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 range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether a COVID-19 booster is still a good idea for me given my autoimmune condition?
2Since this was a Phase 2 study focused on people with autoimmune diseases like mine who didn't respond well to initial COVID-19 vaccines, how do you assess my own antibody response, and should I be getting tested to see if I have adequate protection right now?
3The trial was measuring whether a booster could produce a 'protective antibody response' in people on immunosuppressive therapies — given the medications I'm currently taking, how likely is it that my immune system can mount that kind of response to a booster?
4Because this trial included both adult and pediatric patients across several autoimmune conditions including RA, SLE, and MS, are the findings or treatment approaches from similar research relevant to my specific diagnosis and age group?
5Given that this trial was terminated, are there other active studies or standard-of-care recommendations for COVID-19 booster strategies in people with autoimmune diseases that you think might be a better path for me to consider?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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).
. 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.