Imovax® Rabies and VERORAB® Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Post-Exposure Prophylaxis Regimen at One Year

Summary

The primary objective of the study is to demonstrate that a short intramuscular (IM) pre-exposure prophylaxis (PrEP) regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate. The secondary objectives of the study are: * To describe the immunogenicity of the PrEP regimen in each group * To describe the antibody persistence in each group 6 months and 1 year after the last PrEP vaccination * To describe the immunogenicity of the simulated post-exposure prophylaxis (PEP) regimen in each group * To describe the safety profile of study vaccines administered as PrEP regimen and as a simulated PEP regimen in each group

Timeline

Start

2018-09-26

Primary completion

2019-01-19

Completion

2020-04-08

Outcome

Missed primary endpoint

paper Non-inferiority of Group 1 versus Group 2 in terms of seroconversion rates 14 days post-last PrEP injection (primary objective) was not demonstrated. PMID 35933278 ↗

Publications

• Quiambao BP, Lim JG, Bosch Castells V, Augard C, Petit C, Bravo C, Delore V, Houillon G. One-week intramuscular or intradermal pre-exposure prophylaxis with human diploid cell vaccine or Vero cell rabies vaccine, followed by simulated post-exposure prophylaxis at one year: A phase III, open-label, randomized, controlled trial to assess immunogenicity and safety. Vaccine. 2022 Aug 26;40(36):5347-5355. doi: 10.1016/j.vaccine.2022.07.037. Epub 2022 Aug 3.

Drugs

Indications

No indication recorded.