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Safety and Immune Response of a Rabies Vaccine With the Essen Schedule and a Two-Dose Booster
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
Summary
Rabies is caused by rabies virus with a 100% mortality rate in humans. Most of cases occur in Africa and Asia, mainly in underserved populations. Rabies is a vaccine-preventable disease in both humans and animals. Over the years, the Vero cell rabies vaccine has been recognized by the World Health Organization (WHO) and the European Union, and is widely used globally. Currently, one of the post-exposure prophylaxis (PEP) regimens recommended by the World Health Organization (WHO) is the five-dose "Essen" regimen (1-1-1-1-1), involving one intramuscular dose administered on days 0, 3, 7, 14, and 28 respectively. This clinical trial was to assess the immunogenicity and safety of a freeze-dried human rabies vaccine (Vero Cell) in healthy population for the large-scale developing, and explore the booster vaccination.
Official title: Immunogenicity and Safety of Freeze-Dried Human Rabies Vaccine (Vero Cell) With the "Essen" Immunization Schedule and a Two-Dose Booster in Chinese Healthy Subjects Aged 10-60 Years: A Randomized, Blinded, and Comparable Vaccine-Controlled Non-Inferiority Phase III Clinical Trial.
Key Details
Gender
All
Age Range
10 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2022-07-19
Completion Date
2024-12-16
Last Updated
2026-06-29
Healthy Volunteers
Yes
Conditions
Interventions
the tested vaccine
The tested vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd.
the control vaccine
The control vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd.
Locations (1)
Pizhou county Center for Disease Control and Prevention
Pizhou, Jiangsu, China