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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: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extr
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 |
Why NCT05000216 stopped before completion
NCT05000216 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher).
The record links to 0 conditions, and to 5 interventions - of which BNT162b2 is the first listed.
NCT05000216 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05000216's enrollment target sits among peer trials
258 212th of 2000 higher than 1,787 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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