NIH Launches Clinical Trial Studying COVID Booster Response in Autoimmune Disease Non‐Responders

September 1, 2021

Earlier this week, the NIH announced that they are launching a new clinical trial to determine the antibody response of a booster dose in autoimmune disease patients who did not respond to an initial full dose of the COVID-19 vaccine. 

The NIH estimates that 8% of Americans live with an autoimmune disease and this population has experienced higher rates of severe disease from COVID-19 than the general population. “It is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both” (1). 

The trial will include 600 participants, 18+ years of age, living with one of five autoimmune diseases: rheumatoid arthritis, pemphigus, systemic lupus erythematosus, systemic sclerosis, or multiple sclerosis. Participants must be taking one of three immunosuppressive therapies, including mycophenolate mofetil (MMF) or mycophenolic acid (MPA), methotrexate (MTX), or B cell-depleting drugs. These immunosuppressive therapies have been associated with low antibody production after the COVID-19 vaccine. 

Participants will receive an extra dose of the same COVID-19 vaccine as their original dose (Moderna, Pfizer, or Johnson & Johnson). Participants taking MPA or MTX therapies will be assigned to continue or pause their medication before and after receiving the booster dose at random. 

Preliminary results are expected in November of this year. 





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