drugset / Trial / NCT06433440

Safety and Immunogenicity of Purified Verocell Rabies Vaccine PVRV Administered Intramuscularly and Intradermally

NCT06433440 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

Rabies is fatal disease but preventable with rabies vaccines and immunoglobulins, conventionally involves intramuscular (IM) administration of the vaccine. However, switching the intradermal (ID) route offers potential advantages in dosing, time and cost without compromising efficacy and safety. Therefore, this study aims to compare the safety and immunogenicity of a short-term three-doses intradermal regimen (3D-ID) with a conventional five-doses intramuscular regimen (5D-IM) of the purified Vero cell rabies vaccine (PVRV), administered via both intramuscular (IM) and intradermal (ID) routes as post-exposure prophylaxis (PEP).

Timeline

Start
2020-07-01
Primary completion
2021-08-30
Completion
2021-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject PVRV Vaccine 0.2 ml Intramuscular
Subject PVRV Vaccine 0.5 ml Intramuscular

Indications