Staphylococcus Aureus Infection Clinical Trial
Official title:
A Phase Ia Single-center, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults Aged 18-65 Years in China
Before this study, there will be an open-label, dose-escalation pilot study with a total of
30 participants with 10 per dosage group. The aim of the pilot study is to explore the
preliminary safety of an experimental recombinant staphylococcus aureus vaccine.
This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical
trial. This study will determine the safety and side-effect profile, and immunogenicity of an
experimental recombinant staphylococcus aureus vaccine. The study will be carried out
following a dose-escalation method from the low dosage to the high dosage, i.e. the higher
dosage vaccine could only be administrated after the first seven-day safety of the lower
dosage vaccine is confirmed after safety observation.
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