Actively Recruiting
Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations
Led by Liaoning Chengda Biotechnology CO., LTD · Updated on 2025-08-13
180
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
Sponsors
L
Liaoning Chengda Biotechnology CO., LTD
Lead Sponsor
S
Shenzhen Center for Disease Control and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study adopts a parallel-controlled design and includes a study group and a control group. The study group will enroll 150 special population participants (including non-HIV-related immunocompromised individuals, patients with chronic diseases, and elderly individuals) who receive their first post-exposure treatment following WHO category II or III rabies exposure. The control group will include 30 healthy adults with similar exposure. Blood samples will be collected at Day 14 and Day 90 after completion of the full vaccination schedule to assess rabies virus neutralizing antibody seroconversion rates and titers. Immunogenicity and antibody persistence will be compared between the two groups. Additionally, all adverse events occurring within 30 minutes and within 7 days after each dose will be recorded to evaluate safety.
CONDITIONS
Official Title
Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with WHO category II or III rabies exposure presenting at the study site for post-exposure prophylaxis and vaccination.
- Healthy adults aged 18 to less than 60 years planned for the control group, confirmed by medical history and examination.
- Subjects planned for the study group meeting any of the following: long-term immunocompromised status (including primary immunodeficiency diseases, hematologic or solid organ malignancies, aplastic anemia, autoimmune diseases with immunosuppressive therapy of 4 weeks or more within the past 12 months, history of splenectomy or immunologic organ removal, or recent stem cell/organ transplantation within 2 years).
- Subjects with clinically confirmed diabetes mellitus, chronic hepatitis, liver cirrhosis, chronic glomerulonephritis, nephrotic syndrome, or chronic renal insufficiency.
- Subjects aged 60 years or older.
- Subjects or their legally authorized representatives able to understand the study, voluntarily agree, and sign informed consent.
- Subjects able to comply with follow-up visits and provide valid identification.
You will not qualify if you...
- History of previous rabies vaccination.
- History of human immunodeficiency virus (HIV) infection.
- Any other conditions the investigator deems unsuitable for participation in the clinical study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Luohu District People's Hospital.
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
L
Li Tong
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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