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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286493
First Posted: January 31, 2011
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute
  Purpose
Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.

Condition Intervention
HIV Rabies Biological: rabies vaccines on day 0 and 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination

Resource links provided by NLM:


Further study details as provided by Suda Sibunruang, Queen Saovabha Memorial Institute:

Primary Outcome Measures:
  • Rabies Neutralizing Antibody Titers [ Time Frame: Day 360 ]

    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.



Enrollment: 33
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rabies vaccines on day 0 and 3
Cell culture Rabies vaccines on day 0 and 3
Biological: rabies vaccines on day 0 and 3
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286493


Locations
Thailand
Queen Saovabha Memorial Institute
Bangkok, Thailand, 10330
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute
  More Information

Additional Information:
Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01286493     History of Changes
Other Study ID Numbers: RC5303
First Submitted: January 26, 2011
First Posted: January 31, 2011
Results First Submitted: April 21, 2014
Results First Posted: June 4, 2014
Last Update Posted: November 18, 2015
Last Verified: October 2015

Keywords provided by Suda Sibunruang, Queen Saovabha Memorial Institute:
HIV
booster
rabies
immune response

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs