Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response

Queen Saovabha Memorial Institute

Status: Completed

Conditions: Rabies

Treatments: Biological: Human Rabies Immune Globulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01610362

RC5504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers age 18-60 years.

Exclusion criteria

• received prior rabies immunization
• pregnancy
• immunocompromised conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

5-dose IM rabies vaccines, HRIG 20 IU/kg

Active Comparator group

Description:

Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg

Treatment:

Biological: Human Rabies Immune Globulin

5-dose IM rabies vaccines, HRIG 40 IU/kg

Experimental group

Description:

Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg

Treatment:

Biological: Human Rabies Immune Globulin