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Clinical Trials/JPRN-jRCTs031190118
JPRN-jRCTs031190118
Completed
Phase 1

Phase I clinical study on safety and efficacy of Ebola vaccine iEvac-Z

Koga Michiko0 sites30 target enrollmentOctober 18, 2019
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Koga Michiko
Enrollment
30
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 18, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Koga Michiko

Eligibility 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

  • •(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

Outcomes

Primary Outcomes

Not specified

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