The Clinical Studies Support Team (CSST) develops and fosters overseas relationships through continuous support of research studies and clinical trials involving pathogens of high consequence. When deployed, the team provides in-person training and assistance with assays, equipment, and project management.
Through its involvement with the NIAID special projects effort (in coordination with the Collaborative Clinical Research Branch [CCRB]), the CSST’s collaboration on studies have produced achievements, such as:
- Establishment of serologic testing as a primary endpoint for vaccine trials in Mali, Guinea, Liberia, and Sierra Leone
- Testing and refinement of diagnostic assays for alternative matrices to support public-health measures and clinical-trial endpoints for high-consequence pathogens
- Genome-wide association study of Ebola virus disease survivors
- Sequencing and genomics of SARS-CoV-2 for research and public-health surveillance in Liberia
- Training of laboratory staff in appropriate use of personal protective equipment, laboratory safety, and portable containment devices in West Africa
Today, the CSST at the IRF-Frederick supports research laboratories in four countries in Western and Middle Africa. These efforts assist with clinical trials and research studies, build local and national capacity through laboratory and biosafety trainings, and respond to public-health crises as requested.
Main Areas of Focus
- Clinical and research studies support through:
- Implementation of new technologies
- Assay development and deployment
- Data analyses
- Project development
- Strategy and planning
- Providing subject matter expertise on high-consequence pathogens
- Laboratory capability and infrastructure development through:
- Theoretical and hands-on training
- Equipment deployment and maintenance
- Development of standard operating procedures (SOPs)
- Providing subject matter expertise on high-consequence pathogens in low-resource settings
Capabilities
- Deployable team with BSL-4 experience
- Clinical trial and research study support:
- Collection, processing, storage, and transport of samples in low‑resource settings
- Serologic testing
- Molecular testing
- Sequencing and bioinformatics
- Protocol and SOP development
- Hands-on laboratory training in:
- Safe handling of high-consequence pathogens in low‑resource settings
- Conventional and custom serological, molecular, and immunological assays
- Next-generation sequencing and bioinformatics in austere environments
Studies, Partnerships, and Collaborations
- The Partnership for Research on Ebola Virus in Liberia (PREVAIL) Researching Ebola Virus in Africa | NIH: National Institute of Allergy and Infectious Diseases
- PREVAIL I, III, V, VI (Ebola virus)
- PREVAIL XI (SARS-CoV-2)
- PREVAIL XII (Lassa virus)
- Pamoja Tulinde Maisha (PALM) Researching Ebola Virus in Africa | NIH: National Institute of Allergy and Infectious Diseases
- PALM 005 (Ebola virus)
- PALM 007 (mpox virus)
- Partnership of Clinical Research in Guinea (PREGUI) Partnership of Clinical Research in Guinea (PREGUI) | NIH: National Institute of Allergy and Infectious Diseases
- Mali-University Clinical Research Center (UCRC) Mali-University Clinical Research Center (UCRC) | NIH: National Institute of Allergy and Infectious Diseases
- Global Alliance for Preventing Pandemics (GAPP) The Global Alliance for Preventing Pandemics (GAPP) | Columbia University Mailman School of Public Health
Location
Integrated Research Facility at Fort Detrick (IRF-Frederick)
Contact Information
Jens H. Kuhn, M.D., Ph.D., Ph.D., M.S.
Principal Scientist and Director of Virology (Contractor)
Irina Maljkovic Berry, Ph.D.
Study Director/Assoc. Supervisor, Clinical Study Support Team (Contractor)
IRF-Frederick
Standards
All procedures are well-documented and adhere to standard operating procedures (SOPs), methods, or study-approved plans and agreements.
Collaboration Opportunities
- Studies relevant to human disease
- Use of surrogate systems to test clinical hypotheses
- Use of biological systems to answer questions regarding disease pathogenesis and strategies for intervention including antimicrobials, vaccines, and other countermeasures
- Developing and incorporating cutting-edge technologies to understand infectious diseases
Read more about how to work with the IRF-Frederick.