Tracking the Immune Response to SARS-CoV-2 modRNA Vaccines in an Open-label Multicenter Study in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab s.c. (KYRIOS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine
研究概览
简要总结
This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.
详细描述
This was a four cohort, multicenter, open-label, prospective study of 34 (optionally up to 60) patients who had relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA vaccination (initial vaccinations or booster vaccines) as part of clinical routine. The maximal duration of the study for an individual patient was 22 months.
- The first cohort was RMS patients receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine prior to starting ofatumumab treatment.
- The second cohort was participants receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine while already stable on ofatumumab treatment for at least 4 weeks (since first dose).
Cohort 1a - Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
Cohort 1b - Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
Cohort 2a - Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing Multiple Sclerosis (RMS) diagnosis
- •eligible for ofatumumab treatment
- •willing and eligible to receive SARS-CoV-2 mRNA vaccine
排除标准
- •known prior or current COVID-19 infection
- •previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab
- •no previous vaccination with a non-modRNA SARS-CoV-2 vaccine.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Cohort 1a
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
干预措施: Ofatumumab (Drug)
Cohort 1b
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
干预措施: Ofatumumab (Drug)
Cohort 2a
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
干预措施: Ofatumumab (Drug)
Cohort 2b
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine
时间窗: 1 month after second dose of vaccine or booster vaccine
Participants who established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either 1 month after second dose of vaccine or 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment.
次要结局
- Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine(At Week 1, Months 6, 12 and 18 after second dose of vaccine or 1 Month after 1st booster, 1 Month after 2nd booster)
- Increase in Specific T-cells After Receiving an modRNA Booster Vaccine(Last value before booster to 1 month after booster)
- Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)(Baseline, Week 1 after Vacc, Month 1, 6, 12 after Vacc, 1 month after 1st booster, 1 month after 2nd booster)
- SARS-CoV-2 Specific CD4+ Effector Memory T-cells(Baseline, Months 1 ,6, 12 and 18 after vaccinationse of vaccine or 1,6 and 12 months after booster vaccine)