COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
第2相
早期終了
NCT05000216
| 対象疾患 | Rheumatoid Arthritis, Systemic Lupus Erythematosus, Pemphigus Vulgaris, Multiple Sclerosis |
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| 相 | 第2相 |
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| スポンサー | National Institute of Allergy and Infectious Diseases (NIAID) |
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| ステータス | 早期終了 |
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| 参加者数 | 258 名 |
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| 介入（薬剤） | Moderna mRNA-1273, BNT162b2, Ad26.COV2.S, Continue IS (MMF or MPA), Continue IS (MTX) |
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| 開始日 | 2021年8月13日 |
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| 完了日 | 2023年6月22日 |
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| 結果公開日 | 2025年8月22日 |
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概要
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)
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4
Week 4 Status Post Receipt of COVID-19 Vaccination · Percentage of participants
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | NA Percentage of participants |
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| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | NA Percentage of participants |
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| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | NA Percentage of participants |
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| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | NA Percentage of participants |
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| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | NA Percentage of participants |
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| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | NA Percentage of participants |
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Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4
Week 4 Status Post Receipt of COVID-19 Vaccination · Percentage of participants
| Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | NA Percentage of participants |
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| Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | NA Percentage of participants |
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| Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | NA Percentage of participants |
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| Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | NA Percentage of participants |
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| Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | NA Percentage of participants |
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| Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | NA Percentage of participants |
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Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4
Week 4 Status Post Receipt of COVID-19 Vaccination · Percentage of participants
| Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | NA Percentage of participants |
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| Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | NA Percentage of participants |
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| Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | NA Percentage of participants |
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| Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | NA Percentage of participants |
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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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