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

This study is currently recruiting participants.
Verified May 2012 by Queen Saovabha Memorial Institute
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier:
NCT01286493
First received: January 26, 2011
Last updated: May 30, 2012
Last verified: May 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 Queen Saovabha Memorial Institute:

Primary Outcome Measures:
  • Rabies Neutralizing Antibody titers [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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, 30, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.

    for 7 times in 1 year.



Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286493

Contacts
Contact: Suda Sibunruang, MD +66 2 2520161 ext 125 sudapunrin@gmail.com
Contact: Wipaporn Jaijaroensup, RN +66 2 2520161 ext 124 wisup@yahoo.com

Locations
Thailand
Queen Saovabha Memorial Institute Not yet recruiting
Bangkok, Thailand, 10330
Contact: Suda Sibunruang, MD    +66 2 2520161 ext 125    sudapunrin@gmail.com   
Contact: Wipaporn Jaijaroensup, RN    +66 2 2520161 ext 124    wisup@yahoo.com   
Principal Investigator: Suda Sibunruang, MD         
Queen Saovabha Memorial Institute Recruiting
Bangkok, Thailand, 10330
Contact: Suda Sibunruang, M.D.    +66 2 252 0161 ext 131    sudapunrin@gmail.com   
Principal Investigator: Suda Sibunruang, M.D.         
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01286493     History of Changes
Other Study ID Numbers: RC5303
Study First Received: January 26, 2011
Last Updated: May 30, 2012
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014