Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of the Third Dose Using Inactivated COVID-19 Vaccine in Population Aged 18 Years and Above
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2
研究概览
简要总结
This is a phase Ⅳ follow-up clinical trial based on the previous Phase Ⅳ clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older.
详细描述
This study is a phase 4 clinical trial to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine，to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older. The experimental vaccine is manufactured by Sinovac Life Sciences Co., Ltd.. A total of 180 healthy subjects received two dose of inactivated COVID-19 vaccine (CoronaVac) based on primary immunization in previous Phase Ⅳ clinical trial will be enrolled, including 90 adults aged 18-59 years and 90 elderly elderly aged 60 years and older.Subjects in each age group will receive the booster immunization of CoronaVac(the third dose) and will be collected blood sample before booster immunization and 14 days after booster immunization.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Participated in the clinical studies on the safety and immunogenicity of Inactivated COVID-19 Vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in Rushan city, Shandong Province from July to October 2021;
- •The interval between complete immunization with two doses of COVID-19 vaccine is 6-8 months;
- •Subjects will be willing to participate in the study and follow the study procedure to collect venous blood;
- •Proven legal identity;
排除标准
- •History of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- •Fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease;
- •Pregnancy or lactation;
- •Receipt of attenuated live vaccines in the past 14 days;
- •Receipt of inactivated or subunit vaccines in the past 7 days
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
结局指标
主要结局
Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2
时间窗: 14 days after the booster immunization of inactivated COVID-19 vaccine
The seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
次要结局
- Seropositive rate of neutralizing antibody against Prototype SARS-CoV-2(14 days after the booster immunization of inactivated COVID-19 vaccine)
- GMT of neutralizing antibody against Prototype SARS-CoV-2(14 days after the booster immunization of inactivated COVID-19 vaccine)
- GMI of neutralizing antibody against SARS-CoV-2 strains(14 days after the booster immunization of inactivated COVID-19 vaccine)
- GMI of neutralizing antibody against Prototype SARS-CoV-2(14 days after the booster immunization of inactivated COVID-19 vaccine)
- GMT of neutralizing antibody against SARS-CoV-2 strains(14 days after the booster immunization of inactivated COVID-19 vaccine)
- Seropositive rate of neutralizing antibody against SARS-CoV-2 strains(14 days after the booster immunization of inactivated COVID-19 vaccine)
- Seropositive rate of antibody against hepatitis A(6-8 months after vaccination of Hepatitis A vaccine)
- GMC of antibody against hepatitis A(6-8 months after vaccination of Hepatitis A vaccine)
- Seroconversion rate of neutralizing antibody against SARS-CoV-2 strains(14 days after the booster immunization of inactivated COVID-19 vaccine)
- Incidence rate of adverse reactions(0-28 days after booster immunization with COVID-19 vaccine.)