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
26 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
Researchers are evaluating the immune response and safety of a lyophilized Vero cell-derived human rabies vaccine in special populations after exposure to rabies. The study includes groups of immunocompromised individuals, patients with chronic diseases, elderly participants, and a control group of healthy adults. The goal is to compare how well the vaccine triggers antibody production and how long antibodies last between these groups following WHO category II or III rabies exposure. Participants will receive post-exposure rabies vaccination according to either the Zagreb (2-1-1) or Essen (five-dose) regimen based on national guidelines. The study group includes 150 special population participants divided into immunocompromised, chronic disease, and elderly subgroups, each with 50 individuals. A control group of 30 healthy adults aged 18 to under 60 years will also be studied. Vaccination schedules and subgroup assignment are based on health conditions and age. Participants will have blood samples collected 14 and 90 days after completing their full vaccination schedule to measure rabies virus neutralizing antibody levels and seropositivity rates. Safety monitoring includes recording adverse events occurring within 30 minutes and up to 7 days after each vaccine dose through telephone follow-up. The study assesses both the immune response and safety profile of the rabies vaccine in these special and healthy populations over the course of the vaccination and follow-up period.
CONDITIONS
Brief 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 for post-exposure prophylaxis and vaccination.
- Healthy adults aged 18 to less than 60 years for the control group, confirmed healthy by medical history and examination.
- Participants with long-term immunocompromised status including primary immunodeficiency, hematologic or solid malignancies, aplastic anemia, autoimmune diseases with immunosuppressive therapy lasting at least 4 weeks within the past year, history of splenectomy or major immune organ removal, or recent stem cell/organ transplant within 2 years.
- Participants with clinically confirmed diabetes, chronic hepatitis, liver cirrhosis, chronic glomerulonephritis, nephrotic syndrome, or chronic renal insufficiency.
- Participants aged 60 years or older.
- Ability to understand study procedures, voluntarily consent, and comply with follow-up visits with valid identification.
You will not qualify if you...
- History of previous rabies vaccination.
- History of human immunodeficiency virus (HIV) infection.
- Any other condition deemed unsuitable for participation by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks depending on vaccination regimen
Participants receive post-exposure rabies vaccination using either the Zagreb or Essen regimen and are observed for vaccine safety and immunogenicity.
5 to 6 visits depending on the vaccination schedule chosen
Duration - Up to 90 days after completion of full vaccination
Participants are followed up with blood sample collections to evaluate rabies virus neutralizing antibodies and safety monitoring continues through telephone follow-ups after each vaccine dose.
2 blood sample visits and telephone follow-ups within 7 days after each vaccine dose
Trial Site Locations
Total: 1 location
1
Luohu District People's Hospital.
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
L
Li Tong
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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