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Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability

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ClinicalTrials.gov Identifier: NCT02996890
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Themis Bioscience GmbH

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.


Condition or disease Intervention/treatment Phase
Zika Virus Biological: MV-ZIKA Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : January 4, 2018
Actual Study Completion Date : April 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

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




Primary Outcome Measures :
  1. Immunogenicity: Functional anti-Zika antibodies as measured by PRNT [ Time Frame: 56 days ]
    Functional anti-Zika antibodies as measured by PRNT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996890


Locations
Austria
Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology
Vienna, Austria, 1090
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Themis Bioscience GmbH
Investigators
Principal Investigator: Christa Firbas, MD Medical University of Vienna
Principal Investigator: Ursula Wiedermann, MD, Univ. Prof. Medical University of Vienna

Responsible Party: Themis Bioscience GmbH
ClinicalTrials.gov Identifier: NCT02996890     History of Changes
Other Study ID Numbers: MV-ZIKA-101
2016-004212-34 ( EudraCT Number )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Zika Virus Infection
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs