RABV,Rabies virus
Conditions
Interventions
Four-dose group:Inoculate the experimental vaccine on days 0, 7, and 21 (2 doses of the first dose)
Five-dose group:Inoculate the experimental vaccine on days 0, 3, 7, 14, and 28
Five-dose group:Inoculate the control vaccine on days 0, 3, 7, 14, and 28
Sponsors
Hunan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Aged 10-60 years; 2) Willing to participate in the experiment and sign the informed consent or informed notice; 3) The subject and/or his/her guardian undertake to comply with the requirements of the clinical study protocol; 4) Armpit body temperature < 37.5? under 14 years old (including 14 years old), and armpit body temperature < 37.3? above 14 years old.
Exclusion criteria
Exclusion criteria: Exclusion criteria for first dose 1) History of rabies vaccine immunization or rabies virus passive immunization; 2) History of injury to dogs or other mammals within 12 months prior to initial vaccination; 3) Use of blood products within 4 months prior to initial vaccination; 4) Receive any vaccine within 14 days prior to initial vaccination; 5) Used other investigational or unregistered products (drugs or vaccines) within 1 month before the first vaccination, or planned to participate in other clinical studies after being enrolled in this clinical study; 6) Congenital or acquired immune deficiency. Receiving immunosuppressive therapy, such as long-term (oral) systemic glucocorticoid therapy (oral) systemic glucocorticoid therapy, such as prednisone or similar drugs, for more than 2 weeks; 7) History of convulsion, epilepsy, encephalopathy and psychosis or family history; 8) Allergic to any component of the study vaccine (such as human blood albumin, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, sucrose, maltose, etc.); Have a history of severe allergies, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction); 9) Any history of severe adverse reactions to vaccines or drugs, such as urticaria, eczema, dyspnea, angioneurotic edema, etc.; 10) Patients with acute febrile illness (body temperature =38.5?) and infectious diseases within 3 days before vaccination; 11) Congenital heart disease, developmental disabilities or chronic diseases, such as asthma, diabetes, thyroid disease; 12) Developed urticaria within 1 year before receiving the experimental vaccine; 13) Systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg (with or without medication); 14) Suffering from thrombocytopenia or other clotting disorders (which may cause contraindication of intramuscular injection); 15) Women of childbearing age have a positive urine pregnancy test, or have a birth plan during pregnancy, lactation, or within 2 months; 16) Any circumstances which the investigator considers likely to affect the evaluation of the trial. Exclusion criteria for subsequent vaccination 1) Newly discovered or newly developed cases meeting the criteria for initial exclusion before vaccination. 2) Any situation that the investigator considers likely to affect the evaluation of the experiment. Exclusion criteria for immunopersistent blood collection 1) Incomplete vaccination; 2) Blood samples were collected 14 days before the first dose or after the full dose; 3) The subjects received rabies immunoglobulin or other rabies vaccines within 12 months after the completion of full immunization (3 months for blood collection); 4) Long-term use (=15 days) of immunosuppressants or other immunomodulatory drugs (such as glucocorticoid drugs) after vaccination may affect the immune effect of rabies vaccine; Any situation that the investigator considers likely to affect the evaluation of the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| antibody positive conversion rate ;GMC;antibody positive conversion rate ;GMC;The incidence of local and systemic adverse events (AE);The incidence of solicited adverse events;The incidence of non solicited adverse events;The incidence of serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| antibody positive conversion rate ;GMC;antibody positive conversion rate ;GMC;antibody positive conversion rate ;GMC; | — |
Countries
China
Contacts
Public ContactFangjun Li
Hunan Provincial Center for Disease Control and Prevention
Outcome results
None listed