Human Immunology Project Consortium (U19 Clinical Trial Optional) | RFA AI 20 079

Frequently Asked Questions (FAQs)

What is the Human Immunology Project Consortium (HIPC) U19 opportunity (RFA-AI-20-079)?

RFA-AI-20-079 is an NIH cooperative agreement (U19) opportunity intended to fund a network of research teams that deeply profile human immune responses in infectious diseases, including HIV. The program emphasizes modern, high-throughput immune profiling and systems immunology approaches to connect immune measurements with real clinical outcomes.

What is the main purpose of this funding opportunity?

The purpose is to support projects that can capture an integrated, high-dimensional view of human immunity in the context of vaccination, vaccine adjuvants, and natural infection, and to translate those measurements into molecular signatures and biomarkers associated with clinically meaningful outcomes.

What kinds of scientific approaches does HIPC emphasize?

The opportunity emphasizes systems immunology and high-throughput immune profiling technologies, rather than focusing on single immune readouts. Projects are expected to generate broad, integrated immune datasets that can be related to detailed clinical information and outcomes.

Which disease areas are in scope?

The scope includes infectious diseases, explicitly including HIV. The broader framing is understanding immune responses across different infectious disease contexts, including responses to vaccines, vaccine adjuvants, and natural infections.

What is meant by "deeply profiling" immune responses?

In this context, it means using modern, high-throughput technologies to measure many immune features at once, creating high-dimensional datasets that reflect an integrated view of the immune system rather than a single marker or assay result.

Are projects expected to use human cohorts?

Yes. Projects are expected to follow well-characterized human cohorts. The program pairs high-dimensional immune profiling with detailed clinical phenotyping so immune signatures can be interpreted alongside participant characteristics, exposures, disease status, vaccination history, and outcomes.

Is longitudinal sampling required or encouraged?

Longitudinal data collection is a clear expectation of the program description. Immune responses should be tracked over time rather than captured only at a single time point.

What is "clinical phenotyping" in the context of this FOA?

Clinical phenotyping refers to collecting detailed clinical and participant-level information (such as characteristics, exposures, disease status, vaccination history, and outcomes) so immune measurements can be interpreted in a clinically meaningful way.

What are the key scientific goals of the program?

A key goal is to measure both the diversity of immune responses across individuals and the shared patterns that may appear across people and across different infectious disease contexts. The intent is to move toward predictive and mechanistic insights, not only descriptive findings.

What kinds of outputs are expected from funded projects?

Expected outputs include molecular signatures that define immune response profiles and biomarkers that correlate with outcomes after vaccination, adjuvant exposure, or infection in humans. The resulting datasets are intended to help identify immune patterns that predict protection, durable immunity, vaccine responsiveness, or other clinically meaningful endpoints.

How are the results intended to be used?

The signatures, biomarkers, and datasets are intended to accelerate vaccine and immunotherapy development by clarifying what successful immune protection looks like in people and enabling cross-study comparisons and meta-analyses.

What does the FOA say about data sharing?

Data sharing is described as a major program goal. The FOA emphasizes rapid public access to HIPC-generated data and metadata through public repositories and portals, specifically noting ImmPort as a key platform.

Do applicants need a plan for standardized data submission?

Yes. The emphasis on rapid public access and use of repositories like ImmPort signals that applicants should plan for standardized, well-annotated data submission and should anticipate reuse of their datasets for cross-study comparisons and meta-analyses.

What is ImmPort and how does it relate to this opportunity?

ImmPort is specifically identified as a key platform for public access to HIPC-generated data and metadata. Projects should be designed with the expectation that their data will be shared via such public repositories/portals.

Is there a Coordinating Center associated with HIPC?

Yes. The announcement references a companion FOA that funds a HIPC Coordinating Center. While separate from this U19 mechanism, the Coordinating Center is described as essential for fostering collaboration, supporting dissemination of consortium findings, and helping develop or adopt robust methods for data integration, analysis, presentation, and visualization.

How are U19 awardees expected to interact with the broader HIPC network?

U19 projects are expected to operate as part of a broader network where harmonization, integration, and shared tooling are important. The program structure anticipates collaboration and interoperability across funded groups.

What funding mechanism is used for this opportunity?

This opportunity uses an NIH cooperative agreement mechanism (U19). Cooperative agreements typically involve substantial NIH programmatic involvement compared to a standard grant.

What does "substantial NIH programmatic involvement" imply?

Based on the description of a cooperative agreement, it implies NIH staff are expected to have a more active programmatic role than they would under a standard grant mechanism.

What is the activity area and CFDA number listed?

The activity area is health, and the CFDA number listed is 93.855.

What is the award ceiling listed in the notice?

The notice lists an award ceiling of $1,500,000.

What was the original closing date for this solicitation?

The original closing date listed is June 4, 2021. This indicates the specific solicitation described was tied to that submission window and was time-bound.

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations and governments. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses.

Are minority-serving institutions and specific organization types explicitly included?

Yes. The FOA explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, Historically Black Colleges and Universities, and tribally controlled colleges and universities, as well as faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Can non-U.S. (foreign) institutions apply as the applicant organization?

No. Non-U.S. (foreign) institutions are not eligible to apply as the applicant organization.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are not eligible.

Are foreign components allowed at all?

Yes. Foreign components (as defined by the NIH Grants Policy Statement) are allowed. This typically supports certain international collaborations or project elements when justified, even though the applicant organization must be U.S.-based.

What types of teams is this opportunity designed to support?

The opportunity is aimed at teams (single institutions or multi-institution consortia) that can combine access to well-characterized cohorts, rigorous clinical characterization, and cutting-edge immune profiling, along with a clear plan to generate interoperable datasets that will be shared quickly and used broadly.

What is the overarching program vision for impact?

The program is structured to produce both individual-study insights and integrated, cross-cohort knowledge. The intent is to define immune correlates, signatures, and biomarkers relevant to vaccines, adjuvants, and natural infection in humans, with broad reuse of shared data across the research community.