JPRN-jRCT2051210052已完成1 期
A Randomized, Open-label, Uncontrolled, phase I / II study to Assess Safety and Immunogenicity of Two or Three Dosing of Intramuscular / Intradermal AG0302-COVID19
Daikyoji Yuichi0 个研究点目标入组 400 人开始时间: 2021年7月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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 18 years or older
- •(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) Subjects with a history of vaccination for the prevention of COVID-19
- •(4) Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study
- •(5) Subjects with an axillary temperature of 37.5 degrees or higher at the time of screening
- •(6) Subjects with an axillary temperature of 37.5 degrees or higher before the first vaccination
- •(7) Subjects who have a history of anaphylaxis
- •(8) Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
- •(9) Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
- •(10) Subjects with a history of convulsion or epilepsy
- •(11) Subjects with a history of diagnosis of immunodeficiency
- •(12) Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
- •(13) Subjects who have current bronchial asthma
- •(14) Subjects who have had a fever of 39.0 degrees or higher within 2 days after vaccination, or who have been suspected of having an allergy such as a systemic rash
- •(15) Females who wish to become pregnant from the time of obtaining consent to 12 weeks after the first vaccination, 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 the first vaccination
- •(16) 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)
- •(17) 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)
- •(18) Subjects who have been administered with drugs that affect the immune system (excluding external preparations) such as immunomodulators (DMARDs, etc.), immunosuppressants, biologics, etc. within 4 weeks before vaccination
- •(19) 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
- •(20) Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
- •(21) Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
- •(22) Subjects who are judged to be ineligible for this clinical trial by the investigator
研究者
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