Develop Immunological Assays for Influenza Clinical Studies and Trials

NIAID is pursuing a universal influenza vaccine to provide durable protection against multiple influenza virus strains. To that end, the Institute will support developing new assays and reagents to characterize immune responses as new vaccine platforms and antigenic targets evolve.

Apply through our new funding opportunity announcement (FOA) Development and Optimization of Next-Generation Immunological Assays To Support Influenza Clinical Studies and Trials (UH2/UH3, Clinical Trial Not Allowed) if you can build a well-integrated, cross-disciplinary research team with diverse expertise in assay development and optimization, clinical research, immunology, and influenza virology.

Phased Innovation Award

This initiative uses an uncommon award mechanism: the Phased Innovation Awards Cooperative Agreement (UH2/UH3). The mechanism is designed to support promising, high-risk research and development projects that also necessitate NIAID staff involvement.

Your application should include plans for two years of support in the UH2 phase, in which you’ll pursue early development of an immunological assay, and three years of support in the UH3 phase, in which you’ll further develop and optimize the assay.

To transition between phases, you must first demonstrate progress toward a set of transition milestones that you’ll propose in your application’s Research Strategy. NIAID staff will assess milestone completion and likelihood of future success before continuing an award’s funding into the UH3 phase.

Research Priorities

NIAID seeks improved sampling and assays for assessing mucosal immune responses. This entails better use of high-throughput platforms, minimizing sample collection volumes, and non-invasive sampling methods.

With those goals in mind, suggested activities for the UH2 phase include:

• Optimizing sample collection procedures/techniques (e.g., mucosal sampling)
• Developing assay technologies such as nanotechnology and microfluidic-based systems, multiplex systems, or robotics
• Developing assays, including preparing a detailed assay development plan

Followed by a UH3 phase that could include the following example activities:

• Developing assays, including preparing an assay development plan and report
• Optimizing assays, including preparing an assay optimization plan and report

Applicants should already have access to well-characterized human clinical samples to correlate assay results to known disease or vaccination. The consent under which the samples were collected must allow for your project’s proposed use. You’ll also need to use appropriate positive and negative controls for assay development. 

Be sure to include an intellectual property strategy to address any issues with your use of assays or reagents for research purposes or commercial development.

Conversely, NIAID will consider nonresponsive and not review applications with the following:

• Projects focused on biomarker discovery
• Research focused on traditional hemagglutination inhibition, microneutralization, or neuraminidase inhibition assays
• Research projects without access to well-characterized human clinical samples, obtained with appropriate informed consent
• Clinical trials
• Missing transition milestones or a UH3 phase Research Strategy
• Missing intellectual property strategy

Read the FOA linked above for additional details.

Application Requirements

Your budget request cannot exceed $500,000 in annual direct costs. The UH2 phase is limited to two years; the UH3 phase is limited to three years.

This FOA has a single application submission deadline: July 1, 2022, at 5 p.m. local time of the applicant organization.

Direct questions to Dr. Chelsea Lane, our scientific/research contact for the FOA, at 240-627-3741 or mary.lane@nih.gov. For questions about peer review, contact Dr. Mario Cerritelli at 240-669-5199 or cerritem@mail.nih.gov.