Lyophilized Vero-cell Rabies Vaccine in Immunocompromised, Chronic Disease, and Elderly Patients

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

This project tests whether a freeze-dried Vero-cell rabies vaccine produces protective antibody responses and is safe in people exposed to rabies who are elderly, have chronic diseases, or are non-HIV immunocompromised.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Sex: All
• Sponsor: Liaoning Chengda Biotechnology CO., LTD (Industry-sponsored)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07120464 on ClinicalTrials.gov

What this trial studies

This is a parallel-controlled observational study enrolling 150 special-population participants (divided into immunocompromised, chronic disease, and elderly subgroups of 50 each) and 30 healthy adult controls, all presenting after WHO category II or III rabies exposure. All participants receive standard post-exposure vaccination and have blood drawn at Day 14 and Day 90 after completing the vaccination schedule to measure rabies virus neutralizing antibody seroconversion rates and titers. Immunogenicity and antibody persistence will be compared between the special-population group and healthy controls. Safety is monitored by recording adverse events occurring within 30 minutes and within 7 days after each vaccine dose.

Who should consider this trial

Good fit: Ideal candidates are people with WHO category II or III rabies exposures who are either non-HIV immunocompromised, have chronic diseases, or are aged 60 years and older and who present for post-exposure prophylaxis.

Not a fit: People without recent rabies exposure, children, and individuals with HIV-related immunodeficiency (who are not included) are not represented in this study and therefore may not directly benefit from its findings.

Why it matters

Potential benefit: If successful, the results could support confident use of this vaccine in older adults and people with chronic illnesses or non-HIV immunocompromise by showing it elicits protective antibodies and has an acceptable safety profile.

How similar studies have performed: Vero-cell rabies vaccines have established immunogenicity and safety in healthy adults, but data are limited for non-HIV immunocompromised, chronically ill, and elderly groups specifically.

Eligibility criteria

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.

Where this trial is running

Shenzhen, Guangdong

• Luohu District People's Hospital. — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Fang Huang — Shenzhen Center for Disease Control and Prevention
• Study coordinator: Li Tong

Conditions Rabies Exposure; Immunocompromised; Chronic Disease; Immunocompromised Patients; Chronic Diseases; Elderly Population; Rabies Vaccine; Vaccine Immunogenicity