Press release
Friday, August 27, 2021
The process will also test paused immunosuppressive medication to improve antibody response.
The National Institutes of Health has initiated a clinical trial to evaluate the antibody response to an additional dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen. The trial will also investigate 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 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the NIH, and is conducted by the Centers of Excellence in Autoimmunity funded by NIAID.
“Many people who have an autoimmune disease that requires immunosuppressive therapy have had a deficient immune response to authorized and approved COVID-19 vaccines, which puts these people at a high risk of developing the disease,” the NIAID director said. , Anthony S. Fauci, MD. they are determined to find ways to obtain a protective immune response to vaccines in this population. This new study is an important step in that direction. “
It is estimated that 8% of Americans have autoimmune disease, which includes a disproportionate number of people from minority communities most affected by COVID-19. Researchers have reported higher rates of severe COVID-19 and death in people with autoimmune diseases than in the general population. It is unclear whether this is attributable to autoimmune disease, the immunosuppressive drugs taken to treat it, or both.
The results of recent studies indicate that administering an additional dose of an authorized COVID-19 vaccine to solid organ transplant recipients, who must take immunosuppressive drugs, may improve the immune response to the vaccine in many of these people. . A NIAID study is underway to investigate this further. Recent findings in solid organ transplant recipients also suggest that an additional dose of a COVID-19 vaccine may help some people with autoimmune diseases who take certain immunosuppressive drugs. The Food and Drug Administration has recently amended the emergency use authorizations for Pfizer-BioNTech and Moderna COVID-19 vaccines to allow the administration of an additional dose to solid organ transplant recipients and other people who have an equivalent level of immunocompromise.
The new NIAID trial, called COVID – 19 Booster Vaccine in Autoimmune Disease Responders, will initially include people with one of five autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis. Immunosuppressive therapies commonly taken by people with these diseases have been associated with deficient immune responses to vaccines.
The study team will enroll approximately 600 participants 18 years of age or older in 15 to 20 locations nationwide. Participants must have had a negative or suboptimal antibody response to two doses of the Modern COVID-19 vaccine, two doses of the Pfizer-BioNTech COVID-19 vaccine, or one dose of the Johnson & Johnson COVID-19 vaccine. all received before registration. Participants should also take one of three immunosuppressive therapies: mycophenolate mofetil (MMF) or mycophenolic acid (MPA); methotrexate (MTX); or drugs that deplete B cells.
All participants will receive an additional dose of the same COVID-19 vaccine they originally received. Participants who are taking MMF / MPA or MTX will then be randomly assigned to continue taking their immunosuppressive medication without alterations or to pause their medication for a short period of time before and after receiving the dose of MMF / MPA or MTX. additional vaccine. The main objective of the study is to determine the proportion of participants who have a significantly better antibody response four weeks after receiving the additional vaccine dose than they obtained after the original vaccines.
Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021.
Judith James, MD, Ph.D., Meggan Mackay, MD, MS, Dinesh Khanna, MBBS, M.Sc. MD, FRCPC Dr. James is vice president of clinical affairs and program chair of the Arthritis and Clinical Immunology Research Program at the Oklahoma Medical Research Foundation in Oklahoma City. Dr. Mackay is a professor at the Institute of Molecular Medicine at the Feinstein Institute for Medical Research in Manhasset, New York. Dr. Khanna is the professor of rheumatology at Frederick GL Huetwell and the director of the scleroderma program at 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 Neurotherapy, head of the multiple sclerosis division, and the Distinguished Professor of President Melissa and Paul Anderson at the University of Pennsylvania in Philadelphia.
Additional information about COVID-19 booster vaccine in the trial that does not respond to autoimmune diseases, including study site locations, is available at ClinicalTrials.gov with study identifier NCT05000216.
NIAID conducts and supports research — at NIH, throughout the United States, and around the world — to study the causes of infectious and immune-mediated diseases and to develop better means to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other NIAID-related materials are available on the NIAID website.
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