Clinical trialNCT05000216TerminatedPhase 2Interventional

COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment258Juvenile Dermatomyositis (JDM)Juvenile Idiopathic Arthritis (JIA)Multiple Sclerosis (MS)Pediatric SLEPediatric-Onset Multiple Sclerosis (POMS)Pemphigus Vulgaris+3 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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)

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Amit Bar-Or, MD, FRCP
Center for Neuroinflammation and Neurotherapeutics, Perelman School of Medicine, University of Pennsylvania
Study Chair
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Dinesh Khanna, MBBS, MSc
University of Michigan Health, Michigan Medicine
Study ChairKOL profile →
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Judith A. James, MD, PhD
Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation
Study ChairKOL profile →
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Meggan C. Mackay, MD, MS
Center of Autoimmune Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research
Study ChairKOL profile →
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Natasha Mckerran Ruth, MD
Medical University of South Carolina, Pediatric Rheumatology
Study Chair
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Stacy Ardoin, MD
Nationwide Children's Hospital Rheumatology Department
Study Chair
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Tracey Wright, MD
UT Southwestern Medical Center, Pediatric Rheumatology
Study Chair
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Virginia Pascual, MD
Drukier Institute for Children's Health, Weill Cornell Medical College
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

29 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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
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
Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases
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
Manhasset, New York, United States
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
Manhasset, New York, United States
Columbia University Irving Medical Center: Department of Neurology, Multiple Sclerosis Center
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
New York University Langone Medical Center: Department of Medicine, Division of Rheumatology
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
Medical University of South Carolina, Shawn Jenkins Children'S Hospital
Charleston, South Carolina, United States
Ut Southwestern (peds)
Dallas, Texas, United States
University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics
Houston, Texas, United States
Benaroya Research Institute at Virginia Mason: Internal Medicine
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

SARS-COV-2 (COVID-19) vaccine, vector non-replicatingBNT162b2BNT162b2, BivalentContinue ISModerna mRNA-1273Moderna mRNA-1273, BivalentMonovalent [B.1.351] CoV2 preS dTM-AS03Withhold IS

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 13 Aug 2021
Primary completion: 22 Jun 2023
Completion: 28 Mar 2024
Last update posted: 10 Jun 2026
Registered enrollment: 258
Registry id: NCT05000216

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.