NIAID seeks applications through the notice of funding opportunity (NOFO) Multidisciplinary Research to Accelerate Hepatitis B Cure in Persons Living with HIV and HBV (U19, Clinical Trial Not Allowed). The NOFO’s purpose is to support research on the impact of host and viral heterogeneity on pathogenesis of disease, viral persistence, and immunopathology of Hepatitis B virus (HBV) and inform cure strategies for HBV in people living with HIV (PLWH).
We aim to establish observational patient cohorts of people living with HBV to facilitate multidisciplinary research in basic, translational, and clinical arenas, which in turn should accelerate understanding of HBV cure in PLWH.
Research Objectives and Scope
Apply if you can develop research projects to identify novel host and viral factors that underlie disease mechanisms with an emphasis on identifying immunotherapies, novel drug targets, and biomarkers for HBV cure. Your application should combine at least one clinical research project and one basic or translational research project to accelerate discovery and increase clinical impact.
Focus on the study of primary viral isolates from different genotypes and include objectives that address multiple stages of the natural life cycle of HBV in PLWH.
Examples of research areas of interest include:
- Determining the impact of host and viral heterogeneity on disease progression, persistence, immunopathology, and the impact on therapeutic outcomes including HBV or HIV drug resistance.
- Elucidating the live microenvironment in distinct stages of chronic HBV and the impact of HBV viral infection on the immunological response.
- Measuring the size of the latent HBV reservoir and designing targeted approaches to eradicate the persistent reservoir (e.g., cccDNA, iDNA).
- Determining the clinical impact of HBV iDNA on the immune response.
- Discovering and developing new surrogate markers that predict progression through the different stages of chronic HBV, including the immune response, inflammation (e.g., hepatic flares), liver injury, and indicators or predictors of treatment response.
- Developing noninvasive diagnostic tools to assess stages of HBV disease progression, liver injury, and hepatic flares.
Clinical sites must be in locations with high incidence or prevalence of chronic HBV in PLWH. They must have an established infrastructure, including experienced local investigators capable of conducting multidisciplinary clinical studies that meet U.S. regulatory requirements for human subject protection; adequate laboratory facilities and personnel to perform protocol-specific tests; access to patient populations that are suitable to study people living with HBV and HIV; track record of successful enrollment of volunteers in clinical studies; and expertise in virology and immunology.
You should leverage existing clinical data and sample repositories from previously funded cohort studies, such as:
- Multicenter AIDS Cohort Study and the Women’s Interagency HIV Study (MACS/WIHS) Combined Cohort Study
- African Cohort Study (AFRICOS)
- Hepatitis B Research Network (HBRN)
- AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT)
- D.C. Cohort Longitudinal HIV Study (DC cohort)
- CFAR Network of Integrated Clinical Systems (CNICS)
Finally, your application should include a cross-disciplinary team of investigators that engages preclinical and clinical researchers in HBV and HIV. Try to include early career scientists where possible (e.g., research track investigators, staff scientists, and assistant-level professors).
Other Program Components
In addition to at least two synergistic research projects (again, one clinical and one basic or translational), this multi-component program also requires an administrative core, at least two scientific cores (but no more than four), a shared resource core, and a statistical and data management center. Those components are detailed in the NOFO.
Your application must also include a Plan for Enhancing Diverse Perspectives (PEDP), submitted as an Other Project Information attachment (refer to Section IV. Application and Submission Information). The PEDP is assessed as part of the scientific and technical peer review evaluation, and NIAID staff will consider it with respect to funding decisions.
Award and Deadline Information
Your application budget is not limited but must reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period, although it cannot exceed 5 years.
Applications are due on March 13, 2024, by 5 p.m. local time of the applicant organization.
If you decide to apply, we strongly encourage you to message Dr. Josh Radke, NIAID’s scientific/research contact, at josh.radke@nih.gov or 301-761-6525 to arrange a pre-application meeting to discuss your planned research. He can also answer your questions about the NOFO’s scientific priorities. For concerns related to peer review, instead contact Dr. Kristina Wickham at kristina.wickham@nih.gov or 301-761-5390.