JPRN-jRCT2041210013已完成1 期
Safety and Immunogenicity of COVID-19 Vaccine EXG-5003 in Healty Japanese Adults.
Doi Yohei0 个研究点目标入组 60 人开始时间: 2021年4月23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
- 60
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
- >= 20age old 至 <= 55age old（—）
- 性别
- All
入选标准
- •Has provided written consent for participation
- •-Age between 20 and 55
- •-Has a negative nucleic acid-based test result for SARS-CoV-2
- •-Has a negative antibody test result for SARS-CoV-2
排除标准
- •-Presence of uncontrolled cardiovascular, hemetologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease
- •-Presence of diabetes mellitus
- •-Presence of active autoimmune disease
- •-Positive for HBc, HCV or HIV antibody
- •-History of anaphylactic shock
- •-History of epilepsy
- •-Presence of active malignancy
- •-Presence of lung disase (e.g., COPD, asthma)
- •-Positive urine pregnancy test within 24 hours
- •-Pregnant or lactatingPlanned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug
- •-If female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug
- •-If male, not agreeable to contraception for 90 days after second administration of the trial drug
- •-Prsence of clinically relevant electrocardiogram or vital sign abnormality at screening
- •-Participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days
- •-Rreceived any SARS-CoV-2 vaccine
- •-Received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product
- •-Received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties
- •-Received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid
- •-Deemed ineligible for the study as determined by the principal investigator or a co-investigator
研究者
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