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Trial record 5 of 77 for:    "Rabies" | "Immunologic Factors"

Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults

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ClinicalTrials.gov Identifier: NCT02547727
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute

Brief Summary:
A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.

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

Detailed Description:
A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. So, the investigators hypothesized the same outcome in HIV - infected patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Rabies

Arm Intervention/treatment
Experimental: Four-site intradermal vaccination
0.1 ml of rabies vaccine is distributed to 4 sites over both arms and thigh intradermally on day 0. Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
Biological: rabies vaccine
Rabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.

Active Comparator: Intramuscular vaccination
0.5 ml of rabies vaccine is injected to one arm on day 0 and 3.Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
Biological: rabies vaccine
Rabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.




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)


Secondary Outcome Measures :
  1. Specific T cell response [ Time Frame: Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks ]
    Specific T cell response is measured by OX-40 assay

  2. Cytokines assessment [ Time Frame: Change from baseline of cytokines levels at 1 week ]
    A few cytokines levels are measured by multiplex bead array assay



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected patients
  • Age 18 - 60 years
  • Received primary rabies immunization

Exclusion Criteria:

  • Have any active opportunistic infections
  • Received blood or blood product within 3 months
  • Allergy to vaccine or any vaccine components
  • 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): NCT02547727


Contacts
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Contact: Suda Sibunruang, MD +66 81 7366076 sudapunrin@gmail.com
Contact: Terapong Tantawichien, MD +66 81 7350654 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
Chulalongkorn University
Investigators
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Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university

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Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT02547727     History of Changes
Other Study ID Numbers: 495/2015
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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

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