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

NCT07120464 | Recruiting

• 1 other identifier: CDB-RV-PM-2025001
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Rabies Exposure; Immunocompromised; Chronic Disease

Keywords

Immunocompromised Patients; Chronic Diseases; Elderly Population; Rabies Vaccine; Vaccine Immunogenicity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  90 days post completion of full vaccination.

Secondary Outcomes (1)

• Safety profile of rabies vaccine

  Within 30 minutes and 7 days after each vaccine dose.

Study Arms (4)

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.

Other: Observation Only

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.

Other: Observation Only

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.

Other: Observation Only

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.

Other: Observation Only

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.

Chronic Disease Group; Elderly Group; Healthy Adult Control Group; Immunocompromised Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaoning Chengda Biotechnology CO., LTD: lead
• Shenzhen Center for Disease Control and Prevention: collaborator

Study Sites (1)

Luohu District People's Hospital.

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fang Huang

  Shenzhen Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Tong

CONTACT

15811315908; 14877107@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)