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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
145
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
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Erasmus Medical Centre
Rotterdam, Rotterdam, Netherlands
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)
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