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

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ClinicalTrials.gov Identifier: NCT01622062
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Rabies Biological: PVRV Biological: PVRV and pERIG Favirab® Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 29, 2012
Actual Primary Completion Date : November 14, 2018
Actual Study Completion Date : November 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
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
Biological: PVRV
0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally
Other Name: VERORAB®

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
Biological: PVRV and pERIG Favirab®
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 Name: VERORAB®; pERIG Favirab®

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
Biological: PVRV and pERIG Favirab®
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 Name: VERORAB®; pERIG Favirab®




Primary Outcome Measures :
  1. Percentage of participants with seroconversion on Day 14 [ Time Frame: Day 14 post vaccination ]
    Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL


Secondary Outcome Measures :
  1. Percentage of participants with seroconversion before and after primary vaccination [ Time Frame: Day 0, Day 14, Day 90 ]
    Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL

  2. Percentage of participants with seroconversion after primary vaccination (antibody persistence) [ Time Frame: Year 1 to Year 5 ]
    Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL

  3. Percentage of participants with seroconversion after booster vaccination [ Time Frame: Year 5 + 11 days ]
    Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL

  4. Geometric mean titers (GMTs) before and after primary vaccination [ Time Frame: Day 0, Day 14, Day 90 ]
    Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test

  5. GMTs after primary vaccination (antibody persistence) [ Time Frame: Year 1 to Year 5 ]
    Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test

  6. GMTs after booster vaccination [ Time Frame: Year 5 + 11 days ]
    Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test

  7. Number of participants reporting solicited injection site reactions following primary and booster vaccination [ Time Frame: 7 days after each and any injection ]
    Solicited injection site reactions are tenderness (for participants aged ≤ 23 months), pain (for participants aged ≥ 2 years), redness and swelling (for all participants)

  8. 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 ]
    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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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622062


Locations
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Philippines
Muntinlupa, Philippines, 1781
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01622062     History of Changes
Other Study ID Numbers: RAB40
U1111-1122-2546 ( Other Identifier: WHO )
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available, Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com.

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Rabies
Verorab®
Favirab®

Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases