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    Clinical Trial Results:
    A Phase I/IIa Sporozoite Challenge Study to assess the safety, immunogenicity and protective efficacy of intravenous boosting with malaria vaccine candidates ChAd63 and MVA encoding ME-TRAP

    Summary
    EudraCT number
    		 2017-001075-23
    Trial protocol
    		 GB  
    Global end of trial date
    10 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2021
    First version publication date
    04 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAC066
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03707353
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Churchill Hospital, Old road, Headington, Oxford, United Kingdom, OX3 7LE
    Public contact
    Professor Adrian Hill, University of Oxford, +44 1865617610, adrian.hill@ndm.ox.ac.uk
    Scientific contact
    Professor Adrian Hill, University of Oxford, +44 1865617610, 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
    10 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess the efficacy (occurrence of P. falciparum parasitemia, assessed by PCR) of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, against malaria sporozoite challenge, in healthy malaria-naïve volunteers. • To assess the safety of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, in healthy malaria-naïve 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 escalation (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 1-2 hours after vaccination to monitor for any immediate adverse effects. - Volunteers seen within 3 days of vaccination for safety review and provided with 24/7 contact number for trial clinician and emergency contact card for the department. -Volunteers phoned daily by the clinic team prior to first in-person follow up after CHMI
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 2018
    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: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    42
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The first enrolment (recruitment start) took place on 30th October 2018. The last enrolment (recruitment end) took place on 4th February 2019. Note: Group 3 and 4 were first enrolled in parallel with Week 4 for groups A, 1 and 2. Groups 3 and 4 have been included in Week 0 for clarity of baseline information.

    Pre-assignment
    Screening details
    		 Inclusion / Exclusion criteria Informed consent Medical History Physical Examination Biochemistry Haematology Urinalysis Serum Β-HCG (women only) Coagulation profile Review contraindications HBV,HCV,HIV serology Anti- P. falciparum serology (if deemed necessary)

    Period 1
    Period 1 title
    Week 0
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Laboratory investigators processing blood films and samples for PCR analysis were blinded to group allocation. No other blinding was used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3-dose regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAd63 ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAd63 ME-TRAP 5x10^10 vp administered intramuscularly into the deltoid of the arm at week 0

    Arm title
    		 Group 1
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAd63 ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAd63 ME-TRAP 5x10^10 vp administered intramuscularly into the deltoid of the arm at week 0

    Arm title
    		 Group 2
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAd63 ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAd63 ME-TRAP 5x10^10 vp administered intramuscularly into the deltoid of the arm at week 0

    Arm title
    		 Group 3
    Arm description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5
    Arm description
    		 Controlled human malaria infection (CHMI) only at week 11-12
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group A Group 1 Group 2 Group 3 Group 4 Group 5
    Started
    3
    9
    10
    7
    7
    6
    Completed
    3
    9
    9
    7
    7
    6
    Not completed
    0
    0
    1
    0
    0
    0
         Non-attendance post D0
    -
    -
    1
    -
    -
    -
    Period 2
    Period 2 title
    Week 4
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Laboratory investigators processing blood films and samples for PCR analysis were blinded to group allocation. No other blinding was used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3-dose regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MVA ME-TRAP 2 x 10^8 pfu administered intramuscularly into the deltoid of the arm at week 4

    Arm title
    		 Group 1
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MVA ME-TRAP 2 x 10^8 pfu administered intramuscularly into the deltoid of the arm at week 4

    Arm title
    		 Group 2
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MVA ME-TRAP 2 x 10^8 pfu administered intramuscularly into the deltoid of the arm at week 4

    Arm title
    		 Group 3
    Arm description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAd63 ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAd63 ME-TRAP 5x10^10vp administered intramuscularly into the deltoid of the arm at week 4

    Arm title
    		 Group 4
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAd63 ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAd63 ME-TRAP 5x10^10vp administered intramuscularly into the deltoid of the arm

    Arm title
    		 Group 5
    Arm description
    		 Controlled human malaria infection (CHMI) only at week 11-12
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Group A Group 1 Group 2 Group 3 Group 4 Group 5
    Started
    3
    9
    9
    7
    7
    6
    Completed
    3
    8
    9
    7
    7
    6
    Not completed
    0
    1
    0
    0
    0
    0
         Consent withdrawn by subject
    -
    1
    -
    -
    -
    -
    Period 3
    Period 3 title
    Week 8
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Laboratory investigators processing blood films and samples for PCR analysis were blinded to group allocation. No other blinding was used

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3-dose regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    MVA ME-TRAP 2 x 10^7 pfu administered intravenously via peripheral cannula at week 8

    Arm title
    		 Group 1
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAd63 ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    ChAd63 ME-TRAP 5 x 10^10vp administered intravenously via peripheral cannula at week 8

    Arm title
    		 Group 2
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    MVA ME-TRAP 2 x 10^7 pfu administered intravenously via peripheral cannula at week 8

    Arm title
    		 Group 3
    Arm description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAd63 ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    ChAd63 ME-TRAP 5 x 10^10vp administered intravenously via peripheral cannula at week 8

    Arm title
    		 Group 4
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA ME-TRAP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    MVA ME-TRAP 2 x 10^7 pfu administered intravenously via peripheral cannula at week 8

    Arm title
    		 Group 5
    Arm description
    		 Controlled human malaria infection (CHMI) only at week 11-12
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Group A Group 1 Group 2 Group 3 Group 4 Group 5
    Started
    3
    8
    9
    7
    7
    6
    Completed
    2
    8
    9
    6
    7
    6
    Not completed
    1
    0
    0
    1
    0
    0
         Physician decision
    -
    -
    -
    1
    -
    -
         Lost to follow-up
    1
    -
    -
    -
    -
    -
    Period 4
    Period 4 title
    Week 11-12: CHMI
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Laboratory investigators processing blood films and samples for PCR analysis were blinded to group allocation. No other blinding was used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3
    Arm description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4
    Arm description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5
    Arm description
    		 Controlled human malaria infection (CHMI) only at week 11-12
    Arm type
    		 CHMI Control group

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4 [1]
    		Group 1 Group 2 Group 3 Group 4 Group 5
    Started
    8
    9
    6
    7
    6
    Completed
    8
    9
    6
    7
    5
    Not completed
    0
    0
    0
    0
    1
         Consent withdrawn by subject
    -
    -
    -
    -
    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: Group A was not included in the challenge at Week 11-12.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Week 0
    Reporting group description
    		 -

    Reporting group values
    		 Week 0 Total
    Number of subjects
    		 42 42
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 42 42
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 25 (18 to 45) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 30 30

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3-dose regimen)

    Reporting group title
    Group 1
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 2
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 3
    Reporting group description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 4
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 5
    Reporting group description
    		 Controlled human malaria infection (CHMI) only at week 11-12
    Reporting group title
    Group A
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3-dose regimen)

    Reporting group title
    Group 1
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 2
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 3
    Reporting group description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 4
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 5
    Reporting group description
    		 Controlled human malaria infection (CHMI) only at week 11-12
    Reporting group title
    Group A
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3-dose regimen)

    Reporting group title
    Group 1
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 2
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 3
    Reporting group description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 4
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 5
    Reporting group description
    		 Controlled human malaria infection (CHMI) only at week 11-12
    Reporting group title
    Group 1
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 2
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 3
    Reporting group description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 4
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 5
    Reporting group description
    		 Controlled human malaria infection (CHMI) only at week 11-12

    Primary: To assess the efficacy (occurrence of P. falciparum parasitemia, assessed by PCR) of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, against malaria sporozoite challenge, in healthy malaria-naïve volunteers

    		 Close Top of page
    End point title
    		 To assess the efficacy (occurrence of P. falciparum parasitemia, assessed by PCR) of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, against malaria sporozoite challenge, in healthy malaria-naïve volunteers [1]
    End point description
    End point type
    Primary
    End point timeframe
    Duration of the trial
    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. A link to the paper can be shared following publication, if required.
    End point values
    		 Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    8
    9
    6
    7
    6
    Units: Number of negative cases
    8
    9
    6
    7
    6
    No statistical analyses for this end point

    Primary: To assess the safety of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, in healthy malaria-naïve volunteers

    		 Close Top of page
    End point title
    		 To assess the safety of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, in healthy malaria-naïve volunteers [2]
    End point description
    End point type
    Primary
    End point timeframe
    Duration of trial
    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: This is a descriptive safety endpoint, where volunteers were vaccinated with MVA ME-TRAP and ChAd63 ME-TRAP. Forty two volunteers were vaccinated in total. This sample size should allow an estimation to be made of the frequency and magnitude of outcome measures, rather than aiming to obtain statistical significance for differences between groups.
    End point values
    		 Group A Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    2
    8
    9
    6
    7
    6
    Units: Adverse Events
    2
    8
    9
    6
    7
    6
    No statistical analyses for this end point

    Secondary: To assess cell-mediated immunogenicity generated in malaria naïve individuals of vaccination schedules incorporating intramuscular prime dose(s) followed by intravenous booster with ChAd63 and MVA encoding ME-TRAP

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    End point title
    		 To assess cell-mediated immunogenicity generated in malaria naïve individuals of vaccination schedules incorporating intramuscular prime dose(s) followed by intravenous booster with ChAd63 and MVA encoding ME-TRAP
    End point description
    End point type
    Secondary
    End point timeframe
    T Cell responses to ME-TRAP measured before the intravenous vaccination and approximately 28 days after intravenous vaccination, prior to challenge.
    End point values
    		 Group A Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    2
    8
    9
    6
    7
    6
    Units: ELISPOT Responses
    2
    8
    9
    6
    7
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All AEs occurring in the 28 days following each vaccination collected from diary cards, clinical review, clinical examination, laboratory results, or reported by the volunteer, whether or not attributed to study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3-dose regimen)

    Reporting group title
    Group 1
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with ChAd63-ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 2
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by a further boost with MVA ME-TRAP (3 dose regimen) and CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 3
    Reporting group description
    		 ChAd63 ME-TRAP in a homologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 4
    Reporting group description
    		 ChAd63 ME-TRAP and MVA ME-TRAP in a heterologous prime-boost regime, followed by CHMI. Repeat CHMI for sterilely protected volunteers.

    Reporting group title
    Group 5
    Reporting group description
    		 Controlled human malaria infection (CHMI) only at week 11-12

    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 analysis at this time. A link to the paper can be shared following publication, if required. Please note, a single SAE was reported in this trial and has been included in these results.
    Serious adverse events
    		 Group A Group 1 Group 2 Group 3 Group 4 Group 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Infection
    Additional description: Volunteer hospitalised for possible bacterial/viral infection 3 weeks following administration of intravenous ChAd63 ME-TRAP. Deemed unlikely to be related to vaccination.
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Group A Group 1 Group 2 Group 3 Group 4 Group 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Sep 2018
    REC only amendment to align with comments from MHRA Inclusion of serum beta hCG measurement at screening Clarification on SUSAR reporting Reduction in IV MVA ME-TRAP dose to 2 x 10^7 pfu
    10 Sep 2018
    Addition of lead-in group (Group A ) in order to provide further safety data Extension of vaccination windows to +/-10 days Addition of Southampton and Imperial sites Revision to compensation amounts IMPD update for the intravenous route
    14 Jan 2019
    Addition of John Radcliffe Hospital site Addition of NHS consent form for use for volunteers undergoing procedures at the John Radcliffe Hospital site only Correction of typographical errors in protocol

    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.
    A second challenge was originally planned for groups 1, 2, 3 and 4 in addition to the introduction of Group 6 as a challenge only control. The second challenge did no go ahead before trial end.
    For support, Contact us.
    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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