Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-004050-29
    Sponsor's Protocol Code Number:Vvax001-UMCG-02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-004050-29
    A.3Full title of the trial
    A phase II study to determine the efficacy and safety of Vvax001, a therapeutic Semliki Forest Virus based cancer vaccine, in patients with HPV-16 induced grade 3 cervical intraepithelial neoplasia.
    Een fase II studie om de effectiviteit en veiligheid te bepalen van Vvax001 als therapeutisch vaccin bij patiënten met HPV-16 geïnduceerde graad 3 cervicale intraepitheliale neoplasie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study investigating the efficacy and safety of Vvax001, a therapeutic cancer vaccine, in patients with premalignant cervical lesions.
    Fase II onderzoek naar de werkzaamheid en veiligheid van het therapeutische kankervaccin Vvax001, in patiënten met een voorstadium van baarmoederhalskanker.
    A.3.2Name or abbreviated title of the trial where available
    Vvax001 cancer vaccine in HPV-16 related disease
    Vvax001 kankervaccin in HPV-16 gerelateerde ziekte
    A.4.1Sponsor's protocol code numberVvax001-UMCG-02
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportDutch Cancer Society (KWF)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointDept. Obstetrics & Gynaecology
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503613008
    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 nameVvax001
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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
    HPV-16 induced pre malignant cervical lesions
    HPV-16 geïnduceerde voorstadia van baarmoederhalskanker
    E.1.1.1Medical condition in easily understood language
    Pre malignant cervical lesions caused by HPV-16 infection
    Voorstadia van baarmoederhalskanker veroorzaakt door HPV-16 infectie
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this trial is to determine clinical efficacy of Vvax001 by monitoring regression of CIN grade 3 lesions.
    Het primaire doel van deze studie is het bepalen van de klinische werkzaamheid van Vvax001 door regressie van CIN graad 3 laesies nauwgezet te vervolgen.
    E.2.2Secondary objectives of the trial
    The secondary objectives are 1) immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T cell immune responses, 2) HPV-16 clearance, and 3) side effects / adverse events related to intramuscular administration of Vvax001. Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
    De secundaire doelstellingen zijn 1) vaststellen van immunologische activiteit van Vvax001 bepaald middels HPV-16 E6,E7-specifeke T cel immuun responsen; 2) vaststellen van HPV-16 klaring; en 3) monitoren van veiligheidsprofiel en bijwerkingen van Vvax001 gepaard gaande met intramusculaire toediening. Toxiciteit zal worden ingedeeld op basis van de NCI Common Terminology Criteria for Adverse Events (CTCAE) versie 4.0
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult female patients (≥18 years) who have newly been diagnosed with HPV-16 positive CIN3 lesions and have signed written informed consent according to local guidelines. Patients of child-bearing potential should test negative using a pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study.
    Volwassen vrouwelijke patiënten (≥18 jaar) die nieuw gediagnosticeerd zijn met HPV-16 gerelateerde CIN3 laesies en het informed consent formulier ondertekend hebben, welke in overeenstemming is met de lokale richtlijnen. Patiënten in de vruchtbare leeftijd mogen niet zwanger zijn, wat getest zal worden middels een zwangerschapstest, en moeten toestemming geven om gedurende de gehele behandeling en follow-up periode van de studie anticonceptie te gebruiken.
    E.4Principal exclusion criteria
    * PAP5 lesions.
    * Previously undergone treatment for CIN lesions.
    * Adenocarcinoma in situ within CIN3 lesion.
    * History of autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the study) of high dose immunosuppressive therapy.
    * History of a malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the cervical cancer type.
    * Participation in a study with another investigational drug within 30 days prior to the enrolment in this study.
    * Clinically significant findings as judged by the investigator on screening/study entry including those from biochemistry, haematology and urinalysis performed at screening.
    * Any condition that in the opinion of the investigator could interfere with the conduct of the study.
    * Pregnancy.
    * PAP5 laesies.
    * Eerder behandeld voor CIN laesies.
    * Adenocarcinoma in situ in de CIN3 laesie.
    * Auto-immuunziekte of systemische ziekte dat de immunocompetentie van de patiënt verlaagt, of gebruik van hoge dosis immunosuppressieve medicatie (tot 4 weken voor de start van de studie).
    * Andere maligniteit in de voorgeschiedenis, uitgezonderd laag-stadium tumoren die histologisch onderscheiden kunnen worden van baarmoederhals kanker.
    * Deelname aan een wetenschappelijke studie met een ander te onderzoeken medicijn 30 dagen voorafgaand aan deze studie.
    * Klinisch relevante afwijkingen die de onderzoeker ontdekt tijdens de screening/studie, zoals een afwijkende biochemie, hematologie en urineanalyse.
    * Elke andere conditie waarbij de onderzoeker meent dat het interfereert met het uitvoeren van deze studie.
    * Zwangerschap.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the clinical efficacy of Vvax001. To assess vaccine induced clinical responses, histology of the pre-treatment diagnostic biopsy will be compared to histology of the post-treatment therapeutic biopsy/LLETZ. A positive response is defined as a reduction from CIN3 to CIN1, or a change from CIN3 to no dysplasia.
    De primaire uitkomstmaat van deze studie is de klinische werkzaamheid van Vvax001. Om de geïnduceerde klinische respons te bepalen, zal het biopt verkregen voorafgaand aan vaccinatie vergeleken worden met het biopt verkregen na vaccinatie (week 25). Een positieve respons wordt gedefinieerd als een reductie van een CIN3 laesie naar CIN1 of van een CIN3 laesie naar geen laesie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated via colposcopy at week 9 and week 17 (respectively 3 and 11 weeks after the third vaccination) and via biopsy at week 25 (19 weeks after the third vaccination).
    De primaire uitkomstmaat zal middels colposcopie beoordeeld worden in week 9 en 17 (respectievelijk 3 en 11 weken na de derde vaccinatie) en middels biopsie beoordeeld worden in week 25 (19 weken na de derde vaccinatie).
    E.5.2Secondary end point(s)
    Secondary endpoints are 1) the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses in peripheral blood at baseline, week 7, week 9, week 17 and week 25; 2) HPV16 clearance; and 3) potential side effects/adverse events related to Vvax001. Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
    Secundaire uitkomstmaten zijn 1) de immunologische activiteit van Vvax001 bepaald middels het vervolgen van HPV-16 E6,7-specifieke T cel responsen in perifere bloedcellen verkregen voorafgaand aan de studie en in week 7, 9, 17 en 25; 2) HPV16 klaring; en 3) het veiligheidsprofiel en bijwerkingen gepaard gaande met intramusculaire toediening van Vvax001. Toxiciteit zal worden ingedeeld op basis van de NCI Common Terminologie Criteria voor Adverse Events (CTCAE) Versie 4.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated continuously throughout the entire duration of the trial up to 19 weeks after the third vaccination (week 25). The total duration of this trial will be 25 weeks.
    De secundaire uitkomstmaten zullen gedurende de volledige looptijd van de studie worden gemeten tot en met 19 weken na de derde vaccinatie (week 25). De totale studieduur bedraagt 25 weken.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunological activity of Vvax001 and HPV-16 clearance
    Immunologische activiteit van Vvax001 en HPV-16 klaring
    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 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 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 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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 18
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state18
    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)
    Patients with complete regression will be followed-up by cytology at 3, 6 and 12 months after exit from the study. Hereafter, patients will be monitored through regular national screening programs.
    Patiënten met complete regressie zullen worden vervolgd middels cytologisch onderzoek 3, 6 en 12 maanden na het laatste bezoek in verband met de studie. Hierna zullen de patiënten vervolgd worden middels het reguliere nationale screeningsprogramma.
    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 Decision2020-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-06
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA