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

April 28, 2022 updated by: Suda Sibunruang, Queen Saovabha Memorial Institute

Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Queen Saovabha Memorial Institute, Thai Red Cross Society
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suda Sibunruang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks
Cytokines assessment
Time Frame: Change from baseline of cytokines levels at 1 week
A few cytokines levels are measured by multiplex bead array assay
Change from baseline of cytokines levels at 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Saovabha Memorial Institute

Collaborators

Chulalongkorn University

Investigators

  • Principal Investigator: Suda Sibunruang, MD, Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 495/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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