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    Clinical Trial Results:
    A Phase I/IIa Sporozoite Challenge Study to Assess the Safety and Protective Efficacy of Concomitant Administration of the Combination Malaria Vaccine Candidate Regimen of RTS,S/AS01¬B + ChAd63 and MVA encoding ME-TRAP and also RTS,S/AS01B alone

    Summary
    EudraCT number
    		 2014-001301-40
    Trial protocol
    		 GB  
    Global end of trial date
    16 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2016
    First version publication date
    30 Oct 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAC059
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02252640
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    CTRG, Old Road, Oxford, United Kingdom, OX3 7LE
    Public contact
    Professor Adrian Hill, University of Oxford, 01865 617610, adrian.hill@ndm.ox.ac.uk
    Scientific contact
    Professor Adrian Hill, University of Oxford, 01865 617610, adrian.hill@ndm.ox.ac.uk
    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
    Final
    Date of interim/final analysis
    16 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish whether the combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with two different dosing regimens of RTS,S/AS01B, and of RTS,S/AS01B alone at either full standard dose or with a reduced third dose can demonstrate safety and efficacy against malaria sporozite challenge, in healthy malaria naive volunteers.
    Protection of trial subjects
    - Volunteers given at least 24 hours to read VIS before being seen and then given plenty of opportunity to ask questions prior to agreeing to take part in a study. - Screening visit including full medical history, physical examination and baseline blood tests to ensure volunteers are healthy prior to enrolment. - Vaccination carried out in clinical environment with staff trained in resuscitation in case of allergic reaction. - Safety review prior to dose escalations (LSM) - Total blood volume taken during study kept to volume that should not compromise healthy volunteers (i.e. less than regular donation to blood transfusion service). - Volunteers observed for 30 mins - 2 hours (depending on trial) after vaccination to monitor for any immediate adverse effects. - Volunteers seen within 1 – 3 days of vaccination (most trials) for safety review and provided with 24/7 contact number for trial clinician and emergency contact card for the department. - ECG and cholesterol checked prior to enrolment to aid cardiac risk assessment - Age range 18 – 45 years (tighter than for Phase I) - Volunteers given emergency contact card detailing that they have been infected with malaria. - Volunteers seen twice daily once blood stage malaria is possible with twice daily malaria films and PCR - Malaria treated promptly when diagnosed with highly efficacious medication and at least half of doses directly observed. - Volunteers provided with symptomatic treatment (antipyretic/analgesic and antiemetic) in case of malaria symptoms. - Volunteers followed up until at least 2 consecutive negative blood films seen.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    45
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The planned trial period is 11 to 13 months from the first study visit, provided if any group 1-4 volunteers are sterilely protected at first challenge, and undergo re-challenge. Without re-challenge, the planned trial period is 8 months from first vaccination.

    Pre-assignment
    Screening details
    		 Inclusion / Exclusion criteria Informed consent Medical History Physical Examination Urinalysis Β-HCG urine test (women only) Review contraindications Physical observations HBV,HCV,HIV Haematology Biochemistry

    Period 1
    Period 1 title
    Week 0
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) in week 0 followed by the same dose in week 4 and 8 and malaria challenge in week 11
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01.

    Arm title
    		 Group 2
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) in weeks 0 and 4 followed by the 1/5th of the standard dose in week 8 and malaria challenge in week 11
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01.

    Arm title
    		 Group 3
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and 8 & malaria challenge in week 11
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01.

    Arm title
    		 Group 4
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01.

    Arm title
    		 Group 5
    Arm description
    		 The arm was the control arm and the volunteers in this arm did not receive any experimental medication.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4 Group 5
    Started
    10
    10
    10
    11
    4
    Completed
    8
    9
    10
    9
    4
    Not completed
    2
    1
    0
    2
    0
         Consent withdrawn by subject
    2
    1
    -
    2
    -
    Period 2
    Period 2 title
    Week 4
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 2
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) in weeks 0 and 4 followed by the 1/5th of the standard dose in week 8 and malaria challenge in week 11
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01, 1/5th standard dose of RTS,S/AS01B will contain 10mcg of RTS,S and one fifth of the standard dose of AS01

    Arm title
    		 Group 3
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and 8 & malaria challenge in week 11 less
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01.

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01.

    Arm title
    		 Group 4
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01.

    Number of subjects in period 2 [1]
    		Group 2 Group 3 Group 4
    Started
    10
    10
    11
    Completed
    9
    10
    10
    Not completed
    1
    0
    1
         Consent withdrawn by subject
    1
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subject numbers completing each period differes from previous due to inclusion of control arm which received challenge agent but no IMP.
    Period 3
    Period 3 title
    Week 8
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 3
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and 8 & malaria challenge in week 11
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01, ChAd63 ME-TRAP will be given intramuscularly at a dose of 5 x 1010 vp MVA ME-TRAP will be given intramuscularly at a dose of 2 x 108 pfu

    Arm title
    		 Group 4
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01.

    Number of subjects in period 3 [2]
    		Group 3 Group 4
    Started
    10
    10
    Completed
    10
    10
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subject numbers completing each period differes from previous due to inclusion of control arm which received challenge agent but no IMP.
    Period 4
    Period 4 title
    Week 11
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Group 4
    Arm description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RTS,S/AS01B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The standard dose of RTS,S/AS01B will contain 50mcg of RTS,S and standard adult dose of AS01, ChAd63 ME-TRAP will be given intramuscularly at a dose of 5 x 1010 vp MVA ME-TRAP will be given intramuscularly at a dose of 2 x 108 pfu

    Number of subjects in period 4 [3]
    		Group 4
    Started
    11
    Completed
    9
    Not completed
    2
         Consent withdrawn by subject
    2
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subject numbers completing each period differes from previous due to inclusion of control arm which received challenge agent but no IMP.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) in week 0 followed by the same dose in week 4 and 8 and malaria challenge in week 11

    Reporting group title
    Group 2
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) in weeks 0 and 4 followed by the 1/5th of the standard dose in week 8 and malaria challenge in week 11

    Reporting group title
    Group 3
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and 8 & malaria challenge in week 11

    Reporting group title
    Group 4
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.

    Reporting group title
    Group 5
    Reporting group description
    		 The arm was the control arm and the volunteers in this arm did not receive any experimental medication.

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Total
    Number of subjects
    		 10 10 10 11 4 45
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 10 10 10 11 4 45
        From 65-84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 7 3 6 3 23
        Male
    		 6 3 7 5 1 22

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) in week 0 followed by the same dose in week 4 and 8 and malaria challenge in week 11

    Reporting group title
    Group 2
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) in weeks 0 and 4 followed by the 1/5th of the standard dose in week 8 and malaria challenge in week 11

    Reporting group title
    Group 3
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and 8 & malaria challenge in week 11

    Reporting group title
    Group 4
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.

    Reporting group title
    Group 5
    Reporting group description
    		 The arm was the control arm and the volunteers in this arm did not receive any experimental medication.
    Reporting group title
    Group 2
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) in weeks 0 and 4 followed by the 1/5th of the standard dose in week 8 and malaria challenge in week 11

    Reporting group title
    Group 3
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and 8 & malaria challenge in week 11 less

    Reporting group title
    Group 4
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.
    Reporting group title
    Group 3
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and 8 & malaria challenge in week 11

    Reporting group title
    Group 4
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.
    Reporting group title
    Group 4
    Reporting group description
    		 This arm received RTS,S/AS01B (Standard dose) & ChAd63 ME-TRAP in week 0 followed by RTS,S/AS01B (Standard dose) & MVA ME-TRAP in week 4 and RTS,S/AS01B (1/5 Standard dose) & MVA ME-TRAP in week 8. The malaria sporozite challenge to take place in week 11.

    Primary: Efficacy assessed by Controlled Human Malaria Infection (CHMI) with P. falciparum by mosquito bite

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    End point title
    		 Efficacy assessed by Controlled Human Malaria Infection (CHMI) with P. falciparum by mosquito bite [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    Completely protected individuals are those who do not, by Day 23 following sporozoite challenge, develop blood stage infection
    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: Due to the confidential nature of this information, we have not provided this analysis at this time. The publication will be uploaded at a later date.
    [2] - 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: Due to the confidential nature of this information, we have not provided this analysis at this time. The publication will be uploaded at a later date.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    8
    9
    10
    9
    Units: Number
    8
    9
    10
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs collected and reviewed from day of vaccination to 90 days post malaria challenge. SAEs reported to the sponsor within 24 hours of awareness. SUSARs reported within 15 days of awareness (7 days for fatal or life threatening events)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Frequency threshold for reporting non-serious adverse events: 1%
    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: Due to the confidential nature of this information, we have not provided this data at this time. The publication will be uploaded at a later date. There were a total of 2 SAEs, none of which were realted to any of the IMPs or challenge procedures.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Nov 2014
    To extend the shelf life of RTS,S lot for use in clinical trial
    12 Nov 2014
    To extend the shelf life of ChAd63 ME-TRAP for use in trial
    22 Dec 2014
    Change has been made to the window period for the second and third vaccination- extended from +2 days to +7 days to decrease the loss to follow-up
    09 Feb 2015
    To extend the shelf life of MVA ME-TRAP lot for a further year

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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