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
This will be a Phase Ib, two-center study in approximately 160 healthy adults aged 18-55 yearsThe 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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Klinische Studie| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
ClinicalTrials.gov - (2023) vom: 11. Dez. Zur Gesamtaufnahme - year:2023 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: October 8, 2019, Last downloaded: ClinicalTrials.gov processed this data on December 20, 2023, Last updated: December 20, 2023 |
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| Study ID: |
NCT04119440 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG003185338 |
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| 245 | 1 | 0 | |a Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS |b 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 |
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| 520 | |a This will be a Phase Ib, two-center study in approximately 160 healthy adults aged 18-55 yearsThe 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. | ||
| 650 | 2 | |a Coronavirus Infections | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Active, not recruiting | |
| 650 | 4 | |a Phase: Phase 1 | |
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