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Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease

This study has been terminated.
(Due to a safety signal found at a planned interim safety review, further conduct of this safety study is not recommended hence the study was terminated.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424501
First received: August 25, 2011
Last updated: November 29, 2016
Last verified: December 2015
Results First Received: November 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Tuberculosis
Interventions: Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Biological: Placebo

  Participant Flow
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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 was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions, and medical history of subjects was collected. Prior to vaccination, subjects’ pre-vaccination body temperature was evaluated.

Reporting Groups
  Description
TB Treatment GSK 692342 Group Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
TB Treatment Saline Group Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
TB Treated GSK 692342 Group Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
TB Treated Saline Group Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
TB Naive GSK 692342 Group Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
TB Naive Saline Group Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.

Participant Flow:   Overall Study
    TB Treatment GSK 692342 Group   TB Treatment Saline Group   TB Treated GSK 692342 Group   TB Treated Saline Group   TB Naive GSK 692342 Group   TB Naive Saline Group
STARTED   7   6   24   25   40   40 
COMPLETED   6   5   22   25   40   40 
NOT COMPLETED   1   1   2   0   0   0 
Withdrawal by Subject                1                1                1                0                0                0 
Lost to Follow-up                0                0                1                0                0                0 



  Baseline Characteristics
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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
TB Treatment GSK 692342 Group Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
TB Treatment Saline Group Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
TB Treated GSK 692342 Group Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
TB Treated Saline Group Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
TB Naive GSK 692342 Group Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
TB Naive Saline Group Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
Total Total of all reporting groups

Baseline Measures
   TB Treatment GSK 692342 Group   TB Treatment Saline Group   TB Treated GSK 692342 Group   TB Treated Saline Group   TB Naive GSK 692342 Group   TB Naive Saline Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   6   24   25   40   40   142 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.9  (11.5)   44.7  (11.8)   44.5  (10.3)   47  (9.8)   33.8  (8.5)   33.3  (9.8)   38.7  (9.98) 
Gender 
[Units: Participants]
Count of Participants
             
Female      1  14.3%      2  33.3%      13  54.2%      7  28.0%      16  40.0%      21  52.5%      60  42.3% 
Male      6  85.7%      4  66.7%      11  45.8%      18  72.0%      24  60.0%      19  47.5%      82  57.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Solicited Local Symptoms   [ Time Frame: During the 7 day (Days 0-6), after each vaccine dose ]

2.  Primary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: During the 7 day (Days 0-6), after each vaccine dose ]

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

4.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Up to day 210 ]

5.  Secondary:   Number of Subjects With Anti-mycobacterium Tuberculosis Fusion Protein M72 Antibodies   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Day 30 – D30), post-dose 2 (Days 60 – D60 and 210 – D210) ]

6.  Secondary:   Concentrations of Mycobacterium Tuberculosis Fusion Protein M72   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Day 30 – D30), post-dose 2 (Days 60 – D60 and 210 – D210) ]

7.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of the Different Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

8.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing 2 or More Immune Markers Among 6   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

9.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

10.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

11.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

12.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

13.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

14.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

15.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

16.  Secondary:   Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

17.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing at Least 2 Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

18.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing 2 or More Immune Markers Among 6   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

19.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

20.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

21.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

22.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

23.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

24.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

25.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]

26.  Secondary:   Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers   [ Time Frame: Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210) ]


  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
Due to a safety signal found at a planned interim safety review, further conduct of this safety study is not recommended hence the study was terminated.


  More Information
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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: NCT01424501     History of Changes
Other Study ID Numbers: 114886
Study First Received: August 25, 2011
Results First Received: November 29, 2016
Last Updated: November 29, 2016