COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
Stopped: The study was closed due to continued enrollment hurdles.
United States258 participantsStarted 2021-08-13
Plain-language summary
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result \>200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine.
The study will focus on 5 autoimmune diseases in adults:
* Systemic Lupus Erythematosus (SLE)
* Rheumatoid Arthritis (RA)
* Multiple Sclerosis (MS)
* Systemic Sclerosis (SSc), and
* Pemphigus.
This study will focus on 4 autoimmune diseases in pediatric participants:
* Systemic Lupus Erythematosus (SLE)
* Juvenile Idiopathic Arthritis (JIA)
* Pediatric-Onset Multiple Sclerosis (POMS)
* Juvenile Dermatomyositis (JDM)
Who can participate
Age range2 Years
SexALL
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Exclusion criteria
✕. An increase/addition of any IS medications, or
✕. A suggestion of MS relapse per the investigator. 6. Recent or current SARS-CoV-2 infection defined as:
✕. Documented SARS-CoV-2 infection in the past 30 days (from the day the participant is diagnosed by positive test to Screening).
✕. Positive result on a molecular COVID-19 test at Screening. 8. Inflammatory myocarditis/pericarditis within 6 weeks of any COVID-19 vaccine doses.
✕. Individuals 18 years of age or older that meet classification criteria for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), rheumatoid arthritis (RA), multiple sclerosis (MS), or pemphigus
✕. Participants must meet the 2019 ACR/EULAR or 2012 SLICC classification criteria for SLE, the 2010 ACR/EULAR classification criteria for RA, the 2013 EULAR/ACR classification criteria for SSc, the 2017 McDonald criteria for MS, and the international consensus criteria for pemphigus.
✕. If a participant has been diagnosed with more than one autoimmune disease, the participant will be assessed based on the disease that is selected for study entry 6. Must be currently taking one of the following IS medications with or without additional disease-related medications: MMF (minimum of 1000 mg per day)/MPA (minimum of 720 mg per day), MTX (minimum of 7.5mg per week), or B cell depleting agents within the past 18 months (such as rituximab, ocrelizumab, ofatumumab).
What they're measuring
1
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4
Timeframe: Week 4 Status Post Receipt of COVID-19 Vaccination
2
Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4
Timeframe: Week 4 Status Post Receipt of COVID-19 Vaccination
3
Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4
Timeframe: Week 4 Status Post Receipt of COVID-19 Vaccination
Trial details
NCT IDNCT05000216
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. If taking MMF/MPA or MTX, the participant must have initiated therapy at least 8 weeks prior to randomization and be taking the same medications (regardless of dose) as at the time of the initial COVID-19 vaccine regimen. Note: Participants who withheld their IS medications around their initial vaccinations are eligible to participate.