Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-26 @ 6:46 AM
Study NCT ID:
NCT03989050
Status:
WITHDRAWN
Last Update Posted:
2024-09-20
First Post:
2019-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples will be obtained for determination of pneumococcal antibody-titers during clinical routine care. One sample will be drawn before vaccination. After 30 days, a second blood sample will be taken during an already planned visit at the (outpatient) clinic. Titer assessment will be performed along STIKO recommendations for immunocompromised patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Administrative reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pneumococcal antibody kinetics', 'timeFrame': '1 Month', 'description': 'Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI'}], 'secondaryOutcomes': [{'measure': 'Determination of applicability of current assessment methodology', 'timeFrame': '1 year', 'description': 'Correlation of serotype specific IgG antibodies measured by ELISA and those measured by OPA after pneumococcal vaccination in patients receiving ICI'}, {'measure': 'Incidence of irAE', 'timeFrame': '1 year', 'description': 'Assessment of the incidence of irAE in patients vaccinated during ICI treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune Checkpoint Inhibitor', 'Pneumococcal Vaccination'], 'conditions': ['Melanoma', 'Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': "This is a prospective observational study of vaccine efficacy and safety in adult patients with malignancies (melanoma/Hodgkin's lymphoma/Non-small cell lung cancer). The primary objective is to compare serotype specific immunoglobulin G (IgG) antibody titres before and after pneumococcal vaccination in patients receiving Immune Checkpoint Inhibitors (ICI). As an explorative objective, serotype specific IgG antibodies measured by ELISA and those measured by Opsonophagocytosis assay (OPA) after pneumococcal vaccination in patients receiving ICI will be correlated. In addition, the incidence of immune related adverse events (irAE) in patients vaccinated during ICI treatment will be determined.", 'detailedDescription': 'Physicians will be informed by mail and pocket cards with all necessary information about the study, in particular eligibility criteria. Patients currently receiving Immune Checkpoint Inhibitors will be approached by their treating physicians in case of an already scheduled vaccination against S. pneumonia. If a patient agrees to participate in the study and to sign an informed consent form, basic data on demographics, underlying disease, comorbidities, and irAE will be obtained from the electronic health record and entered into the eCRF.\n\nPneumococcal antibody titers will be drawn at baseline and after 30 days. We will actively follow-up on study patients for four months after enrolment and screen health records of the enrolled patients after four months to record occurrence of irAE.\n\nA blood sample (9 ml) will be drawn before vaccination. Vaccination will either be performed by the treating physician or by a general practitioner. After 30 days, a second blood sample will be taken during an already planned visit at the (outpatient) clinic. Titer assessment will be performed along STIKO recommendations for immunocompromised patients.\n\nAll samples for ELISA and OPA titer determination will be stored frozen at Department I for Internal Medicine and titers will be analyzed in batch at the end of this study. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (RKI STIKO recommendations).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients treated with ICI (for melanoma, NSCLC, or other malignancy), vaccinated against S. pneumonia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form\n* Age ≥18 years\n* Receiving pneumococcal vaccination for the first time along STIKO criteria\n* Therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agentfor melanoma, NSCLC or other malignancy\n\nExclusion Criteria:\n\n* Patients unwilling/ineligible for vaccination under current STIKO recommendations\n* Previous vaccination with any licensed or experimental pneumococcal vaccine\n* Concurrent treatment with anti-CTLA-4 agent'}, 'identificationModule': {'nctId': 'NCT03989050', 'acronym': 'SPICE', 'briefTitle': 'Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors', 'orgStudyIdInfo': {'id': 'SPICE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Melanoma patients', 'description': 'Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for melanoma'}, {'label': 'Non-small cell lung cancer (NSCLC) patients', 'description': 'Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for NSCLC'}, {'label': 'other malignancy patients', 'description': 'Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for other malignancy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '42283', 'city': 'Wuppertal', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'HELIOS University Hospital Wuppertal', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'overallOfficials': [{'name': 'Sibylle C Mellinghoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Sibylle C Mellinghoff', 'investigatorAffiliation': 'University of Cologne'}}}}