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| Name | Class |
|---|---|
| Chengdu Olymvax Biopharmaceuticals Inc. | INDUSTRY |
| PLA Army Medical University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunization schedule of day 0-3-7 | Experimental | Three doses of schedule given at day 0, 3 and 7. |
|
| Immunization schedule of day 0/0-3-7 | Experimental | Four doses of schedule given at day 0/0, 3 and 7. |
|
| Immunization schedule of day 0/0-7 | Experimental | Three doses of schedule given at day 0/0 and 7. |
|
| Immunization schedule of day 0/0-7-14 | Experimental | Four doses of schedule given at day 0/0, 7 and 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7 | Biological | 36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse reactions after vaccination | Occurrence of solicited adverse reactions within 21 days afte vaccination with the Recombinant | within 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of unsolicited adverse reactions after vaccination | Occurrence of unsolicited adverse reactions within 42 days after vaccination with the Recombinant Staphylococcus aureus vaccine | within 42 days after the vaccination |
| Occurrence of serious adverse events after the vaccination. |
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Inclusion Criteria:
Healthy volunteers aged 18 to 70 years (aged over 18 and under 71 years)
Exclusion Criteria:
• Prior receipt of Staphylococcus aureus vaccine
Following Immunization exclusion standard:
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| Name | Affiliation | Role |
|---|---|---|
| Fangyue Meng, Master | Jiangsu, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suining County Center for Disease Control and Prevention | Xuzhou | Jiangsu | 221000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35473663 | Derived | Zhu FC, Zeng H, Li JX, Wang B, Meng FY, Yang F, Gu J, Liang HY, Hu YM, Liu P, Peng LS, Hu XK, Zhuang Y, Fan M, Li HB, Tan ZM, Luo P, Zhang P, Chu K, Zhang JY, Zeng M, Zou QM. Evaluation of a recombinant five-antigen Staphylococcus aureus vaccine: The randomized, single-centre phase 1a/1b clinical trials. Vaccine. 2022 May 20;40(23):3216-3227. doi: 10.1016/j.vaccine.2022.04.034. Epub 2022 Apr 23. | |
| 33873093 |
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Deidentified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.
within 6 months of study completion
Data access requests will be reviewed by the sponsor and requestors will be required to sign a Date Access Agreement.
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| Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7 | Biological | 36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7 |
|
| Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7 | Biological | 36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7 |
|
| Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14 | Biological | 36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14 |
|
Occurrence of serious adverse events within 6 months after the vaccination with the Recombinant Staphylococcus aureus vaccine |
| 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. | 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. | 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. | within 42 days after vaccianation |
| Specific functional antibody responses to the Staphylococcus aureus vaccine | Specific functional antibody responses to the Staphylococcus aureus vaccine at day 7, 14, 21 and 42 | within 42 days after vaccianation |
| Derived |
| Wei J, Cheng X, Zhang Y, Gao C, Wang Y, Peng Q, Luo P, Yang L, Zou Q, Zeng H, Gu J. Identification and application of a neutralizing epitope within alpha-hemolysin using human serum antibodies elicited by vaccination. Mol Immunol. 2021 Jul;135:45-52. doi: 10.1016/j.molimm.2021.03.028. Epub 2021 Apr 16. |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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