Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety and Immunogenicity of MVA-MERS-S_DF-1
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.
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.
Study Design
Conditions
MERS (Middle East Respiratory Syndrome)
Intervention
MVA-MERS-S_DF1 - Low Dose, MVA-MERS-S_DF1 - High Dose, Placebo
Location
CTC North
Hamburg
Germany
20251
Status
Not yet recruiting
Source
Universitätsklinikum Hamburg-Eppendorf
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04119440
- ClinicalTrials.gov processed this data on October 11, 2019
Published on BioPortfolio: 2019-10-15T11:11:26-0400
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