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    Clinical Trial Results:
    Therapeutic HPV vaccine (BNT113) trial in HPV16 driven carcinoma.

    Summary
    EudraCT number
    		 2014-002061-30
    Trial protocol
    		 GB  
    Global end of trial date
    24 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2025
    First version publication date
    24 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RHMCAN0983
    Additional study identifiers
    ISRCTN number
    		 ISRCTN51789191
    US NCT number
    		 NCT03418480
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Southampton NHS Foundation Trust
    Sponsor organisation address
    MP138, R&D Department, Level E, Southampton General Hospital, Tremona Road, Southampton, United Kingdom, SO16 6YD
    Public contact
    Karen Martin, Southampton Clinical Trials Unit, 44 2381205154, ctu@soton.ac.uk
    Scientific contact
    Karen Martin, Southampton Clinical Trials Unit, 44 2381205154, ctu@soton.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
    23 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I objective: To establish a safe and tolerable dose of BNT113 [Arms 1A and 1B]. Phase II objectives: To assess if there is evidence of clinical effect (according to irRECIST 1.1 criteria) [Arm 1B] at 3 months after the last vaccination; to assess if there is evidence of clinical effect in terms of a significant increase of immune cells following BNT113 administration [Arm 1B].
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 2017
    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: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    0
    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)
    19
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 16 May 2017, and 17 Jan 2023, 30 patients were recruited (Arm 1A Cohort 1 n=6, Arm 1A Cohort 2 n=11, Arm 1B n=13) to receive treatment.

    Pre-assignment
    Screening details
    		 A total of 69 patients were screened, 10 were excluded due to non-HPV16+ cancer, 6 were excluded due to clinician’s choice, and 23 were excluded due to other reasons.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1A
    Arm description
    		 Arm 1A included patients with previously treated HPV16+ head and neck squamous cell carcinoma.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    q1w x 4 then q2w x 4 with intrapatient dose escalation from 7.2 μg to 29 μg (Cohort 1, first 6 patients) or to 72.8μg (Cohort 2, last 11 patients)

    Arm title
    		 Arm 1B
    Arm description
    		 Arm 1B included patients with HPV16+ advanced disease.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    q1w x 4 then q2w x 4 with intrapatient dose escalation from 7.2 μg to 72.8 μg

    Number of subjects in period 1
    		Arm 1A Arm 1B
    Started
    17
    13
    Completed
    12
    7
    Not completed
    5
    6
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1A
    Reporting group description
    		 Arm 1A included patients with previously treated HPV16+ head and neck squamous cell carcinoma.

    Reporting group title
    Arm 1B
    Reporting group description
    		 Arm 1B included patients with HPV16+ advanced disease.

    Reporting group values
    		 Arm 1A Arm 1B Total
    Number of subjects
    		 17 13 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 9 19
        From 65-84 years
    		 7 4 11
    Age continuous
    Units: years
        median (full range (min-max))
    		 63 (37 to 78) 58 (49 to 72) -
    Gender categorical
    Units: Subjects
        Female
    		 4 10 14
        Male
    		 13 3 16
    Primary site of cancer
    Primary site of cancer
    Units: Subjects
        Anal
    		 0 5 5
        Cervix
    		 0 2 2
        Neck
    		 2 1 3
        Oropharynx
    		 3 1 4
        Pelvis
    		 0 1 1
        Penis
    		 0 1 1
        Tongue
    		 5 1 6
        Tonsil
    		 7 0 7
        Missing
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Arm 1A
    Reporting group description
    		 Arm 1A included patients with previously treated HPV16+ head and neck squamous cell carcinoma.

    Reporting group title
    Arm 1B
    Reporting group description
    		 Arm 1B included patients with HPV16+ advanced disease.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received at least 1 dose or underwent DTH control reaction assessment.

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received at least 1 maximum dose or their individual maximum tolerated dose.

    Primary: Dose limiting toxicities

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    End point title
    		 Dose limiting toxicities [1]
    End point description
    End point type
    Primary
    End point timeframe
    During or within one week after the vaccination cycle
    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: Only descriptive statistics
    End point values
    		 Arm 1A Arm 1B
    Number of subjects analysed
    17
    12
    Units: Subject
        Yes
    0
    0
        No
    17
    12
    No statistical analyses for this end point

    Primary: Immune response: T cell response at any time

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    End point title
    		 Immune response: T cell response at any time [2]
    End point description
    End point type
    Primary
    End point timeframe
    Post-vaccination
    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: Only descriptive statistics
    End point values
    		 Arm 1A Arm 1B
    Number of subjects analysed
    10
    9
    Units: Subject
        E6 and E7 Positive
    2
    2
        E6 Positive, E7 Negative
    3
    1
        E6 Negative, E7 Positive
    0
    0
        E6 and E7 Negative
    4
    3
        Missing
    1
    3
    No statistical analyses for this end point

    Primary: Immune response: Antibody response at any time

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    End point title
    		 Immune response: Antibody response at any time [3]
    End point description
    End point type
    Primary
    End point timeframe
    Post-vaccination
    Notes
    [3] - 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: Only descriptive statistics
    End point values
    		 Arm 1A Arm 1B
    Number of subjects analysed
    15
    9
    Units: Subject
        E2 and E7 Positive
    0
    2
        E2 Positive, E7 Negative
    0
    0
        E2 Negative, E7 Positive
    8
    3
        E2 and E7 Negative
    6
    4
        Missing
    1
    0
    No statistical analyses for this end point

    Primary: Disease control rate

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    End point title
    		 Disease control rate [4] [5]
    End point description
    End point type
    Primary
    End point timeframe
    Post-treatment
    Notes
    [4] - 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: Only descriptive statistics
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive statistics
    End point values
    		 Arm 1B Per protocol population
    Number of subjects analysed
    9
    9
    Units: Subject
        Stable disease
    5
    5
        Progression
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Arm 1A
    Reporting group description
    		 Arm 1A included patients with previously treated HPV16+ head and neck squamous cell carcinoma.

    Reporting group title
    Arm 1B
    Reporting group description
    		 Arm 1B included patients with HPV16+ advanced disease.

    Serious adverse events
    		 Arm 1A Arm 1B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 17 (11.76%)
    8 / 13 (61.54%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Nervous system disorders
    Cauda equina syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    General disorders and administration site conditions
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 13 (15.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm 1A Arm 1B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    12 / 13 (92.31%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    5 / 17 (29.41%)
    2 / 13 (15.38%)
         occurrences all number
    12
    2
    Fatigue
         subjects affected / exposed
    10 / 17 (58.82%)
    3 / 13 (23.08%)
         occurrences all number
    32
    6
    Influenza like illness
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 13 (7.69%)
         occurrences all number
    3
    2
    Pain
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 13 (23.08%)
         occurrences all number
    3
    3
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 17 (17.65%)
    3 / 13 (23.08%)
         occurrences all number
    3
    3
    Dyspnoea
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Nasal congestion
         subjects affected / exposed
    5 / 17 (29.41%)
    0 / 13 (0.00%)
         occurrences all number
    6
    0
    Oropharyngeal pain
         subjects affected / exposed
    4 / 17 (23.53%)
    1 / 13 (7.69%)
         occurrences all number
    4
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Body temperature increased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 13 (0.00%)
         occurrences all number
    6
    0
    Headache
         subjects affected / exposed
    9 / 17 (52.94%)
    3 / 13 (23.08%)
         occurrences all number
    23
    10
    Presyncope
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    3
    Syncope
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 13 (15.38%)
         occurrences all number
    1
    2
    Tremor
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 13 (30.77%)
         occurrences all number
    2
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 13 (30.77%)
         occurrences all number
    2
    7
    Diarrhoea
         subjects affected / exposed
    3 / 17 (17.65%)
    2 / 13 (15.38%)
         occurrences all number
    7
    3
    Dyspepsia
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Nausea
         subjects affected / exposed
    8 / 17 (47.06%)
    5 / 13 (38.46%)
         occurrences all number
    21
    5
    Paraesthesia oral
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 13 (23.08%)
         occurrences all number
    1
    4
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Back pain
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 13 (30.77%)
         occurrences all number
    3
    4
    Limb discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Muscle spasms
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    2
    4
    Pain in extremity
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jan 2017
    Addition of 12 month continutation of treatment period for Arm 1B patients; Movement of secondary endpoints to tertiary endpoints, clarity and further information on the procedures of dose modification in the event of adverse drug reactions, clarity on the preventative management of adverse drug reactions, change to the information about the storage of the vaccine to fall in line with the changes in the IMPD
    19 Oct 2017
    Exclusion criteria has been updated to clarify the upper limits of patients with elevated Liver Function Tests; Consenting timeline for Arm 1A and 1B extended, as well as allowing routine treatment day bloods to be taken up to 1 working day prior to vaccination. Clarifications on continued treatment options and dose modifications also included.
    11 Jul 2018
    Clarification of blood requirements for standard pathology blood analysis, Change from C5a analysis to NHS complement function, HPV ISH changed to HPV typing, Cytokine blood withdrawal clarification, Clarification of tissue biopsy procedure, Removal of 7 day time-lag between dosing for both Arms, Clarification for vital sign monitoring, Change of name of IMP manufacturer, Clarification of reporting requirements.
    19 Dec 2019
    Removal of DTH and Complement function test; additional clarity regarding withdrawal of consent, storage temperatures for IMP updated, RNA (LIP) changed to RNA-LPX to harmonise with Investigator Brochure
    24 Feb 2021
    CI location and contact details updated; Updated drug name to BNT113. Change of manufacturing name to BioNTech Manufacturing GmbH. DTH analysis added back as tertiary endpoint to protocol
    22 Mar 2022
    Change in exclusion criteria, patients with history of anaphylactic reactions or severe allergies are no longer excluded from the trial. There are additional recommended actions for treatment of Adverse Drug Reactions (ADR) in appendix 2, and in preventative management of ADRs, such as adequate hydration and use of paracetamol pre and post vaccination. Footers in the schedule of observations have been updated to clarify when end of treatment and follow up visits should occur, there is also a new appendix 7 with a table of follow up visit schedule for patients who continue to maintenance treatment. The dose escalation diagram has been updated to clarify whether to dose escalate or reduce following a significant adverse drug reaction. Covid-19 vaccination status will now be collected as part of medical history.
    19 Dec 2022
    Study Title updated, ref to anti CD40 removed ; Arm 1B eligibility inclusion HPV16+ unknown primary; Window for weight, phys exam, ECOG - 3 days, New Stage 1 Consent added, Clarification scheduling of scans during maintenance treatment, Removed 24h overnight stays, Clinical Safety updates to wording (BNT)
    02 Aug 2023
    Change to Eligibility, cancer survivals free of disease for 1 year eligible, mandatory biopsies removed, definition of vaccine immunogenicity clarified, decrease in maintenance from 12 to 6 months.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Mar 2020
    COVID-19 lockdown
    05 Oct 2020
    12 Jan 2021
    COVID-19 lockdown
    01 Feb 2021
    12 Feb 2021
    Clinical Trial Unit resource issue (Arm 1B only)
    01 Jul 2021
    05 Apr 2022
    Pause to recruitment until revised IMPD approved to enable QP release of IMP
    27 Apr 2022
    19 Apr 2023
    Fungal contamination of the outer packaging of HARE-40 IMP Kit B
    -

    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.

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