Two D.C.-area facilities are recruiting volunteers to test the efficacy of different doses of a monkeypox vaccine with the hope that they can stretch available supplies.
The National Institutes of Health, in Bethesda, Maryland, and George Washington University, in D.C., are among eight locations conducting the trials across the U.S.
“We are looking for anyone between the ages of 18 and 50,” said Dr. David Diemert, director of the George Washington University Vaccine Research Unit. “You do not need to be at increased risk of monkeypox, because we’re really just looking at the antibody response. So pretty much anyone can give us an answer to that question.”
The Food and Drug Administration has given emergency use authorization for monkeypox vaccines inserted between skin layers — known as intradermal dosing — at one-fifth of the dose, as well as deeper, subcutaneous, injections between the skin and muscle.
“We’re looking at the dose that’s been authorized under emergency use by the FDA as an intradermal dose. But we’re also looking at a smaller dose than that to see if it can get equivalent antibody responses. So we can stretch out the number of doses even further,” Diemert said.
Every participant will receive the vaccine.
“There is an altruistic part to this; you could be helping out in a big way to increase the supply of vaccine in the country,” Diemert said. “And then you also are getting the vaccine, so potentially will be protected as well.”
The trial involves a total of seven visits involved spread over a year; most will be during the first couple of months. Those in the trial will receive a total of $500, if they come for all seven visits.
“We’re aiming to finish enrollment by the end of this week. So very fast, and then we’ll get the initial readout approximately two months after that. So we’re just looking at antibody responses after the second dose because this is a two-dose series. So everyone gets one dose and then another one, four weeks later, and then we check a couple of weeks after that to see what the antibody responses are in the space of a few months that will have an answer,” Diemert explained.
Interested volunteers can find additional information on the ClinicalTrials.gov website.
For more information on the trials in D.C. at George Washington University Medical Faculty Associates, call (202) 994-1599 or email gwvru@gwu.edu.
For more information on the trials in Bethesda, Maryland, at the National Institutes of Health — Clinical Center, National institute of Allergy and Infectious Diseases Laboratory of Immunoregulation, Clinical Research Section, call (800) 411-1222 or email ccopr@nih.gov.
The research is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
