An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level
研究概览
简要总结
Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN).
Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T cell-dependent neoantigen response].
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a confirmed diagnosis of relapsing remitting MS per the 2010 McDonald criteria.
- •Must have a known tetanus immunization history with most recent tetanus vaccination given 2 to 15 years prior to Screening and an anti-tetanus serum immunoglobulin titer at Screening that is less than or equal to one-half the upper limit of detection for the assay.
- •Must have been on a stable approved dose of Tecfidera (240 mg twice daily [BID]) [Group 1] for ≥6 months or on a stable approved dose of a non-pegylated IFN (e.g., Avonex, Betaseron, Rebif, Extavia) [Group 2] for ≥3 months prior to Day
排除标准
- •Clinical relapse requiring treatment within 30 days prior to Day
- •Pneumococcal vaccination within 5 years prior to Screening.
- •Previous exposure to meningococcal vaccines.
- •Known hypersensitivity to Td, PPSV23, or MCV4 or their components.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Non-Pegylated IFN Treated Plus Vaccinations
Participants on a stable approved dose of a non pegylated IFN for ≥3 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:
Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
干预措施: tetanus diphtheria toxoids vaccine (Biological)
Non-Pegylated IFN Treated Plus Vaccinations
Participants on a stable approved dose of a non pegylated IFN for ≥3 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:
Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
Non-Pegylated IFN Treated Plus Vaccinations
Participants on a stable approved dose of a non pegylated IFN for ≥3 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:
Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
干预措施: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) (Biological)
Non-Pegylated IFN Treated Plus Vaccinations
Participants on a stable approved dose of a non pegylated IFN for ≥3 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:
Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
干预措施: non-pegylated interferon (Drug)
Tecfidera Treated Plus Vaccinations
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥6 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:
Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
干预措施: dimethyl fumarate (Drug)
Tecfidera Treated Plus Vaccinations
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥6 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:
Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
干预措施: tetanus diphtheria toxoids vaccine (Biological)
Tecfidera Treated Plus Vaccinations
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥6 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:
Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
Tecfidera Treated Plus Vaccinations
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥6 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:
Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
干预措施: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) (Biological)
结局指标
主要结局
Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level
时间窗: Up to Week 4 (Day 28) postvaccination
Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.
次要结局
- Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level(Up to Week 4 (Day 28) postvaccination)
- Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination(Up to Week 4 (Day 28) postvaccination)
- Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination(Up to Week 4 (Day 28) postvaccination)
- Number of Participants With Shifts From Baseline in Blood Chemistry(Screening to Week 4)
- Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level(Up to Week 4 (Day 28) postvaccination)
- Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level(Up to Week 4 (Day 28) postvaccination)
- Ratio of Serum Tetanus Level at Day 28 to Prevaccination(Up to Week 4 (Day 28) postvaccination)
- Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs(Day 1 to Week 4)
- Number of Participants With Shifts From Baseline in Hematology(Screening to Week 4)
- Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level(Up to Week 4 (Day 28) postvaccination)
- Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level(Up to Week 4 (Day 28) postvaccination)
- Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination(Up to Week 4 (Day 28) postvaccination)
- Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level(Up to Week 4 (Day 28) postvaccination)
- Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level(Up to Week 4 (Day 28) postvaccination)
- Number of Participants With Abnormalities in Vital Signs(Screening to Week 4)