Opportunity Information: Apply for PAR 20 120
The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (PAR 20-120) is a National Institutes of Health (NIH) funding opportunity that supports late-stage preclinical work needed to move a promising HIV/AIDS vaccine candidate into readiness for first-in-human or other early clinical testing. It is structured as a cooperative agreement (U19), which typically means NIH staff will have substantial involvement during the project period, and it is explicitly labeled “Clinical Trial Not Allowed.” In practical terms, the program is meant to fund the complicated, expensive, and highly regulated development steps that sit between an advanced research-stage vaccine concept and the point where a clinical trial application can be filed, without paying for the clinical trial itself.
The central goal of IPCAVD is translation: helping a multidisciplinary team take a vaccine candidate that is far enough along to be considered “advanced” and complete the remaining work needed for regulatory submission(s) that would allow clinical testing to begin. The FOA emphasizes the full package of development activities that commonly block progress when an academic or early biotech vaccine program tries to cross into the regulated clinical space. This includes final down-selection of the most viable candidate (for groups that may have multiple related constructs or platforms) and then building a development pathway that meets regulatory expectations for quality, manufacturing, and safety.
The funded scope is broad and intentionally end-to-end across preclinical-to-clinical transition tasks. Examples of supported activities include technology transfer (moving a process from a research lab into a manufacturing setting), process development and optimization (tightening and standardizing how the vaccine is produced), development and qualification of assays (so potency, identity, purity, and other key attributes can be measured reliably), and analytical testing necessary to define and control the product. The FOA also supports current Good Manufacturing Practice (cGMP) manufacturing, quality assurance oversight, safety testing, product release testing, and establishment of stability programs for both drug substance and drug product. It further includes IND-enabling studies (the preclinical studies generally required to support an Investigational New Drug application) and the preparation and submission of regulatory filings needed to open a clinical trial.
A key boundary in this opportunity is that it does not pay for running the clinical studies. Applicants are instead encouraged to line up a path to clinical execution through other mechanisms, such as collaborating with NIAID-supported clinical trial networks or building partnerships that can support trial implementation and funding once the regulatory package is ready. This design reflects a division of labor: IPCAVD funds the specialized development work to reach “trial-ready” status, while clinical networks or other sponsors fund and operate the trials.
Eligibility is intentionally broad and includes many organization types that might contribute to vaccine development, from universities and nonprofits to companies and government entities. Eligible applicants include state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; public housing authorities/Indian housing authorities; and federally recognized tribal governments as well as tribal organizations that are not federally recognized governments. The FOA also highlights additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities. This wide net fits the program’s multidisciplinary nature, where a single project may require academic discovery expertise, specialized assay labs, experienced regulatory teams, and cGMP manufacturing capabilities that may be distributed across multiple partners.
From an administrative standpoint, the opportunity is categorized as discretionary funding in the health area and is associated with CFDA number 93.855. The agency listed is NIH (with the program context pointing to NIAID given the reference to NIAID clinical trial networks). The FOA was created on 2020-03-03, and the original closing date shown is 2022-03-09. The award ceiling listed is $3,000,000. While the number of expected awards is not provided in the supplied source text, the ceiling indicates the program is designed to support substantial, resource-intensive development work that typically cannot be covered by smaller research grants.
Overall, IPCAVD is best understood as a “bridge-to-clinic” program for HIV/AIDS vaccines: it supports the manufacturing, testing, quality systems, and regulatory documentation needed to responsibly and credibly reach an IND (or similar regulatory milestone), while requiring applicants to plan for clinical testing through collaborations or other funding sources rather than using IPCAVD dollars to conduct the trials themselves.Apply for PAR 20 120
- 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 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2020-03-03.
- Applicants must submit their applications by 2022-03-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
- 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.
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Frequently Asked Questions (FAQs)
What is the Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD)?
The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (PAR 20-120) is an NIH funding opportunity designed to support late-stage preclinical development work for a promising HIV/AIDS vaccine candidate. Its purpose is to help move an advanced candidate to the point where it is ready for first-in-human or other early clinical testing, without paying for the clinical trial itself.
What is the main goal of IPCAVD?
The central goal is translation: enabling a multidisciplinary team to complete the remaining development work needed for regulatory submission(s) that would allow clinical testing to begin. In other words, it funds the steps that turn an advanced vaccine concept into a trial-ready product package that meets regulatory expectations.
Does this funding opportunity allow clinical trials?
No. The program is explicitly labeled "Clinical Trial Not Allowed." The intent is to fund the development activities needed to prepare for clinical testing (including regulatory filings), but not to fund the conduct of clinical studies.
If clinical trials are not allowed, what clinical-related work can be supported?
The opportunity supports work that prepares for clinical testing, such as IND-enabling studies and the preparation and submission of regulatory filings needed to open a clinical trial. The key boundary is that IPCAVD funds the development pathway to become trial-ready, not the actual running of the trial.
What type of award mechanism is used for IPCAVD?
IPCAVD uses a cooperative agreement mechanism (U19). This typically means NIH staff will have substantial involvement during the project period compared to a traditional grant.
What does "cooperative agreement (U19)" mean in practical terms?
Because it is a U19 cooperative agreement, NIH involvement is expected to be substantial over the course of the project. This structure is commonly used for complex, multi-component programs where coordination and active programmatic participation are important.
What stage of vaccine development is IPCAVD intended to support?
IPCAVD is aimed at late-stage preclinical development for HIV/AIDS vaccines. It is meant for vaccine candidates that are already advanced and need the remaining development work required to reach regulatory readiness for early clinical testing.
What kinds of activities does IPCAVD fund?
The funded scope is intentionally broad across the preclinical-to-clinical transition. Examples include technology transfer, process development and optimization, assay development and qualification, analytical testing, cGMP manufacturing, quality assurance oversight, safety testing, product release testing, stability programs for drug substance and drug product, IND-enabling studies, and regulatory filing preparation and submission.
Does IPCAVD support technology transfer?
Yes. Supported activities include technology transfer, such as moving a process from a research lab into a manufacturing setting.
Does IPCAVD support manufacturing activities?
Yes. The FOA supports current Good Manufacturing Practice (cGMP) manufacturing, along with related quality and release activities that are typically required for regulated clinical readiness.
What is meant by process development and optimization in this program?
Process development and optimization refers to tightening, standardizing, and improving how the vaccine is produced so it can meet quality and reproducibility expectations required for regulated clinical use.
Are assay development and qualification covered?
Yes. The FOA supports development and qualification of assays so key attributes (such as potency, identity, purity, and other product characteristics) can be measured reliably.
Does IPCAVD support analytical testing?
Yes. Analytical testing needed to define and control the product is within the supported scope, including testing used to understand and monitor critical product attributes.
Does the program include stability testing?
Yes. The FOA includes establishing stability programs for both drug substance and drug product.
Does IPCAVD support safety testing?
Yes. Safety testing is specifically listed among the supported activities, including the types of studies and oversight generally needed for regulatory readiness.
What are IND-enabling studies, and are they supported here?
IND-enabling studies are the preclinical studies generally required to support an Investigational New Drug (IND) application. IPCAVD supports these IND-enabling studies as part of preparing a vaccine candidate for regulatory submission.
Does IPCAVD fund preparation and submission of regulatory filings?
Yes. The FOA includes preparation and submission of regulatory filings needed to open a clinical trial, consistent with the program goal of reaching trial-ready status.
Does the program help with down-selection among multiple vaccine candidates?
Yes. The FOA notes support for final down-selection of the most viable candidate in cases where groups may have multiple related constructs or platforms.
What is the "bridge-to-clinic" concept in this opportunity?
IPCAVD functions as a bridge-to-clinic program: it funds the expensive, regulated development steps between an advanced research-stage vaccine concept and the point where a clinical trial application can be filed, while requiring that clinical trial execution be supported through other mechanisms.
If IPCAVD does not fund clinical trials, how are applicants expected to plan for clinical testing?
Applicants are encouraged to line up a path to clinical execution through other mechanisms, such as collaborating with NIAID-supported clinical trial networks or building partnerships that can support trial implementation and funding after the regulatory package is ready.
Which agency offers this funding opportunity?
The listed agency is the National Institutes of Health (NIH). The program context points to NIAID due to references to NIAID-supported clinical trial networks.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.855.
What is the maximum award amount (award ceiling)?
The award ceiling listed for this opportunity is $3,000,000.
How many awards are expected to be made?
The number of expected awards is not provided in the supplied information.
When was the FOA created?
The FOA was created on 2020-03-03.
What is the closing date listed for this opportunity?
The original closing date shown is 2022-03-09.
What funding category and area is this opportunity associated with?
It is categorized as discretionary funding in the health area.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; public housing authorities/Indian housing authorities; federally recognized tribal governments; and tribal organizations that are not federally recognized governments.
Are minority-serving institutions specifically included as eligible applicants?
Yes. The FOA highlights additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are specifically mentioned among the additional eligible categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included among the highlighted eligible categories.
Are non-U.S. (foreign) entities eligible?
Yes. Non-U.S. (foreign) entities are included among the highlighted eligible categories.
Why does the FOA emphasize a multidisciplinary team?
The program is designed around the reality that moving a vaccine into regulated clinical readiness often requires multiple types of expertise and infrastructure, such as academic discovery capabilities, specialized assay laboratories, experienced regulatory teams, and cGMP manufacturing capacity that may be spread across different partners.
What problem is IPCAVD trying to solve for vaccine developers?
It targets the complicated, expensive, and highly regulated development steps that commonly block progress when an academic or early biotech vaccine program tries to move from advanced research into the regulated clinical space.
What is meant by "trial-ready" in this context?
In this opportunity, "trial-ready" refers to having a credible development package that meets regulatory expectations for quality, manufacturing, testing, and safety, along with the necessary regulatory documentation and submissions that would allow early clinical testing to begin.
Does this program support quality assurance and product release activities?
Yes. The supported scope includes quality assurance oversight and product release testing, which are key components of regulated development and cGMP readiness.
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