An observational study in Rabies Exposure, Immunocompromised and Chronic Disease, sponsored by Liaoning Chengda Biotechnology CO., LTD. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Liaoning Chengda Biotechnology CO., LTD · Observational
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.
This is a controlled study consisting of a study group and a control group. The study group will include special population participants (non-HIV-related immunocompromised individuals, patients with chronic diseases, and elderly individuals) who are receiving their first clinical visit after confirmed WHO category II or III rabies exposure. The control group will include healthy adults aged 18 to under 60 years who also present after similar exposure. The study group will be further divided into three subgroups based on the health status of the participants, with 50 individuals in each subgroup:
If a participant meets criteria for more than one subgroup (e.g., aged ≥60 years and also has immunodeficiency or a chronic disease), subgroup assignment will be prioritized based on disease condition: immunocompromised first, then chronic disease, and finally elderly, to ensure each participant is assigned to the most representative subgroup.
All participants (both in the study and control groups) may choose either the Zagreb regimen (2-1-1) or the Essen regimen (five-dose schedule) for post-exposure rabies vaccination. Adverse events occurring within 0-7 days after each vaccine dose will be collected via telephone follow-up to understand post-vaccination responses.
Blood samples will be collected at Day 14 after completion of the full vaccination schedule (i.e., Day 35 from first dose for Zagreb regimen and Day 42 for Essen regimen), and again at Day 90 (Day 111 and Day 118 from first dose for Zagreb and Essen, respectively). Rabies virus neutralizing antibodies will be tested and compared between groups to evaluate the immunogenicity of rabies vaccination in special populations after exposure. Safety data will also be analyzed and compared between groups.
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's planned enrollment of 180 is below the median of 419 across 249 observational studies indexed under Chronic Disease.
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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.
Subjects planned to be included in the study group who meet any of the following conditions:
Exclusion Criteria:
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.
Other: Observation Only
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.
Other: Observation Only
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.
Other: Observation Only
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.
Other: Observation Only
All 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.
Time frame: 14 days post completion of full vaccination.
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.
Time frame: 90 days post completion of full vaccination.
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.
Time frame: Within 30 minutes and 7 days after each vaccine dose.
Plan to share: No
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Liaoning Chengda Biotechnology CO., LTD