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

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

Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

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

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

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

Sponsor

Queen Saovabha Memorial Institute

Investigators

  • Principal Investigator: Suda Sibunruang, MD, Queen Saovabha Memorial Institute

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)

August 1, 2017

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 24, 2017

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

  • 1/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Rabies

Clinical Trials on Blood drawn after rabies booster vaccination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe