CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
MV-CHIK lyophilised formulation, low dose +4 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/NCT03635086
NCT03635086Phase 2Completed
CompareCT.gov

Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers

Themis Bioscience GmbH·interventional·Posted Aug 17, 2018·Updated Oct 22, 2021

In Brief

A Phase 2 clinical trial evaluating MV-CHIK lyophilised formulation, low dose, MV-CHIK liquid frozen formulation, low dose, and 3 other interventions for Chikungunya Virus Infection. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChikungunya Virus Infection
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 17, 2018
Enrollment StartAug 22, 2018
Primary CompletionJan 25, 2019
Study CompletionNov 16, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.9 years ago

Interventions

MV-CHIK lyophilised formulation, low dosebiological

MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.

MV-CHIK liquid frozen formulation, low dosebiological

MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.

MV-CHIK SPS® formulation, low dosebiological

MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.

MV-CHIK liquid frozen formulation, high dosebiological

MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.

Placeboother

Sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.