Staphylococcus aureus infection after orthopedic surgery
Conditions
Interventions
Test group:MRSA vaccine
Control group:placebo
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 71 years, both male and female; 2. Orthopedic surgery patients with closed single or multiple fractures such as calcaneus, pilon fracture, tibial shaft, tibial plateau, and distal femur; 3. Before the vaccination, the body temperature of the armpit is not higher than 37.0 degree; 4. Women of childbearing age who have a negative urine or blood pregnancy test and can guarantee contraception during the study of this clinical trial; 5. Able to fill in the diary card independently or with the assistance of family members to complete the prescribed content; 6. Sign the informed consent form: a) the subject must give consent to the trial before enrolled, and voluntarily (or by a legal representative) sign the informed consent form; b) the subject or his/her legal representative is able to communicate with researchers and is able to complete the trail pursuant to the protocol.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose of vaccination: 1.Patients who have been diagnosed with a disease caused by Staphylococcus aureus infection and received blood products or immunoglobulin in the 12 months before signing the informed consent; 2.Abnormal blood coagulation function (such as lack of blood coagulation factor, blood coagulopathy, platelet abnormality) diagnosed by the doctor or a history of obvious bruise or blood coagulation disorder; 3.Have a history of allergy to the vaccine or vaccine components (including mHIN2, SpA5, mSEB, MntC protein and aluminum phosphate), and have serious side effects on the vaccine, such as allergies, asthma, urticaria, dyspnea, angioedema or abdominal pain Vaccination exclusion criteria 4.Have a history of immunodeficiency, or have other acquired, congenital immunodeficiency diseases, or parents, siblings have autoimmune diseases or immunodeficiency; or have a history of organ transplantation; 5.Spleenless, functional spleenless, and spleenless or splenectomy caused by any condition; 6.History of thyroidectomy, or need treatment for thyroid disease within 12 months before signing informed consent; 7.Have had immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute non-complicated dermatitis superficial corticosteroid therapy) within 6 months before signing the informed consent form; 8.Received live attenuated vaccine within 28 days before receiving the test vaccine; 9.Received subunit, inactivated vaccine or allergy treatment within 14 days before receiving the test vaccine; 10.Patients with abnormal skin of deltoid muscle at the injection site; 11.People with diabetes who have poor blood glucose control (fasting venous blood glucose >=11mmol / L), active severe infection, bronchial asthma, angioedema, severe cardiovascular and cerebrovascular disease, history of malignant tumor, or have other serious diseases May increase the risk of disease or interfere with the observation of this clinical trial indicator; 12.Alcoholism, drug addiction, drug abuse and addicts; 13.Women of childbearing age are in pregnancy, lactation, have a pregnancy intention or pregnancy test (test urine HCG or blood HCG positive, and cannot take effective contraception during the test (effective contraception includes sterilization, IUD, oral contraceptives or Diaphragm method); 14.Participated in clinical trials of other drugs or medical devices within 3 months before signing the informed consent; 15.Those with a history of severe neurological or mental illness and other incapacity or cognitive ability; 16.Those with other diseases that have serious diseases and are likely to be life-threatening during the treatment period and follow-up period, the researchers believe that they will not be able to evaluate the efficacy or are unlikely to complete the expected course of treatment and follow-up; 17.Other researchers believe that there are any situations that are not suitable for selection. Subsequent vaccination exclusion criteria: 1.From the last vaccination to the current vaccination period, there have been grade 3 or above adverse reactions / severe adverse reactions related to research vaccination; 2.Those who are allergic to any component of this clinical trial vaccine; 3.People with acute and chronic infections within the vaccination time window; 4.Any situation in the first dose exclusion criteria occurred after enr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean concentration (GMC) of antibodies against each antigen component in serum on days 10-14 after the first immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentration (GMC), geometric mean growth factor (GMFI) and four-fold growth rate of antibodies against various antigen components in serum on the 7th day after the first immunization;Geometric mean multiple of growth (GMFI) and four-fold growth rate for each antigen component in serum on days 10-14 after the first immunization;Geometric mean concentration (GMC), geometric mean multiple of growth (GMFI) and four-fold growth rate for each antigen component in serum on the 42nd day after the first immunization;Geometric mean concentration (GMC), geometric mean multiple of growth (GMFI) and four-fold growth rate for each antigen component in serum on the 180th day after the first immunization.;OPK functional antibody levels in serum of subjects on day 7 after the first immunization;OPK functional antibody levels in serum of subjects on days 10-14 after the first immunization;OPK functional antibody levels in serum of subjects on day 42 after the first immunization;OPK functional antibody levels in serum of subjects on day 180 after the first immunization;The safety of recombinant Staphylococcus aureus vaccine (E. coli) in the target population of orthopedic surgery at 18-70 years old; | — |
Countries
China
Contacts
Public ContactJiang Xieyuan
Beijing Jishuitan Hospital
Outcome results
None listed