Skip to main content
OpenTrials
Completed

NCT Number: NCT02996890

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Zika Virus Arbovirus Infections Flaviviridae Infections Flavivirus Infections Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases Zika Virus Infection

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MV-ZIKA

Biological

MV-Zika vaccine

Placebo

Other

physiological saline

Primary outcomes

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

    Time frame: 56 days

    Functional anti-Zika antibodies as measured by PRNT.

Sponsors and collaborators

Lead sponsor

Themis Bioscience GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2016
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.