Rabies
Conditions
Keywords
rabies, immunoglobulin, dosage
Brief summary
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.
Detailed description
* Controlled trial study. * All 50 volunteers who had never had rabies immunization would be enrolled and designated into 2 groups. group 1 : 15 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 20 IU/kg of human rabies immune globulin (HRIG). group 2 : 35 Healthy volunteers age 18 - 60 yr receive 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of human rabies immune globulin (HRIG). 5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28 and 90 for rabies neutralizing antibody titers (RNab). The GMTs of RNab among both groups would be analyzed and compared.
Interventions
BIOLOGICALHuman Rabies Immune Globulin
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
Sponsors
Queen Saovabha Memorial Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteers age 18-60 years.
Exclusion criteria
* received prior rabies immunization * pregnancy * immunocompromised conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg | Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period | Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg would be determined on day 0,14, 28 and 90. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who have Rabies Neutralizing antibody titers above protective levels. | Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period.. | Number of participants who have Rabies Neutralizing antibody titers above protective levels (\> 0.5 IU/mL as recommended by WHO)at 3-month period. |
Countries
Thailand
Outcome results
None listed