JPRN-jRCTs031190118已完成1 期
Phase I clinical study on safety and efficacy of Ebola vaccine iEvac-Z
Koga Michiko0 个研究点目标入组 30 人开始时间: 2019年10月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 <= 45age old（—）
- 性别
- Male
入选标准
- •(1)Healthy male, age: 20 yrs to 45 yrs at giving consent
- •(2)Body Mass Index (BMI): 18 to 30 at screening
- •(3)Liver function (AST,ALT), renal function (serum creatinine),WBC,Hb,Plt counts: within institutional normal range
- •(4)Ability to give consent by written form
排除标准
- •(1)History of Ebola hemorrhagic fever or travel history to endemic countries during the Ebola hemorrhagic fever epidemic period
- •(2)Those who have intentions to travel to Ebola epidemic area during participation
- •(3)Positive for Hepatitis B virus surface antigen and Hepatitis C virus antibody
- •(4)Medication within 14 days before the administration of the study drug and medication during the study period. (external medicine for local control is allowed).
- •(5)Administration of live vaccine within 4 weeks prior to study drug administration, that of inactivated vaccine or toxoid within 2 weeks prior to study drug administration, and any vaccination during the study period
- •(6)Previous participation to any clinical trials
- •(7)History of congenital or acquired immunodeficiency
- •(8)Episode of febrile disease within one month before the administration of the study drug
- •(9)Episode of serious side effect by vaccination
- •(10)The person who has a serious side effect of pharmaceutical products with in the past or the past of serious food allergy
- •(11)The person whose blood donation career applies to any of the following
- •The person who donated blood of 400mL in whole blood within 12 weeks before screening
- •The person who donated blood of 200mL in whole blood within four weeks before screening
- •The person who performed ingredient blood donation within two weeks before screening
- •The person whose quantity of one-year total blood donation before screening reaches whole blood 1,200mL
- •(12)Disagree with contraception
- •(13)Principal investigator's decision
研究者
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