Evaluation of efficacy and safety of Ebola vaccine iEvac-Z in huma
- Conditions
- Health Condition
- Registration Number
- JPRN-jRCTs031190118
- Lead Sponsor
- Koga Michiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 30
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method