The National Institutes of Health (NIH) began a Phase 2 clinical trial last week to investigate any antibody response generated by an extra dose of authorized/approved COVID-19 vaccines among patients with autoimmune disease who experienced no response from a previous vaccine regimen.
The results of such a trial — designated the COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders trial — could be of outsized importance for the estimated 8 percent of Americans with autoimmune disease, particularly in minority communities already severely hit by the COVID-19 pandemic. Those with autoimmune disease face higher rates of severe COVID-19 and death than the rest of the general population, although the exact cause — the disease, the immunosuppressive medications to treat it or a mix of both — is unknown.
“Many people who have an autoimmune disease that requires immunosuppressive therapy have had a poor immune response to the authorized and approved COVID-19 vaccines, placing these individuals at high risk for the disease,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said. “We are determined to find ways to elicit a protective immune response to the vaccines in this population. This new study is an important step in that direction.”
Results of recent studies have suggested an extra dose of authorized vaccines to solid organ transplant recipients, who are among those needing to take immunosuppressive medications, could improve their immune response to the vaccine. This prompted NIAID to investigate the issue further, particularly as the Food and Drug Administration (FDA) has now amended emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow an additional dose for solid organ transplant recipients and others with equivalent levels of immunocompromise.
While the extra dose will be the primary concern of the trial, researchers will also take the opportunity to investigate if pausing immunosuppressive medications could improve antibody response to COVID-19 vaccines among those with autoimmune disease. Participants will initially include approximately 600 people at least 18 years old, with one of five autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis.
The study is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID)-funded Autoimmunity Centers of Excellence, but NIAID is also its sponsor and funder. Researchers will study participants for 13 months, although preliminary results are expected in November.