This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune
response to different COVID-19 vaccine booster doses in participants with autoimmune disease
requiring immunosuppressive medications. All study participants will have negative serologic
or sub-optimal responses (defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result 50
U/mL) to initial COVID-19 vaccine regimen with Moderna COVID-19 vaccine, Pfizer-BioNTech
COVID-19 vaccine, or Janssen COVID-19 vaccine.
The study will initially focus on 5 autoimmune diseases:
Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis (RA)
Multiple Sclerosis (MS)
Systemic Sclerosis (SSc), and
In this study, participants will be assigned to one of 3 cohorts based on their
Cohort A: Receipt of MMF or MPA ( other rheumatic disease medications, including
--Participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA),
without additional B cell depleting medications or methotrexate (MTX), will be placed in
Cohort B: Receipt of MTX ( other rheumatic disease medications, including biologics)
--Participants who are taking MTX (without additional B cell depleting medications or
MMF/ MPA) will be placed in this cohort.
Cohort C: Receipt of B cell depletion therapy within the past 12 months ( other
rheumatic disease medications) --Participants taking B cell depletion medications,
regardless of whether they are also taking MMF or MTX, will be placed in this cohort.
Treatment Arms: Participants in Cohorts A, B, and C will be assigned to receive a booster of
the same vaccine as their original vaccine series (Moderna COVID-19 vaccine, Pfizer-BioNTech
COVID-19 vaccine, or Janssen COVID-19 vaccine).
Participants in Cohorts A and B will be randomized into two immunosuppressive medication (IS)
treatment plans as follows:
Participants continue to take their immunosuppressive medications without alterations in
schedule and dosing.
Participants withhold their immunosuppressive medications before and after the booster,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.