Did you respond poorly to original COVID-19 vaccine regimen? OMRF seeks volunteers for trial

The National Institutes of Health has named the Oklahoma Medical Research Foundation one of the lead sites for a nationwide COVID-19 vaccine clinical trial. The study will assess the antibody response to an extra vaccine dose in people living with certain autoimmune diseases who did not respond well to an original COVID-19 vaccine regimen.

Dr. Judith James, OMRF vice president of clinical affairs, is one of the study's lead investigators. The Phase 2 trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH.

The study team will enroll about 600 participants at more than a dozen sites nationwide. The study will initially include people with one of five autoimmune diseases: multiple sclerosis, rheumatoid arthritis, pemphigus, systemic sclerosis or systemic lupus erythematosus.

Participants must have a negative or suboptimal antibody response to two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccines or one dose of the Johnson & Johnson COVID-19 vaccine, all received before enrollment. Participants also must be taking one of three immunosuppressive therapies: mycophenolate mofetil or mycophenolic acid, methotrexate, or B cell-depleting drugs such as rituximab or ocrelizumab.

Those who are interested in volunteering for the trial can get more information by calling OMRF at 405-271-7745