CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 263 enrolled
Drug / intervention
MV-CHIK low dose +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02861586
NCT02861586Phase 2Completed
CompareCT.gov

Double Blinded, Randomized, Priorix®- and Placebo-controlled, Trial to Evaluate the Optimal Dose of MV-CHIK Vaccine (Against Chikungunya Virus) in Regard to Immunogenicity, Safety and Tolerability in Healthy Volunteers

Themis Bioscience GmbH·interventional·Posted Aug 10, 2016·Updated Oct 29, 2021

In Brief

A Phase 2 clinical trial evaluating MV-CHIK low dose, MV-CHIK high dose, and 2 other interventions for Chikungunya Virus Infection. Completed, enrolled 263 participants across 4 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine against Chikungunya virus after one or two vaccinations by comparison of two different dose levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChikungunya Virus Infection
CountriesAustria, Germany
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 10, 2016
Enrollment StartAug 17, 2016
Primary CompletionSep 1, 2017
Study CompletionApr 16, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.9 years ago

Interventions

MV-CHIK low dosebiological

recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose

MV-CHIK high dosebiological

recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose

Priorix®biological

lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection

physiological saline solutionbiological

sterile physiological saline solution 0.9% used as placebo