COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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
- Pemphigus.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Autoimmunity Centers of Excellence Rho Federal Systems Division, Inc.