January 2019 DAIT Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year 2020 Concepts

Fiscal Year 2020 Small Business Innovation Research (SBIR) Contract Solicitation Topics

Development of Sample Sparing Assays for Monitoring Immune Responses

Request for Applications—proposed FY 2020 initiative

Contact: Kasia Bourcier

Objective: The objective of this initiative is to accelerate development of sample sparing assays that will broaden availability of well-characterized tools for monitoring immune responses in basic and clinical research. The newly developed assays would be valuable for gaining further insights into the fundamental understanding of the immune system, and be equally important for immune monitoring in healthy and disease conditions such as allergy, asthma, autoimmunity, primary immunodeficiency, transplantation, and infection.

Description: This program will solicit applications with the potential to support immunological research to develop innovative and validated sample sparing assays that lead to the maximum use of the sampled material and/or a significant reduction in the amount of sample required. Assays that will be supported could include, but are not limited to, novel approaches for monitoring antigen-specific responses and various cell populations, assessments of T and B regulatory cells, cytokine and signaling networks, gene function/expression studies, and proteomics. Techniques that integrate multiple measurements as a sample sparing concept are of interest and will be encouraged. Integration of many datasets obtained from the same sample could lead to a better understanding of immune function and at the same time reduce the amount of sample material needed for analysis.

For renewal we are planning to introduce the Infrastructure and Opportunities Fund to enable collaboration between investigators within the group and increase program outreach and training among DAIT’s consortia.

Human Leukocyte Antigen (HLA) and Killer-Cell Immunoglobulin-Like Receptor (KIR) Region Genomics in Immune-Mediated Diseases

Request for Applications—proposed FY 2020 initiative

Contact: Jeff Rice

Objective: The goal of the HLA and KIR Region Genomics in Immune-Mediated Diseases program is to define the association between variations in HLA and KIR genetic regions and immune-mediated diseases, including risk, progression, and severity of or protection from disease, and organ, tissue, and cell transplantation outcomes. Understanding the connection between these regions and disease phenotype and/or transplantation outcome will provide insight into the mechanism of disease, improve predictive power of screening, and may lead to more precise therapies. The program will also continue to generate high-quality HLA- and KIR-disease association data correlated with patient phenotypes that will be submitted to publicly accessible databases.

Description: This program will support retrospective or prospective studies to investigate the relationship between genetic variation in the HLA and KIR regions and immune-mediated diseases. Areas of research may include:

  • The role of donor/recipient HLA and KIR matching in transplantation outcome, graft-versus-host disease, or rate of leukemic relapse following bone marrow transplant
  • Association of HLA and KIR region genes with susceptibility to and progression of immune-mediated diseases and disease phenotype
  • Association of HLA and KIR region variations in food allergy
  • Association of somatic HLA and KIR region variations in cancer susceptibility, phenotype, and prognosis
  • Discovery of novel HLA and KIR region genes associated with immune-mediated diseases or transplantation outcome
  • Mechanistic studies into the basis of HLA and KIR region disease associations

Changes in this renewal:

Expansion of scope to include cancer, pending commitment from the National Cancer Institute.

Immunobiology of Xenotransplantation Cooperative Research Program

Request for Applications—proposed FY 2020 initiative

Contact: Nasrin Nabavi

Objective: The long-term goal of this program is to develop novel and effective strategies for applying xenotransplantation in the clinic. The research focus of this competing renewal initiative is to address the remaining key immunologic and physiologic issues required to achieve safe and efficacious xenotransplantation using preclinical pig to nonhuman primate (NHP) models of pancreatic islet, kidney, heart, lung, or liver xenotransplantation. The goals of this program are to 1) delineate the cellular and molecular mechanisms of xenograft rejection and the induction of tolerance, 2) develop and optimize effective strategies to improve xenograft survival, and 3) characterize and address the physiological compatibility/functions of xenografts post-transplant.

Description: This initiative will support new or competing renewal proposals focused on 1) developing or optimizing genetically-modified models of pig to NHP xenotransplantation of pancreatic islet, kidney, heart, lung, or liver, including optimal combinations of genetic modifications and improved surgical techniques and 2) defining and ultimately resolving the physiological and immunological barriers of successful xenograft application in clinic.

Radiation/Nuclear Countermeasure Product Development Support Services Contract

Request for Proposals—proposed FY 2020 initiative

Contact: Deborah Blyveis

Objective: To provide additional funds to continue and expand nonclinical and clinical efforts for product development of radiation/nuclear medical countermeasure candidate drugs and biodosimetry devices for inclusion in the Strategic National Stockpile for use during a radiation emergency.

Description: The initiative will provide funds to continue and expand product development of radiation countermeasures efforts of the current medical countermeasures against radiological threats: product development support services program. The program will provide a comprehensive and broad range of nonclinical and clinical support services and support continued animal and product development efforts for licensure of both candidate drugs and biodosimetry devices. The types of product development support services will include: screening and efficacy evaluation of candidate drugs; non-good laboratory practice (GLP) and GLP toxicology and safety pharmacology in animal models; current Good Manufacturing Practices manufacturing support; GLP pivotal animal efficacy studies; Phase I clinical safety and pharmacokinetic studies; and regulatory submission support for candidate drugs and biodosimetry devices. This renewal will continue and build upon the previously awarded product support services contracts.

RNCP-Wide Dosimetry Guidance and Monitoring of Sources and Irradiation Protocols

For the published request for proposals, see the January 22, 2019 solicitation, RNCP-Wide Dosimetry Guidance & Monitoring of Sources and Irradiation Protocols (Clinical Trials Not Allowed).

Development of Vaccines for the Treatment of Opioid Use Disorder

Broad Agency Announcement—proposed FY 2020 initiative

Contact: George Ralis

Objective: The objective of this initiative is to develop innovative and safe multivalent opioid vaccines that protect against heroin and fentanyl. Vaccine targets may include downstream metabolites (e.g., 6-acetylmorphine and morphine). Anti-opioid vaccines would induce high-affinity antibodies that reduce neurotropic effects and opioid-induced respiratory depression; would protect against overdose; and are specific to the targeted opioids and do not interfere with therapeutics to treat overdose or addiction, or with physiologic or pharmacologic pain control methods.

Description: This program will support foundational vaccine development activities, including adjuvant screening, immunogen design, and elucidation of fundamental immune mechanisms required to induce protective anti-opioid antibodies. These mechanisms may include determining the effect of immunogen design on immunity; the impact of opioid use on immune function and production of protective anti-opioid antibodies; and the importance of antibody subtypes on opioid vaccine efficacy. Vaccine candidates will be evaluated in appropriate animal models, and lead candidates will be selected for further testing using well-defined evaluation criteria. The proposed program will support investigational new drug application-enabling activities and current Good Manufacturing Practice production through early-stage safety and immunogenicity (Phase I) clinical trials of lead vaccine candidate(s), where applicable.

Characterizing and Improving Humanized Immune System Mouse Models

Broad Agency Announcement—proposed FY 2020 initiative

Contact: Liem Nguyen

Objective:

  • More fully characterize and further develop humanized immune system (HIS) mouse models
  • Conduct direct comparisons of HIS mice derived from fetal versus non-fetal human tissue sources

Description: This is a new initiative and supports research that includes but is not limited to:

  • Optimizing and characterizing HIS mouse models engrafted with fetal or non-fetal tissue sources
  • Direct comparisons of HIS mice generated with human fetal tissue versus non-fetal tissue sources
  • Optimizing and/or developing HIS mouse models that:
    • Recapitulate human innate immunity, T cell function, B cell/antibody responses (subset development and function)
    • Compare engraftment, development, and functional immunity to human pathogens and immune-mediated diseases
    • Demonstrate functional human mucosal immune responses
    • Recapitulate human secondary lymphoid tissue development

Adjuvant Development for Vaccines Against Infectious or Immune-Mediated Diseases

Note: NIAID topic for NIH SBIR contract solicitation.

Request for Proposals

Contact: Charles H. Jackson, Jr.

Adjuvant Discovery for Vaccines Against Infectious or Immune-Mediated Diseases

Note: NIAID topic for NIH SBIR contract solicitation.

Request for Proposals

Contact: Charles H. Jackson, Jr.

Production of Adjuvants

Note: NIAID topic for NIH SBIR contract solicitation.

Request for Proposals

Contact: Charles H. Jackson, Jr.

Reagents for Immunologic Analysis of Non-Mammalian or Underrepresented Mammalian Models

Note: NIAID topic for NIH SBIR contract solicitation.

Request for Proposals

Contact: Charles H. Jackson, Jr.

Content last reviewed on February 19, 2019