Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen
Protocol No. RAB40
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.
|Start Date||Duration in Months||Target Completion Date||Actual Completion Date|
|Sanofi Pasteur||Private Business||NCR||CDRR-NCR-S-8|
|Name||Phone Number||Postal Address|
|Erah Jean Bariaemail@example.com||+632 4799106||4F Feliza Bldg, 108 V.A Rufino St., Legaspi Village Makati City|
|Name||Phone Number||Postal Address|
|Ruby Dizonfirstname.lastname@example.org||+632 4799124||4F Feliza Bldg, 108 V.A Rufino St., Legaspi Village Makati City|
|Beatriz P. Quiambao, MD||Pediatric and Infectious Diseases Specialist||Research Institute for Tropical Medicine|
|Project Location||Institutional Ethics Review Board|
|Research Institute for Tropical Medicine||Research Institute for Tropical Medicine Institutional Review Board|
•To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal PEP regimen (with and without rabies immunoglobulin), is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID PEP regimen with rabies immunoglobulin in terms of seroprotection rate at Day 14.
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 •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 (HIV), 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 (HIV), Hepatitis B virus, or Hepatitis C virus, as reported by the parent/guardian •Prior history of seizures .
Biological: Purified Vero cell Rabies Vaccine (PVRV); Biological: PVRV + purified Equine Rabies Immunoglobulin (pERIG)
Study participants will receive either Verorab®, with or without Favirab®, according to WHO categorization of contacts, depending on the group allocation, from Day 0 to 28, and a booster vaccine at 5 years post-primary vaccination.
01 Jun 2012
|No records found.|