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Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins

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Disease Information

Descriptive Information
Brief Title † Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
Official Title † Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment
Brief Summary Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.
Detailed Description - Controlled trial study - All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups. group 1 : 25 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of equine rabies immune globulin (ERIG). group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG). group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG). 5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab). The GMTs of RNab among both groups would be analyzed and compared.
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary Outcome Measure † Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14
Secondary Outcome Measure † Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28
Condition † Rabies
Intervention † Biologicalrabies vaccine
Study Arms / Comparison Groups Rabies vaccine, IM day 0,3,7,28 with RIG Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 28 with equine rabies immunoglobulin 40 IU/Kg on day 0. Rabies vaccine, IM day 0,3,7,14 with RIG Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 14 with equine rabies immunoglobulin 40 IU/Kg on day 0. Rabies vaccine, IM Day 0,3,7,14,28 with RIG Rabies exposed victims receive rabies vaccination intramuscularly on Day 0,3,7,14,28 with equine rabies immunoglobulin 40 IU/Kg on day 0
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 75
Start Date † September 2015
Completion Date December 2018
Primary Completion Date December 2018
Eligibility Criteria † Inclusion Criteria: - healthy volunteers age 18-60 years. Exclusion Criteria: - received prior rabies immunization - pregnancy - immunocompromised conditions
Gender Both
Ages 18 Years - 60 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Suda Sibunruang, MD, +66 2 2520161, sudapunrin@gmail.com
Location Countries † Thailand
Administrative Information
NCT ID † NCT01641315
Organization ID RC5502
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Queen Saovabha Memorial Institute
Collaborators ††
Investigators † Principal Investigator: Suda Sibunruang, MD, Queen Saovabha Memorial Institute
Information Provided By
Verification Date November 2016
First Received Date † July 12, 2012
Last Updated Date November 23, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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