Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations

Sponsor
Liaoning Chengda Biotechnology CO., LTD
Study ID
NCT07120464
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Disease
  • Immunocompromised
  • Rabies Exposure

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Observation Only — OTHER
    All participants will receive post-exposure rabies vaccination using either the Zagreb or Essen regimen, in accordance with national immunization guidelines.

Study Details

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 Dates

First listed
Aug 13, 2025
Start date
Aug 15, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Healthy Adult Control Group
    Healthy adults aged 18 to under 60 years who seek medical attention after confirmed WHO category II or III rabies exposure and have no known chronic illness or immunocompromising condition.
  • Arm: Immunocompromised Group
    Participants diagnosed with rabies category II or III exposure who are immunocompromised due to conditions such as primary immunodeficiency, hematologic or solid malignancies, aplastic anemia, or autoimmune diseases receiving long-term immunosuppressive therapy. A total of 50 participants will be enrolled in this group.
  • Arm: Chronic Disease Group
    Participants diagnosed with rabies category II or III exposure who have chronic health conditions including diabetes, chronic hepatitis, cirrhosis, chronic glomerulonephritis, nephrotic syndrome, or chronic renal insufficiency. A total of 50 participants will be enrolled in this group.
  • Arm: Elderly Group
    Participants aged 60 years and above (including those aged exactly 60) with category II or III rabies exposure and no exclusionary comorbidities beyond age-related health changes. A total of 50 participants will be enrolled in this group.

Primary Outcome Measure

Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 14 after full vaccination [ Time Frame: 14 days post completion of full vaccination. ]

Central Contacts

Related Studies