Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults

Summary

The primary objective of this study is: To demonstrate the VRVg-2 is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose PrEP regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42, ie. 14 days after the 3rd injection (for Primary Series Cohort 1). The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested To demonstrate that: * the observed proportion of participants in the VRVg2(VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97% * VRVg is non inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28 * 2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group * the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97% * 2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort1) To describe: * the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups * the immune response induced by VRVg at D14 after a booster dose of VRVg administered at M12 (Cohort1) and between M24 up to M36 (Cohort2) * the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort2) * safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg

Timeline

Start

2019-10-21

Primary completion

2020-03-25

Completion

2025-04-24

Publications

• Chokephaibulkit K, Huoi C, Tantawichien T, Mootsikapun P, Kosalaraksa P, Kiertiburanakul S, Ratanasuwan W, Vangelisti M, Laot T, Huang Y, Petit C, Pineda-Pena AC, Frago C. Noninferiority Study of Purified Vero Rabies Vaccine-Serum Free in 3-dose and 2-dose Preexposure Prophylaxis Regimens in Comparison With Licensed Rabies Vaccines. Clin Infect Dis. 2025 Oct 6;81(3):654-666. doi: 10.1093/cid/ciae581.

Drugs

Indications