Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations
NCT07120464 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180
Last updated 2025-08-13
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.
Conditions
- Rabies Exposure
- Immunocompromised
- Chronic Disease
Interventions
- OTHER
-
Observation Only
All participants will receive post-exposure rabies vaccination using either the Zagreb or Essen regimen, in accordance with national immunization guidelines.
Sponsors & Collaborators
-
Shenzhen Center for Disease Control and Prevention
collaborator OTHER_GOV -
Liaoning Chengda Biotechnology CO., LTD
lead INDUSTRY
Principal Investigators
-
Fang Huang · Shenzhen Center for Disease Control and Prevention
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-15
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-31
Countries
- China
Study Locations
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