COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

Stopped early · Phase 2

Conditions studied: Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS), Systemic Sclerosis (SSc), Pediatric SLE, Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Pediatric-Onset Multiple Sclerosis (POMS)

In brief

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)

Key facts

Study ID

NCT05000216

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

258

Starts

2021-08-13

Expected to finish

2024-03-28

Last updated by the study team

2026-06-10

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
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• 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).
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• 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.
• If enrolling in the BCDT cohort, the participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months.
• No changes in background IS medications, including MMF/MPA or MTX, in the 4 weeks prior to Screening, excluding the following:
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• HCQ,
• Intraarticular steroids,
• The addition of prednisone at ≤10mg per day or prednisone at any dose when given for ≤3 days, and
• Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or COPD, are permitted.
• Adult General Exclusion Criterion 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
• Adult female participants who are planning a pregnancy during the course of the trial.
• Adult Stage 1-Specific Inclusion Criterion 5. Negative or suboptimal serologic response to initial COVID-19 vaccine regimen, defined as an Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL, at Screening visit.
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• Initial COVID-19 vaccine regimen is defined as either:
• i.2 doses of the Pfizer-BioNTech COVID-19 Vaccine ii. 2 doses of the Moderna COVID-19 Vaccine
• Adult Stage 1-Specific Exclusion Criterion 7. Receipt of a COVID-19 vaccine booster prior to Screening with the Moderna COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, or Janssen COVID-19 Vaccine.
• Adult Stage 2 (Newly Recruited)-Specific Inclusion Criteria 2. History of severe allergic reaction to the COVID-19 vaccine, or to any component of the COVID-19 vaccine, that is to be administered in Stage 2, including polysorbate for participants receiving the Sanofi-GSK COVID-19 Vaccine, or to PEG.
• Negative or suboptimal serologic response to a previous COVID 19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows:
• 3 doses of the Pfizer-BioNTech COVID-19 Vaccine
• 3 doses of the Moderna COVID-19 Vaccine
• 2 doses of the Janssen COVID-19 Vaccine

Where it is running

• UCLA Medical Center: Division of Rheumatology — Los Angeles, California, United States
• Yale University School of Medicine: Rheumatology, Allergy & Immunology — New Haven, Connecticut, United States
• The Emory Clinic: Division of Rheumatology — Atlanta, Georgia, United States
• Indiana University Medical Center, Riley Hospital for Children — Indianapolis, Indiana, United States
• Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases — Boston, Massachusetts, United States
• Boston Children's Hospital: Department of Pediatrics, Rheumatology Program — Boston, Massachusetts, United States
• Brigham & Women's Hospital: Department of Medicine, Rheumatology, Immunology — Boston, Massachusetts, United States
• University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology — Ann Arbor, Michigan, United States
• Washington University School of Medicine in St. Louis: Division of Rheumatology — St Louis, Missouri, United States
• Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases — Manhasset, New York, United States
• Feinstein Institute for Medical Research — Manhasset, New York, United States
• New York University Langone Medical Center: Department of Medicine, Division of Rheumatology — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University Irving Medical Center: Department of Neurology, Multiple Sclerosis Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• University of North Carolina Children's Hospital — Chapel Hill, North Carolina, United States
• Duke University Medical Center: Division of Rheumatology and Immunology — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Nationwide Children's Hopspital — Columbus, Ohio, United States
• Oklahoma Children's Hospital-Pediatrics Specialties Clinic — Oklahoma City, Oklahoma, United States
• Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program — Oklahoma City, Oklahoma, United States
• Temple Health: Rheumatology — Philadelphia, Pennsylvania, United States
• University of Pennsylvania Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina, Nexus Research Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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