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

Primary Purpose

Rabies

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Blood drawn after rabies booster vaccination
Sponsored by
Queen Saovabha Memorial Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rabies focused on measuring rabies vaccination

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Queen Saovabha Memorial InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

single visit 4-site ID vaccination

Conventional IM vaccination

Arm Description

Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.

Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.

Outcomes

Primary Outcome Measures

Rabies Neutralizing Antibody Titers (RNab)
Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)

Secondary Outcome Measures

Rabies specific T cell response
Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)

Full Information

First Posted
July 14, 2017
Last Updated
April 28, 2022
Sponsor
Queen Saovabha Memorial Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03228069
Brief Title
Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults
Official Title
Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Saovabha Memorial Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
rabies vaccination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single visit 4-site ID vaccination
Arm Type
Experimental
Arm Description
Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.
Arm Title
Conventional IM vaccination
Arm Type
Active Comparator
Arm Description
Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.
Intervention Type
Procedure
Intervention Name(s)
Blood drawn after rabies booster vaccination
Intervention Description
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 Measure Information:
Title
Rabies Neutralizing Antibody Titers (RNab)
Description
Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)
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.
Secondary Outcome Measure Information:
Title
Rabies specific T cell response
Description
Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)
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.
Other Pre-specified Outcome Measures:
Title
Rabies specific regulatory T cells
Description
Rabies specific regulatory T cells is measured by flow cytometry method
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suda Sibunruang, MD
Phone
+66 2 2520161
Ext
125
Email
sudapunrin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Terapong Tantawichien, MD
Phone
+66 2 2520161
Ext
132
Email
terapong_tantawichien@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suda Sibunruang, MD
Organizational Affiliation
Queen Saovabha Memorial Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Saovabha Memorial Institute
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suda Sibunruang, MD
Phone
+66 2 2520161
Ext
125
Email
sudapunrin@gmail.com
First Name & Middle Initial & Last Name & Degree
Terapong Tantawichien, MD
Phone
+66 2 2520161
Ext
132
Email
terapong_tantawichien@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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