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Trial record 4 of 75 for:    "Rabies" | "Immunologic Factors"

Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults

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ClinicalTrials.gov Identifier: NCT03228069
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute

Brief Summary:
To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before

Condition or disease Intervention/treatment Phase
Rabies Procedure: Blood drawn after rabies booster vaccination Not Applicable

Detailed Description:
Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Rabies

Arm Intervention/treatment
Experimental: single visit 4-site ID vaccination
Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.
Procedure: Blood drawn after rabies booster vaccination
Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.

Active Comparator: Conventional IM vaccination
Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.
Procedure: Blood drawn after rabies booster vaccination
Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.




Primary Outcome Measures :
  1. Rabies Neutralizing Antibody Titers (RNab) [ Time Frame: GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment. ]
    Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)


Secondary Outcome Measures :
  1. Rabies specific T cell response [ Time Frame: Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment. ]
    Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)


Other Outcome Measures:
  1. Rabies specific regulatory T cells [ Time Frame: Numbers of Rabies specific regulatory T cells after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment. ]
    Rabies specific regulatory T cells is measured by flow cytometry method



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy HIV-infected adults
  • Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.

Exclusion Criteria:

  • Have any active opportunistic infections
  • Received blood or blood product within 3 months
  • Received anti-malarial drugs
  • Received rabies vaccination in a previous year.

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): NCT03228069


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 Recruiting
Bangkok, Thailand, 10330
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   
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, Medical doctor, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT03228069     History of Changes
Other Study ID Numbers: 1/2017
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 vaccination

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