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Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination

Primary Purpose

HIV, Rabies

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
rabies vaccines on day 0 and 3
Sponsored by
Queen Saovabha Memorial Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, booster, rabies, immune response

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • HIV infected patients 18-60 years of age
  • Ever received primary rabies immunization

Exclusion Criteria:

  • currently have any active opportunistic infections
  • have received blood or blood product within previous 3 months
  • history of allergy to vaccine or any vaccine components
  • currently received anti-malarial drugs

Sites / Locations

  • Queen Saovabha Memorial Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rabies vaccines on day 0 and 3

Arm Description

Cell culture Rabies vaccines on day 0 and 3

Outcomes

Primary Outcome Measures

Rabies Neutralizing Antibody Titers
Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2011
Last Updated
October 19, 2015
Sponsor
Queen Saovabha Memorial Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01286493
Brief Title
Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination
Official Title
Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.
Detailed Description
The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Rabies
Keywords
HIV, booster, rabies, immune response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rabies vaccines on day 0 and 3
Arm Type
Experimental
Arm Description
Cell culture Rabies vaccines on day 0 and 3
Intervention Type
Biological
Intervention Name(s)
rabies vaccines on day 0 and 3
Intervention Description
All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360
Primary Outcome Measure Information:
Title
Rabies Neutralizing Antibody Titers
Description
Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year.
Time Frame
Day 360

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: HIV infected patients 18-60 years of age Ever received primary rabies immunization Exclusion Criteria: currently have any active opportunistic infections have received blood or blood product within previous 3 months history of allergy to vaccine or any vaccine components currently received anti-malarial drugs
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

12. IPD Sharing Statement

Links:
URL
http://www.saovabha.com
Description
http://www.saovabha.com/th/academic.asp

Learn more about this trial

Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination

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