此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19

2022年2月13日 更新者:Sinovac Biotech Co., Ltd

A Randomized, Double-Blinded Clinical Trial to Evaluate Additional Dose of Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine in Healthy Individuals Previously Vaccinated With CoronaVac

This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.

研究概览

详细说明

This study a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine .The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.A total of 1200 subjects who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month will be enrolled.All of subjects will be randomly divided into two groups in a 1:1 ratio .Subjects in experimental group will receive high-dosage SARS-CoV-2 inactivated vaccine.Subjects in control group will receive medium-dosage SARS-CoV-2 inactivated vaccine .

研究类型

介入性

注册 (预期的)

1200

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Jiangsu
      • Xinqi、Jiangsu、中国、221400
        • Xinqi City Center for Disease Control and Prevention

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults aged 18-59;
  • Proven legal identity;
  • The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
  • Have received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd at an interval of 21 to 35 days and is currently 6-8 months (180 to 240 days) after the second dose.

Exclusion Criteria:

  • History of SARS-CoV-2 infection(laboratory confirmed);
  • Have received three and more doses of inactivated SARS-CoV-2 vaccine;
  • Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
  • Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
  • Axillary temperature >37.0°C;
  • Already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results);
  • Participated in other clinical trials prior to enrollment and during the follow-up period, or planned to participate in other clinical trials during the clinical trial period;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Experimental Group
600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .
SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
其他名称:
  • 电晕吸尘器
有源比较器:Control Group
600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
其他名称:
  • 电晕吸尘器

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
大体时间:Day 28 after booster vaccination
GMT of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination.
Day 28 after booster vaccination

次要结果测量

结果测量
措施说明
大体时间
Immunogenicity index-seropositive rate of neutralizing antibodies(CZ02 strain)
大体时间:Day 28 after booster vaccination
The seropositive rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
大体时间:Day 28 after booster vaccination
The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
大体时间:Day 28 after booster vaccination
GMI of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies(Delta Strain)
大体时间:Day 28 after booster vaccination
The seropositive rate of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta Strain)
大体时间:Day 28 after booster vaccination
The seroconversion rate of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(Delta Strain)
大体时间:Day 28 after booster vaccination
GMI of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain)
大体时间:Day 28 after booster vaccination
The seroconversion rate of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies(Omicron Strain)
大体时间:Day 28 after booster vaccination
The seropositive rate of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain)
大体时间:Day 28 after booster vaccination
GMI of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain)
大体时间:Day 28 after booster vaccination
GMT of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies(Delta Strain)
大体时间:Day 28 after booster vaccination
GMT of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination

其他结果措施

结果测量
措施说明
大体时间
Immunogenicity index-the seropositive rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain)
大体时间:6 months after the booster vaccination
The seroconversion rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) 6 months after the booster vaccination
6 months after the booster vaccination
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain)
大体时间:6 months after the booster vaccination
GMI of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) 6 months after the booster vaccination
6 months after the booster vaccination

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hongxing Pan, Master、Jiangsu Provincial Center for Disease Prevention and Control

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年12月17日

初级完成 (实际的)

2021年12月21日

研究完成 (预期的)

2022年6月1日

研究注册日期

首次提交

2021年10月14日

首先提交符合 QC 标准的

2021年10月14日

首次发布 (实际的)

2021年10月15日

研究记录更新

最后更新发布 (实际的)

2022年3月2日

上次提交的符合 QC 标准的更新

2022年2月13日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅