ClinicalTrials.gov record
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
ClinicalTrials.gov ID: NCT05000216
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.
ClinicalTrials.gov public records Last synced May 20, 2026, 8:43 AM EDT
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)
Study identification
- NCT ID
- NCT05000216
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- NIH
- Enrollment
- 258 participants
Conditions and interventions
Conditions
Interventions
- Ad26.COV2.S Biological
- BNT162b2 Biological
- BNT162b2, Bivalent Biological
- Continue IS (B cell depletion therapy) Biological
- Continue IS (MMF or MPA) Drug
- Continue IS (MTX) Drug
- Moderna mRNA-1273 Biological
- Moderna mRNA-1273, Bivalent Biological
- Monovalent [B.1.351] CoV2 preS dTM-AS03 Biological
- Withhold IS (B cell depletion therapy) Drug
- Withhold IS (MMF or MPA) Drug
- Withhold IS (MTX) Drug
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 12, 2021
- Primary completion
- Jun 21, 2023
- Completion
- Mar 27, 2024
- Last update posted
- Aug 21, 2025
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 Aug 21, 2025 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05000216 live on ClinicalTrials.gov.