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

This study is currently recruiting participants.
Verified July 2012 by Queen Saovabha Memorial Institute
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier:
NCT01610362
First received: May 29, 2012
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Rabies
 Biological: Human Rabies Immune Globulin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response

Resource links provided by NLM:

MedlinePlus related topics: Rabies
U.S. FDA Resources

Further study details as provided by Queen Saovabha Memorial Institute:

Primary Outcome Measures:
  • Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg [ Time Frame: Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Number of participants who have Rabies Neutralizing antibody titers above protective levels. [ Time Frame: Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period.. ] [ Designated as safety issue: Yes ]
    Number of participants who have Rabies Neutralizing antibody titers above protective levels (> 0.5 IU/mL as recommended by WHO)at 3-month period.


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5-dose IM rabies vaccines, HRIG 20 IU/kg
Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg
 Biological: Human Rabies Immune Globulin
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
Other Name: Human Rabies Immune Globulin produced by Thai Red Cross
Experimental: 5-dose IM rabies vaccines, HRIG 40 IU/kg
Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg
 Biological: Human Rabies Immune Globulin
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
Other Name: Human Rabies Immune Globulin produced by Thai Red Cross

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers age 18-60 years.

Exclusion Criteria:

  • received prior rabies immunization
  • pregnancy
  • immunocompromised conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610362

Contacts
Contact: Suda Sibunruang, M.D. +66 81 7366076 sudapunrin@gmail.com
Contact: Terapong Tantawichien, M.D. +66 2 252 0161 ext 125 queensaovabha@hotmail.com

Locations
Thailand
Queen Saovabha Memorial Institute, Thai Red Cross Society Recruiting
Bangkok, Thailand, 10330
Contact: Suda Sibunruang, M.D.     +66 81 7366076     sudapunrin@gmail.com    
Contact: Terapong Tantawichien, M.D.     +66 2 2520161 ext 125     queensaovabha@hotmail.com    
Principal Investigator: Suda Sibunruang, M.D.            
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Suda Sibunruang, M.D. Queen Saovabha Memorial Institute, Thai Red Cross Society
  More Information

No publications provided

Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01610362     History of Changes
Other Study ID Numbers: RC5504
Study First Received: May 29, 2012
Last Updated: July 12, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Queen Saovabha Memorial Institute:
rabies
immunoglobulin
dosage

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
 Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013