“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,” said NIAID Director Anthony S. Fauci, M.D.
‘A new clinical Trial will test pausing immunosuppressive medication can improve antibody response to COVID-19.’
An estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities.
Researchers have reported higher rates of severe COVID-19 and death in people with autoimmune disease than in the general population. It is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.
The Food and Drug Administration recently amended the emergency use 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 who have an equivalent level of immunocompromise.
These recent findings also suggest that an extra dose of a COVID-19 vaccine may help some people with autoimmune disease who take certain immunosuppressive medications.
The new NIAID trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, initially will 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 associated with poor immune responses to vaccines. The study team will enroll approximately 600 participants ages 18 years and older at 15 to 20 sites nationwide.
Participants 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 enrollment.
Participants also must be taking one of three immunosuppressive therapies: mycophenolate mofetil (MMF) or mycophenolic acid (MPA); methotrexate (MTX); or B cell- depleting drugs.
All participants will receive an extra dose of the same COVID-19 vaccine as they received originally. Then those participants who are taking MMF/MPA or MTX will be assigned at random either to continue taking their immunosuppressive medication without alteration or pause taking their medication for a short period before and after receiving the extra vaccine dose.
The main goal of the study is to determine the proportion of participants who have a significantly better antibody response four weeks after receiving the extra vaccine dose than they did after their original vaccinations.
Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021.
Source: Medindia
