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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02996890
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : August 18, 2022
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

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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 : May 3, 2017
Actual Primary Completion Date : January 4, 2018
Actual Study Completion Date : April 17, 2018

Resource links provided by the National Library of Medicine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT02996890

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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
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: Themis Bioscience GmbH Identifier: NCT02996890    
Other Study ID Numbers: V186-001
2016-004212-34 ( EudraCT Number )
MV-ZIKA-101 ( Other Identifier: Themisbio )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Zika Virus Infection
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections