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Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01165203
First received: July 15, 2010
Last updated: May 11, 2017
Last verified: May 2017
Results First Received: May 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Herpes Zoster
Interventions: Biological: Herpes Zoster Vaccine GSK1437173A
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
No text entered.

Reporting Groups
  Description
GSK1437173A Group Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Placebo Group Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.

Participant Flow for 2 periods

Period 1:   Active Phase
    GSK1437173A Group   Placebo Group
STARTED   74   49 
COMPLETED   69   47 
NOT COMPLETED   5   2 
Serious Adverse Event                1                0 
Withdrawal by Subject                2                1 
Migrated/moved from study area                0                1 
Lost to Follow-up                2                0 

Period 2:   Extended Safety Follow-up Phase
    GSK1437173A Group   Placebo Group
STARTED   74   49 
COMPLETED   67   45 
NOT COMPLETED   7   4 
Serious Adverse Event                1                0 
Withdrawal by Subject                2                2 
Migrated/moved from study area                2                1 
Lost to Follow-up                2                0 
Other-subjects business reasons                0                1 



  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
GSK1437173A Group Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Placebo Group Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
   GSK1437173A Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 74   49   123 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.6  (10.68)   45.1  (11.36)   46.0  (10.93) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5   6.8%      2   4.1%      7   5.7% 
Male      69  93.2%      47  95.9%      116  94.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
African heritage/African American   6   2   8 
Asian-East Asian heritage   0   1   1 
Asian-Japanese heritage   1   0   1 
White-Caucasian/European heritage   66   42   108 
Unspecified   1   4   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: From Month 0 to Month 18 ]

2.  Primary:   Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine   [ Time Frame: From screening (up to 21 days prior to Month 0) until Month 18 ]

3.  Primary:   Number of Subjects With Any Fatal SAEs   [ Time Frame: From screening (up to 21 days prior to Month 0) until Month 18 ]

4.  Primary:   Number of Subjects With Any Adverse Events (AEs) of Specific Interest   [ Time Frame: From Month 0 until Month 18 ]

5.  Primary:   Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms   [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

6.  Primary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

7.  Primary:   Number of Subjects With Unsolicited AEs   [ Time Frame: Within 30 days (Days 0-29) after each vaccination ]

8.  Primary:   Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges   [ Time Frame: At Screening Visit (up to 21 days prior to Month 0) ]

9.  Primary:   Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges   [ Time Frame: At Month 1 ]

10.  Primary:   Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges   [ Time Frame: At Month 2 ]

11.  Primary:   Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges   [ Time Frame: At Month 3 ]

12.  Primary:   Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges   [ Time Frame: At Month 6 ]

13.  Primary:   Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges   [ Time Frame: At Month 7 ]

14.  Primary:   Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects   [ Time Frame: From Month 0 until Month 18 ]

15.  Primary:   Number of Subjects With Any AIDS-defining Condition   [ Time Frame: From Month 0 until Month 18 ]

16.  Primary:   Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count   [ Time Frame: From Month 1 to Month 7 ]

17.  Primary:   Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status   [ Time Frame: From Month 0 to Month 18 ]

18.  Primary:   Number of Subjects With Any AIDS-defining Condition, by HIV Status   [ Time Frame: From Month 0 to Month 18 ]

19.  Primary:   Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status   [ Time Frame: From Month 1 to Month 7 ]

20.  Primary:   Frequency of gE-specific CD4 T-cells   [ Time Frame: At Month 7 ]

21.  Primary:   ­Anti-gE Antibody (Ab) Concentrations   [ Time Frame: At Month 7 ]

22.  Secondary:   ­Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells   [ Time Frame: At Month 0, 1, 2, 3, 6, 7 and 18 ]

23.  Secondary:   ­Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status   [ Time Frame: At Months 0, 1, 2, 3, 6, 7 and 18 ]

24.  Secondary:   ­Anti-VZV and Anti-gE Antibody Concentrations   [ Time Frame: At Months 0, 1, 2, 3, 6, 7 and 18 ]

25.  Secondary:   ­Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status   [ Time Frame: At Months 0, 1, 2, 3, 6, 7 and 18 ]

26.  Secondary:   Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications   [ Time Frame: From Month 0 until Month 18 ]

27.  Secondary:   CD4 Count   [ Time Frame: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18 ]

28.  Secondary:   HIV VL   [ Time Frame: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: NCT01165203     History of Changes
Other Study ID Numbers: 112673
Study First Received: July 15, 2010
Results First Received: May 11, 2017
Last Updated: May 11, 2017