Immunogenicity and Safety of a Purified Vero Rabies Vaccine

Phase 2 Completed 320 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.

Timeline

Start: 2017-04-17
Primary completion: 2018-01-08
Completion: 2018-01-08

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper All analyses were descriptive. PMID 37921410 ↗

Publications

Pichon S, Guinet-Morlot F, Saleh J, Essink B, Pineda-Pena AC, Moureau A, Petit C, Minutello AM. Safety and immunogenicity of three dose levels of an investigational, highly purified Vero cell rabies vaccine: A randomized, controlled, observer-blinded, Phase II study with a simulated post-exposure regimen in healthy adults. Hum Vaccin Immunother. 2023 Dec 15;19(3):2275453. doi: 10.1080/21645515.2023.2275453. Epub 2023 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Imovax® Rabies	Vaccine	—	Intramuscular
Subject	VRVg 1	Unknown	—	Intramuscular
Subject	VRVg-2	Vaccine	—	Intramuscular
Background	Human Rabies Immunoglobulins (HRIG)	Protein / enzyme biologic	—	Intramuscular