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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
| IDT Biologika Dessau.Rossau | UNKNOWN |
| German Center for Infection Research | OTHER |
| CR2O |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Vaccination with 2x10^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336. |
|
| High Dose | Experimental | Vaccination with 2x10^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336. |
|
| Placebo | Placebo Comparator | Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA-MERS-S_DF1 - Low Dose | Biological | Administrations of the low dose via the intramuscular route |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 1, 14, 29, 42, 56, 84, 168, 336, 364 |
| Frequency and severity of local injection site reactogenicity signs and symptoms | day 1, 14, 29, 42, 84, 336 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory | day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany | |||
| Erasmus Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39389076 | Derived | Raadsen MP, Dahlke C, Fathi A, Hardtke S, Kluver M, Krahling V, Gerresheim GK, Mayer L, Mykytyn AZ, Weskamm LM, Zoran T, van Gorp ECM, Sutter G, Becker S, Haagmans BL, Addo MM; MVA-MERS-S_DF-1 Study group. Safety, immunogenicity, and optimal dosing of a modified vaccinia Ankara-based vaccine against MERS-CoV in healthy adults: a phase 1b, double-blind, randomised placebo-controlled clinical trial. Lancet Infect Dis. 2025 Feb;25(2):231-242. doi: 10.1016/S1473-3099(24)00423-7. Epub 2024 Oct 7. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| UNKNOWN |
| Erasmus Medical Center | OTHER |
| Monipol Deutschland GmbH | UNKNOWN |
Randomized, double-blinded with an open-label run-in Phase (Part A) Part A: Open-label Part B: Double-blind
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Double-blinded
| MVA-MERS-S_DF1 - High Dose | Biological | Administrations of the high dose via the intramuscular route |
|
| Placebo | Other | Administrations of placebo via the intramuscular route |
|
| Rotterdam |
| Rotterdam |
| 3015 |
| Netherlands |
| D007239 |
| Infections |