Staphylococcus aureus infection after orthopedic surgery
Conditions
Interventions
experimental group:recombinant five-antigen Staphylococcus aureus vaccine with 3 injections at day 0/0-7
Placebo control group:Physiological saline with 3 injections at day 0/0-7
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Males or females aged = 18 years and = 70 years; 2. Patients undergoing elective surgery for closed single or multiple fractures of the calcaneus, pilon, tibial shaft, tibial plateau, distal femur, etc.; 3. Women of childbearing potential or male subjects must agree to take effective contraceptive measures during the trial; 4. Subjects who voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Medical history of Staphylococcus aureus infection within 12 months before signing the informed consent form; 2. The external fixator is not removed before internal fixation but will be continued for =2 weeks or pin-site infections occur after external fixation, or external fixation is considered to be necessary by the investigator after internal fixation; 3. Use of blood products or immunoglobulins within 3 months before the first dose; 4. Allergic to components (including mHIN2, SpA5, mSEB, MntC protein and aluminum phosphate) of the investigational vaccine, or with a history of severe allergic reactions to vaccination (e.g., acute allergic reaction, asthma, urticaria, dyspnea, angioedema or abdominal pain, etc.); 5. Known to be immunosuppressed or immunodeficient that has been confirmed or suspected based on medical history, including human immunodeficiency virus infection, or a history of organ transplantation; 6. Subjects with a history of thyroidectomy, or requiring treatment due to thyroid disease within 6 months before screening; 7. Presence of asplenia, functional asplenia, and asplenia or splenectomy under any circumstances; 8. Medical history of bleeding disorders due to coagulation factor deficiency or coagulation disorder, or anticoagulants required to be continued due to coagulation-related diseases during screening; 9. Long-term use of immunosuppressive therapy (more than 14 days), cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and topical corticosteroid therapy for acute non-complicated dermatitis) within 6 months before signing the informed consent form; 10. Use of any live attenuated vaccine within 28 days before the first dose; 11. Use of any other vaccine or anti-allergy treatment within 14 days before the first dose; 12. Presence of skin abnormality at the deltoid muscle of the upper arm where it is intended for injection; 13. Presence of diabetes with suboptimal glycemic control (fasting venous blood glucose =11 mmol/L), active severe infection, angioedema, severe cardiovascular and cerebrovascular diseases, severe respiratory diseases (e.g., bronchial asthma, active tuberculosis, pulmonary fibrosis), a history of malignancy (subjects who have basal cell carcinoma of the skin or carcinoma in situ of the cervix cured for more than 5 years are acceptable), or other serious diseases, or participation in the trial that at the discretion of the investigator may increase the risk of disease or interfere with the observation of this clinical trial; 14. Patients with a history of fainting at the sight of a needle or blood, or unable to tolerate phlebotomy; 15. Subjects who are suspected or known to have alcohol or drug dependence; 16. Pregnant or breastfeeding women, or subjects who plan to become pregnant or breastfeed during the study; 17. Participation in clinical trials of other drugs or medical devices within 3 months before signing the informed consent form; 18. Presence of medical history of severe neurological or psychiatric diseases, and those without capacity to act or cognitive ability; 19. Other conditions that are deemed inappropriate by the investigator to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infection rate of Staphylococcus aureus after orthopedic surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events;Incidence of solicited adverse events;Incidence of unsolicited adverse events;Geometric Mean Concentration;Geometric Mean Opsonic Index; | — |
Countries
China
Contacts
Public ContactJiang Xieyuan
Outcome results
None listed