The Efficacy of COVID-19 Vaccine in Patients With HIV Infection，a Prospective and Multicenter Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
研究概览
简要总结
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with HIV may be at higher risk than those without HIV for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of coronavirus vaccine for patients with HIV.
详细描述
This study is a prospective, single-arm, open-label clinical trial. A total of 200 patients with HIV infection were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years and less than 60 years
- •Patients diagnosed as HIV infection with viral inhibition or preparing to start antivirus therapy were included .
- •The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.
排除标准
- •Patients with acute attack of chronic diseases.
- •Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
- •Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
- •Pregnant or lactating women.
- •Suffering serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
- •Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / uroedema.
- •Patients who are receiving immunosuppressants such as glucocorticoid.
结局指标
主要结局
The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
时间窗: Within 2 months after the first dose of COVID-19 vaccination
We design a questionnaire for collecting the side effect, answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire. The questionnaire will be collected on each visit, and blood is drawn for laboratory test.
The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection
时间窗: Within 2 months after the first dose of COVID-19 vaccination
The titers of anti-SARS-CoV-2 antibodies will be detected on each follow-up time for evaluating the efficacy and persistence of COVID-19 vaccine in patients with HIV infection.
次要结局
- The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection(Within 13 months after the first dose of COVID-19 vaccination)
- The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection(Within 13 months after the first dose of COVID-19 vaccination)