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Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations
Sponsor: Liaoning Chengda Biotechnology CO., LTD
Summary
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
180
Start Date
2025-08-15
Completion Date
2026-12-31
Last Updated
2025-08-13
Healthy Volunteers
Yes
Interventions
Observation Only
All participants will receive post-exposure rabies vaccination using either the Zagreb or Essen regimen, in accordance with national immunization guidelines.
Locations (1)
Luohu District People's Hospital.
Shenzhen, Guangdong, China