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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
144
Xiaokui Hu
Taishing, Jiangsu, China
Occurrence of injection site adverse reactions after vaccination
Occurrence of solicited injection site adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Time frame: within 21 days after the vaccination
Occurrence of systematic adverse reactions after vaccination
Occurrence of solicited systematic adverse reactions within 21 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Time frame: within 21 days after the vaccination
Occurrence of unsolicited adverse reactions after vaccination.
Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine
Time frame: within 42 days after the vaccination
Occurrence of serious adverse events after the vaccination.
Occurrence of serious adverse events within 6 months after the vaccination with the Recombinant Staphylococcus aureus vaccine
Time frame: within 6 months after the vaccination
Changes of the blood routine after vaccination.
Changes of the blood routine after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
Time frame: day 0-17 after the vaccination
Changes of the blood biochemistry after vaccination.
Changes of the blood biochemistry after vaccination with the Recombinant Staphylococcus aureus vaccine on day 3, 7, 10, 14 and 17.
Time frame: day 0-17 after the vaccination
Geometric mean titre against specific antigens
Geometric mean titre measured at day 0, 7, 14, 21, 42 and month 3, 6.
Time frame: within 6 months after the vaccination
Geometric mean fold increase against specific antigens
Geometric mean fold increase measured at day 7, 14, 21, 42 and month 3, 6.
Time frame: within 6 months after the vaccination
Positive conversion rate of serum against specific antigens
Positive conversion rate of serum measured at day 7, 14, 21, 42 and month 3, 6.
Time frame: within 6 months after the vaccination
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