June 2016 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 Find a Funding Opportunity.

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

Table of Contents

Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Biomarkers/Devices

Broad Agency Announcement—proposed FY 2018 initiative

Contact: Anuj Patel

Objective: This initiative will address gaps and accelerate the research and development of medical countermeasures against acute and delayed radiation syndromes. The initiative will also advance the development of the approaches currently used for detecting levels of radiation exposure to inform triage and medical interventions.

Description: This initiative will support the research and development of medical countermeasures against acute and delayed radiation syndromes and biodosimetric approaches for measuring radiation exposure and assessing intensity of radiation-induced tissue/organ injuries.

Adjuvant Development Program

Broad Agency Announcement—proposed FY 2018 initiative

Contact: Mirabel Miranda

Objective: The objective of this solicitation is to support the development of one adjuvant per award toward licensure for human use through the conduct of one or more of the following activities:

  • Optimize one candidate compound for enhanced safety and efficacy; this may include structural alterations or modifications to formulation or delivery.
  • Establish an immunological profile of activity and immunotoxicity that will be of use to evaluate the capability of the adjuvant to advance to human testing.
  • Conduct preclinical investigational new drug (IND)-enabling studies such as pilot lot or current Good Manufacturing Practices manufacturing of adjuvant or adjuvant:vaccine, toxicology, stability testing, and pharmacokinetics/absorption, distribution, metabolism, and excretion studies.

Depending on the developmental stage at which an adjuvant is entered into the program, the offeror may choose to perform some or all of the IND-enabling studies described above.

Description:

  1. In the main proposal, the initiative will support the development of vaccine adjuvants toward licensure for human use with vaccine(s) against one or more non-HIV pathogens relevant to human disease.
  2. In the elective component, DAIDS will fund multiple one-year HIV Envelope Immunogen Elective Studies within a parent non-HIV application for testing of adjuvants:
    • One-year/non-severable task for small animal studies, to be conducted in years 2, 3, 4, or 5 of an awarded parent contract.
    • Total cost: $500,000 per award.
    • Offerors may submit proposals for proof-of-concept studies in nonhuman primates (NHPs) through one of three DAIDS-supported Simian Vaccine Evaluation Units, pending assessment of HIV elective data and approval by DAIDS.

Changes to Initiative

  1. In the main proposal, offerors are no longer required to develop adjuvant:vaccine combinations against NIAID emerging/re-emerging disease pathogens. Rather, they are allowed to focus on any (one or more) non-HIV disease pathogen relevant to human disease. This change is expected to expand the scope of pathogens targeted with adjuvant:vaccine combinations.
  2. DAIDS will no longer fund a main proposal for developing adjuvant:vaccine combinations against HIV because other programs address this area.
  3. DAIDS added a statement to the HIV Envelope Immunogen Elective Studies indicating that offerors may submit proposals for proof-of-concept studies in NHPs through one of three DAIDS-supported Simian Vaccine Evaluation Units, pending assessment of HIV elective data and approval by NIAID.

Asthma and Allergic Diseases Cooperative Research Centers

For the published request for applications, see the August 10, 2016 Guide announcement, Asthma and Allergic Diseases Cooperative Research Centers (U19).

Clinical Trials in Organ Transplantation in Children: Limited Competition

For the published request for applications, see the November 28, 2016 Guide announcement, Limited Competition: Clinical Trials in Organ Transplantation in Children (CTOT-C): Mechanistic Ancillary Studies (U01).

Small Grants on Primary Immunodeficiency Diseases (R03)/Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R21)

For the published program announcements, see the July 19, 2016 Guide announcements, Small Grants on Primary Immunodeficiency Diseases (R03) and Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R21).

Content last reviewed on November 29, 2016