Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use

Summary

The aim of this study is to generate data on immunogenicity and safety of Purified Vero Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the registration of VRVg in the USA. Primary Objectives: * To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42. * To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%. Secondary Objectives: * To assess the clinical safety of VRVg each vaccine after each vaccine injection when administered in a pre-exposure schedule. * To describe the immune response induced by each vaccine 21 days after two vaccinations (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of the primary vaccination series. * To describe antibody persistence at 6 and 12 months after the first vaccination in all subjects, and at 18 and 24 months in a subset of subjects.

Timeline

Start

2013-02

Primary completion

2014-04

Completion

2015-12

Publications

• Pichon S, Moureau A, Petit C, Chu L, Essink B, Muse D, Saleh J, Guinet-Morlot F, Minutello AM. Safety and immunogenicity of a serum-free purified Vero rabies vaccine in healthy adults: A randomised phase II pre-exposure prophylaxis study. Vaccine. 2022 Aug 5;40(33):4780-4787. doi: 10.1016/j.vaccine.2022.06.040. Epub 2022 Jun 28.

Drugs

Indications