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VRVg-2

Phase 3

Rabies (Healthy Volunteers) | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 18, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment640

FDA Designations

No designations recorded

Clinical trial landscape

VRVg-2 · 1 trial · 1 indication

Phase 3 1
NCT03965962Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in AdultsRabies (Healthy Volunteers)
COMPLETED640 Analytics
PHASE3COMPLETED
Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults
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Study Endpoints

Primary Endpoints

Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis
Day 28

RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.

Secondary Endpoints

Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
Day 0 (pre-vaccination), Day 14, Day 28 and Day 42
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: VRVg-2 + HRIGEXPERIMENTALParticipants received 0.5 milliliters (mL) intramuscular (IM) injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
Group 2: Verorab + HRIGACTIVE_COMPARATORParticipants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
Group 3: Imovax Rabies + HRIGACTIVE_COMPARATORParticipants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
Group 4: VRVg-2EXPERIMENTALParticipants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.

Interventions

NameTypeDescription
VRVg-2BIOLOGICALPharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Purified Inactivated Rabies VaccineBIOLOGICALPharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Human Diploid Cell Vaccine (HDCV)BIOLOGICALPharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Rabies immune globulin (human)BIOLOGICALPharmaceutical form: Solution for injection; Route of administration: IM
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion criteria : * Men or women aged \>=18 years on the day of inclusion (\>= 18 years means from the day of the 18th birthday onwards, with no upper age limit). * Able to attend all scheduled visits and to comply with all trial procedures. * Body Mass Index (BMI): 18.5 kilograms per square met...

Countries:France
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Frequently asked questions about VRVg-2

What is VRVg 2 used for?

VRVg 2 is a purified Vero rabies vaccine being developed by Sanofi for the prevention of rabies virus infection. It is intended for use in healthy volunteers and is currently in clinical development for rabies prophylaxis.

Who makes VRVg 2?

VRVg 2 is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is VRVg 2 in?

VRVg 2 is in Phase 2 clinical development. It has completed a Phase 2 trial and a Phase 3 trial, both of which are finished. The vaccine is investigational and has not been approved by regulatory authorities.

What clinical trials is VRVg 2 in?

VRVg 2 has been studied in two completed trials. NCT03145766 was a Phase 2 trial in the United States with 320 participants, and NCT03965962 was a Phase 3 trial in France with 640 participants, both involving healthy adults aged 18 years and older.

How does VRVg 2 work?

VRVg 2 is a monoclonal antibody vaccine that works by stimulating the immune system to produce antibodies against the rabies virus. It is designed to provide protection against rabies infection when administered before or after exposure.

Is VRVg 2 the same as a purified Vero rabies vaccine?

Yes, VRVg 2 is a purified Vero rabies vaccine. It is manufactured using Vero cells, a standard cell line used for vaccine production, and is being developed as a potential rabies vaccine for human use.