NCT04765215Unknown不适用
Investigation of the Effectiveness of CoronaVac Vaccine in Cancer Patients With Active Chemotherapy and Comparison With Healthy People.
Asoc. Prof. Erdoğan Selçuk Şeber1 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2021年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Antibody levels above the defined cut-off
研究概览
简要总结
This study aimed to investigate the effectiveness of CoronaVac vaccine, which is more than 90% protective in healthy people, in cancer patients receiving active chemotherapy. In this study, to collect information to measure the amount of antibodies produced by the vaccine in the blood of volunteers with the CoronoVac vaccine and to compare it with healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old and above
- •Having completed two doses of CoronoVac vaccine on time
- •Those with a pathological diagnosis of breast cancer or lung cancer
- •Being the first dose of vaccine during active chemotherapy period
- •Ecog performance score 0-1
- •Patients who signed the informed voluntary consent form
- •Over 18 years old
- •Ecog performance score is 0-1
- •Those who have completed 2 doses of coronovac vaccine within the recommended period
- •Volunteer who signed the informed consent form
排除标准
- •For all groups
- •Being confirmed or suspected covid-19 before vaccination
- •Symptomatic covid-19 infection
- •Being addicted to alcohol or drugs
- •Having a fever of 37.8 ° C as a suspect before vaccination
结局指标
主要结局
Antibody levels above the defined cut-off
时间窗: Between the third and sixth weeks after the second dose of vaccine
SARS-CoV-2 IgG II ≥ 50.0 AU/ml (positive) and SARSCoV- 2 IgM \>1 (positive)
次要结局
未报告次要终点
研究者
Asoc. Prof. Erdoğan Selçuk Şeber
Namik Kemal University (BAP)
Namik Kemal University
研究点 (1)
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