COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Frequency and grade of any unsolicited AEs (including 'significant disease flares'*)
研究概览
简要总结
This study will evaluate the Moderna RNA-based COVID-19 vaccine currently approved by Health Canada in people with rheumatic diseases. This study will help understand what the side effects of the vaccine in these patients are, and what is their capacity to develop antibodies that may confer protection from the COVID-19 disease.
详细描述
The purpose of this study is to evaluate the safety, local reactions (reactogenicity), capacity to form antibodies against the coronavirus (immunogenicity) and long-term persistence of those antibodies following two doses of a Health Canada approved RNA-based COVID-19 vaccine in patients with rheumatic diseases.
Two doses from the Moderna vaccine will be administered intramuscularly. The time between dose 1 and dose 2 of the vaccine will be 28 days.
This research study will recruit 220 participants (165 patients and 55 healthy controls), men and women, aged 18 years or older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(all of the following):
- •Adults ages 18 years and older;
- •For the cases, established diagnosis of:
- •RA done by a rheumatologist according to the 2010 American College of Rheumatology (ACR) /European League Against Rheumatism (EULAR) criteria, OR
- •SLE done by a rheumatologist according to the 1997 revised ACR criteria and/or the 2013 SLICC lupus classification criteria and/or the 2019 EULAR/ACR criteria;
- •For the cases, stable treatment (≥3 months prior to enrollment for biologics/small molecules and MMF; >3 weeks of a specific dose in case of steroids);
- •For the controls, people without a diagnosis of a chronic rheumatic disease who can have comorbidities as in patients with rheumatic diseases;
- •Able to comprehend the investigational nature of the protocol and provide informed consent;
- •Male or non-pregnant female;
- •Women of childbearing potential must agree to use at least one acceptable primary form of contraception.
排除标准
- •(any of the following):
- •Positive pregnancy test either at screening or just prior to each vaccine administration.
- •Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
- •Acute illness, as determined by the site PI or appropriate sub-investigator, with or without fever [oral temperature >38.0°C (100.40F)] within 72 hours prior to each vaccination.
- •Diagnosis of hepatitis B, hepatitis C virus, or human immunodeficiency virus (HIV).
- •History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
- •Participation in another clinical trial or plan to do so during the study. If a patient was on a drug trial, recruitment could occur following 2 half-lives of the study drug.
- •Vaccines within the 2 weeks prior to any dose of COVID-19 vaccine or until 30 days after any dose of COVID-19 vaccine.
- •Lactating female.
- •Immunoglobulin therapy or blood products within the past month.
- •Prior diagnosis of COVID-19 in the past 3 months.
- •Planned changes in baseline drug treatments (except prednisone) for rheumatic diseases prior to D
- •For patients required to be on cohort 8: Planned reduction of prednisone dose below 10 mg prior to D21.
研究组 & 干预措施
Vaccine
Study participants (People with rheumatic diseases and age matched controls).
干预措施: Moderna COVID-19 vaccine (Biological)
结局指标
主要结局
Frequency and grade of any unsolicited AEs (including 'significant disease flares'*)
时间窗: during the 28-day follow-up period post-each vaccine dose.
\* 'Significant' disease flares: defined as worsening of clinical disease activity documented by the treating physician and requiring intensification of therapy.
Frequency and grade of each solicited local and systemic adverse events (AEs)
时间窗: during a 7-day follow-up period post each vaccination
次要结局
- Geometric mean titer (GMT) of antibody(at Day 57)
- Percentage of patients who seroconverted(baseline and Day 57)
- Geometric mean fold rise (GMFR) in IgG titer(baseline and Day 57)
研究者
Ines Colmegna
MD, Associate Professor, Rheumatology - Department of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre