- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01622062
Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen
April 22, 2022 updated by: Sanofi Pasteur, a Sanofi Company
Verorab® Immunogenicity and Safety After a One-week, 4-site, Intradermal (ID) Post-exposure Prophylaxis Regimen (4-4-4-0-0) Followed by a One-visit, 4-site, ID Booster at Five Years
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants with WHO Category II exposure will receive PEP, using "one-week, 4-site" ID vaccination regimen.
Participants with WHO Category III exposure will receive PEP, using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab® or using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®.
All participants will receive a "single-visit, 4-site" booster vaccination five years later.
Study Type
Interventional
Enrollment (Actual)
600
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Muntinlupa, Philippines, 1781
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 50 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
- Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
- Prior history of mammal animal bite within the past 5 years.
For infants or toddlers :
- Known personal or maternal seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus, as reported by the parent/guardian
- Prior history of seizures .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Group 1
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
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0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally
Other Names:
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EXPERIMENTAL: Group 2
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
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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)
Other Names:
0.1 mL of vaccine administered intradermally in 2-site TRC (2-2-2-0-2) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)
Other Names:
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ACTIVE_COMPARATOR: Group 3
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
|
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)
Other Names:
0.1 mL of vaccine administered intradermally in 2-site TRC (2-2-2-0-2) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with seroconversion on Day 14
Time Frame: Day 14 post vaccination
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Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
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Day 14 post vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with seroconversion before and after primary vaccination
Time Frame: Day 0, Day 14, Day 90
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Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
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Day 0, Day 14, Day 90
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Percentage of participants with seroconversion after primary vaccination (antibody persistence)
Time Frame: Year 1 to Year 5
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Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
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Year 1 to Year 5
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Percentage of participants with seroconversion after booster vaccination
Time Frame: Year 5 + 11 days
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Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
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Year 5 + 11 days
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Geometric mean titers (GMTs) before and after primary vaccination
Time Frame: Day 0, Day 14, Day 90
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Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
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Day 0, Day 14, Day 90
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GMTs after primary vaccination (antibody persistence)
Time Frame: Year 1 to Year 5
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Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
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Year 1 to Year 5
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GMTs after booster vaccination
Time Frame: Year 5 + 11 days
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Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
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Year 5 + 11 days
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Number of participants reporting solicited injection site reactions following primary and booster vaccination
Time Frame: 7 days after each and any injection
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Solicited injection site reactions are tenderness (for participants aged ≤ 23 months), pain (for participants aged ≥ 2 years), redness and swelling (for all participants)
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7 days after each and any injection
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Number of participants reporting solicited systemic reactions following primary and booster vaccination
Time Frame: From Day 0 up to 7 days after injection 3, and 7 days after subsequent injections
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Solicited systemic reactions are Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability for participants aged ≤ 23 months and Fever (Temperature), Headache, Malaise, and Myalgia for participants aged ≥ 2 years
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From Day 0 up to 7 days after injection 3, and 7 days after subsequent injections
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 29, 2012
Primary Completion (ACTUAL)
November 14, 2018
Study Completion (ACTUAL)
November 14, 2018
Study Registration Dates
First Submitted
June 14, 2012
First Submitted That Met QC Criteria
June 15, 2012
First Posted (ESTIMATE)
June 18, 2012
Study Record Updates
Last Update Posted (ACTUAL)
April 25, 2022
Last Update Submitted That Met QC Criteria
April 22, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAB40
- U1111-1122-2546 (OTHER: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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