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Apply for support through the funding opportunity announcement (FOA) Development of HIV Broadly Neutralizing Antibody Susceptibility Assays (R61/R33, Clinical Trial Not Allowed) if you can carry out high-risk, milestone-driven research to develop innovative assays that measure HIV susceptibility to broadly neutralizing antibodies (bNAbs) in clinical laboratories.
Research Objectives and Scope
NIAID encourages studies that facilitate early-stage assay development and demonstrate feasibility and clinical utility, followed by verification and late-stage method validation. The assays should measure HIV susceptibility to bNAbs in clinical laboratories.
Ultimately, if bNAbs receive regulatory approval as antiviral reagents, the assay must also be appropriate for use in determining eligibility for treatment with a requisite bNAb—similar to current tests for anti-retroviral drug resistance.
Your application should include multidisciplinary collaboration between experts in the fields of virology and biotechnology with expertise in sequencing, microfluids, bioengineering, synthetic biology, nanotechnology, machine learning, clinical laboratory procedures, and regulations. In addition, researchers must have access to relevant well-characterized diverse clinical samples, including diverse HIV-subtypes and sample types from existing biospecimen repositories, or through specimen collection by other mechanisms separate from this FOA.
Phased Innovation Awards
Due to the high-risk, high-impact nature of the research, this funding opportunity uses the R61/R33 Exploratory/Developmental Phased Award activity code.
In the R61 phase, applicants can receive support for up to three years for milestone-driven research for early-stage assay development that demonstrates feasibility and clinical utility. In the R33 phase, they can receive up to two years of support for additional activities, such as expanded assay development, optimization, proof-of-concept validation with human samples, and usability testing.
Before the end of the R61 phase, awardees will submit an R33 transition package, which should include a detailed progress report describing how they met initial milestones and a description of how the work justifies continuing to the originally proposed R33 studies. Approval to transition to the R33 phase will be based on original R61/R33 peer review recommendations, successful completion of R61 milestones, program priorities, and availability of funds.
Nonresponsive Research Areas
NIAID will consider applications proposing the following types of studies to be nonresponsive and not review them.
- Attempting to isolate and/or screen for novel bNAbs
- Conducting clinical trials (all phases)
- Studying HIV envelope diversity unrelated to bNAb resistance
- Developing assays that will not be transferrable to a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
- Basic bNAb biology
- Studies without measurable milestones for the R61 phase
Submission Information and Deadline
Application budgets are not limited but should reflect the actual needs of the proposed project. The total maximum funding period for the entire R61/R33 award is five years.
Include letters of support or collaboration to demonstrate the commitment and specific involvement of collaborators, partners, or available resources. NIAID strongly encourages letters of support to demonstrate access and/or availability of required specimens.
All applications are due by August 3, 2022, at 5 p.m. local time of the applicant organization.
Send inquiries to Dr. Keith Crawford, NIAID’s scientific and research contact, at 240-669-2816 or email@example.com. For peer review-related questions, contact Dr. Vishakha Sharma at 301-761-7036 or firstname.lastname@example.org.