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    Clinical Trial Results:
    A Phase I/II Study to assess the safety, immunogenicity and protective efficacy of novel malaria vaccine candidates ChAdOx1 LS2 and MVA LS2 in healthy UK adults

    Summary
    EudraCT number
    		 2017-001049-28
    Trial protocol
    		 GB  
    Global end of trial date
    20 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

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    Trial identification
    Sponsor protocol code
    VAC067
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03203421
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    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
    20 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of new candidate malaria vaccines ChAdOx1 LS2 administered alone, and with MVA LS2 in a prime-boost regimen by the intramuscular routes in healthy malaria-naïve volunteers To assess the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of ChAdOx1 LS2 and MVA LS2 administered in prime-boost vaccination regimen against malaria sporozoite challenge, in healthy malaria-naïve volunteers.
    Protection of trial subjects
    - Volunteers given at least 24 hours to read Participant Information Leaflet before being seen for screening, and then given plenty of opportunity to ask questions prior to agreeing to take part in a study. - Written informed consent is obtained before performing any study procedures. - Volunteers given the opportunity to withdraw from the rial at any time without affecting their normal medical care. - Screening visit including full medical history, physical examination and baseline blood tests to ensure volunteers are eligible. - Vaccination carried out in clinical environment with staff trained in resuscitation in case of allergic reaction. - Safety review prior to dose escalation (Local safety monitor)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jul 2017
    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: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Volunteers were recruited through advertisements distributed or posted in public places - including buses and trains, newspapers, radio, website or social media, and Oxford vaccine centre databases. Information sheet was available to the volunteer at least 24 hours prior to the screening visit.

    Pre-assignment
    Screening details
    		 - Review of inclusion/exclusion criteria - Informed consent - Medical history, concomitant medication - Physical examination - Urinalysis, B-HCG urine test (women only) - Haematology, biochemistry - Diagnostic serology: HBsAg, HCV and HIV antibodies - Immunology: Human Leukocyte Antigen (HLA) typing

    Period 1
    Period 1 title
    Week 0 - Prime
    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
    		 Single dose ChAdOx1 LS2 5 x 10^9 vp
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAdOx1 LS2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAdOx1 LS2 5x10^9 vp administered intramuscularly into the deltoid of the non-dominant arm.

    Arm title
    		 Group 2
    Arm description
    		 ChAdOx1 LS2 and MVA LS2 in a heterologous prime-boost regime followed by CHMI
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAdOx1 LS2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAdOx1 LS2 2.5 x 10^10 vp administered intramuscularly into the deltoid of the non-dominant arm.

    Arm title
    		 Control Group
    Arm description
    		 Controlled human malaria infection (CHMI) of unvaccinated group.
    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 Control Group
    Started
    3
    10
    5
    Completed
    3
    10
    5
    Period 2
    Period 2 title
    Week 8 (window: 1-10 weeks post prime)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 2
    Arm description
    		 ChAdOx1 LS2 and MVA LS2 in a heterologous prime-boost regime followed by CHMI
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA LS2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MVA LS2 2 x 10^8 pfu administered intramuscularly into the deltoid of the non-dominant arm.

    Arm title
    		 Group 1
    Arm description
    		 Single dose ChAdOx1 LS2 5 x 10^9 vp
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAdOx1 LS2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAdOx1 LS2 5x10^9 vp administered intramuscularly into the deltoid of the non-dominant arm.

    Arm title
    		 Control Group
    Arm description
    		 Controlled human malaria infection (CHMI) of unvaccinated group.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Group 2 Group 1 Control Group
    Started
    10
    3
    5
    Completed
    10
    3
    6
    Not completed
    0
    0
    2
         Consent withdrawn by subject
    -
    -
    2
    Joined
    0
    0
    3
         Additional controls added
    -
    -
    3
    Period 3
    Period 3 title
    Week 11 - CHMI (2-4 weeks post boost)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 2
    Arm description
    		 ChAdOx1 LS2 and MVA LS2 in a heterologous prime-boost regime followed by CHMI
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAdOx1 LS2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAdOx1 LS2 5x10^9 vp administered intramuscularly into the deltoid of the non-dominant arm.

    Arm title
    		 Control Group
    Arm description
    		 Controlled human malaria infection (CHMI) of unvaccinated group.
    Arm type
    		 CHMI

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 1
    Arm description
    		 Single dose ChAdOx1 LS2 5 x 10^9 vp
    Arm type
    		 Experimental

    Investigational medicinal product name
    ChAdOx1 LS2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ChAdOx1 LS2 5x10^9 vp administered intramuscularly into the deltoid of the non-dominant arm.

    Number of subjects in period 3
    		Group 2 Control Group Group 1
    Started
    10
    6
    3
    Completed
    9
    6
    2
    Not completed
    1
    0
    1
         Consent withdrawn by subject
    1
    -
    1

    Baseline characteristics

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

    Reporting group values
    		 Week 0 - Prime Total
    Number of subjects
    		 18 18
    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)
    		 18 18
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Single dose ChAdOx1 LS2 5 x 10^9 vp

    Reporting group title
    Group 2
    Reporting group description
    		 ChAdOx1 LS2 and MVA LS2 in a heterologous prime-boost regime followed by CHMI

    Reporting group title
    Control Group
    Reporting group description
    		 Controlled human malaria infection (CHMI) of unvaccinated group.
    Reporting group title
    Group 2
    Reporting group description
    		 ChAdOx1 LS2 and MVA LS2 in a heterologous prime-boost regime followed by CHMI

    Reporting group title
    Group 1
    Reporting group description
    		 Single dose ChAdOx1 LS2 5 x 10^9 vp

    Reporting group title
    Control Group
    Reporting group description
    		 Controlled human malaria infection (CHMI) of unvaccinated group.
    Reporting group title
    Group 2
    Reporting group description
    		 ChAdOx1 LS2 and MVA LS2 in a heterologous prime-boost regime followed by CHMI

    Reporting group title
    Control Group
    Reporting group description
    		 Controlled human malaria infection (CHMI) of unvaccinated group.

    Reporting group title
    Group 1
    Reporting group description
    		 Single dose ChAdOx1 LS2 5 x 10^9 vp

    Primary: The safety and tolerability of ChAdOx1 LS2 administered alone and with MVA LS2 in a prime-boost vaccination regimen in healthy malaria-naive volunteers assessed by the frequency and severity of adverse events

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    End point title
    		 The safety and tolerability of ChAdOx1 LS2 administered alone and with MVA LS2 in a prime-boost vaccination regimen in healthy malaria-naive volunteers assessed by the frequency and severity of adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    All AEs occurring in the 28 days following each vaccination collected from diary cards, clinical review, clinical examination and laboratory results.
    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 scientific paper can be uploaded following publication if required.
    End point values
    		 Group 2 Control Group Group 1
    Number of subjects analysed
    9
    6
    2
    Units: Adverse events
    9
    6
    2
    No statistical analyses for this end point

    Primary: The efficacy of ChAdOx2 LS2 and MVA LS2 administered in a prime-boost vaccination regimen against malaria sporozoite challenge, in healthy malaria-naive volunteers

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    End point title
    		 The efficacy of ChAdOx2 LS2 and MVA LS2 administered in a prime-boost vaccination regimen against malaria sporozoite challenge, in healthy malaria-naive volunteers [2]
    End point description
    End point type
    Primary
    End point timeframe
    Completely protected individuals who did not develop blood stage infection by Day 21 following sporozoite challenge.
    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 scientific paper can be uploaded following publication if required.
    End point values
    		 Group 2 Control Group Group 1
    Number of subjects analysed
    9
    6
    2
    Units: volunteer
    9
    6
    2
    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
    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 technical difficulties, non-serious AE could not be uploaded in this report. these will be available in the trial publication.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2017
    Minor clarifications as requested by MHRA. Table 6 - Additional 2.5mls at C-1 visit for Group 2 volunteers; Tables 8 and 9 updated to reflect this
    09 Jun 2017
    Addition of MVA LS2 to replace homologous regimen with heterologous prime-boost trial design. Clarification Imperial College London premises to be used for sporozoite challenge procedures but not to be listed as trial site. Correction of typographical errors incl. section 7.3 IMP storage.

    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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