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

Information source: Queen Saovabha Memorial Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rabies

Intervention: Human Rabies Immune Globulin (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: Queen Saovabha Memorial Institute

Official(s) and/or principal investigator(s):
Suda Sibunruang, M.D., Principal Investigator, Affiliation: Queen Saovabha Memorial Institute, Thai Red Cross Society

Overall contact:
Suda Sibunruang, M.D., Phone: +66 81 7366076, Email: sudapunrin@gmail.com

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg

Secondary outcome: Number of participants who have Rabies Neutralizing antibody titers above protective levels.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- healthy volunteers age 18-60 years.

Exclusion Criteria:

- received prior rabies immunization

- pregnancy

- immunocompromised conditions

Locations and Contacts

Suda Sibunruang, M.D., Phone: +66 81 7366076, Email: sudapunrin@gmail.com

Queen Saovabha Memorial Institute, Thai Red Cross Society, Bangkok 10330, Thailand; Recruiting
Suda Sibunruang, M.D., Phone: +66 81 7366076, Email: sudapunrin@gmail.com
Terapong Tantawichien, M.D., Phone: +66 2 2520161, Ext: 125, Email: queensaovabha@hotmail.com
Suda Sibunruang, M.D., Principal Investigator
Additional Information

Starting date: June 2012
Last updated: July 12, 2012

Page last updated: August 20, 2015

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