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    Clinical Trial Results:
    A pilot study of the impact of BCG administration on the immunogenicity of serogroup C meningococcal conjugate vaccine in healthy infants

    Summary
    EudraCT number
    		 2013-003488-71
    Trial protocol
    		 GB  
    Global end of trial date
    27 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Apr 2019
    First version publication date
    19 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OVG-2013/04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02002156
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Oxford Vaccine Group and Jenner Institute, CCVTM, Churchill Hospital, Oxford, United Kingdom, OX3 7LE
    Public contact
    Oxford Vaccine Group, University of Oxford, 44 1865611400, andrew.pollard@paediatrics.ox.ac.uk
    Scientific contact
    Oxford Vaccine Group, University of Oxford, 44 1865611400, andrew.pollard@paediatrics.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 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterise the impact of BCG immunisation given at birth or 3 months of age on the initial response to infant serogroup C meningococcal vaccine (MenC).
    Protection of trial subjects
    Ethical, Legal and Management Protection: Every effort was made to ensure that parents or guardians giving informed consent were able to understand fully the nature of the study including the risks,burdens, benefits and implications that taking part had for their child. The study involved the collection of blood samples that would not normally be part of routine care. In order to minimise any discomfort, local anaesthetic cream was offered to numb the skin prior to the sample being collected. The members of the study team undertaking venepuncture had specific training and experience in this technique. With the parent/guardians agreement two attempts at blood sampling were made and if unsuccessful a further visit was arranged by the study team. Strict inclusion and exclusion criteria applied to the enrolment of each study participant. The study complied with the Data Protection Act which requires data to be anonymised as soon as it is practical to do so ensuring that the participant's anonymity was maintained throughout the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 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: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    28
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study required that participants were enrolled as soon as possible after birth. Study information was provided before rather than after birth wherever practically possible, at visits to hospital and/or community-based antenatal clinics and ultrasound appointments, or sent by post.

    Pre-assignment
    Screening details
    		 No pre-screening was performed for this trial. Following consent at the first trial visit, screening was restricted to confirmation of eligibility, review of medical history and medical examination.

    Period 1
    Period 1 title
    Visit 1 Enrolment and Randomisation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial was not blinded after randomisation had been completed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 BCG administered at V1
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bacillus Calmette-Guérin (BCG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    The BCG vaccine was given according to current UK guidelines. Wherever possible, BCG was administered into the left upper arm at the insertion of the deltoid muscle as detailed in these guidelines. The tip of the shoulder was avoided because of the increased risk of keloid formation at this site. The dose administered was 0.05 mL for children under 12 months, 0.1 mL for children 12 months and older.

    Arm title
    		 Group 2
    Arm description
    		 BCG administered at visit 3 (3 months)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bacillus Calmette-Guérin (BCG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    The BCG vaccine was given according to current UK guidelines. Wherever possible, BCG was administered into the left upper arm at the insertion of the deltoid muscle as detailed in these guidelines. The tip of the shoulder was avoided because of the increased risk of keloid formation at this site. The dose administered was 0.05 mL for children under 12 months, 0.1 mL for children 12 months and older.

    Arm title
    		 Group 3
    Arm description
    		 Control - BCG offered at visit 7 (13 months)
    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
    Started
    10
    9
    9
    Completed
    10
    9
    9
    Period 2
    Period 2 title
    Follow up visits (2-7)
    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
    		 BCG administered at V1 All participants in the three groups in this trial followed the same visit schedule, part from the BCG administration date. The visit schedule was as follows: Visit 2 and 4(2 and 4 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 2 and 4 months. Visit 3, 6 and 7 (3, 12 and 13 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 3, 12 and 13 months, including MenC. Collection of blood samples. Visit 5 (5 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Collection of blood samples.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bacillus Calmette-Guérin (BCG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    The BCG vaccine was given according to current UK guidelines. Wherever possible, BCG was administered into the left upper arm at the insertion of the deltoid muscle as detailed in these guidelines. The tip of the shoulder was avoided because of the increased risk of keloid formation at this site. The dose administered was 0.05 mL for children under 12 months, 0.1 mL for children 12 months and older.

    Arm title
    		 Group 2
    Arm description
    		 BCG administered at visit 3 (3 months) All participants in the three groups in this trial followed the same visit schedule, part from the BCG administration date. The visit schedule was as follows: Visit 2 and 4(2 and 4 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 2 and 4 months. Visit 3, 6 and 7 (3, 12 and 13 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 3, 12 and 13 months, including MenC. Collection of blood samples. Visit 5 (5 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Collection of blood samples.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bacillus Calmette-Guérin (BCG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    The BCG vaccine was given according to current UK guidelines. Wherever possible, BCG was administered into the left upper arm at the insertion of the deltoid muscle as detailed in these guidelines. The tip of the shoulder was avoided because of the increased risk of keloid formation at this site. The dose administered was 0.05 mL for children under 12 months, 0.1 mL for children 12 months and older.

    Arm title
    		 Group 3
    Arm description
    		 Control - BCG offered at visit 7 (13 months) All participants in the three groups in this trial followed the same visit schedule, part from the BCG administration date. The visit schedule was as follows: Visit 2 and 4(2 and 4 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 2 and 4 months. Visit 3, 6 and 7 (3, 12 and 13 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 3, 12 and 13 months, including MenC. Collection of blood samples. Visit 5 (5 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Collection of blood samples.
    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
    Started
    10
    9
    9
    Completed
    10
    8
    8
    Not completed
    0
    1
    1
         Consent withdrawn by subject
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 BCG administered at V1

    Reporting group title
    Group 2
    Reporting group description
    		 BCG administered at visit 3 (3 months)

    Reporting group title
    Group 3
    Reporting group description
    		 Control - BCG offered at visit 7 (13 months)

    Reporting group values
    		 Group 1 Group 2 Group 3 Total
    Number of subjects
    		 10 9 9 28
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 10 9 9 28
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 5 5 16
        Male
    		 4 4 4 12

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 BCG administered at V1

    Reporting group title
    Group 2
    Reporting group description
    		 BCG administered at visit 3 (3 months)

    Reporting group title
    Group 3
    Reporting group description
    		 Control - BCG offered at visit 7 (13 months)
    Reporting group title
    Group 1
    Reporting group description
    		 BCG administered at V1 All participants in the three groups in this trial followed the same visit schedule, part from the BCG administration date. The visit schedule was as follows: Visit 2 and 4(2 and 4 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 2 and 4 months. Visit 3, 6 and 7 (3, 12 and 13 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 3, 12 and 13 months, including MenC. Collection of blood samples. Visit 5 (5 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Collection of blood samples.

    Reporting group title
    Group 2
    Reporting group description
    		 BCG administered at visit 3 (3 months) All participants in the three groups in this trial followed the same visit schedule, part from the BCG administration date. The visit schedule was as follows: Visit 2 and 4(2 and 4 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 2 and 4 months. Visit 3, 6 and 7 (3, 12 and 13 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 3, 12 and 13 months, including MenC. Collection of blood samples. Visit 5 (5 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Collection of blood samples.

    Reporting group title
    Group 3
    Reporting group description
    		 Control - BCG offered at visit 7 (13 months) All participants in the three groups in this trial followed the same visit schedule, part from the BCG administration date. The visit schedule was as follows: Visit 2 and 4(2 and 4 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 2 and 4 months. Visit 3, 6 and 7 (3, 12 and 13 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Administration of routine schedule vaccines due at 3, 12 and 13 months, including MenC. Collection of blood samples. Visit 5 (5 months): Confirmation of ongoing consent, eligibility and collection of interim medical history. Collection of blood samples.

    Subject analysis set title
    MenC IgG (Primary Objective)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    MenC-specific IgG at 8 weeks following the dose of MenC vaccine (i.e. at 20 weeks of age if no delay in the schedule). (The log10-transformed MenC-specific lgG was summarised by the subjects and each group at 20 weeks of age. The exponentiated differences between log10-transformed group means was compared and presented as geometric mean ratios/titres with associated 95% confidence intervals)

    Primary: MenC-specific IgG at 8 weeks following the dose of MenC vaccine

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    End point title
    		 MenC-specific IgG at 8 weeks following the dose of MenC vaccine [1]
    End point description
    End point type
    Primary
    End point timeframe
    MenC-specific IgG at 8 weeks following the dose of MenC vaccine
    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: All comparisons were considered exploratory and hypothesis-generating as this is an under powered study. Results were interpreted with appropriate caution due to the large degree of variation expected with small studies. Statistical testing of hypotheses was not conducted as this is a small pilot study. All results will be available in the trial publication which will be publicly available.
    End point values
    		 Group 1 Group 2 Group 3 Group 1 Group 2 Group 3
    Number of subjects analysed
    10
    9
    9
    9
    8
    8
    Units: Titre
    10
    9
    9
    10
    9
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Solicited adverse events to the trial vaccines were not collected for this trial, as all vaccines are licensed and were used in accordance with their marketing authorisation. SAEs were collected throughout the trial period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Protocol
    Dictionary version
    Current ap
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Solicited adverse events to the trial vaccines were not collected for this trial, as all vaccines are licensed and were used in accordance with their marketing authorisation.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2013
    Documents were amended to make it clearer that the study invitation is only for babies who would not normally receive a BCG vaccine. We modified the recruitment text short and long, and updated the parent information booklet accordingly. A document was added to give to parents which outlines what samples are taken at each visit, for each of the three groups. Recruitment text documents were updated.
    24 Feb 2014
    Exploratory objective wording in the protocol was clarified around the analyses of monocyte and lymphotcyte ratios and removal of a duplicated sentence regarding MenC SBA. A correction to the site of a vaccination was also made to the protocol.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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