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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02996890
Other study ID # V186-001
Secondary ID 2016-004212-34MV
Status Completed
Phase Phase 1
First received
Last updated
Start date May 3, 2017
Est. completion date April 17, 2018

Study information

Verified date August 2022
Source Themis Bioscience GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects. After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28. Subjects will return on day 56 for the final visit.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date April 17, 2018
Est. primary completion date January 4, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - healthy volunteers aged 18 to 55 - subjects of child bearing potential must perform reliable method of contraception Exclusion Criteria: - immune deficiency, history of HIV, HBV, HCV - drug addiction - vaccination within 4 weeks prior to study or planned vaccination during study - prior receipt of any Zika vaccine - recent infection 1 week prior to screening - relevant medical history interfering with aim of study - neoplastic disease, hematological malignancy - history of autoimmune disease - psychological condition that affects ability to participate in the study - history of severe adverse reactions to vaccine administration - history of anaphylaxis - allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator - use of immunosuppressive drugs within 30 days before screening or planned use during study - receipt of blood products within 120 days before screening or planned use during study - pregnancy, unreliable contraception method - decision of the investigator - regular blood plasma donor

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MV-ZIKA
MV-Zika vaccine
Other:
Placebo
physiological saline

Locations

Country Name City State
Austria Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology Vienna
Austria Medical University of Vienna, Department of Clinical Pharmacology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Themis Bioscience GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunogenicity: Functional anti-Zika antibodies as measured by PRNT Functional anti-Zika antibodies as measured by PRNT. 56 days
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