Rabies
Conditions
Interventions
Open group:Thirty adult (18-60 years old) subjects were initially enrolled to receive the experimental vaccine according to the 5-dose schedule (days 0, 3, 7, 14, 28), and a preliminary safety assessm
Control group with 5 doses of vaccine:The experimental vaccine was administered in 5 doses (0, 3, 7, 14, 28 days)
Test vaccine 5 dose group:The experimental vaccine was administered in 5 doses (0, 3, 7, 14, 28 days)
Experimental vaccine group 4 doses 1:The experimental vaccine was administered according to a 4-dose schedule (0, 3, 7, 14 days)
Experimental vaccine group 4 doses 2:The experimental vaccine was administered according to a 4-dose schedule (0, 3, 7, 28 days)
Sponsors
Sichuan Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The age of the subject is 10-60 years old (=10 years old, 14 years old was <37.3?, and armpit body temperature of subjects <14 years old was <37.5?; 6. Adult subjects or minor subjects and their guardians shall comply with the requirements of the clinical study protocol.
Exclusion criteria
Exclusion criteria: Exclusion Criteria at 1-dose: 1. A history of rabies vaccine immunization or rabies virus passive immunization was asked; 2. A history of grade 2 or 3 injury in animals susceptible to rabies virus (cats, dogs, etc.) within 12 months prior to the first dose of vaccination (the assessment criteria was the Technical Guidelines for Rabies Prevention and Control (2016)); 3. Plan to participate in other clinical trials during the clinical study; 4. Allergic to any component of the test vaccine; History of severe allergies that require medical intervention, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, allergic necrosis reaction (Arthus reaction), severe urticaria, dyspnea, angioneurotic edema, etc.; 5. Have been diagnosed with a congenital or acquired immunodeficiency disease, such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other immune disease that the investigator has determined may affect the evaluation of the trial; 6. Known or suspected serious medical conditions upon inquiry include: severe respiratory diseases, poorly controlled chronic diseases, severe liver and kidney diseases, severe cardiovascular diseases, malignant tumors, etc.; 7. * Medically unmanageable hypertension, such as systolic blood pressure >120mmHg and/or diastolic blood pressure >80mmHg in subjects 10 to 17 years of age prior to enrollment, systolic blood pressure of 140mmHg and/or diastolic blood pressure of 90mmHg in subjects 18 years of age and older; 8. Coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by a physician; 9. Asplenia, functional asplenia, and any condition resulting in asplenia or splenectomy; 10. Have received immunosuppressive therapy within 3 months prior to vaccination or plan to receive immunosuppressive therapy throughout the study period; 11. Plan to receive such treatment within 30 days after the first dose to the full dose, such as long-term systemic glucocorticoid therapy (2 weeks or more at a dose of >2mg/kg/ day or >20mg/ day of prednisone or equivalent); Allow topical use (such as ointment, eye drops, inhalants or nasal sprays); 12. * Received immunoglobulins or blood-related products within 3 months prior to vaccination or plan to receive them throughout the study period; 13. * Acute illness or acute onset of chronic disease within 3 days prior to vaccination; 14. * Antipyretic, analgesic and anti-allergic drugs were used within 3 days prior to vaccination; 15. * Have received COVID-19 vaccine or live attenuated vaccine within 28 days prior to vaccination, and have received inactivated vaccines other than COVID-19 inactivated vaccines within 14 days prior to vaccination; 16. Previous or current diagnosis of neurological or psychiatric disorders (including but not limited to dementia, schizophrenia, bipolar disorder, etc.) or confirmed Seizures, convulsions (excluding febrile convulsions in children 5 years of age and younger)), and other neuropsychiatric disorders deemed unsuitable for participation in this study by the investigator; 17. Due to various medical, psychological, social, or other conditions that, in the judgment of the investigator, are inconsistent with the study protocol or cannot be complied with. For the criteria marked with an (*), if the subject has the conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody SCR and GMC were detected on the 14th day after the first dose of the experimental vaccine and control vaccine in the 5-dose group;Antibody SCR and GMC were detected on day 14 after the first dose in the 4-dose experimental vaccine group and the 5-dose control vaccine group;Antibody SCR was detected on day 42 after the first dose of vaccine in the 5 dose test vaccine group and the 5 dose control vaccine group;Antibody SCR on day 42 after the first dose of vaccine in the 4-dose experimental vaccine group and the 5-dose control vaccine group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody SCR and GMC on day 28 after the first dose in each group;Antibody GMC was detected on day 42 after the first dose in the 5 dose test vaccine group and the 5 dose control vaccine group;Antibody GMC was detected on day 42 after the first dose in the 4-dose experimental vaccine group and the 5-dose control vaccine group;Antibody SCR and GMC were detected on day 42 after the first dose in the experimental vaccine 4-dose group and the experimental vaccine 5-dose group;Antibody SCR and GMC were detected on day 14 after the first dose in the experimental vaccine 4-dose group and the experimental vaccine 5-dose group;All subjects in each group were completely free of antibody SCR and GMC at 3, 6, and 12 months;Incidence of AR/AE within 30 minutes after each dose in each group;Incidence of AR/AE in each group within 7 days of each dose (if the inoculation interval is less than 7 days, the actual interval is used);Incidence of AR/AE in each group from the first dose to 30 days after the full dose;Incidence of all serious adverse events (SAEs) within 6 months after the first dose to full immunity; | — |
Countries
China
Contacts
Public ContactTing Huang
Sichuan Center for Disease Control and Prevention
Outcome results
None listed