Status:
COMPLETED
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10-60 Years
Lead Sponsor:
Ab&B Bio-tech Co., Ltd.JS
Collaborating Sponsors:
Hubei Provincial Center for Disease Control and Prevention
Conditions:
Rabies
Eligibility:
All Genders
10-60 years
Phase:
PHASE1
Brief Summary
The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out s...
Eligibility Criteria
Inclusion
- Age at enrollment ranged from 10 to 60 years；
- Subjects/subjects and their guardians voluntarily agreed to participate in the study and signed an informed consent form;
- Participants and their families are permitted to participate in study follow-up visits as required by the protocol (no long-term departure or family relocation plan)；
- Female subjects were non-pregnant or lactating (negative urine pregnancy test before vaccination) and had no plans to get pregnant within 2 months after enrollment；
- The axillary temperature was \< 37.3 ° C.
Exclusion
- a Exclusion criteria for the first dose:
- A history of rabies vaccine and specific passive immune preparation injection, and a history of dog or other mammal bite/scratch within the past 1 year;
- Those who are allergic to any component of the trial vaccine, or have had previous allergies to any component of the vaccine, or have had a history of severe allergies requiring medical intervention, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioedema, etc;
- Fever (axillary temperature ≥37.3 ° C) within 3 days before the first dose of vaccination, acute or chronic infectious diseases (active tuberculosis, active viral hepatitis), or acute exacerbation of a chronic disease;
- Received blood/blood-related products or immune globulin within 3 months before the first dose of vaccine, or plan to use such a product after enrollment until 1 month after the last dose of vaccine;
- Vaccinate any vaccine within 14 days before the first dose of vaccine;
- Asplenia or functional asplenia due to any condition (e.g., splenectomy);
- Have been diagnosed with congenital or acquired immunodeficiency (HIV), or have been on immunosuppressive therapy within 3 months (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2mg/kg/ day or ≥20mg/ day of prednisone or prednisone equivalent);
- Severe congenital malformations or autoimmune (hereditary) diseases, severe chronic diseases (including but not limited to thalassemia, heart disease, kidney disease, diabetes mellitus, hereditary allergies, Guillain-Barre syndrome, etc.);
- People with a medical or family history of seizures, epilepsy, encephalopathy and psychosis;
- Contraindications to intramuscular injection (e.g. having been diagnosed with thrombocytopenia, any coagulopathy, or receiving anticoagulant therapy);
- Drug-uncontrolled hypertension, defined as pre-enrollment systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg (for adults aged 18 years and over);
- Are participating in other investigational or unregistered clinical studies of products (drugs or vaccines), or plan to participate in other clinical studies before the end of this clinical study;
- Patients with clinically significant abnormalities in laboratory tests such as blood routine, blood biochemistry, and urine routine could not be enrolled according to the comprehensive judgment of the investigators;
- The investigator considered the subject to have any condition that might interfere with the assessment of the purpose of the study.
- b Exclusion criteria for subsequent doses:
- Positive urine pregnancy test；
- Severe anaphylaxis after the previous dose;
- Grade 4 adverse events associated with trial vaccination after the previous dose;
- Exposure during the course (bite or scratch from dogs, cats or other mammals);
- Subject has any other conditions that warrant discontinuation of vaccination as determined by the investigator.
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06132789
Start Date
November 27 2023
End Date
August 16 2024
Last Update
January 2 2026
Active Locations (1)
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1
Gucheng Center for Disease Control and Prevention
Xiangyang, Hubei, China