Limited Submissions Internal Call for Proposals: NIH Human Immunology Project Consortium (HIPC)

This Funding Opportunity Announcement (FOA) for the Human Immunology Project Consortium (HIPC) solicits applications from single institutions or consortia of institutions to participate in a network of human immunology profiling research groups in the area of infectious diseases, including HIV.

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Please Contact Limited_Submission@unc.edu to receive the complete internal solicitation.

Limited Submissions Internal Call for Proposals: NIH Human Immunology Project Consortium (HIPC)

UNC Internal Deadline: 11:59PM, Monday, March 29, 2021

NIH LOI Deadline: May 4, 2021

NIH Full Proposal Deadline: June 4, 2021

Number of Applications per Institution: Only one application per institution is allowed.

Funding Instrument: Cooperative Agreement

Award Budget: Application budgets are limited to $1,500,000 direct costs per year.

Award Project Period: The scope of the proposed project should determine the project period. The maximum project period is 5 years.

Program Description: This Funding Opportunity Announcement (FOA) for the Human Immunology Project Consortium (HIPC) solicits applications from single institutions or consortia of institutions to participate in a network of human immunology profiling research groups in the area of infectious diseases, including HIV. Applications are sought that propose to employ established and recent advances in immune profiling technologies to study the human immune system (1) before and after vaccination against an infectious pathogen; (2) before and after administration of a vaccine adjuvant that selectively targets immune components; and (3) during or following naturally-occurring infection.

Studies supported under this FOA will measure the diversity and commonalities of human immune responses under a variety of conditions and over time using high-throughput systems immunology approaches coupled with detailed clinical phenotyping in well-characterized human cohorts. In order to gain a comprehensive understanding of human immunity, cohorts may include vulnerable populations such as older adults, children, pregnant women, under-represented minorities, and individuals with immune-mediated conditions (autoimmune diseases, atopic diseases) or who have received tissue/organ transplants.  Inclusion of these populations will allow HIPC to contribute to our understanding of these conditions.

The major goals of this program are to:  

• 1. Support longitudinal analysis of human immune responses in clinically well-characterized cohorts to determine how these profiles are perturbed and eventually returned to a new homeostatic state after challenge with an antigen (e.g., vaccination or natural infections) and/or adjuvant(s).
  2. Develop molecular signatures that define immune response profiles and/or identify biomarkers across the lifespan that correlate with the outcomes of vaccinations, adjuvants or natural infections in humans.
  3. Advance research by promoting rapid public access to HIPC-supported data and meta-data through public portals such as ImmPort.

 

Research Objectives: This initiative is a renewal of the HIPC program to support longitudinal immune profiling of individuals receiving licensed vaccines or naturally exposed/infected with pathogenic organisms, as well as individuals participating in vaccine/adjuvanted vaccine clinical trials or controlled human pathogen challenge studies funded by other mechanisms.  Investigators funded under this program also will utilize the immune profiling data to develop and validate overall immune signatures associated with disease outcomes or vaccine efficacy, as well as signatures that may characterize the responses of a particular population (e.g., older adults, younger children, individuals with atopic or autoimmune conditions or who have received tissue/organ transplants.) 

While this program will not support clinical trials requiring an Investigational New Drug (IND) authorization or IND equivalent, it will support clinical trials that do not require an IND.  In addition, this program will support clinical studies using U. S. Food and Drug Administration (FDA) approved interventions (e.g., licensed vaccines) that are prescribed for use per indication (as described in the intervention’s product label) and are exempt by regulatory authorities from needing an IND.

The individual HIPC U19 awardees will be responsible for conducting immune profiling studies and developing and validating immune signatures associated with disease outcomes and vaccine efficacy, including identification of immune correlates of protection or disease progression/pathogenicity.

Examples of research areas of interest include, but are not limited to:

• • Measurement of dynamic, longitudinal changes in immune profiles following vaccination, adjuvant administration, or natural infection with a pathogen that correlate with clinical outcome.
  • Comparison of longitudinal immune profiles among ethnically diverse or special populations (e.g., infants, neonates, older adults, atopic individuals, transplant recipients, patients with autoimmune disease) after natural infection or administration of a vaccine or adjuvant, including examination of differential responses in males versus females.
  • Analyses of cellular populations and tissue/organ compartments associated with development and maintenance of long-term immunological memory to infection and vaccination.
  • Identification of immune profiles that correlate with vaccine efficacy or surrogates of efficacy.
  • Comparison of immune profiles in vaccinated populations to immune profiles in populations with naturally acquired infections.
  • Identification of markers of mucosal, tissue/organ or skin immune responses that reflect or contrast with markers of systemic response.
  • Systems serology and other high throughput characterization of humoral immunity.
  • Dissociation of markers of protective immunity from markers of vaccine toxicity/reactogenicity.
  • Examination of the role of the human microbiome in modifying immune responses to vaccinations or natural infections

 

To Apply: Submit the following via the Limited Submissions, Awards, and Internal Funding Management System by 11:59PM, Monday, March 29, 2021: