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    Clinical Trial Results:
    A Phase I/IIa Sporozoite Challenge Study to Assess the Safety and Protective Efficacy of adjuvanted R21 at different doses and the Combination Malaria Vaccine Candidate Regimen of adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP.

    Summary
    EudraCT number
    		 2016-001265-92
    Trial protocol
    		 GB  
    Global end of trial date
    21 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2019
    First version publication date
    04 Jan 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAC065
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02905019
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Old Road, Oxford, United Kingdom,
    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
    21 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a clinical trial in which healthy volunteers will be administered experimental malaria vaccines. Three groups of volunteers will receive vaccination with the novel malaria vaccine candidate, R21 at three different dose schedules given in combination with the vaccine adjuvant, Matrix-M1. Vaccines will be delivered at 4 week intervals (ie. At 0, 4 & 8 weeks). A fourth group will receive 10ug R21 with Matrix M1 at 0, 4 and 8 weeks in combination with ChAd63 ME-TRAP and MVA ME-TRAP given at 1 and 9 weeks, respectively. A fifth group will receive a 2-doe schedule of 10/10ug R21/Matrix-M given 4 weeks apart. The vaccine schedule containing R21 alone, and ChAd63 ME-TRAP and MVA ME-TRAP have been tested independently in clinical trials, however, the vaccine schedule containing both R21, ChAd63 ME-TRAP and MVA ME-TRAP has not yet been tested. The first principal research objective is to measure how well this new malaria vaccine strategy acts to prevent malaria disease.
    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 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    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: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    66
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion / Exclusion criteria Informed consent Medical History Physical Examination Urinalysis B-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
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 2
    Arm description
    		 2 vaccinations of 50μg R21 and one dose of 10μg R21 followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    R21 at doses of 10μg and 50μg administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 3
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 plus single doses of ChAd63 ME-TRAP and MVA ME-TRAP followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    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 was administered at 5 x 10^10 viral particles intramuscularly in the deltoid muscle of either arm.

    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 was administered at 2 x 10^8 plaque forming units intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 4a
    Arm description
    		 Served as infectivity controls.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4b
    Arm description
    		 Served as infectivity controls.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5
    Arm description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 and a single dose of 2μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 6
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 7
    Arm description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4a Group 4b Group 5 Group 6 Group 7
    Started
    13
    12
    12
    6
    6
    8
    2
    7
    Completed
    12
    11
    12
    6
    6
    7
    2
    7
    Not completed
    1
    1
    0
    0
    0
    1
    0
    0
         Consent withdrawn by subject
    1
    1
    -
    -
    -
    1
    -
    -
    Period 2
    Period 2 title
    Week 4
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 2
    Arm description
    		 2 vaccinations of 50μg R21 and one dose of 10μg R21 followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 3
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 plus single doses of ChAd63 ME-TRAP and MVA ME-TRAP followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 5
    Arm description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 and a single dose of 2μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 6
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 7
    Arm description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 4a
    Arm description
    		 Served as infectivity controls.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4b
    Arm description
    		 Served as infectivity controls.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Group 1 Group 2 Group 3 Group 5 Group 6 Group 7 Group 4a Group 4b
    Started
    12
    11
    12
    7
    2
    7
    6
    6
    Completed
    11
    11
    10
    7
    2
    7
    6
    6
    Not completed
    1
    0
    2
    0
    0
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    2
    -
    -
    -
    -
    -
    Period 3
    Period 3 title
    Week 8
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 2
    Arm description
    		 2 vaccinations of 50μg R21 and one dose of 10μg R21 followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    R21 at doses of 10μg and 50μg administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 3
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 plus single doses of ChAd63 ME-TRAP and MVA ME-TRAP followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    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 was administered at 5 x 10^10 viral particles intramuscularly in the deltoid muscle of either arm.

    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 was administered at 2 x 10^8 plaque forming units intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 5
    Arm description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 and a single dose of 2μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 6
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 7
    Arm description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 4a
    Arm description
    		 Served as infectivity controls.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4b
    Arm description
    		 Served as infectivity controls.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Group 1 Group 2 Group 3 Group 5 Group 6 Group 7 Group 4a Group 4b
    Started
    11
    11
    10
    7
    2
    7
    6
    6
    Completed
    11
    11
    10
    7
    2
    7
    6
    6
    Period 4
    Period 4 title
    Challenge time
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 2
    Arm description
    		 2 vaccinations of 50μg R21 and one dose of 10μg R21 followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 3
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 plus single doses of ChAd63 ME-TRAP and MVA ME-TRAP followed by CHMI by sporozoite challenge (mosquito bite) at week 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 4a
    Arm description
    		 Served as infectivity controls.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4b
    Arm description
    		 Served as infectivity controls.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5
    Arm description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 and a single dose of 2μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 6
    Arm description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Arm title
    		 Group 7
    Arm description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R21 with adjuvant Matrix-M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10μg R21 adjuvanted with 50μg Matrix-M1 administered intramuscularly in the deltoid muscle of either arm.

    Number of subjects in period 4 [1]
    		Group 1 Group 2 Group 3 Group 4a Group 4b Group 5 Group 6 Group 7
    Started
    11
    11
    9
    6
    6
    7
    2
    7
    Completed
    11
    11
    9
    6
    6
    7
    2
    7
    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: One participant from group 3 withdrew from the study prior to the Challenge time period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Week 0
    Reporting group description
    		 -

    Reporting group values
    		 Week 0 Total
    Number of subjects
    		 66 66
    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)
    		 66 66
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 36 36
        Male
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 2
    Reporting group description
    		 2 vaccinations of 50μg R21 and one dose of 10μg R21 followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 3
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 plus single doses of ChAd63 ME-TRAP and MVA ME-TRAP followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 4a
    Reporting group description
    		 Served as infectivity controls.

    Reporting group title
    Group 4b
    Reporting group description
    		 Served as infectivity controls.

    Reporting group title
    Group 5
    Reporting group description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 and a single dose of 2μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 6
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 7
    Reporting group description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.
    Reporting group title
    Group 1
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 2
    Reporting group description
    		 2 vaccinations of 50μg R21 and one dose of 10μg R21 followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 3
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 plus single doses of ChAd63 ME-TRAP and MVA ME-TRAP followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 5
    Reporting group description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 and a single dose of 2μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 6
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 7
    Reporting group description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 4a
    Reporting group description
    		 Served as infectivity controls.

    Reporting group title
    Group 4b
    Reporting group description
    		 Served as infectivity controls.
    Reporting group title
    Group 1
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 2
    Reporting group description
    		 2 vaccinations of 50μg R21 and one dose of 10μg R21 followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 3
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 plus single doses of ChAd63 ME-TRAP and MVA ME-TRAP followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 5
    Reporting group description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 and a single dose of 2μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 6
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 7
    Reporting group description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 4a
    Reporting group description
    		 Served as infectivity controls.

    Reporting group title
    Group 4b
    Reporting group description
    		 Served as infectivity controls.
    Reporting group title
    Group 1
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 2
    Reporting group description
    		 2 vaccinations of 50μg R21 and one dose of 10μg R21 followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 3
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 plus single doses of ChAd63 ME-TRAP and MVA ME-TRAP followed by CHMI by sporozoite challenge (mosquito bite) at week 12

    Reporting group title
    Group 4a
    Reporting group description
    		 Served as infectivity controls.

    Reporting group title
    Group 4b
    Reporting group description
    		 Served as infectivity controls.

    Reporting group title
    Group 5
    Reporting group description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 and a single dose of 2μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 6
    Reporting group description
    		 3 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Reporting group title
    Group 7
    Reporting group description
    		 2 vaccinations of 10μg R21/ 50μg matrix-M1 followed by CHMI by sporozoite challenge (mosquito bite) at week 12.

    Primary: Efficacy of adjuvanted R21 at two different doses and adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP in healthy malaria-naïve volunteers as assessed by number of completely protected individuals

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    End point title
    		 Efficacy of adjuvanted R21 at two different doses and adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP in healthy malaria-naïve volunteers as assessed by number of completely protected individuals [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    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 trial publication can be uploaded following publication, if required.
    End point values
    		 Group 1 Group 2 Group 3 Group 4a Group 4b Group 5 Group 6 Group 7
    Number of subjects analysed
    11
    11
    9
    6
    6
    7
    2
    7
    Units: ELISpot
    11
    11
    9
    6
    6
    7
    2
    7
    No statistical analyses for this end point

    Primary: Safety of adjuvanted R21 at two different doses and adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP in healthy malaria-naïve volunteers as assessed by frequency of adverse events

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    End point title
    		 Safety of adjuvanted R21 at two different doses and adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP in healthy malaria-naïve volunteers as assessed by frequency of adverse events [2]
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    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: Due to the confidential nature of this information, we have not provided this analysis at this time. The trial publication can be uploaded following publication, if required.
    End point values
    		 Group 1 Group 2 Group 3 Group 4a Group 4b Group 5 Group 6 Group 7
    Number of subjects analysed
    13
    12
    12
    6
    6
    8
    2
    7
    Units: Adverse events
    13
    12
    12
    6
    6
    8
    2
    7
    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
    19
    Reporting groups
    Reporting group title
    Group 1
    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: Due to technical difficulties, no AEs could be uploaded into this report. This information will be available in the trial publication.
    Serious adverse events
    		 Group 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 13 (7.69%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Appendicitis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Group 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jun 2016
    Addition of the chief investigators at sites to the investigator agreement Section 3.5 updated Section 7.4 added – rationale for vaccine doses Tables 9 & 10 – Blood volumes reduced in Group 4 & 5 volunteers Section 11.3 – Reporting procedures for all AEs updated Minor changes throughout the document
    15 Jul 2016
    Minor typographical errors corrected on Page 53 and 75
    12 Sep 2016
    Timelines updated in synopsis Randomisation removed from the entire protocol Minor changes to the schedule of attendances
    28 Oct 2016
    Change of the third dose in Group 2 from 50µg to 10µg
    06 Apr 2017
    Addition of a new group to assess the efficacy of 10/10/2µg R21 adjuvanted with Matrix-M1 Addition of a new group to assess the durable efficacy of 10/10/10µg R21 adjuvanted with Matrix-M1
    08 May 2017
    Addition of a new group to assess the efficacy of a two dose 10/10µg R21 adjuvanted with Matrix-M1 Additional immunology bleed for control group during CHMI follow up. Revised criteria for CHMI follow-up to occur at local site.
    22 Sep 2017
    Removal of 50ml immunology bleed at C+7 for Grps 4b,c, 5- 7.

    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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