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    Clinical Trial Results:
    Using BCG vaccine to strengthen the immune system in the elderly and improve the response to influenza vaccine. A randomized clinical trial.

    Summary
    EudraCT number
    		 2019-002781-12
    Trial protocol
    		 DK  
    Global end of trial date
    05 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2024
    First version publication date
    16 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2019061567
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Southern Denmark, Bandim Health Project
    Sponsor organisation address
    Studiestræde 6, København K, Denmark, 1455
    Public contact
    Christine Stabell Benn, Bandim Health Project, cbenn@health.sdu.dk
    Scientific contact
    Christine Stabell Benn, Bandim Health Project, cbenn@health.sdu.dk
    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 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We tested the effect of BCG vaccine on the specific immune response to seasonal influenza vaccination in elderly people>65 years, with the aim to improve the specific antibody response to the vaccination.
    Protection of trial subjects
    Participants were instructed to report (serious) adverse events in biweekly questionnaires during the six months of follow-up but were also encouraged to contact study personnel directly in case of suspected adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2021
    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
    Denmark: 273
    Worldwide total number of subjects
    273
    EEA total number of subjects
    273
    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)
    0
    From 65 to 84 years
    272
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place from October to November 2021 in Odense, a Danish city of approximately 200,000 inhabitants. Citizens aged 65 years or older, who were eligible for seasonal influenza vaccination, were recruited. Exclusion criteria were known contraindications to BCG and/or influenza vaccination.

    Pre-assignment
    Screening details
    		 We screened 284 individuals for eligibility. Eleven persons did not meet inclusion criteria or declined to participate. In total, 273 individuals were included and randomised to four groups: group 1 (N=67), group 2 (N=69), group 3 (N=67) and group 4 (N=70).

    Pre-assignment period milestones
    Number of subjects started
    		 273
    Number of subjects completed
    		 273

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Group 1 were vaccinated with BCG at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of placebo in the right arm, given by intradermal injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BCG vaccine, AJ Vaccines, Denmark
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Intradermal injection of 0.1 ml of suspended vaccine. After reconstitution, one dose (0.1 ml) contains live attenuated Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331, 2-8 x 10_5 cfu.

    Investigational medicinal product name
    Influvactetra, Mylan ApS, Denmark
    Investigational medicinal product code
    31398
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All participants received the standard dose inactivated influenza vaccine as recommended by the Danish Board of Health for the season of 2021/2022. One dose of the quadrivalent vaccine (Influvactetra) was given by intramuscular injection of 0.5 ml vaccine suspension in the deltoid area of the left arm.

    Investigational medicinal product name
    Sterile 0.9% Sodium Chloride solution
    Investigational medicinal product code
    Other name
    Saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Placebo constituted 0.1 ml of sterile sodium chloride solution (saline) injected in the same way as the real vaccine.

    Arm title
    		 Group 2
    Arm description
    		 Group 2 received placebo at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of placebo in the right arm, given by intradermal injection.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Influvactetra, Mylan ApS, Denmark
    Investigational medicinal product code
    31398
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All participants received the standard dose inactivated influenza vaccine as recommended by the Danish Board of Health for the season of 2021/2022. One dose of the quadrivalent vaccine (Influvactetra) was given by intramuscular injection of 0.5 ml vaccine suspension in the deltoid area of the left arm.

    Investigational medicinal product name
    Sterile 0.9% Sodium Chloride solution
    Investigational medicinal product code
    Other name
    Saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Placebo constituted 0.1 ml of sterile sodium chloride solution (saline) injected in the same way as the real vaccine.

    Arm title
    		 Group 3
    Arm description
    		 Group 3 received placebo at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of BCG vaccine by intradermal injection in the deltoid area of the right arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BCG vaccine, AJ Vaccines, Denmark
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Intradermal injection of 0.1 ml of suspended vaccine. After reconstitution, one dose (0.1 ml) contains live attenuated Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331, 2-8 x 10_5 cfu.

    Investigational medicinal product name
    Influvactetra, Mylan ApS, Denmark
    Investigational medicinal product code
    31398
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All participants received the standard dose inactivated influenza vaccine as recommended by the Danish Board of Health for the season of 2021/2022. One dose of the quadrivalent vaccine (Influvactetra) was given by intramuscular injection of 0.5 ml vaccine suspension in the deltoid area of the left arm.

    Investigational medicinal product name
    Sterile 0.9% Sodium Chloride solution
    Investigational medicinal product code
    Other name
    Saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Placebo constituted 0.1 ml of sterile sodium chloride solution (saline) injected in the same way as the real vaccine.

    Arm title
    		 Group 4
    Arm description
    		 Group 4 were vaccinated with a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm at inclusion (day 0). At day 14, they were vaccinated with BCG by intradermal injection in the deltoid area of the right arm and received a dose of placebo by intramuscular injection in the deltoid area of the left arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Influvactetra, Mylan ApS, Denmark
    Investigational medicinal product code
    31398
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All participants received the standard dose inactivated influenza vaccine as recommended by the Danish Board of Health for the season of 2021/2022. One dose of the quadrivalent vaccine (Influvactetra) was given by intramuscular injection of 0.5 ml vaccine suspension in the deltoid area of the left arm.

    Investigational medicinal product name
    BCG vaccine, AJ Vaccines, Denmark
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Intradermal injection of 0.1 ml of suspended vaccine. After reconstitution, one dose (0.1 ml) contains live attenuated Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331, 2-8 x 10_5 cfu.

    Investigational medicinal product name
    Sterile 0.9% Sodium Chloride solution
    Investigational medicinal product code
    Other name
    Saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Placebo constituted 0.1 ml of sterile sodium chloride solution (saline) injected in the same way as the real vaccine.

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4
    Started
    67
    69
    67
    70
    Completed
    66
    67
    65
    68
    Not completed
    1
    2
    2
    2
         Adverse event, serious fatal
    -
    1
    -
    -
         Consent withdrawn by subject
    1
    1
    -
    1
         Protocol deviation
    -
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Group 1 were vaccinated with BCG at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of placebo in the right arm, given by intradermal injection.

    Reporting group title
    Group 2
    Reporting group description
    		 Group 2 received placebo at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of placebo in the right arm, given by intradermal injection.

    Reporting group title
    Group 3
    Reporting group description
    		 Group 3 received placebo at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of BCG vaccine by intradermal injection in the deltoid area of the right arm.

    Reporting group title
    Group 4
    Reporting group description
    		 Group 4 were vaccinated with a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm at inclusion (day 0). At day 14, they were vaccinated with BCG by intradermal injection in the deltoid area of the right arm and received a dose of placebo by intramuscular injection in the deltoid area of the left arm.

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Total
    Number of subjects
    		 67 69 67 70 273
    Age categorical
    Units: Subjects
        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
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 67 69 67 69 272
        85 years and over
    		 0 0 0 1 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 70.6 (67.9 to 74.4) 70.5 (67.5 to 74.5) 69.2 (66.9 to 74.5) 70.6 (68.4 to 75.5) -
    Gender categorical
    Units: Subjects
        Female
    		 30 32 30 32 124
        Male
    		 37 37 37 38 149
    Previous influenza vaccination
    Units: Subjects
        Yes
    		 62 60 58 69 249
        No
    		 5 9 9 1 24
    Vaccinated against COVID-19
    Units: Subjects
        Yes
    		 67 69 66 69 271
        No
    		 0 0 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Group 1 were vaccinated with BCG at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of placebo in the right arm, given by intradermal injection.

    Reporting group title
    Group 2
    Reporting group description
    		 Group 2 received placebo at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of placebo in the right arm, given by intradermal injection.

    Reporting group title
    Group 3
    Reporting group description
    		 Group 3 received placebo at inclusion (day 0) by intradermal injection in the deltoid area of the right arm. At day 14, they received a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm and a dose of BCG vaccine by intradermal injection in the deltoid area of the right arm.

    Reporting group title
    Group 4
    Reporting group description
    		 Group 4 were vaccinated with a standard dose of inactivated influenza vaccine by intramuscular injection in the deltoid area of the left arm at inclusion (day 0). At day 14, they were vaccinated with BCG by intradermal injection in the deltoid area of the right arm and received a dose of placebo by intramuscular injection in the deltoid area of the left arm.

    Primary: Influenza antibody titre after vaccination

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    End point title
    		 Influenza antibody titre after vaccination
    End point description
    Antibody titre HI GMT after vaccination. Change in GMT from before vs after vaccination is compared between treatment groups and the control group.
    End point type
    Primary
    End point timeframe
    Antibody titre 4 weeks after vaccination (for group 4 it is 6 weeks after vaccination).
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    67
    69
    65
    68
    Units: Antibody GMT
        geometric mean (standard deviation)
    38.3 ( 2.0 )
    41.4 ( 1.8 )
    42.2 ( 2.0 )
    34.8 ( 1.8 )
    Statistical analysis title
    		 Change in influenza antibody GMT
    Statistical analysis description
    Group 1 and 3 were compared with the control group (group 2) in linear regression adjusted for sex, age group, and baseline antibody level (at day 14 before vaccination).
    Comparison groups
    Group 1 v Group 2 v Group 3
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Self-reported infection

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    End point title
    		 Self-reported infection
    End point description
    Infections reported by participants in biweekly surveys. Infection rate was comared between treatment groups and control group (group 2).
    End point type
    Secondary
    End point timeframe
    Within 6 months follow-up
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    67
    69
    67
    70
    Units: Incidence rate/100 pyrs
        number (not applicable)
    224.3
    201.8
    193.4
    211.9
    Statistical analysis title
    		 Self-reported infections
    Statistical analysis description
    Treatment groups were compared with the control group Anderson-Gill Cox regression model with time since inclusion as underlying time scale. The analysis was adjusted for sex and age group
    Comparison groups
    Group 1 v Group 2 v Group 3 v Group 4
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Anderson-Gill Cox
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Six months follow-up.
    Adverse event reporting additional description
    Adverse events were registered within 4 weeks of inclusion, serious adverse events until end of trial. participants could report adverse events via the biweekly questionnaires or directly to the primary investigator at all times during the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 -

    Reporting group title
    Group 2 (control)
    Reporting group description
    		 -

    Reporting group title
    Group 3
    Reporting group description
    		 -

    Reporting group title
    Group 4
    Reporting group description
    		 -

    Serious adverse events
    		 Group 1 Group 2 (control) Group 3 Group 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 67 (5.97%)
    5 / 69 (7.25%)
    3 / 67 (4.48%)
    3 / 70 (4.29%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 69 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 69 (1.45%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Vascular disorders
    Transient cerebral ischemia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 69 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 69 (0.00%)
    1 / 67 (1.49%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 69 (1.45%)
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Pneumothorax
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 69 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 69 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 69 (0.00%)
    1 / 67 (1.49%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 69 (1.45%)
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Wound infection
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 69 (0.00%)
    0 / 67 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1 Group 2 (control) Group 3 Group 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 67 (47.76%)
    3 / 69 (4.35%)
    26 / 67 (38.81%)
    25 / 70 (35.71%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 67 (13.43%)
    1 / 69 (1.45%)
    5 / 67 (7.46%)
    9 / 70 (12.86%)
         occurrences all number
    9
    1
    5
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 67 (10.45%)
    1 / 69 (1.45%)
    3 / 67 (4.48%)
    6 / 70 (8.57%)
         occurrences all number
    7
    1
    3
    6
    Lymph node palpable
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 69 (0.00%)
    3 / 67 (4.48%)
    0 / 70 (0.00%)
         occurrences all number
    3
    0
    3
    0
    Pain at injection site
         subjects affected / exposed
    13 / 67 (19.40%)
    0 / 69 (0.00%)
    13 / 67 (19.40%)
    8 / 70 (11.43%)
         occurrences all number
    13
    0
    13
    8
    Infections and infestations
    Fever
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 69 (1.45%)
    2 / 67 (2.99%)
    2 / 70 (2.86%)
         occurrences all number
    0
    1
    2
    2

    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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