January 2019 DMID 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

Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB)

Request for Applications—proposed FY 2020 initiative

Contact: Karen Lacourciere

Objective: To support the evaluation of early-stage diagnostics and novel diagnostic strategies for tuberculosis (TB) in the context of existing clinical algorithms in TB endemic countries.

Description: This initiative will focus on proof-of-principle studies of novel TB diagnostic tests and strategies, and provide feedback to diagnostic developers on the performance of the technology/strategy for use in an endemic setting. This initiative will establish a partnership of investigators and clinical study sites coordinated and led by a leadership team in TB endemic countries where drug-susceptible and drug-resistant TB is prevalent, where co-infection with HIV is of concern, and where patient demographics are well described and allow access to both adult and pediatric patients and controls. Furthermore, sites will be well coordinated with the local/country TB programs and have established, state-of-the-art diagnostic capabilities for TB. This integrated approach is necessary to assure new diagnostic tests are evaluated in the context of “real-life” clinical algorithms so that they have the potential to improve the diagnostic cascade for both drug-resistant and drug-susceptible TB.

At the time of submission, applicants are expected to have one or more diagnostic tests identified for initial testing. However, it is anticipated that the program will evaluate additional diagnostics during the funding period to ensure the most promising emerging technologies and tests can be advanced. This program, through its leadership team, will also serve as a resource to the community to connect technology holders with clinicians in TB endemic countries to ensure diagnostic development is done with the needs of the primary users and patients in mind.

Diagnostics will not be limited to pulmonary TB, but also include extrapulmonary manifestations of disease.

It is anticipated that investigators in this partnership will identify promising TB diagnostic technologies to be tested, or technology holders will request testing of a promising diagnostic, and the prioritization of these diagnostics will be made in collaboration with an outside advisory board, along with NIAID and the investigators in the partnership.

The emphasis will be on contemporary needs for TB diagnostics, which include true point-of-care tests, as well as platforms that are likely to be used for underserved populations including children and persons with disseminated and/or paucibacillary TB disease. Diagnostics that will be prioritized for testing include product candidates that identify TB using specimens other than sputum, e.g. serum, urine, or stool, allowing identification of paucibacillary or extrapulmonary TB in adult and pediatric patients. Xpert MTB/RIF has revolutionized TB diagnosis. However, this assay continues to have limitations, including cost and infrastructure requirements, and diagnostics that may overcome these limitations would also be prioritized.

New clinical infrastructure will not be developed as part of this program, but this program will leverage existing clinical sites that have the capability to execute TB clinical studies and have access to the appropriate populations.

Discovering and developing new diagnostics will not be within the scope of this program. Furthermore, this program will not support establishing or using a biorepository but will conduct targeted studies with prospective sample collection.

Research Projects To Improve the Predictive Value of Animal Models in Recapitulating Human Immunity to Influenza Infection and Vaccination

Program Announcement With Special Receipt, Referral, and or Review Considerations—proposed FY 2020 initiative

Contact: Chelsea Lane

Objective: Research to improve existing animal models or develop novel animal models that more accurately represent influenza immunity in humans, with an emphasis on increasing the predictive value of models for evaluating novel universal influenza vaccines.

Description: As outlined in NIAID’s recently published strategic plan, NIAID has a specific interest in improving existing animal models to more closely mimic the events that occur in humans during the development and maintenance of immunity to influenza, which are shaped by sequential exposures by natural infection or vaccination (AS Fauci et al. A universal influenza vaccine: The strategic plan for the National Institute of Allergy and Infectious Diseases. Journal of Infectious Diseases, 2018). This initiative will support research to improve existing animal models or develop novel animal models that more accurately represent influenza immunity in humans, with an emphasis on increasing the predictive value of models for evaluating novel universal influenza vaccines.

Examples of such research areas include but are not limited to:

  • Modeling pre-existing immunity to better understand response to vaccination

  • Developing novel animal models that more accurately represent influenza immunity in humans

  • Characterizing the development and maintenance of protective immunity to influenza, including after sequential exposures/infections and/or vaccinations

  • Genomic characterization of animal models to elucidate the impact of genotype on phenotype/susceptibility to influenza infection and/or vaccination outcomes

  • Examining more relevant routes of influenza infection (e.g., aerosol)

  • Using appropriate influenza animal models that better mimic special/high-risk populations (e.g., neonates, pregnant women, elderly)

  • Determining the impact of the microbiome on influenza immunity and/or vaccination

Note: Clinical research using human samples to validate findings in animal model(s) is strongly encouraged.

Research areas NOT appropriate for this initiative include:

Antiviral Drugs To Cure Chronic Hepatitis B Virus Infection

Note: NIAID topic for NIH SBIR contract solicitation.

Request for Proposals

Contact: Charles H. Jackson, Jr.

Broad Spectrum Antibody Against Human Enteroviruses

Note: NIAID topic for NIH SBIR contract solicitation.

Request for Proposals

Contact: Charles H. Jackson, Jr.

Development of Rapid Fungal Diagnostics for Select Endemic Dimorphic Fungi

Note: NIAID topic for NIH SBIR contract solicitation.

Request for Proposals

Contact: Charles H. Jackson, Jr.

Content last reviewed on February 11, 2019