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    Summary
    EudraCT Number:2015-004524-65
    Sponsor's Protocol Code Number:Inf.Q002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-10-28
    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 number2015-004524-65
    A.3Full title of the trial
    Efficacy of nonavalent vaccine against human papilloma virus (HPV ) in HIV infected sexually active men who have sex with men (MSM)
    Effekt af 9-valent vaccine mod humant papilloma virus (HPV) hos HIV smittede seksuelt aktive mænd der har sex med mænd (MSM).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of a vaccine with nine subgroups against human papilloma virus in HIV infected sexually active men who have sex with men.
    Effekten af en vaccine indeholdende ni undergrupper mod humant papilloma virus hos HIV smittede seksuelt aktive mænd der har sex med mænd.
    A.3.2Name or abbreviated title of the trial where available
    HPV-VAX
    HPV-VAX
    A.4.1Sponsor's protocol code numberInf.Q002
    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 SponsorDepartment of Infectious Diseases
    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 supportAIDS- Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportOdense University Hospital Research Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Infectious Diseases
    B.5.2Functional name of contact pointSandra Dröse
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Boulevard 29
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004565412497
    B.5.6E-mailSandra.Droese@rsyd.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 No
    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
    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 INNHuman Papillomavirus 9-Valent Vaccine, Recombinant
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58]
    D.3.9.4EV Substance CodeSUB130889
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The purpose of the study is to investigate the efficacy of a new nonavalent HPV vaccine in sexually active HIV-infected MSM.
    Formålet med forsøget er at undersøge effekten af en ny ni-valent HPV vaccine hos seksuelt aktive, HIV-smittede MSM.
    E.1.1.1Medical condition in easily understood language
    The purpose of the study is to investigate the effect of a new vaccine , which contains nine subgroups against human papilloma virus among sexually active HIV-infected men who have sex with men .
    Formålet med forsøget er at undersøge effekten af en ny vaccine, som indeholder ni undergrupper mod humant papilloma virus hos seksuelt aktive, HIV-smittede mænd der har sex med mænd.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10063001
    E.1.2Term Human papilloma virus infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10071147
    E.1.2Term Human papilloma virus immunization
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The presence of the virus is the most important parameter to assess the risk of HPV disease. Using a sensitive method that can detect all HPV vaccine strains and non- vaccine strains.
    Tilstedeværelse af virus er den vigtigste parameter til at vurdere risiko for HPV sygdom. Der bruges en følsom metode, som kan påvise alle HPV vaccine stammer ligesom ikke- vaccine stammer.
    E.2.2Secondary objectives of the trial
    The secondary endpoint is measuring the level of antibodies at month 12. Measuring the serological response towards the vaccine.
    Det sekundære endepunkt er måling af antistof niveau måned 12. Måling af serologisk respons på vaccinen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • MSM
    • HIV-infected +/- HAART treatment ( Highly Active Antiretroviral Treatment)
    • Age ≥ 18 years og < 52 years
    • Minimum one sexuel contact within the last month
    • No earlier history of anal, penil or oro/pharyngeal neoplasi
    • Able to understand and give informed consent
    • Not previously vaccinated with HPV
    • MSM
    • HIV-positiv patienter +/- HAART behandling ( Highly Active Antiretroviral Treatment)
    • Alder ≥ 18 år og < 52 år
    • Mindst en sexpartner inden for den seneste måned
    • Ikke tidligere diagnosticeret med anal, penil eller oral/pharyngeal neoplasi
    • I stand til at forstå og afgive informeret samtykke
    • Ikke tidligere vaccineret med HPV
    E.4Principal exclusion criteria
    • Alcohol and/or substance use or other circumstances that makes it difficult for the study subject's ability to follow the planned studies
    • Known allergy to trace elements or excipients in the test drugs
    • Alkohol- og/eller substansbrug eller andre omstændigheder, som gør det vanskelligt for forsøgspersonens evne til at følge de planlagte undersøgelser
    • Kendt allergi overfor spor-eller hjælpestoffer i forsøgslægemidlerne
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in the prevalence of infection with HPV vaccine strains (type 6,11,16,18, 31, 33, 45, 52, 58 ) from week 0 to week 52, as a proportion positive for at least one vaccine strain in either anus, oral cavity or penis.
    Det primære endpoint er ændring i prævalens af infektion med HPV vaccinestammer (type 6,11,16,18,31,33,45,52,58) fra uge 0 til uge 52, udtrykt som andel positive for mindst en vaccinestamme i enten anus, mundhule eller penis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time point of evaluation of the primary endpoint is at month 12.
    Tidspunkt for evaluering af det primære endepunkt er ved måned 12.
    E.5.2Secondary end point(s)
    The secondary endpoint is measuring the level of antibodies against the vaccine at month 12.
    In addition observation of side effects towards the vaccine.
    Det sekundære endepunkt er måling af antistof niveau måned 12.
    Derudover er det observation for bivirkninger.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time point of evaluation of the primary endpoint is at month 12.
    Tidspunkt for evaluering af det primære endepunkt er ved måned 12.
    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 No
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 80
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 80
    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)
    No different or new treatment
    Ingen anderledes eller ny behandling
    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 Decision2015-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-08-29
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