tetanus
Conditions
Interventions
Placebo group:TeNT-Hc-free water injection
Positive group:Adsorbed Tetanus Vaccine
low dose group:10ug 0.5ml Recombinant Tetanus Vaccine
middle dose group:20ug 0.5ml Recombinant Tetanus Vaccine
high dose group:30ug 0.5ml Recombinant Tetanus Vaccine
Sponsors
First Affiliated Hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The resident population aged 18-60 years male and female; 2. Obtain the volunteer's own informed consent and sign the informed consent form; 3. Volunteers can comply with the requirements of the clinical trial program and complete all follow-up studies; 4. Ear temperature = 37.5 degree C; 5. BMI index 19-32; 6. Healthy subjects undergoing laboratory tests such as blood routine, urine routine, blood chemistry, and electrolytes; 7. Those who have been questioned for medical history, physical examination, and clinical judgment are in compliance with the volunteers immunized with this product.
Exclusion criteria
Exclusion criteria: Exclusion criteria for first needle immunity 1. Women who are pregnant or breastfeeding, or who have a childbirth plan during the first three months of the study; 2. Infected with tetanus; 3. Accepted inoculation of tetanus vaccine in past 5 years, tetanus-diphtheria combined vaccine or polysaccharide-binding vaccine with TT as carrier protein; 4. allergies, such as those who are allergic to two or more drugs or food allergies, or are known to be allergic to the vaccine component (aluminum hydroxide adjuvant, sodium chloride); 5. Serious adverse reactions to any vaccine, such as allergies, urticaria, dyspnea, angioneurotic edema or abdominal pain; 6. Autoimmune diseases, immunodeficiency or HIV positive, important organs are primary diseases; 7. Systemic chemotherapy in the past 5 years, systemic immunosuppressive therapy, radiation therapy, cytotoxic therapy, high-dose inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, acute non- Treatment of dermatitis with topical corticosteroids); prescription and/or non-prescription patients used within 2 months; physician-diagnosed coagulation disorders (such as clotting factor deficiency, coagulopathy, platelet abnormalities), or significant bruising or clotting disorders; 8. Received other study drugs within the first 3 months of receiving the vaccine for this study; 9. Received blood products within the first 3 months of receiving the vaccine for this study; 10. Live attenuated vaccines received within 30 days of receiving the vaccine for this study; 11. Received a subunit or inactivated vaccine, such as a pneumococcal vaccine, or anti-allergic therapy within the first 14 days of receiving the vaccine for this study; 12. Ongoing anti-TB prevention or treatment; 13. According to the researcher's judgment, due to various medical, psychological, social, occupational, or other conditions, it is contrary to the trial program or affects the subject's signing of informed consent. Follow-up immunity exclusion criteria If one of the following (1) to (3) adverse events (AEs) occurs, the continuation of vaccination is prohibited, but other study steps may be continued at the discretion of the investigator; if one of the following (4) to (5) adverse events occurs The investigator determines whether to continue the vaccination; if one of the following (6) to (7) adverse events occurs, the vaccination may be postponed within the time window set by the plan (without the occurrence of (6) to (7) adverse events. Two-day vaccination is on the 28th day, postponed vaccination within the time window means vaccination within 3 days after 28 days). For the following AEs, subjects must be followed up to the event resolution: (1) any serious adverse event that has a causal relationship with the vaccination of the test vaccine; (2) Serious allergic reactions or hypersensitivity after vaccination (including urticaria/rashes occurring within 30 minutes of vaccination); (3) The occurrence of any first needle exclusion criteria after the election; (4) Acute or new chronic diseases occurred during this vaccination; (5) Grade 3 or above adverse reactions occurred within 72 hours of the previous vaccination; (6) Acute disease at the time of vaccination (acute disease refers to moderate or severe disease with or without fever); (7) Ear temperature >37.5°C at the time of vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Changes in laboratory test indicators;Incidence of Severe adverse events;Serum tetanus toxoid (TT) IgG antibody and anti-TeNT-Hc IgG antibody positivity, geometric mean titers (GMT), geometric mean growth factor (GMFI), and anti-TT and anti-TeNT-Hc antibody concentrations;Serum tetanus toxoid (TT) IgG antibody and anti-TeNT-Hc IgG antibody positivity, geometric mean titers (GMT), geometric mean growth factor (GMFI), and anti-TT and anti-TeNT-Hc antibody concentrations;Serum tetanus toxoid (TT) IgG antibody and anti-TeNT-Hc IgG antibody positivity, geometric mean titers (GMT), geometric mean growth factor (GMFI), and anti-TT and anti-TeNT-Hc antibody concentrations; | — |
Countries
China
Contacts
Public ContactLi Lanjuan
First Affiliated Hospital of Zhejiang University
Outcome results
None listed