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

Primary Purpose

Zika Virus

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
MV-ZIKA
Placebo
Sponsored by
Themis Bioscience GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Zika Virus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

High dose - single shot

Low dose

High dose

Placebo

Arm Description

MV-ZIKA, high dose, one vaccination, day 0

MV-ZIKA, low dose, two vaccinations, day 0 and day 28

MV-ZIKA, high dose, two vaccinations, day 0 and day 28

Physiological saline, two treatments

Outcomes

Primary Outcome Measures

Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
Functional anti-Zika antibodies as measured by PRNT.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2016
Last Updated
August 17, 2022
Sponsor
Themis Bioscience GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02996890
Brief Title
Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
January 4, 2018 (Actual)
Study Completion Date
April 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Themis Bioscience GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zika Virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose - single shot
Arm Type
Experimental
Arm Description
MV-ZIKA, high dose, one vaccination, day 0
Arm Title
Low dose
Arm Type
Experimental
Arm Description
MV-ZIKA, low dose, two vaccinations, day 0 and day 28
Arm Title
High dose
Arm Type
Experimental
Arm Description
MV-ZIKA, high dose, two vaccinations, day 0 and day 28
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Physiological saline, two treatments
Intervention Type
Biological
Intervention Name(s)
MV-ZIKA
Intervention Description
MV-Zika vaccine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
physiological saline
Primary Outcome Measure Information:
Title
Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
Description
Functional anti-Zika antibodies as measured by PRNT.
Time Frame
56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medical University of Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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