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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120464 on ClinicalTrials.gov