A Phase 1 interventional study of MVA-MERS-S_DF1 - Low Dose and MVA-MERS-S_DF1 - High Dose in MERS (Middle East Respiratory Syndrome), sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 1, Interventional, and Prevention
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.
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.
929 studies on the registry are indexed under Coronavirus Infections; 49 are open to participants now.
This study's enrollment of 145 is above the median of 105 across 540 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vaccination with 2x10\^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
Biological: MVA-MERS-S_DF1 - Low Dose
Vaccination with 2x10\^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
Biological: MVA-MERS-S_DF1 - High Dose
Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336.
Other: Placebo
Administrations of the low dose via the intramuscular route
Administrations of the high dose via the intramuscular route
Administrations of placebo via the intramuscular route
Frequency of adverse events associated with MVA-MERS-S_DF-1.
Safety and reactogenicity will be assesssed by observation, questionaire and diary. Changes from baseline for safety laboratory measures will be monitored. Occurence of SAE will be collected throughout the entire study duration.
Time frame: day 1, 14, 29, 42, 56, 84, 168, 336, 364
Frequency and severity of local injection site reactogenicity signs and symptoms
Time frame: day 1, 14, 29, 42, 84, 336
Immunogenicity
Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory
Time frame: day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf