COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
What is the purpose of this trial?
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
- Ages18 years and older
- Trial withEmory University
- Start Date12/16/2021
- End Date01/31/2022
- Last Updated01/04/2022
- Study HIC#2000031152