New Study of Extra COVID-19 Vaccine Dose in People With Autoimmune Disease

Stained scanning electron micrograph of a cell (blue) infected with SARS-CoV-2 (purple). Credit: NIAID

The trial will also test pausing immunosuppressive medications to enhance antibody response.

The National Institutes of Health has begun a clinical trial to assess antibody response to an additional dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who failed to respond to an original COVID-19 vaccine regimen. The trial will also examine whether pausing immunosuppressive therapy for autoimmune diseases improves the antibody response to an additional dose of a COVID-19 vaccine in this population. The Phase 2 study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and is being conducted by the NIAID-funded Autoimmunity Centers of Excellence.

“Many people with autoimmune disease requiring immunosuppressive therapy have had a poor immune response to the authorized and approved COVID-19 vaccines, putting these individuals at high risk for the disease,” said NIAID Director Anthony S. Fauci , MD. are determined to find ways to elicit a protective immune response against the vaccines in this population. This new study is an important step in that direction.”

An estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most affected 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’s unclear whether this is due to the autoimmune disease, the immunosuppressive drugs used to treat it, or both.

The results of recent studies indicate that giving an additional dose of an authorized COVID-19 vaccine to solid organ transplant recipients, who must take immunosuppressive medications, may improve the immune response to the vaccine in many of these individuals. An NIAID investigation is underway to investigate this further. The recent findings in solid organ transplant recipients also suggest that an extra dose of a COVID-19 vaccine may help some people with autoimmune disease who are taking certain immunosuppressive drugs. The Food and Drug Administration recently changed emergency authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow the administration of an additional dose to solid organ transplant recipients and other people with an equivalent level of immune compromise.

The new NIAID study, called COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders, will initially include people with one of five autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis . The immunosuppressive therapies commonly taken by people with these diseases have been linked to a poor immune response to vaccines.

The research team will enroll approximately 600 participants ages 18 and older at 15 to 20 locations nationwide. Entrants must have had a negative or suboptimal antibody response to two doses of the Moderna COVID-19 vaccine, two doses of the Pfizer-BioNTech COVID-19 vaccine, or one dose of the Johnson & Johnson COVID-19 vaccine, all received prior to registration. Participants must also take one of three immunosuppressive therapies: mycophenolate mofetil (MMF) or mycophenolic acid (MPA); methotrexate (MTX); or B-cell-degrading drugs.

All participants will receive an additional dose of the same COVID-19 vaccine as they originally received. Then the participants taking MMF/MPA or MTX will be randomly assigned to either continue taking their immunosuppressive medication without modification or to pause their medication for a short period before and after receiving the additional vaccine dose. The main goal of the study is to determine the percentage of participants who had a significantly better antibody response four weeks after receiving the additional vaccine dose than after their original vaccinations.

Study participants will be followed for a total of 13 months. The first results are expected in November 2021.

The COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders Study is led by Judith James, MD, Ph.D., Meggan Mackay, MD, MS, Dinesh Khanna, MBBS, M.Sc. and Amit Bar-Or, MD, FRCPC Dr. James is vice president of clinical affairs and program chair of the Oklahoma Medical Research Foundation’s Arthritis & Clinical Immunology research program in Oklahoma City. dr. Mackay is a professor at the Institute of Molecular Medicine at the Feinstein Institutes for Medical Research in Manhasset, New York. dr. Khanna is the Frederick GL Huetwell Professor of Rheumatology and the Director of the Scleroderma Program in the Department of Internal Medicine at the University of Michigan in Ann Arbor. dr. Bar-Or is the director of the Center for Neuroinflammation and Neurotherapeutics, chief of the division of multiple sclerosis, and the Distinguished Professor of Melissa and Paul Anderson at the University of Pennsylvania in Philadelphia.

Additional information about the COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders study, including study site locations, is available on ClinicalTrials.gov under study identifier NCT05000216.