This is a single center, open-label phase1b clinical trial. The study will evaluate the safety and immunogenicity of an experimental recombinant staphylococcus aureus vaccine with different immunization schedules in healthy adults aged 18-70 years, including day 0-3-7, day 0/0-3-7, day 0/0-7 and day 0/0-7-14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
144
36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Occurrence of solicited adverse reactions after vaccination
Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant
Time frame: within 21 days after 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: within 17 days 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: within 17 days after the vaccination
Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine
Antibody responses against 5 specific antigens in Staphylococcus aureus vaccine at day 7, 14, 21 and 42, respectively.
Time frame: within 42 days after vaccianation
Specific functional antibody responses to the Staphylococcus aureus vaccine
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36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21 and 42
Time frame: within 42 days after vaccianation