Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00707967
First received: June 27, 2008
Last updated: November 7, 2016
Last verified: October 2016
Results First Received: November 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Tuberculosis
Interventions: Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Biological: Control vaccine with the adjuvant system.
Biological: Control vaccine with physiological saline

  Participant Flow
  Hide 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
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Reporting Groups
  Description
GSK692342 Group Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Control Group Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Placebo Group Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.

Participant Flow:   Overall Study
    GSK692342 Group   Control Group   Placebo Group
STARTED   22   8   7 
COMPLETED   22   8   7 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
GSK692342 Group Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Control Group Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Placebo Group Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Total Total of all reporting groups

Baseline Measures
   GSK692342 Group   Control Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   8   7   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.6  (7.43)   40.0  (5.61)   41.9  (4.67)   40.12  (6.54) 
Gender 
[Units: Participants]
Count of Participants
       
Female      8  36.4%      3  37.5%      0   0.0%      11  29.7% 
Male      14  63.6%      5  62.5%      7 100.0%      26  70.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Solicited Local Symptoms   [ Time Frame: During the 7-day period (Days 0-6) post vaccination following each dose ]

2.  Primary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: During the 7-day period (Days 0-6) post vaccination following each dose ]

3.  Primary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 30-day period (Days 0-29) post vaccination ]

4.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period, from Day 0 up to Day 210 ]

5.  Primary:   Number of Subjects With Normal Biochemical and Haematological Levels   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

6.  Primary:   Number of Subjects With Normal Haematological Levels   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

7.  Primary:   Number of Subjects With Normal Haematological Levels   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

8.  Primary:   Number of Subjects With Biochemical and Haematological Levels Below Normal   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

9.  Primary:   Number of Subjects With Haematological Levels Below Normal   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

10.  Primary:   Number of Subjects With Haematological Levels Below Normal   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

11.  Primary:   Number of Subjects With Biochemical and Haematological Levels Above Normal   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

12.  Primary:   Number of Subjects With Haematological Levels Above Normal   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

13.  Primary:   Number of Subjects With Haematological Levels Above Normal   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

14.  Secondary:   Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines   [ Time Frame: At Day 0, 30, 60 and 210 ]

15.  Secondary:   Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule   [ Time Frame: At Day 0, 30, 60 and 210 ]

16.  Secondary:   Cell Count of CD4+ T Cells   [ Time Frame: At Day 0, 30, 60 and 210 ]

17.  Secondary:   Anti-M72 Specific Antibody Concentrations   [ Time Frame: At Day 0, 30, 60 and 210 ]

18.  Secondary:   Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes   [ Time Frame: From Day 60 to Day 210 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00707967     History of Changes
Other Study ID Numbers: 111517
Study First Received: June 27, 2008
Results First Received: November 7, 2016
Last Updated: November 7, 2016