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.
OMRF Vice President of Clinical Affairs and Arthritis and Clinical Immunology Research Program Chair Judith James, M.D., Ph.D., 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.
NIAID selected OMRF as one of the lead trial sites due to its designation as an Autoimmunity Center of Excellence, one of just 10 in the nation. James, an immunologist and board-certified rheumatologist, is internationally recognized for her work on autoimmune conditions. Since the earliest months of the pandemic, she’s led a team investigating the body’s immune response to Covid-19.
The first Oklahoman to enroll in the trial was Darrell Barnett, a patient in OMRF’s Multiple Sclerosis Center of Excellence.
“When I heard about the extra dose for people who had low antibodies, I wanted to come in right away. I want to do anything I can do to help,” said Barnett. “It feels awesome that this might mean things can go back to normal.”
An estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most severely impacted by Covid-19. Researchers have reported higher rates of severe Covid-19 and death in people with autoimmune disease than in the general population. It is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.
“We’re concerned about people with autoimmune conditions because they are more likely to have breakthrough episodes of Covid even when fully vaccinated due to an inadequate antibody response to their original vaccine regimen,” said James, who holds the Lou C. Kerr Chair in Biomedical Research at OMRF. “In this study we are testing whether giving these people an extra vaccine dose, potentially while pausing their autoimmune disease medicines, will elicit a stronger antibody response without flaring their autoimmune disease.”
The study team will enroll approximately 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 must also be taking one of three immunosuppressive therapies: mycophenolate mofetil or mycophenolic acid, methotrexate, or B cell-depleting drugs such as rituximab or ocrelizumab.
All participants will get an extra dose of the same Covid-19 vaccine as they received initially. Participants taking MMF/MPA or MTX will be randomly assigned to continue taking their immunosuppressive medication without alteration or to pause taking their medication for a short period before and after receiving the extra vaccine dose.
Samples collected from all participants over the next 13 months will be processed and stored at OMRF. Preliminary results are expected in November 2021.
Those who are interested in volunteering for the trial can get more information by calling OMRF at 405-271-7745.
For more information about the Covid-19 Booster Vaccine in Autoimmune Disease Non-Responders trial, read the NIAID announcement or visit www.clinicaltrials.gov and search for National Clinical Trial No. NCT05000216.