Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches using the ChAd63 and MVA vectors encoding the antigens ME-TRAP, CS and AMA1.

    Summary
    EudraCT number
    		 2012-004416-66
    Trial protocol
    		 GB  
    Global end of trial date
    14 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2016
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAC052
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01739036
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford, CTRG
    Sponsor organisation address
    Old Road, Oxford, United Kingdom, OX3 7LE
    Public contact
    Dr Alison Lawrie, University of Oxford, +44 1865857382, alison.lawrie@ndm.ox.ac.uk
    Scientific contact
    Dr Alison Lawrie, University of Oxford, +44 1865857382, alison.lawrie@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
    14 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: To assess the efficacy of each of two combinations of heterologous prime-boost immunisation strategies: 1. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS 2. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1 Secondary Objectives: To assess the safety and immunogenicity of heterologous prime-boost immunisation of malaria-naïve individuals with ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS. To assess the safety and immunogenicity of heterologous prime-boost immunisation of malaria-naïve individuals with ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1.
    Protection of trial subjects
    - Volunteers given at least 24 hours to read the VIS before being seen and then given plenty of opportunity to ask questions prior to agreeing to take part in the 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 the study was kept to a volume that should not compromise healthy volunteers. - Volunteers observed for 30 mins after vaccination to monitor for any immediate adverse effects. - Volunteers seen within 1 day of vaccination 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 - 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
    		 Riamet, Malerone or Chloroquine for treatment of malaria infection. Paracetamol for pain relief.
    Evidence for comparator
    		 No comparator
    Actual start date of recruitment
    04 Apr 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    37
    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 Questionnaire Informed consent Medical History Physical Examination Urinalysis β-HCG urine (women only) Review contraindications Physical Observations HBV,HCV,HIV Haematology Biochemistry Anti- P. Falciparum serology

    Pre-assignment period milestones
    Number of subjects started
    		 37
    Number of subjects completed
    		 37

    Period 1
    Period 1 title
    Day 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
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.
    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
    Mixture of ChAd63 CS 5 x 1010 vp and ChAd63 ME-TRAP 5 x 1010 vp to be administered as the first vaccination of Group 1 participants

    Investigational medicinal product name
    ChAd63 CS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Mixture of ChAd63 CS 5 x 1010 vp and ChAd63 ME-TRAP 5 x 1010 vp to be administered as the first vaccination of Group 1 participants

    Arm title
    		 Group 2
    Arm description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.
    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
    Mixture of ChAd63 CS 5 x 1010 vp, ChAd63 ME-TRAP 5 x 1010 vp, and ChAd63 AMA1 5 x 1010 vp to be administered as the first vaccination of Group 2 participants

    Investigational medicinal product name
    ChAd63 CS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Mixture of ChAd63 CS 5 x 1010 vp, ChAd63 ME-TRAP 5 x 1010 vp, and ChAd63 AMA1 5 x 1010 vp to be administered as the first vaccination of Group 2 participants

    Arm title
    		 Group 3
    Arm description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.
    Arm type
    		 Re-challenge/Previously vaccinated

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4
    Arm description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.
    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
    Started
    15
    15
    1
    6
    Completed
    15
    15
    1
    6
    Period 2
    Period 2 title
    Day 56
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.
    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
    2. Mixture of MVA CS 2 x 108 pfu and MVA ME-TRAP 2 x 108 pfu to be administered as the second vaccination of Group 1 participants

    Investigational medicinal product name
    ChAd63 CS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2. Mixture of MVA CS 2 x 108 pfu and MVA ME-TRAP 2 x 108 pfu to be administered as the second vaccination of Group 1 participants

    Arm title
    		 Group 2
    Arm description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.
    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
    Mixture of MVA CS 1.33 x 108 pfu, MVA ME-TRAP 1.33 x 108 pfu, and MVA AMA1 1.33 x 108 pfu to be administered as the second vaccination of Group 2 participants

    Investigational medicinal product name
    ChAd63 CS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Mixture of MVA CS 1.33 x 108 pfu, MVA ME-TRAP 1.33 x 108 pfu, and MVA AMA1 1.33 x 108 pfu to be administered as the second vaccination of Group 2 participants

    Arm title
    		 Group 3
    Arm description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.
    Arm type
    		 Re-challenge/Previously vaccinated

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4
    Arm description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.
    Arm type
    		 No intervention

    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 4
    Started
    15
    15
    1
    6
    Completed
    15
    14
    1
    6
    Not completed
    0
    1
    0
    0
         Consent withdrawn by subject
    -
    1
    -
    -
    Period 3
    Period 3 title
    Malaria Challenge
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.
    Arm type
    		 Malaria Challenge

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2
    Arm description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.
    Arm type
    		 Malaria Challenge

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3
    Arm description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.
    Arm type
    		 Re-challenge/Previously vaccinated

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4
    Arm description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.
    Arm type
    		 Malaria Challenge

    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 4
    Started
    15
    14
    1
    6
    Completed
    13
    13
    1
    6
    Not completed
    2
    1
    0
    0
         Consent withdrawn by subject
    2
    1
    -
    -
    Period 4
    Period 4 title
    Follow Up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2
    Arm description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3
    Arm description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4
    Arm description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Group 1 Group 2 Group 3 Group 4
    Started
    13
    13
    1
    6
    Completed
    13
    13
    1
    6

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 2
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 3
    Reporting group description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.

    Reporting group title
    Group 4
    Reporting group description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Total
    Number of subjects
    		 15 15 1 6 37
    Age categorical
    Healthy adult volunteers
    Units: Subjects
        Adults (18-64 years)
    		 15 15 1 6 37
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 5 0 5 12
        Male
    		 13 10 1 1 25

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 2
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 3
    Reporting group description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.

    Reporting group title
    Group 4
    Reporting group description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.
    Reporting group title
    Group 1
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 2
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 3
    Reporting group description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.

    Reporting group title
    Group 4
    Reporting group description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.
    Reporting group title
    Group 1
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 2
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 3
    Reporting group description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.

    Reporting group title
    Group 4
    Reporting group description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.
    Reporting group title
    Group 1
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp, followed by intramuscular administration of a mixture of MVA ME-TRAP 2 x 108 pfu and MVA CS 2 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 2
    Reporting group description
    		 Intramuscular administration of a mixture of ChAd63 ME-TRAP 5 x 1010 vp and ChAd63 CS 5 x 1010 vp and ChAd63 AMA1 5 x 1010 vp followed by intramuscular administration of a mixture of MVA ME-TRAP 1.33 x 108 pfu and MVA CS 1.33 x 108 pfu and MVA AMA1 1.33 x 108 pfu eight weeks later, followed by controlled human malaria infection 17-24 days later.

    Reporting group title
    Group 3
    Reporting group description
    		 Controlled human malaria infection administered at an interval of approximately 8-12 months after the initial controlled human malaria infection that the volunteers received in the VAC045 clinical trial.

    Reporting group title
    Group 4
    Reporting group description
    		 Unvaccinated control volunteers who undergo controlled human malaria infection.

    Primary: Controlled human malaria infection of sporozoites

    		 Close Top of page
    End point title
    		 Controlled human malaria infection of sporozoites [1]
    End point description
    End point type
    Primary
    End point timeframe
    Diagnosis of malaria infection following challenge as defined as positive thick film microscopy up to day 21 post challenge.
    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 wil be uploaded at a later date.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    13
    13
    1
    6
    Units: 33
    13
    13
    1
    6
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs collected and reviewed from day of vaccination to 90 days post challenge (total 160 days). SAEs reported within 24 hours of awareness to sponsor. 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
    		 None
    Dictionary version
    N/A
    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 wil be uploaded at a later date. There were a total of 3 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
    21 Feb 2013
    Addition of electrocardiogram as a study procedure. Change of timing of post-vaccination follow-up visit. Corrections to the VIS to match the protocol. Addition of emergency contact cards. Shelf life extension of MVA CS lot 0010210.
    25 Mar 2013
    Change of diary card.
    20 May 2013
    Change to the protocol for day 7 post-CHMI visit Amendment to the phrasing used regarding the day 7 follow up visits after the controlled human malaria infection (CHMI) procedure. The protocol stated that volunteers will be seen for blood tests 3 times on the day, with a gap of 6-8 hours between each visit. This was not possible in practice, and therefore the phrasing was changed to ‘The interval between visits will be as evenly spaced as practicable’.
    31 May 2013
    To extend the shelf life of vaccine ChAd63 CS (Batch No 03O11-01) for a further year to 16th June 2014. To extend the shelf life of vaccine AdCh63 AMA1 (Lot 01 Fill 09-04) for a further year to 17th June 2014.
    17 Jul 2013
    To extend the shelf life of vaccine MVA AMA1 to 3rd August 2014.

    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
    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.

    European Medicines Agency © 1995-Sat May 18 13:49:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA