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

Evaluation of efficacy and safety of Ebola vaccine iEvac-Z in human

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Analysis population (FAS): 29 participants (Cohort 1: 15 participants, Cohort 2: 14 participants) Age [average (standard deviation)] was 34.4 (7.9) years for all. 33.7 (8.6) years old in cohort 1 and 35.1 (7.2) years old in cohort 2. Gender [male/female] was 29/0.

Written informed consent was obtained from 97 participants. After that, 29 participants (Cohort 1: 15 participants, Cohort 2: 14 participants) were enrolled in this study after the screening test. There were no safety issues, and all participants received their first study drug. After that, in Cohort 1, one participant discontinued the second administration of the study drug, one participant discontinued the study due to withdrawal of consent (the second administration was not performed), and in Cohort 2, one participant discontinued the second administration of the study drug. No major nonconformities were observed in this study.

The number of participants who experienced an adverse event in this clinical study was twelve in Cohort 1 (one participant experienced Grade 3 or over) and twelve in Cohort 2 (two participants experienced Grade 3 or over). The number of adverse events, excluding unrelated events, was ten in cohort 1 (no one experienced grade 3 or over) and 10 in cohort 2 (one experienced grade 3 or over). One Grade 3 adverse event for which could not be denied as relation of this vaccination was redness at the injection site, and the second injection was discontinued in this subject. One serious adverse event occurred (retinal detachment), but it was judged to be unrelated to the vaccination.

Regarding the safety, the primary endpoint, one was the redness at the injection site, which was Grade 3, but others were just mild and not particularly frequent. Regarding the efficacy, the secondary endpoint, one participant in Cohort 2 who had the high antibody titer before administration did not increase the antibody titer, but the increase was observed in the other participants. In Cohort 2, the early increase in antibody titer and continuation were observed after administration. Safety and immune induction were confirmed. It is reasonable to conduct the clinical trials beyond Phase II.

The safety of iEvac-Z doses up to 4.69x10^7 FFU/mLx0.5mL was confirmed. It was also confirmed that antibodies were induced at both doses of cohort 1 and 2, but in cohort 2, an earlier rise in antibody titer and continuation was observed.

Mar. 31, 2025

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs031190118

Koga Michiko

IMSUT Hospital, The University of Tokyo

4-6-1 Shirokanedai Minato-ku Tokyo

michiko@ims.u-tokyo.ac.jp

Nagamura Fumitaka

IMSUT Hospital, The University of Tokyo

4-6-1 Shirokanedai Minato-ku Tokyo

+81-3-5449-5462

dctsm@ims.u-tokyo.ac.jp

Complete

Oct. 18, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

(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

Male

Health Condition

iEvac-Z is administered twice at 4 week intervals

(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.)

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.

+81-3-5841-0818

Oct. 04, 2019

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