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    Summary
    EudraCT Number:2021-003895-15
    Sponsor's Protocol Code Number:82720
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2021-003895-15
    A.3Full title of the trial
    Impact of human papillomavirus (HPV) vaccination on burden of disease in patients with actinic keratosis ― a double-blind randomized controlled trial
    Humant papillomvirus (HPV) vaccination til behandling af hudkræftforstadier-- et dobbelt-blindet randomiseret og kontrolleret patientforsøg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Human papillomavirus (HPV) vaccination for treatment of premalignant skin lesions
    Humant papillomvirus (HPV) vaccination til behandling af hudkræftforstadier
    A.3.2Name or abbreviated title of the trial where available
    VAXAK Trial
    A.4.1Sponsor's protocol code number82720
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05202860
    A.5.4Other Identifiers
    Name:H-21047863Number: National Committee on Health Research Ethics (NVK
    Name:NCT05202860Number:ClinicalTrials.gov
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBispebjerg Hospital, Department of Dermatology and Venereology
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInterne Forskningsmidler Bispebjerg og Frederiksberg Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportFonden Af Fam. Kjærsgaard, Sunds
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportMichael Hermann Nielsens Mindelegat afd. B
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion Hovedstadens Forskningsfond til Sundhedsforskning
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBispebjerg Hospital, Department of Dermatology and Venereology
    B.5.2Functional name of contact pointEmily Wenande
    B.5.3 Address:
    B.5.3.1Street AddressNielsine Nielsens Vej 9
    B.5.3.2Town/ cityCopenhagen NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4540505590
    B.5.6E-mailemily.cathrine.wenande@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gardasil® 9
    D.2.1.1.2Name of the Marketing Authorisation holderMSD VACCINS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGardasil® 9
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGardasil® 9
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58] (RECOMBINANT, ADSORBED)
    D.3.9.4EV Substance CodeSUB130921
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in vial
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Actinic Keratosis (AK)
    E.1.1.1Medical condition in easily understood language
    Precursors to skin cancer
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10052567
    E.1.2Term Skin preneoplastic conditions NEC
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10040901
    E.1.2Term Skin neoplasms malignant and unspecified (excl melanoma)
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Endeavoring to develop a new therapeutic and preventative strategy for patients with AK, this study aims to investigate the impact of 9-valent HPV vaccination on AK burden and -development over the course of 12 months.
    E.2.2Secondary objectives of the trial
    To assess local and systemic side effects in HPV vaccinated versus control group over 12 months

    To assess the impact of 9-valent HPV vaccination on new keratinocyte carcinoma development over 12 months
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all the following criteria are eligible to participate in this study:
    1. High AK burden, defined as ≥15 AK lesions in the included test area (50-100 cm2) at baseline
    2. Test area does not involve the ala nasi, eyelids, nasolabial folds, or periauricular skin
    3. >18 years of age at baseline
    4. Fitzpatrick skin phototype I-IV
    5. Legally competent, able to give verbal and written informed consent
    6. Subject is willing to participate and can comply with protocol requirements including the refraining from other therapy (with the exception of KC treatment) in the test area for the duration of the trial.
    7. Women of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment and be on effective contraception until discontinuation of the vaccine therapy. Additional pregnancy testing will not be conducted unless pregnancy is suspected.
    (Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to first visit. Effective contraception is IUD or hormonal contraception as specified in the protocol)
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria are not eligible to participate in this study:
    1. Known or suspected immunosuppression (by disease or immunosupressive drug)
    2. History of vaccine-related allergic reactions or known allergy to Gardasil®9 ingredients or yeast
    3. Previously vaccinated with any HPV vaccine
    4. History of keloids
    5. Other skin diseases present in the test area at baseline
    6. Lactating or pregnant women
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome:
    1) Treatment response in HPV vaccinated versus control group based on:
    Percentage change from baseline (%) in number of AK lesions (grades I and II-III) in the selected test area


    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluated at month 2, 6, 9, and 12
    E.5.2Secondary end point(s)
    2) Treatment response in HPV vaccinated versus control group based on:

    I. New AK lesions (n) arising in the test area since last visit

    II. Partial (≥75%) clearance: atleast 75 % reduction in total number of AK lesions compared to baseline

    III. Complete (100%) clearance: 100 % reduction in total number of AK lesions compared to baseline

    3) Occurance of local and systemic side effects in HPV vaccinated versus control group

    4) New Keratinocyte carcinoma (KC) anywhere on the skin surface in HPV vaccinated versus control group registered over the course of the 12-month trial, compared to average yearly KC rate (determined by medical record or pathology results) 3 years prior to baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2) Treatment response in HPV vaccinated versus control group based on:

    I. Evaluated at month 2, 6, 9, 12
    II. Evaluated at month 12
    III. Evaluated at month 12

    3) Over the course of the 12-month trial period

    4) Over the course of the 12-month trial period
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who discontinue participation in the trial will be offered conventional actinic keratosis treatment and subsequent control at the Department of Dermatology and Venereology at Bispebjerg Hospital according to national guidelines (if deemed indicated by treating physicians). Conventional therapy includes topical/field therapy with 5-fluorouracil, imiquimod, photodynamic therapy, or curettage.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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