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 — VRV12  

Rabies (Healthy Volunteers) Clinical Trial

Official title: Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine - Serum Free Administered at 1 Year Post-3-dose Primary Series, and Between 2 up to 3 Years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand

Status Active, not recruiting

Clinical Trial Summary

The primary objective of this study is:

To demonstrate the Purified Vero Rabies Vaccine - Serum Free (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 pre-exposure prophylaxis (PrEP) regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 IU/mL at Day (D) 42, i.e., 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 VRVg-2 (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 (Cohort 1)

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 Month (M) 12 (Cohort 1) and between M24 up to M36 (Cohort 2)

• the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort 2)

• safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg.

Clinical Trial Description

The duration of each participant's participation in the primary series Cohort 1 of the study will be approximately 7 months (28 day-vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Booster Phase Cohort 1 who received a single booster dose of VRVg-2 (1 booster dose 365 days after primary series followed by 6-month safety follow-up period), the duration will be approximately 18 months.

For Primary Series Cohort 2, the duration of each participant's participation in the study will be approximately 7 months (one week vaccination period followed by 6-month safety follow-up period).

For the subset of adult participants in Immunogenicity Persistence and Booster Phase Cohort 2 who will be followed-up for evaluation of immunogenicity persistence after primary series (including blood samples collection at M6, M12, M18, and between 24 up to 36 months) and who will receive a single booster dose of VRVg-2 (after the blood sample collection between 24 up to 36 months), the duration will be approximately 30 to 42 months. ;

Related Conditions & MeSH terms

• Rabies
• Rabies (Healthy Volunteers)

• NCT number: NCT04127786
• Study type: Interventional
• Source: Sanofi
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 21, 2019
• Completion date: May 12, 2025