COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
Public ClinicalTrials.gov record NCT05000216. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT05000216
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 258 participants
Conditions and interventions
Conditions
Interventions
- Moderna mRNA-1273 Biological
- BNT162b2 Biological
- Ad26.COV2.S Biological
- Continue IS (MMF or MPA) Drug
- Continue IS (MTX) Drug
- Continue IS (B cell depletion therapy) Biological
- Monovalent [B.1.351] CoV2 preS dTM-AS03 Biological
- Withhold IS (MMF or MPA) Drug
- Withhold IS (MTX) Drug
- Withhold IS (B cell depletion therapy) Drug
- Moderna mRNA-1273, Bivalent Biological
- BNT162b2, Bivalent Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 2 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 13, 2021 (Actual)
- Primary completion
- Jun 22, 2023 (Actual)
- Completion
- Mar 28, 2024 (Actual)
- Last update posted
- Jun 10, 2026
2021 – 2024
United States locations
- U.S. sites
- 29
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center: Division of Rheumatology | Los Angeles | California | 90095 | — |
| Yale University School of Medicine: Rheumatology, Allergy & Immunology | New Haven | Connecticut | 06519 | — |
| The Emory Clinic: Division of Rheumatology | Atlanta | Georgia | 30322 | — |
| Indiana University Medical Center, Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases | Boston | Massachusetts | 02114 | — |
| Boston Children's Hospital: Department of Pediatrics, Rheumatology Program | Boston | Massachusetts | 02115 | — |
| Brigham & Women's Hospital: Department of Medicine, Rheumatology, Immunology | Boston | Massachusetts | 02115 | — |
| University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology | Ann Arbor | Michigan | 48109 | — |
| Washington University School of Medicine in St. Louis: Division of Rheumatology | St Louis | Missouri | 63110 | — |
| Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases | Manhasset | New York | 11030 | — |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | — |
| New York University Langone Medical Center: Department of Medicine, Division of Rheumatology | New York | New York | 10016 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Columbia University Irving Medical Center: Department of Neurology, Multiple Sclerosis Center | New York | New York | 10032 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794-8111 | — |
| University of North Carolina Children's Hospital | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center: Division of Rheumatology and Immunology | Durham | North Carolina | 27710 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hopspital | Columbus | Ohio | 43205 | — |
| Oklahoma Children's Hospital-Pediatrics Specialties Clinic | Oklahoma City | Oklahoma | 73104 | — |
| Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program | Oklahoma City | Oklahoma | 73104 | — |
| Temple Health: Rheumatology | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina, Nexus Research Center | Charleston | South Carolina | 29425 | — |
| Medical University of South Carolina, Shawn Jenkins Children's Hospital | Charleston | South Carolina | 29425 | — |
| UT Southwestern (Peds) | Dallas | Texas | 75325 | — |
| University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics | Houston | Texas | 77030 | — |
| Benaroya Research Institute at Virginia Mason: Internal Medicine | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05000216, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05000216 live on ClinicalTrials.gov.