Health Condition
Conditions
Interventions
iEvac-Z is administered twice at 4 week intervals
Sponsors
Koga Michiko
Kawaoka Yoshihiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Evaliation of adverse events (creation of list, calculation of incidence rate, etc.) (2) Statistical examination of each inspection index related to safety evaluation (transition over time etc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response (1) Antibody by vaccination (2) Other immunological indicators Lymphocyte subsets and humoral factors such as IFN-beta and cytokines are assumed,but this is a vaccine that is administered to humans for the first time, and specific items will be added appropriately according to the analysis results. However, genome analysis is not performed. | — |
Contacts
Public ContactFumitaka Nagamura
IMSUT Hospital, The University of Tokyo
Outcome results
None listed