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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: 14877107@qq.com
• Phone: 15811315908

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.