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

Rabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610362
• Other study ID #: RC5504
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: April 5, 2018
• Start date: June 2012
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Queen Saovabha Memorial Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy volunteers age 18-60 years.

Exclusion Criteria:

• received prior rabies immunization

• pregnancy

• immunocompromised conditions

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• Human Rabies Immune Globulin
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0

Locations

Country	Name	City	State
Thailand	Queen Saovabha Memorial Institute, Thai Red Cross Society	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Queen Saovabha Memorial Institute

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg	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.	Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period
Secondary	Number of participants who have Rabies Neutralizing antibody titers above protective levels.	Number of participants who have Rabies Neutralizing antibody titers above protective levels (> 0.5 IU/mL as recommended by WHO)at 3-month period.	Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..