This is 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
two doses of 60µg/0.6ml per dose
two doses of 30µg/0.6ml per dose
two doses of 15µg/0.6ml per dose
Taixing county disease control and prevention
Taishing, Jiangsu, China
Occurrence of solicited adverse reactions after vaccination.
Occurrence of solicited site adverse reactions within 0-14 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).
Time frame: within 0-14 days after the vaccination
Occurrence of unsolicited adverse reactions after vaccination.
Occurrence of unsolicited adverse reactions within 0-35 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli).
Time frame: within 0-35 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 (Escherichia coli).
Time frame: within 6 months after the vaccination
Changes of the laboratory examinations after vaccination.
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 3.
Time frame: day 3 after the vaccination
Changes of the laboratory examinations after vaccination.
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 7.
Time frame: day 7 after the vaccination
Changes of the laboratory examinations after vaccination.
Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 10.
Time frame: day 10 after the vaccination
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