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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286493
• Other study ID #: RC5303
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: October 19, 2015
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: Queen Saovabha Memorial Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Rabies

Intervention

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

Locations

Country	Name	City	State
Thailand	Queen Saovabha Memorial Institute	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Queen Saovabha Memorial Institute

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 360	No

External Links

•   http://www.saovabha.com/th/academic.asp