August 18, 2021
Many lupus patients are at risk for COVID-19 infection because of treatment with corticosteroids and other immunosuppressive medications and will be eligible for booster vaccination. However, there are large gaps in our understanding of who will benefit from the booster vaccines, what strategies will improve response to the vaccine and the best way to measure vaccine effectiveness. The Autoimmune Centers of Excellence, sponsored by the National Institute of Allergy and Infectious Diseases, has just opened a clinical trial to address many of these questions.
The trial is enrolling patients with lupus, rheumatoid arthritis, scleroderma, multiple sclerosis and pemphigus who have had a low antibody response to their primary vaccine regime and who are receiving treatment with B cell depleting therapy, mycophenolate or methotrexate. All participants that fulfill the entry criteria will receive a booster vaccine of the same type as their initial vaccine regimen and will be followed carefully for up to 48 weeks to monitor the immune response (antibody and cell-mediated) to the booster vaccine and any effects the booster has on disease activity. The study has an adaptive design which will permit adding new arms as the trial moves forward and more information is learned. The new arms may include elements such as different age groups (ages 12-18), other autoimmune diseases, additional medications and switching the type of booster vaccine given.
We encourage physicians and patients to consider enrollment in this important trial that will provide vital information about the best strategies to protect patients with lupus and other autoimmune conditions from COVID-19 infection. Two sites are currently open for enrollment, the Oklahoma Medical Research Foundation (Oklahoma City, OK) and the Feinstein Institutes for Medical Research (Manhasset, NY) and an additional 15 sites will be opening around the country in the next few weeks. We will provide contact information for new sites as they open (this information can also be found at: CT.gov NCT05000216), contact information for the sites currently open is
Oklahoma Medical Research Foundation (Oklahoma City, OK): Investigator; Dr. Judith James, email@example.com; Coordinator: Kallena Haynes, Kallena-Haynes@omrf.org, 405-271-7221
Feinstein Institutes (Manhasset, NY): Investigator: Dr. Meggan Mackay, firstname.lastname@example.org
Coordinator: Andrew Shaw, email@example.com , 516-562-2591