ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 42 for:    " January 12, 2011":" February 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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.
ClinicalTrials.gov Identifier: NCT01286493
Recruitment Status : Completed
First Posted : January 31, 2011
Results First Posted : June 4, 2014
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
Rabies
Intervention Biological: rabies vaccines on day 0 and 3
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rabies Vaccines on Day 0 and 3
Hide Arm/Group Description

Cell culture Rabies vaccines on day 0 and 3

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 0,7,14,28,90,180,360

Period Title: Overall Study
Started 33
Completed 30
Not Completed 3
Arm/Group Title Rabies Vaccines on Day 0 and 3
Hide Arm/Group Description

Cell culture Rabies vaccines on day 0 and 3

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 0,7,14,28,90,180,360

Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
Preliminary study
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
43  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
13
  39.4%
Male
20
  60.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 33 participants
33
CD4+ T lymphocyte counts  
Median (Full Range)
Unit of measure:  Cell/mm^3
Number Analyzed 33 participants
489
(94 to 1120)
1.Primary Outcome
Title Rabies Neutralizing Antibody Titers
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As preliminary study, the number of participants was estimated to be above 15 - 20 cases.
Arm/Group Title Rabies Vaccines on Day 0 and 3
Hide Arm/Group Description:

Cell culture Rabies vaccines on day 0 and 3

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 0,7,14,28,90,180,360

Overall Number of Participants Analyzed 33
Geometric Mean (Full Range)
Unit of Measure: IU/ml
8.48
(0.50 to 218.10)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rabies Vaccines on Day 0 and 3
Hide Arm/Group Description

Cell culture Rabies vaccines on day 0 and 3

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 0,7,14,28,90,180,360

All-Cause Mortality
Rabies Vaccines on Day 0 and 3
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rabies Vaccines on Day 0 and 3
Affected / at Risk (%)
Total   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rabies Vaccines on Day 0 and 3
Affected / at Risk (%)
Total   0/33 (0.00%) 
Small sample size heterogeneous characteristics of participants Use only CD4+ T lymphocyte counts as the only immunologic surrogate marker
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr.Suda Sibunruang
Organization: Queen Saovabha Memorial Institute
Phone: +66 2 2520161 ext 125
Responsible Party: Suda Sibunruang, 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