jRCT2051200085已完成不适用
Open-label, uncontrolled, phase I / II study of the safety and immunogenicity of intracutaneous inoculation of the COVID-19 DNA vaccine (AG0302-COVID19) in healthy adults
未提供0 个研究点目标入组 20 人开始时间: 2020年11月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Immunogenicity
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 75age old under（—）
- 性别
- All
入选标准
- •(1) Subjects who have obtained written consent voluntarily to participate in this clinical trial
- •(2) Subjects whose age at the time of obtaining consent is 20 years to 75 years
- •(3) Subjects who are negative for SARS-CoV-2 by PCR test
- •(4) Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody by antibody test
排除标准
- •(1) Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.)
- •(2) Subjects with a history of COVID-19 (hearing from subjects)
- •(3) History of participation (history of inoculation) for the unapproved vaccine clinical trials
- •(4) Subjects with axillary temperature of 37.0 degree or higher
- •(5) Subjects who have a history of anaphylaxis due to the food or the drugs etc.
- •(6) Medical history of serious cardiovascular system, haemal system, respiratory system, liver, kidney, digestive system and neuropsychiatric system, or subjects who has a current medical history
- •(7) Subjects with a history of convulsion or epilepsy
- •(8) Subjects with a history of diagnosis of immunodeficiency
- •(9) Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
- •(10) Subjects who have a history of bronchial asthma
- •(11) Subjects who had a fever of 39.0 degree or higher within 2 days after the last vaccination, and those who suspected allergy such as a systemic rash
- •(12) Females who wish to become pregnant from the date of study registration to 12 weeks after the first inoculation of the investigational drug, and pregnant females who are breast-feeding. In addition, females who may become pregnant and their male sexual partners should use appropriate contraceptives (pill), condoms, vasectomy, tubal ligation, diaphragm, intrauterine devices, spermicides, intrauterine hormone-releasing system, etc. from the study entry date until 12 weeks after vaccination
- •(13) Subjects who have participated in clinical trials of other unapproved drugs and received the investigational drug within 4 weeks before the start of this clinical trial (starting from vaccination day)
- •(14) Subjects who have been received a live vaccine, inactivated vaccine, or toxoid within 4 weeks before the start of this clinical trial (starting from vaccination day)
- •(15) Subjects who have been administered with drugs that affect the immune system (however, excluding external preparations) such as immunomodulators (DMARDs, etc.), immunosuppressants, biologics, etc. within 4 weeks from vaccination
- •(16) Subjects who received blood transfusion or gamma globulin therapy within 12 weeks before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination
- •(17) Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
- •(18) Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
- •(19) Subjects who are judged to be ineligible for this clinical trial by the investigator
结局指标
主要结局
Immunogenicity
时间窗: 2 weeks after the first inoculation of the investigational drug (immediately before the second inoculation), 4 weeks, 6 weeks, and 8 weeks
Rate of change from baseline in SARS-CoV-2 spike (S) glycoprotein-specific antibody titers 2 weeks after the first inoculation of the investigational drug (immediately before the second inoculation), 4 weeks, 6 weeks, and 8 weeks Analyze and assess immunogenicity.
Safety
时间窗: from the time of the first inoculation of the investigational drug to 8 weeks after the first inoculation
Information such as the type, frequency and severity of adverse events that occurred from the time of the first inoculation of the investigational drug to 8 weeks after the first inoculation will be collected to evaluate the safety.
次要结局
未报告次要终点
研究者
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