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Trial record 2 of 75 for:    "Rabies" | "Immunologic Factors"

Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response

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ClinicalTrials.gov Identifier: NCT03524417
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute

Brief Summary:
No study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1).

Condition or disease Intervention/treatment Phase
Rabies Biological: Equine rabies immunoglobulin injection on day 7 Not Applicable

Detailed Description:

Rabies immunoglobulin (RIG) should be administered as soon as possible after the initiation of post-exposure prophylaxis. RIG should not be given after day 7 following the first rabies vaccine dose, because circulating neutralizing antibody will have begun to appear. Nevertheless, no study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7.

The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1). The ongoing study would prove the validity of the recommendation and eliminate the controversies in clinical practice.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Equine Rabies Immunoglobulin Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: RIG injection
RIG injection on day 7
Biological: Equine rabies immunoglobulin injection on day 7
The patients with WHO category III rabies exposure, who have received first dose of rabies vaccination a week before and have not received rabies immunoglobulin were enrolled. Blood for Rabies neutralizing antibody titers (RNab) would be examined on day 0. On the same day, Equine rabies immunoglobulin (ERIG) at the dosage of 40 IU/kg would be injected into and around the wound as much as possible and the rest would be injected intramuscularly at the site distance from rabies vaccine. Then blood for RNab would be serially examined on day 7, 14, 90, 365.




Primary Outcome Measures :
  1. Rabies neutralizing antibody titers [ Time Frame: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks ]
    Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)



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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:

  • Age 18 - 60 years
  • WHO category III rabies exposure
  • Received rabies vaccination on day 0 and 3.

Exclusion Criteria:

  • Received RIG
  • Immunocompromised hosts or receiving immunosuppressive therapy
  • Received blood or blood product within 3 months
  • Received anti-malarial drugs

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): NCT03524417


Contacts
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Contact: Suda Sibunruang, MD +66 2 2520161 ext 125 sudapunrin@gmail.com
Contact: Terapong Tantawichien, MD +66 2 2520161 ext 132 terapong_tantawichien@hotmail.com

Locations
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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
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Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute

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Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT03524417     History of Changes
Other Study ID Numbers: 2/2017
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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