Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland

NCT04594551 | Completed Phase 3

• 2 other identifiers: VRV00014U1111-1238-1726
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 3

Brief Summary

Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects. Secondary Objective: Immunogenicity To describe the immune response induced by VRVg-2 and Verorab vaccines at D90 when co-administered with HRIG at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects. Safety To describe the safety profile of VRVg-2 and Verorab vaccines when co administered with HRIG at D0, after each vaccination.

Conditions

Rabies (Healthy Volunteers)

Keywords

Rabies

Outcome Measures

Primary Outcomes (6)

• Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL

  RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)

  Day 14 (post-vaccination)

• Percentage of participants achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL

  RVNA titers will be measured by RFFIT

  Day 35 (post-vaccination)

• Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification

  RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL

  Day 14 (post-vaccination)

• Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification

  RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL

  Day 35 (post-vaccination)

• Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)

  RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 - RVNA ratios Day14/Day0 will be calculated

  Day 14 (post-vaccination

• Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)

  RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 35 - RVNA ratios Day35/Day0 will be calculated

  Day 35 (post-vaccination)

Secondary Outcomes (8)

• Number of participants reporting immediate adverse events (AEs)

  Within 30 minutes post-vaccination

• Percentage of participants reporting solicited injection site and systemic reactions

  Within 7 days post-vaccination

• Number of participants reporting unsolicited injection site AEs

  Within 28 days post-vaccination

• Number of participants reporting unsolicited systemic AEs

  Between each vaccination and up to 28 days after the last vaccination

• Number of participants reporting serious adverse events (SAEs)

  Up to 6 months after last vaccination

Study Arms (2)

Group 1: VRVg-2 + HRIG

EXPERIMENTAL

VRVg-2 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 \+ HRIG at D0

Biological: Purified vero rabies vaccine - serum free; Biological: Human rabies immunoglobulins

Group 2: Verorab + HRIG

ACTIVE COMPARATOR

Verorab 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 \+ HRIG at D0

Biological: Purified inactivated rabies vaccine; Biological: Human rabies immunoglobulins

Interventions

Purified vero rabies vaccine - serum free BIOLOGICAL

Pharmaceutical form:freeze-dried - Route of administration: intramuscular

Also known as: VRVg-2

Group 1: VRVg-2 + HRIG

Purified inactivated rabies vaccine BIOLOGICAL

Pharmaceutical form:freeze-dried - Route of administration: intramuscular

Also known as: Verorab

Group 2: Verorab + HRIG

Human rabies immunoglobulins BIOLOGICAL

Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular

Also known as: HRIG

Group 1: VRVg-2 + HRIG; Group 2: Verorab + HRIG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to attend all scheduled visits and to comply with all study procedures
• Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2s

You may not qualify if:

• Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
• Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 7 (D90)
• Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine
• Bite by, or exposure to a potentially rabid animal in the previous 6 months without post-exposure prophylaxis
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• At high risk for rabies exposure
• Known systemic hypersensitivity to any of the study/control vaccine components or to human rabies immunoglobulin (HRIG), or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
• Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Personal history of Guillain-Barré syndrome

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Investigational site number 7640002

Bangkok, 10330, Thailand

Location

Investigational site number 7640001

Bangkok, 10400, Thailand

Location

Investigational site number 7640003

Bangkok, 10700, Thailand

Location

Related Links

• VRV00014 Plain Language Results Summary

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 20, 2020
• Study Start: October 11, 2020
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

TH (3)