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.
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.
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.
Clinically confirmed diabetes mellitus, chronic hepatitis, liver cirrhosis, chronic glomerulonephritis, nephrotic syndrome, or chronic renal insufficiency.
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.
This study uses a parallel controlled design with two groups: a study group and a control group. The study group will enroll approximately 150 special population subjects who present for post-exposure prophylaxis after category II or III rabies exposure. These special populations include individuals with immunocompromised conditions excluding HIV infection, patients with chronic diseases, and elderly subjects. The control group will include approximately 30 healthy adults aged 18 to less than 60 years presenting for post-exposure prophylaxis after category II or III rabies exposure.
Cohort
Retrospective
Observation Only
Other interventionAll participants will receive post-exposure rabies vaccination using either the Zagreb or Essen regimen, in accordance with national immunization guidelines.
Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 14 after 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
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.
Safety profile of rabies vaccine
Incidence of local (injection site) and systemic (non-injection site) adverse events/reactions within 30 minutes and up to 7 days after each vaccine dose, including serious adverse events and other adverse events.
Click on the lead sponsor to view all of their trials.
Liaoning Chengda Biotechnology CO., LTD
Lead sponsor
Shenzhen Center for Disease Control and Prevention
Collaborator
