NCT05465785已完成不适用
A Clinical Trial to Evaluate the Immunogenicity Bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in Healthy Population Aged 18-59 Years
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The incidence of adverse reactions(ARs).
研究概览
简要总结
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .
详细描述
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with vaccination course 0, 21, 42 days. 892 subjects aged 18-59 years are recruited and randomly inoculated in a 1:1 ratio from a pilot or commercial batch of Recombinant COVID-19 Vaccine (Sf9 Cell).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged from 18-59 years.
- •Signed informed consent forms of the subjects have been obtained.
- •Able and willing to comply with the requirements of the clinical trial protocol and able to complete approximately 8 months of study follow-up.
- •Axillary temperature < 37.3℃. Subjects who fulfill all the required conditions for receiving the candidate vaccine as established by medical history and physical examination and determined by investigators.
排除标准
- •Positive SARS-CoV-2 antibodies (IgG or IgM) screening results.
- •Positive SARS-CoV-2 Antigen screening results.
- •History of COVID-19 vaccination.
- •Previously diagnosed with COVID-19 infection.
- •History of HIV infection.
- •History or family history of convulsion, epilepsy, encephalopathy and psychosis.
- •Allergy to any component of the candidate vaccine, severe allergy to vaccine in the past, and history of allergy.
- •Women with positive urine pregnancy test results, pregnant, lactating women, or women who have a pregnancy plan during the study.
- •Patients with acute febrile diseases and infectious diseases.
- •Patients with a history of SARS.
- •Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by drugs, etc.
- •Serious chronic diseases or progressive stage of a disease that cannot be steadily controlled, such as asthma, diabetes mellitus, thyroid disease, etc.
- •Congenital or acquired angioedema/angioneurotic edema.
- •Urticaria 1 year before receiving the candidate vaccine.
- •Asplenia or functional asplenia.
- •Thrombocytopenia or other coagulation disorders (which may contraindicate intramuscular injection).
- •Fear of needles.
- •Any immunosuppressant, antiallergic therapy, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months.
- •Blood products within 4 months prior to receiving the candidate vaccine.
- •Any other investigational medicine(s) within 1 month prior to the candidate vaccine.
- •Any live attenuated vaccine within 1 month prior to the candidate vaccine.
- •Any subunit vaccine or inactivated vaccine within 14 days prior to the candidate vaccine.
- •Receiving antituberculosis treatment.
- •Medical, psychological, social or other factors, which in the discretion of the investigators fail to meet the requirements in the trial protocol or affect the subjects to sign the ICFs.
- •Exclusion criteria for the second/third dose:
- •In this trial, the second/third vaccination may be stopped in some cases. They include systemic allergic reaction, severe hypersensitivity, or intolerable Grade 3 or above ARs after the previous dose of vaccine. If these reactions occur, the subjects should not continue to receive the second/third vaccination.
结局指标
主要结局
The incidence of adverse reactions(ARs).
时间窗: Day 0 to day 7
The incidence of ARs within 7 days after each vaccination.
Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR).
时间窗: Day 72
The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination.
次要结局
- The incidence of adverse events (AEs).(Day 0 to Day 72)
- The incidence of ARs.(Day 0 to Day 72)
- The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody.(Day 72)
- The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody(Day 72)
- The incidence of serious adverse events (SAEs).(Day 0 to 6 months after the third vaccination.)
研究者
研究点 (1)
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