# COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

> **NCT05000216** · PHASE2 · TERMINATED · sponsor: **National Institute of Allergy and Infectious Diseases (NIAID)** · enrollment: 258 (actual)

## Conditions studied

- Rheumatoid Arthritis (RA)
- Systemic Lupus Erythematosus (SLE)
- Pemphigus Vulgaris
- Multiple Sclerosis (MS)
- Systemic Sclerosis (SSc)
- Pediatric SLE
- Juvenile Idiopathic Arthritis (JIA)
- Juvenile Dermatomyositis (JDM)
- Pediatric-Onset Multiple Sclerosis (POMS)

## Interventions

- **BIOLOGICAL:** Moderna mRNA-1273
- **BIOLOGICAL:** BNT162b2
- **BIOLOGICAL:** Ad26.COV2.S
- **DRUG:** Continue IS (MMF or MPA)
- **DRUG:** Continue IS (MTX)
- **BIOLOGICAL:** Continue IS (B cell depletion therapy)
- **BIOLOGICAL:** Monovalent [B.1.351] CoV2 preS dTM-AS03
- **DRUG:** Withhold IS (MMF or MPA)
- **DRUG:** Withhold IS (MTX)
- **DRUG:** Withhold IS (B cell depletion therapy)
- **BIOLOGICAL:** Moderna mRNA-1273, Bivalent
- **BIOLOGICAL:** BNT162b2, Bivalent

## Key facts

- **NCT ID:** NCT05000216
- **Lead sponsor:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Sponsor class:** NIH
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2021-08-13
- **Primary completion:** 2023-06-22
- **Final completion:** 2024-03-28
- **Target enrollment:** 258 (ACTUAL)
- **Why stopped:** The study was closed due to continued enrollment hurdles.
- **Last updated:** 2025-08-22

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05000216

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05000216, "COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05000216. Licensed CC0.

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