Rabies
Conditions
Interventions
Essen control group:Vaccination with control vaccine on 0, 3, 7, 14, 28 days
Zagreb test group:Get experimental vaccines on 0 (first 2 doses), 7, and 21 days (1 dose each)
Four simple doses-group 1:Vaccination with trial vaccine on days 0, 3, 7, 14
Essen test group:Vaccination with trial vaccine on days 0, 3, 7, 14 and 28
Four simple doses-group 2:Vaccination with trial vaccine on days 0, 3, 7, 28
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Ages at the time of enrollment are 10-60 years old; 2.Participants and/or their guardians voluntarily agree to participate in the trial and sign an informed consent form; 3. Participants and their families may participate in the trial follow-up as required by the program (no long-term departure or family move out of the trial site plan); 4.Female participants were non-pregnancy and lactation (negative urine pregnancy test before vaccination), and there was no pregnancy plan within 2 months after being selected.
Exclusion criteria
Exclusion criteria: 1.The body temperature under the axillary is >=37.3?; 2.Have a history of injection of rabies vaccines and specific passive immune preparations, and have a history of biting/scratching in canines or other mammals in the past year; 3.Previous vaccination has a history of allergic to any vaccine component, resulting in serious allergic reactions that require medical intervention, such as allergic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioedema, etc. 4.Have a fever three days before the first dose of vaccination, suffer from acute or chronic infectious diseases (active tuberculosis, viral hepatitis) or are in the acute onset of chronic diseases; 5.Have received blood/blood-related products or immunoglobulins within 3 months before the first dose of vaccination; or plan to use such products within 1 month after the last dose of vaccination; 6. Get any vaccine within 14 days before the first dose of vaccination; 7.Asplenishment or functional asplenishment caused by any condition (such as splenectomy); 8.Have been diagnosed with congenital or acquired immunodeficiency (HIV), or received immunosuppressive therapy within 3 months (such as long-term use of systemic glucocorticoids for >=14 days, dose >=2mg/kg/day or >=20mg/day prednisone or equivalent to prednisone dose); 9.Suffering from severe congenital malformations or autoimmune (hereditary) diseases, severe chronic diseases (including but not limited to: thalassemia, heart disease, kidney disease, diabetes, hereditary allergic constitution, Guillimbare syndrome, etc.); 10.Those with a history of convulsions, epilepsy, encephalopathy and psychiatric illness or family history; 11.Contraindications for intramuscular injection (for example: have been diagnosed with thrombocytopenia, any coagulation disorder or treatment with anticoagulants, etc.); 12.Hypertension that cannot be controlled by drugs, such as systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg before admission (suitable for adults aged 18 years and above); 13. Participating in clinical trials of other research or unregistered products (drugs or vaccines), or are planning to participate in other clinical trials before the end of this clinical trial; 14.The researchers believed that there were any conditions in which participants could interfere with the evaluation of the purpose of the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 14 days after the first dose of vaccination ( test group), erum neutralizing antibody seroconversion rate and antibody GMC of all pre-vaccination negative people;Adverse events occurring after each dose of vaccine (including re-exposure immunity);14 days after the last dose of vaccination, the seroconversion rate of neutralizing antibodies among all pre-vaccination negative people;All serious adverse events within 6 months after the first dose of basic immunization to complete immunization of basic immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune persistence study: serum neutralizing antibody positivity rate and GMC of some participants 90 days, 180 days, and 360 days after basic immunity;Comparison of the serum neutralizing antibody seroconversion rate and antibody GMC of all pre-immunization negative people in the Essen trial group, the simple four-dose group 1, and the simple four-d;Comparison of the serum neutralizing antibody seroconversion rate and antibody GMC of all pre-immune negative people 7 days after the first dose of vaccination in the Essen trial group and the Zagreb;Re-exposure immunity study: Serum neutralizing antibody positivity rate and GMC of some participants 14 days, 42 days, 90 days, and 180 days after the first dose of re-exposure immunity;14 days after the last dose of vaccination, serum neutralizing antibody GMC of all pre-vaccination negative people; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed