“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,” stated 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 illness, together with a disproportionate variety of folks within the minority communities.
Researchers have reported larger charges of extreme COVID-19 and demise in folks with autoimmune illness than within the basic inhabitants. It is unclear whether or not that is attributable to the autoimmune illness, the immunosuppressive medicines taken to deal with it, or each.
The Food and Drug Administration not too long ago amended the emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines to permit the administration of an extra dose to strong organ transplant recipients and different individuals who have an equal stage of immunocompromise.
These current findings additionally counsel that an additional dose of a COVID-19 vaccine could assist some folks with autoimmune illness who take sure immunosuppressive medicines.
The new NIAID trial, referred to as COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, initially will embrace folks with one in all 5 autoimmune ailments: a number of sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis.
The immunosuppressive therapies generally taken by folks with these ailments have been related to poor immune responses to vaccines. The examine staff will enroll roughly 600 individuals ages 18 years and older at 15 to twenty websites nationwide.
Participants should have had a damaging or suboptimal antibody response to 2 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 obtained previous to enrollment.
Participants additionally should be taking one in all three immunosuppressive therapies: mycophenolate mofetil (MMF) or mycophenolic acid (MPA); methotrexate (MTX); or B cell- depleting medication.
All individuals will obtain an additional dose of the identical COVID-19 vaccine as they obtained initially. Then these individuals who’re taking MMF/MPA or MTX might be assigned at random both to proceed taking their immunosuppressive medicine with out alteration or pause taking their medicine for a brief interval earlier than and after receiving the additional vaccine dose.
The foremost purpose of the examine is to find out the proportion of individuals who’ve a considerably higher antibody response 4 weeks after receiving the additional vaccine dose than they did after their authentic vaccinations.
Study individuals might be adopted for a total of 13 months. Preliminary outcomes are anticipated in November 2021.