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Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins

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ClinicalTrials.gov Identifier: NCT01641315
Recruitment Status : Completed
First Posted : July 16, 2012
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute

Brief Summary:
Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.

Condition or disease Intervention/treatment Phase
Rabies Biological: rabies vaccine Not Applicable

Detailed Description:
  • Controlled trial study
  • All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups.

group 1 : 25 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 40 IU/kg of equine rabies immune globulin (ERIG).

group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG).

group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab).

The GMTs of RNab among both groups would be analyzed and compared.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment
Study Start Date : September 2015
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
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rabies vaccine, IM day 0,3,7,28 with RIG
Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 28 with equine rabies immunoglobulin 40 IU/Kg on day 0.
Biological: rabies vaccine

Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.

Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.

Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.

Other Name: Equine rabies immunoglobulin produced by Thai Red Cross
Experimental: Rabies vaccine, IM day 0,3,7,14 with RIG
Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 14 with equine rabies immunoglobulin 40 IU/Kg on day 0.
Biological: rabies vaccine

Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.

Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.

Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.

Other Name: Equine rabies immunoglobulin produced by Thai Red Cross
Active Comparator: Rabies vaccine, IM Day 0,3,7,14,28 with RIG
Rabies exposed victims receive rabies vaccination intramuscularly on Day 0,3,7,14,28 with equine rabies immunoglobulin 40 IU/Kg on day 0
Biological: rabies vaccine

Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.

Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.

Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.

Other Name: Equine rabies immunoglobulin produced by Thai Red Cross



Primary Outcome Measures :
  1. Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 [ Time Frame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period ]
    Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.


Secondary Outcome Measures :
  1. Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28 [ Time Frame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period ]
    Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7 and 28 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.



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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): NCT01641315


Locations
Thailand
Queen Saovabha Memorial Institute
Bangkok, Thailand, 10330
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute

Responsible Party: Suda Sibunruang, Principal Investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01641315     History of Changes
Other Study ID Numbers: RC5502
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Suda Sibunruang, Queen Saovabha Memorial Institute:
rabies
rabies immunoglobulin

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