WASHINGTON (Sept 19, 2022) - GW is one of the clinical trial sites evaluating alternative strategies for administering the JYNNEOS monkeypox vaccine to increase the number of available doses. The GW site, which has begun enrollment, is one of eight U.S. research sites across the United States, and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. GW’s participation is funded through a contract with Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research in Frederick, Maryland, which provides scientific support to the NIH.
The GW Vaccine Research Unit is a collaboration between the Departments of Medicine and Microbiology, Immunology and Tropical Medicine located at the George Washington University School of Medicine and Health Sciences, and the GW Medical Faculty Associates. The GW VRU conducts clinical trials of experimental products that are being developed for the prevention of infectious diseases.
“We are excited to be a part of this clinical trial to help stop the spread of monkeypox and learn more about the dosing methods that can keep the most people safe,” David Diemert, clinical director of the George Washington University Vaccine Research Unit and professor of medicine at the GW School of Medicine and Health Sciences, said.
Recently, the FDA issued an emergency use authorization for intradermal (between layers of the skin) administration of the vaccine for adults. This alternative intradermal dosing regimen uses one-fifth of the standard dose used for subcutaneous administration, allowing health care providers to administer up to five times the number of doses per vial of the vaccine. The goal of the clinical trial is to assess the immunogenicity, safety, and tolerability of alternative dosing approaches that would expand the current supply of vaccines.
The trial will enroll more than 200 volunteers at the following sites:
- Saint Louis University in Missouri
- Baylor College of Medicine in Houston
- Brigham and Women’s Hospital in Boston
- The NIH Clinical Center in Bethesda, Maryland
- George Washington University in Washington, D.C.
- Vanderbilt University in Nashville, Tennessee
- The Hope Clinic at Emory University in Decatur, Georgia
- The University of California, San Diego
If you are interested in enrolling at GW’s site, please email [email protected], call 202.994.1599 or go to https://redcap.link/doses. For general information, visit clincialtrials.gov and search identifier NCT05512949. Please do not call or email the NIAID News and Science Writing Branch to inquire about enrolling in this trial.
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