Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS — MVA-MERS-S  

MERS (Middle East Respiratory Syndrome) Clinical Trial

Official title: A Two-center, Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S_DF-1 in Healthy Study Subjects

Status Active, not recruiting

Clinical Trial Summary

The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S_DF-1 the data will be compared to a placebo control group.

Clinical Trial Description

This will be a Phase Ib, two-center study in approximately 160 healthy adults aged 18-55 years

The study is separated in two parts:

Part A:

The study starts with a single center open-label run-in phase of two dose levels (cohort 1 "low dose": 2x10^7 PFU, cohort 2 "high dose": 2x10^8 PFU) in 10 healthy subjects. 5 subjects will be allocated to each dose cohort and will receive immunization on day 0 and day 28.

Part B:

Two-center, randomized, double-blind, placebo-controlled, dose-finding study. This part is a double-blinded trial in approximately 150 healthy subjects. Subjects will be allocated to two different dose cohorts and a placebo cohort; each receiving three vaccine injections. ;

Related Conditions & MeSH terms

• Coronavirus Infections
• MERS (Middle East Respiratory Syndrome)

• NCT number: NCT04119440
• Study type: Interventional
• Source: Universitätsklinikum Hamburg-Eppendorf
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 16, 2021
• Completion date: May 30, 2024