rabies
Conditions
Interventions
Experimental group (Stage 1):Experimental vaccine
Experimental group (Stage 2):Experimental vaccine
Control group:Control vaccine
Exploration and research(Experimental group 2):Experimental vaccine
Exploration and research(Experimental group 3):Experimental vaccine
Sponsors
Jangsu Provincial Center For Disease Control And Prevention
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Healthy volunteers aged 10-60 can comply with the requirements of the clinical trial protocol and complete the visit plan of the entire clinical trial observation period; (2) Volunteers aged 18-60 should have full understanding and cognitive ability, and sign informed consent/Subjects aged 10-17 years old should have certain understanding and cognitive ability and sign the informed acceptance letter, and their legal guardians should have full understanding and cognitive ability and sign the informed consent; (3) Can complete the diary card filling; (4) Female volunteers aged 18-60 whose urine pregnancy test is negative and who can guarantee contraception within 2 months after the first dose of vaccine in this study; (5) Armpit body temperature =37.0?.
Exclusion criteria
Exclusion criteria: (1) A history of rabies vaccine or rabies immunoglobulin vaccination; (2) Severe adverse reactions occurred after previous vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthus reaction), urticaria, dyspnea, angioneurotic edema or abdominal pain; Known allergy to any component of the vaccine, including excipients; People allergic to eggs; (3) Currently suffering or having suffered from convulsions, epilepsy, encephalopathy, psychosis, family history of psychosis or other neurological diseases; (4) have an autoimmune disease or immunodeficiency, such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune disease; (5) Required medical treatment for thyroid disease within the past 12 months; (6) asplenia, functional asplenia, and any condition resulting in asplenia or splenectomy, Guillain-Barre syndrome; (7) Malignant tumors, Active or treated tumors that are not clearly cured, or are likely to recur during the study period; (8) Immunosuppressive therapy, cytotoxic therapy, and inhaled corticosteroids in the past 6 months(Corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis are not included) (9) Those who plan to use immunoglobulin or any blood product during the study period or in the 3 months prior to the first immunization; (10) Physician-diagnosed coagulation disorders (e.g., coagulation factor deficiency, coagulation dysfunction, platelet abnormalities) or obvious bruising or blood clotting disorder; (11) being treated for anti-TB or HIV infection; (12) Those who have received other live attenuated vaccines within 4 weeks prior to the first vaccination, or other subunits or inactivated vaccines within 2 weeks prior to the first vaccination; (13) Those suffering from acute diseases, severe chronic diseases, acute episodes of chronic diseases and fever; (14) serious cardiovascular and cerebrovascular diseases, serious liver and kidney diseases, hypertension and diabetes complications that cannot be controlled by drugs; (15) Women who are breastfeeding, pregnant (including urine pregnancy test positive, applicable to women from menarche to menopause) or plan to become pregnant within 2 months after the first dose of vaccination in the trial; (16) Use of antipyretic, analgesic or antiallergic drugs within 3 days before the first vaccination; (17) Have been bitten or scratched by mammals (such as dogs, cats, etc.) within 3 months before the first dose of vaccination (wound skin damage); (18) have used other investigational or unregistered products (drugs or vaccines) in the six months prior to the study vaccination, or plan to participate in other clinical studies after enrollment in this clinical study (except for the novel coronavirus vaccine for emergency use, but the vaccination information should be recorded in detail at the drug combination); (19) plan to move away from the local area before the end of the study period or for an extended period of time; (20) The volunteer has any other factors that, in the judgment of the researcher, are not suitable for participation in the study. Exclusion criteria for subsequent dose vaccination: Any of the conditions in the exclusion criteria for the first dose of vaccination occurred after enrollment; Grade 3 or more systemic adverse reactions or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody positive conversion rate;geometric mean concentration of antibodies;Antibody positive conversion rate;geometric mean concentration of antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody positive conversion rate;geometric mean concentration of antibodies;Antibody positive conversion rate;geometric mean concentration of antibodies;Antibody positive conversion rate;geometric mean concentration of antibodies;Antibody positive conversion rate;geometric mean concentration of antibodies;adverse event;Adverse reaction;adverse event;Adverse reaction;Serious adverse event; | — |
Countries
China
Contacts
Public ContactFengcai Zhu
Jangsu Provincial Center For Disease Control And Prevention(Public Health Research Institute of Jiangsu Province)
Outcome results
None listed