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    Clinical Trial Results:
    Proof-of-pharmacology clinical trial on a vaccine that elicits a protective humoral immune response against oxidized low density lipoprotein

    Summary
    EudraCT number
    		 2015-005650-35
    Trial protocol
    		 NL  
    Global end of trial date
    30 Aug 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CHDR1503
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre for Human Drug Research
    Sponsor organisation address
    Zernikedreef 8, Leiden, Netherlands, 2333CL
    Public contact
    J. Burggraaf, Centre for Human Drug Research, +31 715246400, kb@chdr.nl
    Scientific contact
    J. Burggraaf, Centre for Human Drug Research, +31 715246400, kb@chdr.nl
    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
    05 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To determine the specific immunoglobulin response against oxLDL after administration of a single 13-valent pneumococcal vaccine.
    Protection of trial subjects
    The 13-valent pneumococcal vaccine consists of wall saccharides and thus no living organisms. Previous research has demonstrated that administration of the vaccine is safe, illustrated by its widespread implementation in clinical use in both infants and adults. Side effects are usually limited to local mild tenderness and, more infrequently, low grade fever (<39 C) or fatigue. Due to the extensive experience with the vaccine, we expect the risk of unexpected SAEs to be low. In terms of benefits, subjects may have a reduction in risk of developing pneumonia, although studies have predominantly been performed in the elderly or infants, thus no adequate estimation of risk reduction can be performed in the subjects of this study. Furthermore, this study may be the next step to show that the 13- valent conjugate vaccine may provide a safe and widely applicable treatment modality for atherosclerosis. Written informed consent was obtained from each individual participating in the study prior to any study procedure and after adequate explanation of the aims, methods, objectives, and potential hazards of the study. It was made clear to each subject that he or she was completely free to refuse to enter the study, or to withdraw from it at any time for any reason.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    05 Apr 2016
    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
    Netherlands: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 05 April 2016 - 30 August 2017

    Pre-assignment
    Screening details
    		 Subjects enrolled are male, aged 18-45 without evidence of any active or chronic disease following a medical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry and urinalysis. Able to participate and willing to give written informed consent and to comply with the study restrictions

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AAA treatment
    Arm description
    		 3 times active treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar-13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0,5 mL Prevenar-13 at baseline, after 4 weeks and after 28 weeks.

    Arm title
    		 Placebo treatment
    Arm description
    		 3 times placebo treatment
    Arm type
    		 Placebo

    Investigational medicinal product name
    0.9% saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0.5 mL 0.9% saline solution at baseline, after 4 weeks and after 28 weeks.

    Arm title
    		 AAP treatment
    Arm description
    		 2 times active , 1 time placebo treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar-13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0,5 mL Prevenar-13 at baseline, after 4 weeks and after 28 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0.5 mL 0.9% saline solution at baseline, after 4 weeks and after 28 weeks.

    Arm title
    		 APP treatment
    Arm description
    		 1 time active, 2 times placebo treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar-13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0,5 mL Prevenar-13 at baseline, after 4 weeks and after 28 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0.5 mL 0.9% saline solution at baseline, after 4 weeks and after 28 weeks.

    Arm title
    		 APA treatment
    Arm description
    		 2 times active, 1 placebo
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar-13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0,5 mL Prevenar-13 at baseline, after 4 weeks and after 28 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0.5 mL 0.9% saline solution at baseline, after 4 weeks and after 28 weeks.

    Number of subjects in period 1
    		AAA treatment Placebo treatment AAP treatment APP treatment APA treatment
    Started
    4
    8
    4
    4
    4
    Completed
    4
    8
    3
    4
    4
    Not completed
    0
    0
    1
    0
    0
         Consent withdrawn by subject
    -
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 24 24
    Age categorical
    Healthy males aged 18-45 years
    Units: Subjects
        Adults (18-64 years)
    		 24 24
    Gender categorical
    Healthy males aged 18-45 years
    Units: Subjects
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    AAA treatment
    Reporting group description
    		 3 times active treatment

    Reporting group title
    Placebo treatment
    Reporting group description
    		 3 times placebo treatment

    Reporting group title
    AAP treatment
    Reporting group description
    		 2 times active , 1 time placebo treatment

    Reporting group title
    APP treatment
    Reporting group description
    		 1 time active, 2 times placebo treatment

    Reporting group title
    APA treatment
    Reporting group description
    		 2 times active, 1 placebo

    Primary: Anti-oxLDL IgG

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    End point title
    		 Anti-oxLDL IgG [1]
    End point description
    Prevenar-induced anti-oxLDL IgG antibodies
    End point type
    Primary
    End point timeframe
    Overall trial (Baseline up to EOS)
    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: Please refer to uploaded charts for the corresponding endpoint and statistical analysis. Also for other primary endpoints.
    End point values
    		 AAA treatment Placebo treatment AAP treatment APP treatment APA treatment
    Number of subjects analysed
    4
    8
    4
    4
    4
    Units: RLU/100ms
        number (not applicable)
    4
    8
    4
    4
    4
    Attachments
    		 CHDR1503_ CSR endpoints and analyses summary_v1.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Active treatment
    Reporting group description
    		 -

    Reporting group title
    Placebo treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Active treatment Placebo treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active treatment Placebo treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 16 (81.25%)
    3 / 20 (15.00%)
    Cardiac disorders
    Dizziness
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Disturbance in attention
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Injection site discomfort
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Malaise
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    liver enzymes increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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