Rabies
Conditions
Interventions
1:Low dose
2:High dose
3:Dose regimen: 2-1-1 on days 0, 7, 21
4:Dose regimen: 2-1-1 on days 0, 3, 7
5:Dose regimen: 2-2-1 on days 0, 3, 7
6:Dose regimen: 2-2-1 on days 0, 2, 7
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 18-49 (over 18 and under 50); 2. Obtain the informed consent of the subject and sign the informed consent form to clarify the content of clinical trial research; 3. Subjects who have never been vaccinated against rabies; 4. Subjects who agreed not to participate in blood donation and avoid elective surgery during the study period; 5. Subjects who can be vaccinated in strict accordance with the immunization schedule; 6. subjects who have the ability and can promise to comply with the requirements of the clinical trial study, such as completing the diary card, receiving follow-up, telephone contact, living in the study area during the study, etc; 7. Subjects whose axillary temperature is less than or equal to 37.0 ?; 8. The pregnancy test results of female subjects are negative (there is evidence that female subjects who do not have the possibility of pregnancy (such as bilateral ovariectomy) may not have pregnancy test); 9. Subjects who agreed to take effective contraceptive measures during the study period (applicable to female subjects with potential pregnancy and male subjects with female partners).
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal values of blood routine, blood biochemistry and blood coagulation in the latest test before randomization, including: alt, AST, blood urea nitrogen > 1.25 times of the upper limit of normal test laboratory; blood creatinine and total bilirubin > 1.1 times of the upper limit of normal test laboratory; blood test values specified in other schemes are beyond the normal range of test laboratory. 2. The urine routine test specified in the scheme shows the abnormal value above level 1 in the classification table of adverse events (except for the occurrence of hematuria in menstrual women), or the researcher thinks that the abnormal value of urine routine has clinical significance; 3. Women who plan to be pregnant during lactation, pregnancy or trial; 4. Patients who have been immunized with rabies vaccine, experimental vaccine, rabies immunoglobulin or other rabies immune products (before or after exposure); 5. Patients who have a history of allergic diseases or are allergic to any component of the test vaccine (inactivated rabies virus, pickup, human albumin, maltose, dextran); 6. Patients with history of drug allergy, convulsion, epilepsy, mental disease, brain disease and obvious severe systemic reaction (such as rash and angioedema) were examined; 7. Patients with clinical symptoms of encephalitis; 8. Patients with uncontrolled acute or chronic diseases, with clinically significant pulmonary, cardiovascular, liver or renal dysfunction (incurable, requiring sustained drug treatment); 9. Patients with metabolism, blood system, lung, heart, gastrointestinal tract, nervous system, kidney, urinary system, endocrine, liver disease or malignant tumor according to clinical judgment; 10. Patients with a history of immune deficiency or autoimmune disease and / or family history; 11. Patients with confirmed or suspected immunosuppressive or immunodeficiency diseases, including those infected with human immunodeficiency virus (HIV); 12. Patients with a history of HBV infection or confirmed by laboratory tests; 13. Patients with a history of HCV infection or confirmed by laboratory tests; 14. Patients with positive antinuclear antibody test results; 15. Blood donation within the past 2 months or plasma protein donation within 14 days; 16. Patients who plan to use or expect to use substances such as immunosuppressants, steroids and non experimental vaccines during the clinical study may affect the response of the subjects to the experimental vaccine; 17. Patients who plan to use immunoglobulins or any blood products during the study period or have used immunoglobulins or any blood products within 3 months before the first immunization; 18. Patients who use immunosuppressants or immunomodulators for a long time (at least 14 days) within three months before the first injection of immunity; 19. In the three months prior to the first immunization, patients who have long-term (at least 14 days) systemic use of corticosteroids, except for local use (such as ointment, eye drops, inhalants or nasal sprays), the local use shall not exceed the dose recommended in the instructions; 20. Patients who have used other research vaccines or drugs other than this trial vaccine within 30 days before the planned use or first immunization during the study period; 21. Participants in other interventional clinical trials; 22. Patients who plan to participate in another clinical trial during the study period; 23. Patients who ha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events;Incidence of solicited adverse events ;Incidence of unsolicited adverse events ;Seroconversion rate of rabies virus neutralizing antibody;Geometric mean titer of rabies virus neutralizing antibody titer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in laboratory test indicators and changes in anti-nuclear antibody levels; | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Provincial Center for Disease Prevention and Control
Outcome results
None listed