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    Summary
    EudraCT Number:2012-002531-29
    Sponsor's Protocol Code Number:NaturalDCformCRPC
    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:2014-07-09
    Trial results View 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 number2012-002531-29
    A.3Full title of the trial
    A randomized phase IIa study: natural dendritic cells for immunotherapy of chemo-naive metastatic castration-resistant prostate cancer patients
    Een gerandomiseerd fase IIa studie: immunotherapie met van nature voorkomende dendrtische cellen voor gemetastaseerd castratie-resistant prostaatkanker patienten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Natural dendritic cells for immunotherapy of metastatic hormone-refractory prostate cancer patients
    Van nature voorkomende dendritische cel vaccinaties als nieuwe behandelingsvorm voor patiënten met uitgezaaide hormoonongevoelige prostaatkanker
    A.3.2Name or abbreviated title of the trial where available
    Natural DC for mCRPC
    Van nature voorkomende DC voor mCRPC
    A.4.1Sponsor's protocol code numberNaturalDCformCRPC
    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 SponsorRadboud University Medical Centre Nijmegen
    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 supportMiltenyi Biotec
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Centre Nijmegen
    B.5.2Functional name of contact pointRadboudumc
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 9101
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243617600
    B.5.5Fax number0031243540339
    B.5.6E-mailJ.deVries@ncmls.ru.nl
    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 nameTumor antigen peptide-loaded myeloid dendritic cell product
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBlood DC loaded with tumor peptides
    D.3.9.3Other descriptive nameautologous blood dendritic cells loaded with tumor peptides
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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.IMP: 2
    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 nameTumor antigen peptide-loaded plasmacytoid dendritic cell product
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNblood DC loaded with tumor peptides
    D.3.9.3Other descriptive nameautologous blood dendritic cells loaded with tumor peptides
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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.IMP: 3
    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 nameTumor antigen peptide-loaded plasmacytoid and myeloid dendritic cell product
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNblood DC loaded with tumor peptides
    D.3.9.3Other descriptive nameautologous blood dendritic cells loaded with tumor peptides
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Asymptomatic or minimally symptomatic, chemo-naive mCRPC patients
    Asymptomatische of minimaal symptomatische, chemotherapie naieve mCRPC patienten
    E.1.1.1Medical condition in easily understood language
    Metastatic hormone-refractory prostate cancer patients with no or minimal symptoms
    Uitgezaaide hormoonongevoelige prostaatkanker patienten met geen of slechts minimale klachten
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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
    To show immunologic efficacy of tumor-peptide loaded natural DC in mCRPC patients
    Aantonen dat van nature voorkomende dendritische cel vaccinaties bij patiënten met uitgezaaide hormoonongevoelige prostaatkanker het immuunsysteem versterken.
    E.2.2Secondary objectives of the trial
    As secondary objectives we aim to demonstrate that natural DC vaccinations are safe, feasible and clinically effective. Also the therapy effect on quality of life will be studied.
    Als secundaire doelstellingen willen we laten zien dat de vaccinaties veilig, haalbaar en werkzaam/effectief zijn in de klinische praktijk. En we willen de invloed van onze behandeling nagaan op de kwaliteit van leven van de patiënt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria

    All patients:
    • Men ≥ 18 years of age and older with confirmed (histologically or cytologically) adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
    • HLA-A2.1 positive
    • Asymptomatic or minimally symptomatic mCRPC
    • Metastatic castrate-resistant disease defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy:
    o PSA progression defined by PCWG2 criteria by a minimum of two rising PSA levels with an interval of at least 1 week between each determination
    o Progression of nodal metastases defined by RECIST version 1.1 criteria or progression on successive MRLs
    o Bone disease progression defined by two or more new lesions on bone scan as described in PCWG2 criteria
    • Maintenance of castrate circumstances:
    o Ongoing primary androgen deprivation therapy (GnRH agonist or antagonist)
    o Serum testosterone level equal to or less than 1.73 nmol/L (50 ng/dL)
    • PSA value equal to or more than 2 ng/ml
    • Absence of visceral metastases, malignant ascites or pleural effusion
    • Clinical absence of brain metastases
    • Inclusion within three months after the moment of manifestation of progressive disease as defined above
    • Chemotherapy naïve
    • Life expectancy ≥ 3 months
    • WHO/ECOG performance status 0-1 (Karnofsky index 100-70)
    • WBC >2.0x109/l, neutrophils >1.5x109/L lymphocytes >0.8x109/L, platelets >100x109/L, hemoglobin >5,6 mmol/L (9.0 g/dL), serum creatinine <150 µmol/L, AST/ALT <3 x ULN, serum bilirubin <1.5 x ULN (exception: Gilbert’s syndrome is permitted)
    • Expected adequacy of follow-up
    • Written informed consent

    Acceptable concomitant therapy

    • The use of oral or intravenous bisphosphonates
    • Radiotherapy for pain relief in patients with bone metastases may be used as a treatment modality, but the need for a radiotherapeutic intervention during the study will be documented as an SRE
    • Inhaled corticosteroids and topical creams for small body areas are permitted
    Deelname is mogelijk indien al het onderstaande van toepassing is:
    • Mannen ≥ 18 jaar met een door de patholoog bevestigde diagnose van prostaatkanker
    • Aanwezigheid van een specifiek witte bloedceltype (HLA-A2.1, ongeveer 45% van de bevolking heeft dit)
    • Geen klachten of slechts minimale klachten ondervindend van de uitgezaaide hormoonongevoelige prostaatkanker
    • Uitgezaaide hormoonongevoelige ziekte gedefinieerd als een of meer van de volgende drie criteria gedurende behandeling met hormonale therapie:
    o Tweemaal een stijging van het PSA-gehalte met een interval van tenminste een week
    o Groei van lymfklier metastasen conform de standaard respons criteria (RECIST)
    o Groei van botuitzaaiingen gedefinieerd als twee of meer nieuwe botuitzaaiingen op een botscan
    • Voortgaande chemische castratie:
    o Voortgaande primaire hormoontherapie (bijvoorbeeld met gosereline (Zoladex®) of andere anti-hormonale medicamenten)
    o Serum testosteron gehalte kleiner dan of gelijk aan 1.73 nmol/L (= 50 ng/dL)
    • PSA-gehalte groter dan of gelijk aan 2 ng/ml
    • Geen uitzaaiingen in andere organen dan de botten
    • Klinische afwezigheid van hersenmetastasen (hier wordt niet standaard op gescreend)
    • Deelname aan de studie binnen drie maanden na het vaststellen van uitgezaaide hormoonongevoelige prostaatkanker
    • Geen eerdere behandeling met chemotherapie
    • Levensverwachting van ≥ 3 maanden
    • WHO/ECOG performance score van 0-1
    • Witte bloedcel gehalte >2.0x109/l, neutrofielen >1.5x109/L, lymfocyten >0.8x109/L, bloedplaatjes >100x109/L, hemoglobine >5,6 mmol/L (9.0 g/dL), serum creatinine <150 µmol/L, AST/ALT <3 x ULN, serum bilirubine <1.5 x ULN (uitzondering: het syndroom van Gilbert is toegestaan)
    • Goede follow-up (opvolging) te verwachten
    • Getekend informed consent formulier

    Acceptabele gelijktijdige therapie:
    • Het gebruik van orale bifosfonaten (onder andere alendroninezuur) of bifosfonaten via het infuus (onder andere pamidronaat)
    • Radiotherapie vanwege pijnlijke botuitzaaiingen. Echter, dit wordt wel gedocumenteerd als zijnde een complicatie van het skelet
    • Gebruik van inhalatie corticosteroiden (bijnierschorshormonen) of corticosteroidenzalf hetwelk op een gedeelte van de huid wordt aangebracht
    E.4Principal exclusion criteria
    Exclusion criteria
    • Hypercalcemia
    • History of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma
    • Known allergy to shell fish
    • Heart failure (NYHA class III/IV)
    • Serious active infections
    • Active hepatitis B, C or HIV infection
    • Active syphilis infection
    • Autoimmune diseases (exception: vitiligo is permitted)
    • Organ allografts
    • An uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation
    • Previous treatment with sipuleucel-T,PROSTVAC, GVAX, chemotherapy, ipilimumab or denosumab (previous treatment with abiraterone acetate or enzalutamide is permitted)
    • Prior radiotherapy within 4 weeks prior to planned vaccination or presence of treatment-related toxicity
    • Continued use of non-steroidal anti-inflammatory drugs
    • Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent
    • Requirement of opiate use for cancer-related pain (at screening)
    • Any serious clinical condition that may interfere with the safe administration of DC vaccinations
    Deelname is ONMOGELIJK indien één van het onderstaande van toepassing is:
    • Te hoog calcium gehalte in het bloed
    • Het bestaan van een tweede vorm van kanker in de afgelopen 5 jaar. Een uitzondering hierop is een adequaat behandeld basaalcel carcinoom van de huid
    • Bekende allergie tegen schaaldieren of schelpdieren
    • Hartfalen (NYHA klasse III/IV)
    • Een aanwezige, ernstige, onderliggende infectie
    • Actieve hepatitis B, C of HIV infectie
    • Actieve syfilis infectie
    • Auto-immuun ziekten (uitzondering: vitiligo is toegestaan)
    • Oncontroleerbare co-morbiditeit, onder andere psychiatrische of sociale problematiek die interfereren met studiedeelname
    • Eerdere behandeling met: sipuleucel-T, PROSTVAC, GVAX, docetaxel, cabazitaxel, ipilimumab of denosumab (eerdere behandeling met abirateron of enzalutamide is WEL toegestaan)
    • Behandeling met radiotherapie binnen vier weken tot een geplande vaccinatie of de aanwezigheid van nog aanwezige bijwerkingen van de radiotherapie die de veilige toediening van dendritische cel vaccinaties in de weg staat
    • Dagelijks gebruik van ontstekingsremmers, zoals dicofenac, ibuprofen of naproxen
    • Dagelijks gebruik van bijnierschorshormonen, gelijk aan meer dan 10 mg prednison per dag of een equivalent hiervan
    • Benodigdheid van morfine middelen vanwege aan kanker gerelateerde pijn (tijdens screening)
    • Elke klinische conditie die de veilige toediening van dendritische cel vaccinaties in de weg staat
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this Radboudumc initiated study is to evaluate the immunogenicity of tumor-peptide loaded natural DC in mCRPC patients. Immunogenicity is defined as the antitumor immune response induced in prostate cancer patients.

    Therefore, immunomonitoring will be performed that includes:
    a) Functional response and tetramer analysis of delayed-type hypersensitivity (DTH)-infiltrating T cells against tumor peptides. The occurrence and magnitude of the response will be compared.
    b) Type I IFN gene expression in PBMC shortly after vaccination. The occurrence and magnitude of the type I IFN response in patients will be compared.
    c) Proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin (KLH), a immunogenic protein providing T cell help.
    Het primaire eindpunt is om te onderzoeken in hoeverre onze van nature voorkomende dendritische cellen bij patiënten met uitgezaaide hormoonongevoelige prostaatkanker het immuunsysteem kunnen versterken. We bestuderen de volgende aspecten van de afweerreactie: a) functionerende soldaatcellen in de huidtest gericht tegen de eiwit stukjes van de prostaatkanker en b) toename van afweersignalen op genniveau in de witte bloedcellen, gemeten kort na een vaccinatie. c) Proliferatie, cytokine productie en antilichaam responsen tegen KLH, een eiwit dat dient als immunogene T cell hulp.
    E.5.1.1Timepoint(s) of evaluation of this end point
    a) After every round of natural DC vaccinations a DTH and biopsies will be performed for functional response and tetramer analysis. This is approximately 5 weeks after the first vaccination.
    b) 4 hours and 24 hours after each vaccination
    c) at the following time points: apheresis, before second vaccination, before third vaccination, before DTH, and 6 weeks after DTH
    a) Na iedere vaccinatieronde met van nature voorkomende DC wordt een DTH en biopten verricht voor functionele responses en tetramer analyses. Dit vindt plaats 5 weken na de 1e vaccinatie.
    b) 4 uur en 24 uur na iedere vaccinatie
    c) ten tijde van: de aferese, voor de tweede en derde vaccinatie, voor de DTH en 6 weken na de DTH.
    E.5.2Secondary end point(s)
    The secondary objectives are the safety and feasibility of vaccinations, the quality of life and the clinical efficacy of mDC and pDC vaccinations. Clinical efficacy is defined as the proportion of subjects who remain 6 months free of: radiological progression, PSA progression, progression free survival, opiate use for cancer-related pain, a skeletal-related event (SRE), decline in WHO/ECOG performance score by ≥ 1 point and initiation of cytotoxic chemotherapy. Overall survival will be verified by gathering the date of death using the electronic hospital records or the electronic records of the general practitioner. Safety will be evaluated by adverse events, WHO performance status, physical examinations and laboratory tests until 6 weeks following the last study treatment. Toxicity will be assessed according to the CTCAE version 4.03. To assess the quality of life four validated questionnaires will be collected every 6 weeks. These screening tools are validated in the Dutch language.
    De secundaire eindpunten zijn de veiligheid en de haalbaarheid van het vaccineren met van nature voorkomende dendritische celen, de kwaliteit van leven voor de patiënt en de klinische werkzaamheid van beide behandelingen (dus beide vormen van nature voorkomende dendritische cellen: myeloide en plasmacytoide dendritische cellen). De kwaliteit van leven wordt bestudeerd met behulp van vragenlijsten. De werkzaamheid van het vaccin, ofwel effectiviteit, wordt gedefinieerd als het aantal patiënten die gedurende 6 maanden: geen groei van de uitzaaiingen hebben op een MRI-scan, geen toename van het PSA-gehalte in het bloed hebben, geen morfine middelen nodig hebben vanwege kanker gerelateerde pijn, geen complicatie van het skelet (onder andere een wervelbreuk, zenuwbeklemming of de noodzaak tot radiotherapie vanwege een pijnlijke botuitzaaiing), geen daling van de WHO performance score van een patiënt, en niet starten met behandeling in de vorm van chemotherapie. Voor het nagaan van het effect van de behandeling op de overleving worden de elektronische ziekenhuisdossiers gecontroleerd of wordt er contact opgenomen met de huisarts van de patient.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety: during the whole trial
    Feasibility: during the whole trial
    Quality of life questionnaires: every 6 weeks
    Clinical efficacy: imaging (before treatment, 6 weeks after the third vaccination, before second round), PSA (every 6 weeks). In case of stable disease or remission of disease also during the second round of vaccinations, the third round of vaccinations, and during the follow-up of 1 year thereafter, imaging and PSA measurement will be performed. Existance of cancer-related pain/ WHO performance score and start of chemotherapy: during the whole trial.
    Veiligheid: gedurende de hele studie
    Uitvoerbaarheid: gedurende de hele studie
    Kwaliteit van leven vragenlijsten: elke 6 weken
    Klinische effectiviteit: beeldvorming (voor start vaccinaties, 6 weken na de 3e vaccinatie, voor de tweede vaccinatieronde), PSA (elke 6 weken). In het geval van stabiele ziekte of remissie van ziekte dan zal ook gedurende de 2e ronde vaccinaties, de 3e ronde vaccinaties en de follow-up daarna gedurende een jaar, imaging en PSA bepaling plaatsvinden. Nagaan van kanker gerelateerde pijn/WHO performance score/ start behandeling met chemotherapie: gedurende de hele studieperiode
    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
    Immunogenicity
    Immunological responses to tumor-associated antigens
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    mDC vaccinations (n=10) vs pDC vaccinations (n=10)
    E.8.2.4Number of treatment arms in the trial3
    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
    Laatste polibezoek van de laatst geincludeerde patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 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 state21
    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)
    None
    Geen
    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 Decision2014-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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