Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)

August 17, 2022 updated by: Themis Bioscience GmbH

Double Blinded, Randomized, Placebo Controlled, Dose Finding Trial to Evaluate the Optimal Dose of MV-ZIKA, a New Vaccine Against Zika Virus, in Regard to Immunogenicity, Safety, and Tolerability in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of Clinical Pharmacology
      • Vienna, Austria, 1090
        • Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose - single shot
MV-ZIKA, high dose, one vaccination, day 0
Biological: MV-ZIKA
MV-Zika vaccine
Other: Placebo
physiological saline
Experimental: Low dose
MV-ZIKA, low dose, two vaccinations, day 0 and day 28
Biological: MV-ZIKA
MV-Zika vaccine
Experimental: High dose
MV-ZIKA, high dose, two vaccinations, day 0 and day 28
Biological: MV-ZIKA
MV-Zika vaccine
Placebo Comparator: Placebo
Physiological saline, two treatments
Other: Placebo
physiological saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
Time Frame: 56 days
Functional anti-Zika antibodies as measured by PRNT.
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Themis Bioscience GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2017

Primary Completion (Actual)

January 4, 2018

Study Completion (Actual)

April 17, 2018

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V186-001
  • 2016-004212-34 (EudraCT Number)
  • MV-ZIKA-101 (Other Identifier: Themisbio)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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