Background and Purpose

The Integrated Research Facility at Fort Detrick (IRF-Frederick) is situated within the National Interagency Confederation for Biomedical Research (NICBR), a group of federal biomedical research facilities located on the National Interagency Biodefense Campus (NIBC) at Fort Detrick, in Frederick, Maryland.

The Integrated Research Facility at Fort Detrick (IRF-Frederick) team has extensive experience in testing potential medical countermeasures for high-consequence viral pathogens. Leveraging this experience, scientists at the IRF-Frederick have developed and are using cell‑based in vitro assays and animal models to test potential therapeutics for and vaccines against COVID‑19. The unique medical imaging capabilities of the IRF-Frederick are also being used to understand pathological consequences of SARS‑CoV‑2 in relevant animal models of disease.

Main Area of Focus

The mission of LaRed is to be a collaborative network of academic health institutions that leads and promotes relevant, timely, efficient, ethical and high quality clinical research on the nature and behavior of emerging infectious diseases, influenza and other viruses in order to improve health.

Clinical Studies

CNSARI (NCT03168282): Evaluation of Culture Negative Severe Acute Respiratory Infection in Mexico.

ILI002 (NCT01418287): An Observational Study to Characterize Children and Adults With Influenza Like Illness (ILI) in Mexico.

IRC003 (NCT01227967): A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications.

FLU-IVIG (NCT02037282): A Phase 1, Open Label, Ascending Dose Cohort Study of the Pharmacokinetics of Anti-Influenza Hyperimmune Intravenous Immunoglobulin in Healthy Subjects.

ILI-2014 (NCT02378090): An Observational Study to Determine the Causes and Identify Increases in Influenza-Like Illness (ILI) in Mexico: The Mexican Emerging Infectious Disease Clinical Research Network (La Red).

NTZ-SARI (NCT02057757): A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Nitazoxanide Versus Placebo in Addition to Standard Care for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness.

SPRINT-SARI (NCT02498587): Short Period Incidence Study of Severe Acute Respiratory Illness.

ZIK01 (NCT02831699): The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico (Zik01).

ACTT (NCT04280705): A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults.

ACTT-2 (NCT04401579): A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-2).

ACTT-3 (NCT04492475): A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-3).

ACTT-4 (NCT04640168): An adaptive randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19.

INSIGHT 011 ICOS (NCT04385251): This is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 managed as outpatients (not hospitalized).

INSIGHT 012 OTAC (NCT04910269): An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19.

INSIGHT 013 ITAC (NCT04546581): An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19.

InVITE (NCT05096091): A multicenter study of COVID-19 vaccine immunogenicity and durability, and breakthrough serious acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections in people who receive a COVID-19 vaccine through their country's national vaccination programs.

STRIVE E1 (NCT05605093): Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor.

STRIVE E2 (NCT05822583): Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Immune Modulation Strategy Trial.

PREGUI is a collaborative biomedical research partnership established in 2015 between the National Institute of Allergy and Infectious Diseases (NIAID) and the Ministry of Health of the Republic of Guinea. The mission of PREGUI is to improve the health and welfare of the Guinean people and people worldwide by conducting and implementing a national and international high-quality research program while building and developing sustainable research capacity in-country.

The Partnership's primary goal is to build a sustainable and clinical research program in Guinea that leverages externally funded research collaborations and generates interest within the research community. The Partnership strives to identify and prioritize research topics and publish and disseminate knowledge that influences public health in Guinea. The Partnership has built a supportive environment that provides research training and development opportunities to clinicians and researchers to enhance the research capacity within Guinea.

Conakry, Guinea’s capital, and Maferinyah, a rural town in the Forecariah prefecture, were chosen as the sites for PREGUI operations. To support research implementation and conduct, core infrastructure and capacities were built at the existing Maferinyah Training and Research Center in Rural Health, including a clinical research unit, pharmacy, participant flow area, laboratory, training and conference rooms, and biorepository, as well as facilities (water, waste, electricity, storage) management, information management capabilities.

Assessments and discussions are underway with the network's leadership to evaluate the strategic plan and determine the best approaches to support PREGUI’s growth in its next phase.

The UCRC is an initiative between the Malian Ministry of Health (MoH), the Ministry of Higher Education, University of Science, Technology and Technology of Bamako (USTTB) and NIAID.  The purpose of the collaboration is to facilitate clinical research in Mali.  The UCRC vision is to become an international clinical research center of excellence in West Africa.  Its mission is to improve the quality of healthcare nationally, regionally, and globally by facilitating excellent clinical research at international standards, strengthening research capacity and providing training.

NIAID has had a longstanding partnership with the USTTB. In 2013 the Malian MoH, recognizing this and the role of the partnership in establishing the country’s first biosafety level 3 (BSL-3) laboratory in 2006, approached NIAID to request continued support for clinical research. The UCRC houses state of the art laboratory infrastructure led by experts. The laboratories include: the Immunocore, the Molecular and Genomics, the BSL-3, the Clinical Laboratory, and a Biorepository with liquid nitrogen storage. The Immunocore includes infrastructure to support studies on humoral and cellular immunity including cutting edge flow cytometers and cell sorting. The newly renovated Molecular and Genomics laboratory includes PCR equipment and multiple sequencing platforms supporting pathogen discovery. The Molecular and Genomics works closely with the UCRC bioinformatician. The BSL-3 is one of two BSL-3 certified laboratories in Mali, capable of handling TB and samples from patients with unknown etiology. The Clinical Laboratory contains equipment essential for clinical laboratory measurements that support clinical studies and trials.   The complete UCRC research infrastructure includes core research capabilities and staff in support of scientific research, operations, data management, biorepository, pharmacy, sequencing, and diagnostic testing.

CIDI is a partnership between NIAID and Radiology and Imaging Sciences at the National Institutes of Health Clinical Center. It was established to perform basic science, translational, and clinical research on the imaging features of infectious disease. CIDI has partnered with the NIAID Integrated Research Facility at Fort Detrick, Maryland, to offer opportunities for investigators to apply advanced imaging technologies to infectious disease research.