NCT04119440

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

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• MERS (Middle East Respiratory Syndrome)

Interventions

Type	Name	Description
BIOLOGICAL	MVA-MERS-S_DF1 - Low Dose	Administrations of the low dose via the intramuscular route
BIOLOGICAL	MVA-MERS-S_DF1 - High Dose	Administrations of the high dose via the intramuscular route
OTHER	Placebo	Administrations of placebo via the intramuscular route

Timeline

• Start date: 2021-04-16
• Primary completion: 2022-11-28
• Completion: 2024-11-06
• First posted: 2019-10-08
• Last updated: 2025-04-24

Locations

2 sites across 2 countries: Germany, Netherlands