CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
vaccine candidate MVA-MERS-Sbiological
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/NCT03615911
NCT03615911Phase 1Completed
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An Open, Single Center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S

Marylyn Addo·interventional·Posted Aug 6, 2018·Updated Oct 6, 2020

In Brief

A Phase 1 clinical trial evaluating vaccine candidate MVA-MERS-S for MERS (Middle East Respiratory Syndrome). Completed, enrolled 26 participants across 1 site.

Detailed Summary

The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Health Organization (WHO) and currently without registered prevention or treatment option. In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will additionally receive a late booster vaccination. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMERS (Middle East Respiratory Syndrome)
CountriesGermany
CollaboratorsPhilipps University Marburg, Ludwig-Maximilians - University of Munich, Charite University, Berlin, Germany, Bernhard Nocht Institute for Tropical Medicine, University of Cologne

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 6, 2018
Enrollment StartNov 28, 2017
Primary CompletionApr 15, 2019
Study CompletionMay 10, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.9 years ago

Interventions

vaccine candidate MVA-MERS-Sbiological

vaccination with MVA-MERS-S in two escalating dose regimes