Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen

NCT01622062 | Completed Phase 3

• 2 other identifiers: RAB40U1111-1122-2546
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen. Primary objective:

• To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen. Secondary objectives:
• Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90.
• Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group.
• Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5.
• Safety: To describe the safety profile of each group after the primary and booster vaccinations.

Conditions

Rabies

Keywords

Rabies; Verorab®; Favirab®

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with seroconversion on Day 14

  Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL

  Day 14 post vaccination

Secondary Outcomes (8)

• Percentage of participants with seroconversion before and after primary vaccination

  Day 0, Day 14, Day 90

• Percentage of participants with seroconversion after primary vaccination (antibody persistence)

  Year 1 to Year 5

• Percentage of participants with seroconversion after booster vaccination

  Year 5 + 11 days

• Geometric mean titers (GMTs) before and after primary vaccination

  Day 0, Day 14, Day 90

• GMTs after primary vaccination (antibody persistence)

  Year 1 to Year 5

Study Arms (3)

Group 1

EXPERIMENTAL

Patients with WHO Category II exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later

Biological: PVRV

Group 2

EXPERIMENTAL

Patients with WHO Category III exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later

Biological: PVRV and pERIG Favirab®

Group 3

ACTIVE COMPARATOR

Patients with WHO Category III exposure receive PEP with PVRV using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later

Biological: PVRV and pERIG Favirab®

Interventions

PVRV BIOLOGICAL

0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally

Also known as: VERORAB®

Group 1

PVRV and pERIG Favirab® BIOLOGICAL

0.1 mL of vaccine administered intradermally in 4 site 'one week' (4-4-4-0-0) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)

Also known as: VERORAB®; pERIG Favirab®

Group 2

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For all patients:
• Patient aged ≤50 years, with WHO category II or III contacts happened within 48 hours before appearance at site.
• For adults:
• Informed consent form has been signed and dated.
• Able to attend all scheduled visits and to comply with all trial procedures.
• For children:
• For children under 18 years of age, informed consent form has been signed and dated by the parent(s) or another legally acceptable representative.
• For children under 18 years, assent form or informed consent form has been signed and dated by the appropriate age-range patient, according to country specific institution requirement as detailed in each country specific assent form or informed consent form.
• Patient and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• For all patients:
• Receipt of chloroquine or other medications used for malaria chemoprophylaxis, with or without other anti-malarial treatment, for more than 4 weeks (duration of anti-malarial course) and part of the treatment received within the 2 weeks before vaccination.
• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial immunization
• Planned participation in another clinical trial during the present trial period
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination and tetanus immunization (related only to current animal bite exposure
• Planned receipt of any vaccine in the 4 weeks following the trial primary and booster vaccination
• Previous immunization against rabies at any time in the past with either the trial vaccine and immunoglobulin or another rabies immunobiological product (in pre-or post-exposure regimen)
• Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
• 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)
• Self-reported seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
• Patient with clinical signs of encephalitis
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

City of Muntinlupa, 1781, Philippines

Location

Related Publications (1)

• Quiambao BP, Ambas C, Diego S, Bosch Castells V, Korejwo J, Petit C, Houillon G. Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines. Vaccine. 2019 Apr 10;37(16):2268-2277. doi: 10.1016/j.vaccine.2019.02.083. Epub 2019 Mar 16.

  PMID: 30890382 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 18, 2012
• Study Start: June 29, 2012
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

PH (1)