Observation Only: All participants will receive post-exposure rabies vaccination using either the Zagreb or Essen regimen, in accordance with national immunization guidelines.
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Subjects with WHO category II or III rabies exposure presenting at the study site for post-exposure prophylaxis and vaccination.
* Subjects planned to be included in the control group, aged 18 to less than 60 years old, healthy as confirmed by medical history, physical examination, and clinical judgment before vaccination.
* Subjects planned to be included in the study group who meet any of the following conditions:
1. Long-term immunocompromised status due to conditions including, but not limited to: clinically confirmed primary immunodeficiency diseases; hematologic or solid organ malignancies; aplastic anemia; clinically confirmed autoimmune diseases with immunosuppressive therapy lasting 4 weeks or longer within the past 12 months prior to enrollment; history of splenectomy or other major immunologic organ removal; hematopoietic stem cell or solid organ transplantation within 2 years prior to enrollment.
2. Clinically confirmed diabetes mellitus, chronic hepatitis, liver cirrhosis, chronic glomerulonephritis, nephrotic syndrome, or chronic renal insufficiency.
3. Age 60 years or older.
* Subjects or their legally authorized representatives are able to understand the study requirements and procedures, voluntarily agree to participate, and sign the informed consent form.
* Subjects are able to comply with all planned follow-up visits and provide valid identification documents of themselves and/or their legally authorized representatives.
Exclusion Criteria:
* History of previous rabies vaccination.
* History of human immunodeficiency virus (HIV) infection.
* Other conditions deemed unsuitable for participation in the clinical study by the investigator.
Primary outcome measure(s)
Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 14 after full vaccination — 14 days post completion of full vaccination. The proportion of subjects with rabies virus neutralizing antibody (RVNA) ≥ 0.5 IU/ml and the antibody titer level in serum at 14 days after completion of the full vaccination schedule.
Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 90 after full vaccination — 90 days post completion of full vaccination. he proportion of subjects with RVNA ≥ 0.5 IU/ml and the antibody titer level in serum at 90 days after completion of the full vaccination schedule.
Trial sites (1)
Facility
City
Region
Status
Luohu District People's Hospital.
Shenzhen
Guangdong
Recruiting
More Liaoning Chengda Biotechnology CO., LTD trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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