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

Primary Purpose

Rabies

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
rabies vaccine
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 - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Saovabha Memorial Institute, Thai Red Cross SocietyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Four-site intradermal vaccination

Intramuscular vaccination

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rabies neutralizing antibody titers
Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)

Secondary Outcome Measures

Specific T cell response
Specific T cell response is measured by OX-40 assay
Cytokines assessment
A few cytokines levels are measured by multiplex bead array assay

Full Information

First Posted
September 9, 2015
Last Updated
April 28, 2022
Sponsor
Queen Saovabha Memorial Institute
Collaborators
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT02547727
Brief Title
Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults
Official Title
Humoral and Cell-mediated Immune Responses After a Four-site Intradermal 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
February 2016 (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
Collaborators
Chulalongkorn University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Four-site intradermal vaccination
Arm Type
Experimental
Arm Description
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.
Arm Title
Intramuscular vaccination
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
rabies vaccine
Intervention Description
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 Measure Information:
Title
Rabies neutralizing antibody titers
Description
Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)
Time Frame
Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
Secondary Outcome Measure Information:
Title
Specific T cell response
Description
Specific T cell response is measured by OX-40 assay
Time Frame
Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks
Title
Cytokines assessment
Description
A few cytokines levels are measured by multiplex bead array assay
Time Frame
Change from baseline of cytokines levels at 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suda Sibunruang, MD
Phone
+66 81 7366076
Email
sudapunrin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Terapong Tantawichien, MD
Phone
+66 81 7350654
Email
terapong_tantawichien@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suda Sibunruang, MD
Organizational Affiliation
Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Saovabha Memorial Institute, Thai Red Cross Society
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suda Sibunruang, M.D.
Phone
+66 81 7366076
Email
sudapunrin@gmail.com
First Name & Middle Initial & Last Name & Degree
Terapong Tantawichien, M.D.
Phone
+66 2 2520161
Ext
125
Email
queensaovabha@hotmail.com
First Name & Middle Initial & Last Name & Degree
Suda Sibunruang, M.D.

12. IPD Sharing Statement

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

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