Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adult and Pediatric Population in Thaïland

NCT04478084 | Completed Phase 3

• 2 other identifiers: VRV09U1111-1227-4143
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 3

Brief Summary

Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses \[2-2-2\]) and Day 42 (to assess the immune response after 4 doses \[2-2-2-0-2\]) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults. Secondary Objectives:

• To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses \[2-2-2\]) when co-administered with ERIG (Group 3 and Group 4) at Day 0 in healthy adults
• To describe the immune response induced by VRVg-2 and Verorab vaccine at D90 (to assess the immune response 90 days post-rabies simulated exposure) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults
• To describe the safety profile of VRVg-2 and Verorab vaccine as standalone in pediatric population or when co-administered with ERIG (Group 3 and Group 4) or HRIG (Group 5 and Group 6) at Day 0 in adults, after each vaccination.

Conditions

Rabies (Healthy Volunteers)

Keywords

Rabies Vaccine

Outcome Measures

Primary Outcomes (6)

• Percentage of participants in Group 1, Group 2, Group 5 and Group 6 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 in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL

  RVNA titers will be measured by RFFIT

  Day 42 (post-vaccination)

• Number of Participants in Group 1, Group 2, Group 5 and Group 6 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 in Group 1, Group 2, Group 5 and Group 6 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 42 (post-vaccination)

• Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants

  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) in Group 1, Group 2, Group 5 and Group 6 Participants

  RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 42 RVNA ratios Day42/Day0 will be calculated

  Day 42 (post-vaccination)

Secondary Outcomes (12)

• Number of participants reporting immediate adverse events (AEs)

  Within 30 minutes post-vaccination

• Percentage of participants reporting solicited injection site reactions

  Within 7 days post-vaccination

• Percentage of participants reporting solicited systemic reactions

  Between Day 0 and Day 3, between Day 3 and Day 7, and during the 7 days following the remaining vaccinations

• 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

Study Arms (6)

Group 1: pediatric participants; VRVg-2

EXPERIMENTAL

VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28

Biological: Purified vero rabies vaccine - serum free VRVg-2

Group 2: pediatric participants; Verorab

ACTIVE COMPARATOR

Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28

Biological: Purified inactivated rabies vaccine

Group 3: adult participants; VRVG-2 + ERIG

EXPERIMENTAL

VRVg-2 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 \+ ERIG at D0

Biological: Purified vero rabies vaccine - serum free VRVg-2; Biological: Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)

Group 4: adult participants; Verorab + ERIG

ACTIVE COMPARATOR

Verorab 8 injections: 2 at Day 0, 2 at Day 3 and 2 at Day 7 \+ ERIG at D0

Biological: Purified inactivated rabies vaccine; Biological: Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)

Group 5: adult participants; VRVG-2 + HRIG

EXPERIMENTAL

VRVg-2 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 \+ HRIG at D0

Biological: Purified vero rabies vaccine - serum free VRVg-2; Biological: Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)

Group 6: adult participants; Verorab + HRIG

ACTIVE COMPARATOR

Verorab 8 injections: 2 at Day 0, 2 at Day 3, 2 at Day 7, and 2 at Day 28 \+ HRIG at D0

Biological: Purified inactivated rabies vaccine; Biological: Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)

Interventions

Purified vero rabies vaccine - serum free VRVg-2 BIOLOGICAL

Pharmaceutical form:freeze-dried Route of administration: intradermal

Group 1: pediatric participants; VRVg-2; Group 3: adult participants; VRVG-2 + ERIG; Group 5: adult participants; VRVG-2 + HRIG

Purified inactivated rabies vaccine BIOLOGICAL

Pharmaceutical form:freeze-dried Route of administration: intradermal

Also known as: Verorab®

Group 2: pediatric participants; Verorab; Group 4: adult participants; Verorab + ERIG; Group 6: adult participants; Verorab + HRIG

Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4) BIOLOGICAL

Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular

Also known as: ERIG

Group 3: adult participants; VRVG-2 + ERIG; Group 4: adult participants; Verorab + ERIG

Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6) BIOLOGICAL

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

Also known as: IMOGAM® Rabies-HT

Group 5: adult participants; VRVG-2 + HRIG; Group 6: adult participants; Verorab + HRIG

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant (adult ≥ 18 years without upper age limit) or participant and participant's parent/LAR (child ≥ 1 to \< 18 years) are able to attend all scheduled visits and to comply with all study procedures
• The following criterion only applies to healthy adults ≥ 18 years:
• \- Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2

You may not qualify if:

• 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 until 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 8 (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, for adults, to ERIG Group 3 and Group 4) or HRIG (Group 5 and Group 6), or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
• Positive skin test to ERIG at Visit 1 for only adult participants enrolled in Group 3 and Group 4 as per superseded Protocol version 5.0
• Self-reported thrombocytopenia
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Investigational Site Number :7640004

Bangkok, 10400, Thailand

Location

Investigational Site Number :7640002

Bangkok, Thailand

Location

Investigational Site Number :7640003

Khon Kaen, 40002, Thailand

Location

Related Links

• VRV09 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
• Masking Details: Modified double-blind: the participant (or legally acceptable representative) and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will prepare and administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: August 4, 2020
• Primary Completion: March 19, 2022
• Study Completion: July 21, 2022
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

TH (3)