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NCT05000216 · ClinicalTrials.gov registry record · Phase 2
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 258
- Enrollment target
NCT05000216 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 258 participants.
The verdict
NCT05000216, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 258 participants
- Enrollment target
Study 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)
Interventions
- BIOLOGICAL BNT162b2
- BIOLOGICAL Ad26.COV2.S
- BIOLOGICAL Moderna mRNA-1273
- DRUG Continue IS (MMF or MPA)
- DRUG Continue IS (MTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2021-08-13 |
| Est. Completion | 2024-03-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05000216
The ClinicalTrials.gov registry entry for NCT05000216 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which BNT162b2 is the first listed.
NCT05000216 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05000216 about?
NCT05000216 is a clinical study titled "COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders". 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...
What is the current status of trial NCT05000216?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2021-08-13. Estimated completion is 2024-03-28.
What interventions are being tested in trial NCT05000216?
The interventions under investigation include: BNT162b2 (BIOLOGICAL), Ad26.COV2.S (BIOLOGICAL), Moderna mRNA-1273 (BIOLOGICAL), Continue IS (MMF or MPA) (DRUG), Continue IS (MTX) (DRUG).
Who is sponsoring clinical trial NCT05000216?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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