Name (Synonyms) | Correlation | |
---|---|---|
drug1667 | MVA-MERS-S_DF1 - Low Dose Wiki | 1.00 |
drug1521 | Kerecis Oral and Nasal Spray Wiki | 1.00 |
drug2122 | Placebo Wiki | 0.05 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
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: 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.
Measure: Frequency of adverse events associated with MVA-MERS-S_DF-1. Time: day 1, 14, 29, 42, 56, 84, 168, 336, 364Description: Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory
Measure: Immunogenicity Time: day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)