NCT05911048尚未招募2 期
A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) in Booster Vaccination in Healthy Population 18 Years Old of Age and Above
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 3,100
- 主要终点
- AE and AR
研究概览
简要总结
A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination to evaluate safety and immunogenicity in healthy population aged 18 years old and above.
详细描述
To evaluate safety of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and immunogenicity superiority of WSK-V101C to Recombinant COVID-19 vaccine (WSK-V101) after booster.
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
- Double (Participant, Investigator)
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
- •Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
- •Basic or booster immunization with COVID-19 vaccine ≥6 months.
- •≥3 months of SARS-CoV-2 infection history, or never infected.
- •Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.
排除标准
- •Axillary temperature ≥37.3℃.
- •SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
- •Anti-SARS-CoV-2 IgM antibody was positive during the screening period.
- •It is in the advanced stage of malignant tumor and the disease control is unstable.
- •Female pregnancy (pregnancy test results are positive), lactation period.
- •Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs.
- •Have other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions.
- •Have been diagnosed with congenital or acquired immunodeficiency, HIV infection.
- •People who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past.
- •Congenital or acquired angioedema/neuroedema.
- •Asplenia or functional asplenia.
- •Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications).
- •Received another investigational drug within 1 month prior to receiving the investigational vaccine.
- •Received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month.
- •Fertile female subjects did not use effective contraception within 1 month prior to enrollment.
- •Fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization.
- •Abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine.
- •Medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.
结局指标
主要结局
AE and AR
时间窗: 0-7 days after vaccination
Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination.
Primary Immunogenicity indicator
时间窗: day 14 post-vaccination
The geometric mean titer (GMT) and seroconversion of neutralizing antibodies (true virus or pseudovirus method) against the current variants of SARS-CoV-2 (such as XBB and its subtypes) at day 14 post-vaccination.
次要结局
- SAE and AE(within12 months post-vaccination.)
- Secondary Immunogenicity indicator 3(day 30 post-vaccination.)
- Secondary Immunogenicity indicator 1(day 14 post-vaccination.)
- AE and AR(0-30 days post-vaccination.)
- Secondary Immunogenicity indicator 2(day 14 post-vaccination)
- Secondary Immunogenicity indicator 4(14 and 30 days post-vaccination.)
研究者
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