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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Queen Saovabha Memorial Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier:
NCT01641315
First received: July 12, 2012
Last updated: July 14, 2012
Last verified: July 2012
  Purpose

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 Intervention
Rabies
Biological: rabies vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment

Resource links provided by NLM:


Further study details as provided by Queen Saovabha Memorial Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 75
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641315

Contacts
Contact: Suda Sibunruang, MD +66 2 2520161 ext 125 sudapunrin@gmail.com
Contact: Saowaluck Tepsumethanon, RN +66 2 2520161 ext 132 queensaovabha@hotmail.com

Locations
Thailand
Queen Saovabha Memorial Institute Not yet recruiting
Bangkok, Thailand, 10330
Contact: Suda Sibunruang, MD    +66 2 2520161 ext 125    sudapunrin@gmail.com   
Contact: Saowaluck Tepsumethanon, RN    +66 2 2520161 ext 132    queensaovabha@hotmail.com   
Principal Investigator: Suda Sibunruang, MD         
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute
  More Information

No publications provided

Responsible Party: Suda Sibunruang, Principal Investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01641315     History of Changes
Other Study ID Numbers: RC5502
Study First Received: July 12, 2012
Last Updated: July 14, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Queen Saovabha Memorial Institute:
rabies
rabies immunoglobulin

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

ClinicalTrials.gov processed this record on August 26, 2014