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    Clinical Trial Results:
    Long-term follow-up of study participants from GlaxoSmithKline (GSK) Biologicals’-sponsored clinical trials evaluating Human Immunodeficiency Virus vaccine [F4co (p24-RT-Nef-p17)/AS01B vaccine] (732461) for therapeutic use.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-018097-64
    Trial protocol
    		 DE  
    Global end of trial date
    19 May 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Jul 2016
    First version publication date
    29 May 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results

    Trial information

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    Trial identification
    Sponsor protocol code
    114083
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01092611
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    24 Sep 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To assess the health status of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To assess CD4 count and viral load kinetics of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To assess time to (re)initiation of ART of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To assess the incidence of specific clinical events (cardiovascular, end stage renal and hepatic events, opportunistic infections, cancers) of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To evaluate the safety of the F4co/AS01B vaccine and to check the safety of study participation
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 7 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 37
    Country: Number of subjects enrolled
    France: 52
    Country: Number of subjects enrolled
    Germany: 69
    Country: Number of subjects enrolled
    United States: 32
    Worldwide total number of subjects
    190
    EEA total number of subjects
    158
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    190
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Pre-assignment period milestones
    Number of subjects started
    		 190
    Number of subjects completed
    		 165

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Unknown completion reason: 25
    Period 1
    Period 1 title
    Year 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Partially blind for the ART-Naïve population: Results for this group may be amended at a forthcoming update of this summary as this group includes subjects previously enrolled in the ongoing 2010-021356-26 study, from which there may be more subjects to be enrolled.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HIV 732462 Naïve Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK HIV vaccine 732462
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No additional vaccine doses were administered in this study, all vaccine doses were administered during the primaty studies.

    Arm title
    		 Placebo Naïve Group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Physiological Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No additional vaccine doses were administered in this study, all vaccine doses were administered during the primaty studies.

    Arm title
    		 Blinded Naïve Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Physiological Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No additional vaccine doses were administered in this study, all vaccine doses were administered during the primaty studies.

    Investigational medicinal product name
    GSK HIV vaccine 732462
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No additional vaccine doses were administered in this study, all vaccine doses were administered during the primaty studies.

    Arm title
    		 HIV 732462 Treated Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK HIV vaccine 732462
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No additional vaccine doses were administered in this study, all vaccine doses were administered during the primaty studies.

    Arm title
    		 Placebo Treated Group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Physiological Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No additional vaccine doses were administered in this study, all vaccine doses were administered during the primaty studies.

    Number of subjects in period 1 [1]
    		HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Started
    9
    8
    129
    9
    10
    Completed
    7
    8
    129
    9
    10
    Not completed
    2
    0
    0
    0
    0
         Lost to follow-up
    2
    -
    -
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 190 enrolled, 25 have an unknown status due to ongoing study 111679 and blinded results

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HIV 732462 Naïve Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Naïve Group
    Reporting group description
    		 -

    Reporting group title
    Blinded Naïve Group
    Reporting group description
    		 -

    Reporting group title
    HIV 732462 Treated Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Treated Group
    Reporting group description
    		 -

    Reporting group values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group Total
    Number of subjects
    		 9 8 129 9 10 165
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.6 ( 8.56 ) 33.9 ( 7.32 ) 36 ( 8.2 ) 44.3 ( 3 ) 43.4 ( 6.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 15 1 0 17
        Male
    		 9 7 114 8 10 148

    End points

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    End points reporting groups
    Reporting group title
    HIV 732462 Naïve Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Naïve Group
    Reporting group description
    		 -

    Reporting group title
    Blinded Naïve Group
    Reporting group description
    		 -

    Reporting group title
    HIV 732462 Treated Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Treated Group
    Reporting group description
    		 -

    Primary: Number of subjects with anti-retroviral therapy (ART) initiation or modification

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    End point title
    		 Number of subjects with anti-retroviral therapy (ART) initiation or modification [1]
    End point description
    End point type
    Primary
    End point timeframe
    At Year 1 post Dose 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    9
    8
    129
    9
    10
    Units: Subjects
        Positive ART initiation
    2
    5
    9
    0
    0
        Negative ART initiation
    7
    3
    120
    0
    0
        Postitive ART modification
    0
    0
    0
    1
    1
        Negative ART modification
    0
    0
    0
    8
    9
    No statistical analyses for this end point

    Primary: Number of subjects with ART modifications by reason

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    End point title
    		 Number of subjects with ART modifications by reason [2]
    End point description
    End point type
    Primary
    End point timeframe
    From Year 0 to Year 1
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    9
    8
    129
    9
    10
    Units: Subjects
        VL Increase
    0
    1
    2
    0
    1
        Physician Decision
    0
    0
    0
    1
    0
        CD4 Decline
    1
    1
    6
    0
    0
        Unknown
    0
    1
    0
    0
    0
        Other
    1
    2
    1
    0
    0
    No statistical analyses for this end point

    Primary: Cluster of Differentiation 4 (CD4) cell count

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    End point title
    		 Cluster of Differentiation 4 (CD4) cell count [3]
    End point description
    End point type
    Primary
    End point timeframe
    At Year 1
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    7
    8
    120
    9
    10
    Units: T cells/million cells
    median (inter-quartile range (Q1-Q3))
        Positive CD4
    569 (475 to 647)
    494 (424 to 535)
    0 (0 to 0)
    732 (639 to 792)
    698 (494 to 923)
        Negative CD4
    702 (463 to 941)
    0 (0 to 0)
    609 (500 to 721)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Primary: Human Immunodeficiency Virus (HIV) Viral Load (VL) in all HIV+ subjects

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    End point title
    		 Human Immunodeficiency Virus (HIV) Viral Load (VL) in all HIV+ subjects [4] [5]
    End point description
    End point type
    Primary
    End point timeframe
    At Year 1
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis did not include the Blinded Group.
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group
    Number of subjects analysed
    7
    8
    120
    Units: RNA copies/mL
    median (inter-quartile range (Q1-Q3))
        Positive VL
    4.39 (4.13 to 4.67)
    4.77 (4.28 to 4.88)
    0 (0 to 0)
        Negative VL
    4.59 (3.79 to 5.38)
    0 (0 to 0)
    2.78 (2.7 to 2.86)
    No statistical analyses for this end point

    Primary: Number of subjects with Human Immunodeficiency Virus (HIV) progression

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    End point title
    		 Number of subjects with Human Immunodeficiency Virus (HIV) progression [6]
    End point description
    End point type
    Primary
    End point timeframe
    At Year 1 post Dose 1
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    9
    8
    129
    9
    10
    Units: Subjects
        Positive HIV
    1
    0
    0
    0
    0
        Negative HIV
    8
    8
    129
    9
    10
    No statistical analyses for this end point

    Primary: Number of subjects with Adverse Events (AEs)

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    End point title
    		 Number of subjects with Adverse Events (AEs) [7]
    End point description
    End point type
    Primary
    End point timeframe
    From Year 0 to Year 1
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    9
    8
    129
    9
    10
    Units: Subjects
        Any Related AEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with potential Immune Diseases (pIMDs)

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    End point title
    		 Number of subjects with potential Immune Diseases (pIMDs) [8]
    End point description
    End point type
    Primary
    End point timeframe
    From Year 0 to Year 1
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    9
    8
    129
    9
    10
    Units: Subjects
        Any pIMDs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs) [9]
    End point description
    End point type
    Primary
    End point timeframe
    From Year 0 to Year 1
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    9
    8
    129
    9
    10
    Units: Subjects
        Any SAEs
    0
    0
    0
    2
    0
        Related SAEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with undetectable VL

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    End point title
    		 Number of subjects with undetectable VL [10] [11]
    End point description
    End point type
    Primary
    End point timeframe
    At Year 1
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis performed only on subjects from ART-Treated Cohort who previously participated in the 112353 study and were stable on HAART with undetectable virus load.
    End point values
    		 HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    9
    10
    Units: Subjects
    9
    10
    No statistical analyses for this end point

    Secondary: Number of subjects with antibodies against vaccine antigens

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    End point title
    		 Number of subjects with antibodies against vaccine antigens [12]
    End point description
    End point type
    Secondary
    End point timeframe
    At Year 1
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis did not include the Blinded Group.
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    7
    8
    8
    8
    Units: Subjects
        Anti-Nef [N=7,8,8,8]
    3
    3
    5
    1
        Anti-P17 [N=7,8,8,8]
    3
    5
    7
    3
        Anti-P24 [N=7,8,8,8]
    7
    8
    7
    7
        Anti-RT [N=6,7,8,8]
    5
    7
    8
    6
        Anti-F4co [N=7,8,8,8]
    7
    8
    8
    7
    No statistical analyses for this end point

    Secondary: Anti-Nef, Anti-P17, Anti-P24, Anti-RT, Anti-F4co antibody concentrations

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    End point title
    		 Anti-Nef, Anti-P17, Anti-P24, Anti-RT, Anti-F4co antibody concentrations [13]
    End point description
    End point type
    Secondary
    End point timeframe
    At Year 1
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis did not include the Blinded Group.
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    7
    8
    8
    8
    Units: mEL.U/mL
    geometric mean (confidence interval 95%)
        Anti-Nef [N=7,8,8,8]
    586.1 (190.3 to 1805)
    478.7 (220.5 to 1039.1)
    634.7 (303.8 to 1326.1)
    290.9 (197.6 to 428.2)
        Anti-P17 [N=7,8,8,8]
    286.3 (75.4 to 1087.1)
    405.7 (92.3 to 1782.4)
    895.8 (241.4 to 3324.5)
    188.9 (79.3 to 450.2)
        Anti-P24 [N=7,8,8,8]
    2237.7 (264.3 to 18948.3)
    2258.7 (300.4 to 16981.1)
    3667.4 (608.3 to 22109.4)
    1287.8 (263 to 6307.4)
        Anti-RT [N=6,7,8,8]
    6609.3 (282.8 to 154452.7)
    11217.4 (1330.1 to 94602.4)
    2883.7 (844.1 to 9851.4)
    620 (145.3 to 2646.3)
        Anti-F4co [N=7,8,8,8]
    3448.4 (546.3 to 21769.4)
    2571.6 (359.5 to 18396.4)
    2503.5 (589.2 to 10637.1)
    408.7 (117.5 to 1421.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with response to antigens

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    End point title
    		 Number of subjects with response to antigens [14]
    End point description
    Breadth was assessed only for the HIV specific CD4+ T cells and was measured by evaluating response to at least 1, 2, 3 antigens and to all 4 antigens.
    End point type
    Secondary
    End point timeframe
    At Year 0 and Year 1
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis did not include the Blinded Group.
    End point values
    		 HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    8
    7
    Units: Subjects
        One antigen, Y0 [N=8,7]
    5
    3
        Two antigens, Y0 [N=8,7]
    4
    0
        Three antigens, Y0 [N=8,7]
    2
    0
        Four antigens, Y0 [N=8,7]
    1
    0
        One antigen, Y1 [N=8,6]
    4
    3
        Two antigens, Y1 [N=8,6]
    2
    0
        Three antigens, Y1 [N=8,6]
    0
    0
        Four antigens, Y1 [N=8,6]
    0
    0
    No statistical analyses for this end point

    Secondary: Frequency of F4-computed fussion protein and Nef, P17, P24, RT antigens – specific cluster of differentiation CD40L+ CD4+ T- cells expressing at least two Interleukins-2 (IL-2)

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    End point title
    		 Frequency of F4-computed fussion protein and Nef, P17, P24, RT antigens – specific cluster of differentiation CD40L+ CD4+ T- cells expressing at least two Interleukins-2 (IL-2) [15]
    End point description
    Magnitude was defined as the frequency of F4co, P17, P24, Nef and RT-specific CD40L+ CD4+ T-cells expressing at least IL-2.
    End point type
    Secondary
    End point timeframe
    At Year 0 and Year 1
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis did not include the Blinded Group.
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    4
    6
    8
    7
    Units: cells/million T-cells
    median (inter-quartile range (Q1-Q3))
        Nef, Y0 [N=4,6,8,7]
    47 (28.5 to 247)
    24.5 (4 to 63)
    213.5 (105.5 to 415)
    61 (58 to 137)
        Nef, Y1 [N=3,2,8,6]
    54 (4 to 56)
    24.5 (20 to 29)
    156 (86 to 259)
    89.5 (32 to 163)
        P17, Y0 [N=4,6, 8,7]
    136 (60.5 to 191.5)
    131.5 (38 to 236)
    270 (114 to 432.5)
    173 (162 to 227)
        P17, Y1 [N=3,2,8,6]
    54 (4 to 185)
    84.5 (45 to 124)
    140 (107.5 to 259.5)
    183.5 (123 to 301)
        P24, Y0 [N=4,6,8,7]
    127.5 (82 to 211.5)
    44.5 (4 to 171)
    448.5 (261.5 to 911)
    327 (264 to 433)
        P24, Y1 [N=3,2,8,6]
    234 (47 to 242)
    211 (176 to 246)
    309.5 (172 to 426)
    351.5 (80 to 438)
        RT, Y0 [N=4,6,8,7]
    198.5 (120 to 413)
    44 (18 to 141)
    1057.5 (243.5 to 2311)
    130 (112 to 184)
        RT, Y1 [N=3,2,8,6]
    73 (51 to 144)
    102 (65 to 139)
    758 (264 to 1033)
    139 (75 to 178)
        F4-computed, Y0 [N=4,6,8,7]
    538 (346.5 to 1007.5)
    233.5 (122 to 577)
    2394 (821.5 to 3817.5)
    794 (610 to 873)
        F4-computed, Y1[N=3,2,8,6]
    373 (158 to 617)
    422 (380 to 464)
    1432 (702 to 1873)
    849 (310 to 1259)
    No statistical analyses for this end point

    Secondary: Frequency of F4-computed fussion protein and Nef, P17, P24, RT antigens – specific cluster of differentiation CD40L+ CD4+ T- cells expressing at least one cytokine

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    End point title
    		 Frequency of F4-computed fussion protein and Nef, P17, P24, RT antigens – specific cluster of differentiation CD40L+ CD4+ T- cells expressing at least one cytokine [16]
    End point description
    Magnitude was defined as the frequency of F4co, P17, P24, Nef and RT-specific CD40L+ CD4+ T-cells expressing at least one cytokine.
    End point type
    Secondary
    End point timeframe
    At Year 0 and Year 1
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis did not include the Blinded Group.
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    4
    6
    8
    7
    Units: cells/million T-cells
    median (inter-quartile range (Q1-Q3))
        Nef, Y0 [N=4,6,8,7]
    53.5 (35 to 271)
    78 (7 to 147)
    244 (110.5 to 438.5)
    78 (76 to 154)
        Nef, Y1 [N=3,2,8,6]
    59 (7 to 90)
    100 (23 to 177)
    234 (108.5 to 325)
    134.5 (52 to 175)
        P17, Y0 [N=4,6, 8,7]
    191.5 (111.5 to 251)
    162 (45 to 499)
    297 (128 to 478.5)
    197 (180 to 277)
        P17, Y1 [N=3,2,8,6]
    119 (76 to 224)
    105.5 (84 to 127)
    176.5 (145.5 to 298.5)
    234 (126 to 377)
        P24, Y0 [N=4,6,8,7]
    188 (169 to 278)
    99 (56 to 404)
    505 (312.5 to 938)
    355 (297 to 463)
        P24, Y1 [N=3,2,8,6]
    321 (152 to 442)
    284 (259 to 309)
    362 (190.5 to 541.5)
    355 (101 to 551)
        RT, Y0 [N=4,6,8,7]
    241 (136.5 to 456.5)
    49.5 (21 to 226)
    1075.5 (290 to 2373)
    162 (115 to 187)
        RT, Y1 [N=3,2,8,6]
    78 (54 to 189)
    206 (190 to 222)
    812 (268.5 to 1155)
    181.5 (92 to 237)
        F4-computed, Y0 [N=4,6,8,7]
    714 (513 to 1195.5)
    363.5 (226 to 1479)
    2494.5 (1002.5 to 4001)
    847 (728 to 954)
        F4-computed, Y1 [N=3,2,8,6]
    646 (341 to 824)
    695.5 (588 to 803)
    1563.5 (799.5 to 2349.5)
    1056 (336 to 1562)
    No statistical analyses for this end point

    Secondary: Frequency of F4-computed fussion protein and Nef, P17, P24, RT antigens – specific cluster of differentiation CD8+ T- cells expressing at least one cytokine

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    End point title
    		 Frequency of F4-computed fussion protein and Nef, P17, P24, RT antigens – specific cluster of differentiation CD8+ T- cells expressing at least one cytokine [17]
    End point description
    The Cytokine Co-expression profile was defined by the frequency of F4co, P17, P24, Nef and RT specific CD4+ (or respectively CD8+) T-cells expressing CD40L and/or IL-2 and/or TNF-α and /or IFN-g.
    End point type
    Secondary
    End point timeframe
    At Year 0 and Year 1
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis did not include the Blinded Group.
    End point values
    		 HIV 732462 Naïve Group Placebo Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Number of subjects analysed
    4
    6
    8
    7
    Units: T cells/million cells
    median (inter-quartile range (Q1-Q3))
        Nef, Y0 [N=4,6,8,7]
    2000.5 (1714 to 5268.5)
    1257 (960 to 2161)
    948 (446.5 to 1905)
    595 (215 to 855)
        Nef, Y1 [N=3,2,8,6]
    3113 (2872 to 3750)
    117110 (1306 to 232914)
    1049 (378.5 to 2881)
    1452 (781 to 2575)
        P17, Y0 [N=4,6,8,7]
    6574.5 (5055.5 to 8156.5)
    821 (564 to 1359)
    575 (200 to 1595.5)
    404 (286 to 492)
        P17, Y1 [N=3,2,8,6]
    9610 (423 to 10636)
    1724 (1142 to 2306)
    952 (436.5 to 1836.5)
    976 (536 to 1258)
        P24, Y0 [N=4,6,8,7]
    4087.5 (764.5 to 7400)
    2196.5 (753 to 4326)
    2205.5 (421 to 7239)
    1005 (399 to 1293)
        P24, Y1 [N=3,2,8,6]
    2922 (695 to 9048)
    6179 (5160 to 7198)
    4053 (220.5 to 10789)
    2144.5 (1162 to 2892)
        RT, Y0 [N=4,6,8,7]
    9425.5 (5288 to 10695)
    2805.5 (1696 to 5286)
    1134 (655.5 to 3862)
    571 (274 to 1041)
        RT, Y1 [N=3,2,8,6]
    10876 (3810 to 14535)
    4958 (1400 to 8516)
    1698.5 (857 to 3674.5)
    2097 (1209 to 3930)
        F4-computed, Y0 [N=4,6,8,7]
    22919 (16454.5 to 27887.5)
    7110.5 (6741 to 11951)
    7708 (2504 to 12663.5)
    2741 (2020 to 5151)
        F4-computed, Y1 [N=3,2,8,6]
    28738 (10905 to 32647)
    129971 (19326 to 240616)
    9971 (2949.5 to 16775.5)
    8731 (5611 to 10583)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Unsolicited AEs from Year 0 to Year 1 post-vaccination period, SAEs from Year 0 to Year 1
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    HIV 732462 Naïve Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Naïve Group
    Reporting group description
    		 -

    Reporting group title
    Blinded Naïve Group
    Reporting group description
    		 -

    Reporting group title
    HIV 732462 Treated Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Treated Group
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were reported, as no vaccine was administered.
    Serious adverse events
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 129 (0.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anal cancer
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 129 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 129 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 HIV 732462 Naïve Group Placebo Naïve Group Blinded Naïve Group HIV 732462 Treated Group Placebo Treated Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 129 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Aug 2011
    Amendment 1 The names of the persons now in charge of the study have been changed on the cover page. Section 11 and Appendix C, which provide country-specific information for participating centres in France, have been added. Some aspects of study design, endpoints and study conclusion have been reworded for clarity.
    06 Feb 2012
    Amendment 2 This amendment was developed in order to extend safety follow-up to the collection of information on 1) Serious adverse events considered by the investigator to be related to study vaccination (which was performed in previous GSK-sponsored trials evaluating the F4co/AS01B vaccine) or study participation and 2) Potential immune–mediated diseases. The US BB-IND number has also been added where required by GSK’s protocol template.
    13 Jan 2014
    Recent data from study TH HIV-008 (Efficacy and safety of HIV vaccine 732462 in ART-naïve HIV-1 infected persons; eTrack study number: 111679) failed to demonstrate a significant reduction of HIV-1 viral load after vaccination with two or three doses of F4co/AS01B, as compared to a placebo. The observed incidence of adverse events after F4co/AS01B vaccination, their type and severity were acceptable. No clinical relevant changes in any laboratory parameters which could be imputed to the F4co/AS01B vaccine were observed. There was no clinically significant dose-dependent reactogenicity variation. A first evaluation of the long-term safety profile has been performed in study TH HIV-011 (cf interim report Y1, includes subjects from studies TH HIV-008 and TH HIV-010), where no significant safety issue was reported. In consequence, the long-term evaluation of the benefit/risk associated with study vaccination has become irrelevant and the present TH HIV-011 study, initially planned to last 7 years, will be prematurely terminated after collection of Year 1 data for all subjects enrolled in the study. Minor changes have been implemented (e.g., update of the listing of contributing authors [names and titles], changes in tenses, addition of abbreviations), and typographical errors/misspellings have been corrected.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Sep 2012
    Recent data from study TH HIV-008 (Efficacy and safety of HIV vaccine 732462 in ART-naïve HIV-1 infected persons; eTrack study number: 111679) failed to demonstrate a significant reduction of HIV-1 viral load after vaccination with two or three doses of F4co/AS01B, as compared to a placebo. In consequence, the long-term evaluation of the benefit/risk associated with study vaccination has become irrelevant and the present TH HIV-011 study, initially planned to last 7 years, will be prematurely terminated after collection of Year 1 data for all subjects enrolled in the study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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