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Principal Investigator: Connie Schmaljohn
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2024
Award: $58,051,257
Funding agency: National Institute of Allergy and Infectious Diseases
The Integrated Research Facility - Frederick (IRF-Frederick) plays a central role in the U.S. Government’s high-containment research on emerging infectious diseases. In FY2024, the IRF-Frederick continued support for COVID-19 research and initiated multiple research studies focused on agents requiring a maximum containment research environment. In addition, post-life analysis of data collected during previous studies has been ongoing.
COVID-19 in vivo research included completion of data analysis for COVID-19 hamster studies including analyses of host lung transcriptomes after exposure to 10 different SARS-CoV-2 variants. Efforts have continued in the development of a non-human primate model that recapitulates severe human disease. COVID-19 in vitro research focused on evaluation of potential therapeutic antibodies and human intravenous immunoglobulin for the treatment of SARS-CoV-2 infection in support of NIAID Division of Clinical Research clinical trials.
In FY2024, the IRF-Frederick initiated a series of studies supporting evaluation of a Nipah virus (NiV) vaccine that was developed by colleagues at the Centers for Disease Control. This product has shown excellent protection in initial studies with additional studies continuing into early FY25. The IRF-Frederick, in collaborative studies with an industry partner, continued evaluation of a small molecule therapeutic for Lassa virus (LASV) infection in the guinea pig model. This product has shown remarkable protective efficacy at very low doses. This project has facilitated advancement of this antiviral toward clinical efficacy trials.
The IRF-Frederick completed studies evaluating an improved process for intraperitoneal injections in rodents and aerosol deposition studies in guinea pigs and hamsters in collaboration with colleagues at the Department of Homeland Security National Biodefense Analysis and Countermeasures Center next door.
The IRF-Frederick has continued development of unique advanced medical and pre-clinical imaging capabilities. The imaging team, in collaboration with CIDI partners, has implemented robust analysis workflows to quantify the PET signal in NHP lungs, brain, vasculature, and immune organs and has adapted clinically validated methods to extract quantitative data from morphological and functional brain MRI scans in NHPs. These approaches continue to be improved with more advanced artificial intelligence (AI) approaches implemented to assist with data analysis. In FY2024, as part of IRF-Frederick’s implementation of a multi-year Imaging Equipment Upgrade Plan, a new MR Solutions pre-clinical MRI system was acquired and will be installed in the coming year.
The IRF-Frederick advanced its organ-chip capability, focusing on the implementation and optimization of alveolus-on-chip and small-airway-on-chip protocols within BSL-2 and BSL-4 for SARS-CoV-2 and NiV. Additional studies are evaluating organoids following infection with EBOV. Other in vitro projects performed in FY2024 include continued development of an EBOV reporter construct for a project aimed at establishing a transgenic mouse model for in vivo virus tracking using optical imaging and projects focused on evaluating regulation of virus infection using multiple viruses. In addition, the IRF-Frederick drug screening team continued to test a range of compounds for potential efficacy against multiple high consequence viruses.
In FY 2024 the Genomics team at the IRF-Frederick made significant advances in their capabilities with development of sequencing process and analysis workflows for an increasing number of viruses, and development of transcriptomic and single cell sequencing capabilities for studies performed in the IRF BSL-4.
The IRF-Frederick Clinical Study Support Team (CSST) provided diagnostic and research support for 10 clinical protocols, using IRF-Frederick on-site resources and staff deployments to OCONUS sites. CSST staff engaged with OCONUS partners for training and capability-building activities in Guinea, Liberia, and Democratic Republic of the Congo (DRC). Importantly, the CSST assumed responsibility as the primary lead of the laboratory diagnostics functional group for the Pamoja Tulinde Maisha (PALM) 007: Mpox Randomized Clinical Trial.
Seven new projects were initiated in FY2024. The IRF-Frederick is engaged in 66 active projects, supporting 68 collaborative partnerships.
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