drugset / Trial / NCT07672626

Safety and Immune Response of a Rabies Vaccine With the Essen Schedule and a Two-Dose Booster

NCT07672626 ↗

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2022-07-19
Primary completion
2024-08-26
Completion
2024-12-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator human rabies vaccine (Vero Cells) Vaccine — Intramuscular

Indications

No indication recorded.