Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
NCT ID: NCT01641315
Last Updated: 2018-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2015-09-30
2018-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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
Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.
Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.
Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG 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
Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.
Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.
Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG 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
rabies vaccine
Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.
Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.
Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Interventions
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rabies vaccine
Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.
Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.
Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnancy
* immunocompromised conditions
18 Years
60 Years
ALL
Yes
Sponsors
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Queen Saovabha Memorial Institute
OTHER
Responsible Party
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Suda Sibunruang
Principal Investigator
Principal Investigators
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Suda Sibunruang, MD
Role: PRINCIPAL_INVESTIGATOR
Queen Saovabha Memorial Institute
Locations
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Queen Saovabha Memorial Institute
Bangkok, , Thailand
Countries
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Other Identifiers
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RC5502
Identifier Type: -
Identifier Source: org_study_id
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