-serving institutions included in the eligibility list?
Yes. The eligibility list explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, and regional organizations.
Can non-U.S. (foreign) organizations apply?
Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).
Are U.S. territories or possessions eligible?
Yes. The eligibility list includes U.S. territories or possessions.
Are federal agencies eligible to apply?
Yes. The eligibility list includes eligible federal agencies.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
What is the program area and how is it classified?
This is an NIH discretionary grant opportunity in the health area.
Which CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
When was the announcement posted, and what were the closing and archive dates shown in the record?
The announcement was posted March 30, 2010. The record indicates a current closing date of November 8, 2011, and archiving in December 2011, reflecting a time-bounded FOA cycle.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants site under the PAR-10-161 listing.
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