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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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rabies Vaccines on Day 0 and 3

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


Participant Flow:   Overall Study
    Rabies Vaccines on Day 0 and 3
STARTED   33 
COMPLETED   30 
NOT COMPLETED   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Preliminary study

Reporting Groups
  Description
Rabies Vaccines on Day 0 and 3

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


Baseline Measures
   Rabies Vaccines on Day 0 and 3 
Overall Participants Analyzed 
[Units: Participants]
 33 
Age 
[Units: Years]
Median (Standard Deviation)
 43  (7.8) 
Gender 
[Units: Participants]
 
Female   13 
Male   20 
Region of Enrollment 
[Units: Participants]
 
Thailand   33 
CD4+ T lymphocyte counts 
[Units: Cell/mm^3]
Median (Full Range)
 489 
 (94 to 1120) 


  Outcome Measures

1.  Primary:   Rabies Neutralizing Antibody Titers   [ Time Frame: Day 360 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size heterogeneous characteristics of participants Use only CD4+ T lymphocyte counts as the only immunologic surrogate marker


  More Information

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
e-mail: sudapunrin@gmail.com



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