NCT03965962

Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults

Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Simulated Rabies Post-exposure Regimen in Healthy Adults in France

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 640 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (\>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection. Secondary Objective: * To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection. * To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer \>= 0.5 IU/mL at Day 28 was at least 95 percent (%). * To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).

Detailed description

Study duration per participant was approximately 7 months including: 1 day of screening and vaccination, a total of 5 vaccine injections over a 28-day period, 1 safety-follow up visit at Day 42, 1 safety follow-up/end of study visit at Day 56 and a 6-month safety follow-up call after last vaccine administration.

Conditions

• Rabies (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	VRVg-2	Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
BIOLOGICAL	Purified Inactivated Rabies Vaccine	Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
BIOLOGICAL	Human Diploid Cell Vaccine (HDCV)	Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
BIOLOGICAL	Rabies immune globulin (human)	Pharmaceutical form: Solution for injection; Route of administration: IM

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-12-22
• Completion: 2021-07-01
• First posted: 2019-05-29
• Last updated: 2025-09-18
• Results posted: 2022-03-11

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated drug study