Immunogenicity and Safety of the CoronaVac Vacccine in Patients With Autoimmune Rheumatic Diseases and People Living With HIV/AIDS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,196
- 试验地点
- 2
- 主要终点
- Immunogenicity 2
研究概览
简要总结
Patients with chronic rheumatic diseases (such as systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], ankylosing spondylitis [AS], juvenile idiopathic arthritis [JIA], poly/dermatomyositis [PM/DM], systemic sclerosis [SSc], systemic vasculitis, and primary Sjögren's syndrome [pSS]) are particularly susceptible to infectious diseases due to autoimmune disorder itself and its treatment (immunosuppressive therapies). Similarly, people living with HIV/AIDS (PLWHA) are predisposed to infections by different agents.
The current 2019 Coronavirus Disease Pandemic-19 (COVID-19), caused by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) began in December 2019 in Wuhan, China, and quickly became a global health and economic emergency by taking to an unprecedented burden on health systems around the world.
However, SARS-Cov-2 infection raised particular concern in patients with autoimmune rheumatic diseases (DRAI) since, due to chronic inflammatory immune dysregulation and the regular use of immunosuppressive drugs, these patients are considered to be at high risk of contracting SARS-CoV-2 and potentially evolving to a worse prognosis.
The overlap between the COVID-19 pandemic and the HIV/AIDS pandemic also poses an additional challenge, as the impact of co-infection is not yet fully known. The response to vaccines for other agents, however, has already been described as compromised in PLWHA.
Vaccination is the most effective preventive measure to control the spread of coronavirus and to reduce associated complications. Usually, live or attenuated vaccines are not recommended for patients with chronic rheumatic diseases using immunosuppressants. However, immunization with inactivated agents is strongly indicated, resulting, in general, in good immunogenicity and adequate vaccine safety, as well as without relevant deleterious effects on diseases.
Vaccine efficacy studies are needed to verify the immunogenicity of the vaccine against COVID-19 in immunosuppressed patients with rheumatological disease and those with HIV-related disease considering the risk of greater severity. In addition, it is important to assess the safety of the vaccine in this population as well as the possibility of reactivating the rheumatological disease itself.
The present study will evaluate the safety and immunogenicity of the CoronaVac (Coronavirus vaccine, Sinovac Biotech Ltd.) in patients with rheumatic diseases and PLWHA
详细描述
A sample of 1254 patients with rheumatic diseases and 542 healthy controls matched for age and sex was calculated as follows.
1.A) Evaluation of patients with SLE compared to a healthy control group matched for age and sex. The investigators calculated 74 patients in each arm, which will be compared independently to the healthy control group:
- 74 SLE patients treated with hydroxychloroquine alone;
- 74 SLE patients with mild immunosuppression (azathioprine or methotrexate and prednisone <10 mg/day);
- 74 patients with moderate to severe immunosuppression (mycophenolate mofetil or cyclophosphamide and/or prednisone >10 mg/day);
- 50 patients with belimumab (convenience sample). Total: 272 SLE patients and 74 healthy controls.
1.B) Evaluation of RA patients compared to healthy controls matched for age and sex. The investigators calculated 61 patients in each arm, which will be independently compared to the control group:
- 61 RA patients only with conventional synthetic disease-modifying drugs (DMARDs);
- 61 RA patients with biological disease-modifying drugs (bDMARDs) with anti-TNF (anti-tumor necrosis factor) action;
- 61 RA patients with bDMARDs with non-anti-TNF action and with impact on the production of immunoglobulins (abatacept and rituximab);
- 61 RA patients with bDMARDs with anti-IL-6 (anti-interleukin-6) action (tocilizumab) and synthetic drugs with anti-JAK (anti-janus kinase) action (tofacitinib).
Total: 244 RA patients vs. 61 healthy controls. 1.C) Evaluation of the interruption of the use of methotrexate (MTX) for 4 weeks from the first dose of vaccination in RA patients. Inclusion: patients using MTX in a stable dose for at least 4 weeks, prednisone maximum dose of 7.5 mg/day, in association or not with other drugs, to be randomized in two arms: one that keeps the therapy stable and the other which suspends MTX for 4 weeks from the first dose. The investigators calculated 96 patients in each arm:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •RA patients according to the classification criteria of the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR).
- •Patients with axial spondyloarthritis (ASAS criteria 2009) and psoriatic arthritis (CASPAR 2012 criteria).
- •SLE patients according to the SLICC classification criteria.
- •SSc patients according to the ACR preliminary criteria.
- •Patients with inflammatory myopathies according to the Bohan and Peter's criteria.
- •Patients with primary vasculitis.
- •Patients with pSS (2002 American-European Consensus group criteria and/or 2016 classification criteria of the EULAR/ACR.
- •Patients with primary APS (primary antiphospholipid syndrome) (Sydney classification criteria).
- •Patients with HIV-related illness.
排除标准
- •History of anaphylactic response to vaccine components.
- •Acute febrile illness.
- •Guillain-Barré syndrome, decompensated heart failure (class III or IV), demyelinating disease.
- •History of live virus vaccine up to 4 weeks before, virus vaccine inactivated up to 2 weeks before.
- •History of having received blood products up to 6 months before the study.
- •Individuals who do not accept to participate in the study and/or whose guardians do not agree to participate in the study.
- •Hospitalized patients.
- •Patients with severe conditions requiring hospitalization.
结局指标
主要结局
Immunogenicity 2
时间窗: 8 months
Seroconversion rate of anti-SARS-Cov-2 IgG antibodies
Immunogenicity 1
时间窗: 8 months
Presence of ≥30% of neutralizing activity of SARS-CoV-2 antibodies
次要结局
未报告次要终点