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

Not Applicable

Completed

• Conditions: Rabies; HIV
• Interventions: Biological: rabies vaccines on day 0 and 3

• Registration Number: NCT01286493
• Lead Sponsor: Queen Saovabha Memorial Institute

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.

Study Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-31
• Study Start: 2011-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-04-21
• Results First Submitted QC: 2014-05-18
• Results First Posted: 2014-06-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rabies vaccines on day 0 and 3	rabies vaccines on day 0 and 3	Cell culture Rabies vaccines on day 0 and 3

Primary Outcome Measures

Name	Time	Method
Rabies Neutralizing Antibody Titers	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.

Trial Locations

Locations (1)

Queen Saovabha Memorial Institute; 🇹🇭 Bangkok, Thailand