It is estimated that up to 41 million people in the United States suffer from autoimmune diseases, which prompt their immune systems to mistakenly attack organs and tissues. These diseases — such as type 1 diabetes and rheumatoid arthritis — are often treated with medicines that reduce immune system activity. Vaccines work by triggering a strong immune response, making antibodies that help the body recognize and fight bacteria and viruses. However, researchers have found that many people with autoimmune diseases are not responding to the current COVID-19 vaccine regimens, and this lack of response puts them at risk of severe infection. A new trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID) is looking at ways to help people with autoimmune diseases benefit from COVID-19 vaccines.
As part of the Phase 2 trial, researchers are enrolling approximately 600 people age 18 years and older at 15 to 20 sites around the country. People are eligible for the study if their immune systems did not respond to one of the approved vaccine regimens or if they had a weak response. The study includes people being treated for one of five autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis. The immunosuppressive therapies commonly taken by people with these diseases have been associated with poor immune responses to vaccines. All participants in the study receive an additional dose (booster vaccination) of the same COVID-19 vaccine they originally received. Participants are then assigned at random to either continue their immune-suppressing medication as usual or briefly pause their medication. Researchers will measure each person’s antibody response after four weeks and see which group has the better response. Preliminary results are expected in November 2021.
COVID-19 vaccines were rigorously tested for people with healthy immune systems. The answers from this study are needed to ensure that people with autoimmune diseases can be protected from SARS-CoV-2, the virus that causes COVID-19.