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Trial record 13 of 80 for:    "Rabies" | "Immunologic Factors"

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

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ClinicalTrials.gov Identifier: NCT01610362
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute

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.

Condition or disease Intervention/treatment Phase
Rabies Biological: Human Rabies Immune Globulin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
Study Start Date : June 2012
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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.. ]
    Number of participants who have Rabies Neutralizing antibody titers above protective levels (> 0.5 IU/mL as recommended by WHO)at 3-month period.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers age 18-60 years.

Exclusion Criteria:

  • received prior rabies immunization
  • pregnancy
  • immunocompromised conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610362


Locations
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Thailand
Queen Saovabha Memorial Institute, Thai Red Cross Society
Bangkok, Thailand, 10330
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
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Principal Investigator: Suda Sibunruang, M.D. Queen Saovabha Memorial Institute, Thai Red Cross Society

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Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01610362     History of Changes
Other Study ID Numbers: RC5504
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by Suda Sibunruang, Queen Saovabha Memorial Institute:
rabies
immunoglobulin
dosage
Additional relevant MeSH terms:
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Rabies
Immunologic Factors
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Physiological Effects of Drugs