Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-31 @ 1:08 AM
Study NCT ID:
NCT04446832
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VACcination of LIver Transplantation Candidates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071497', 'term': 'Immunogenicity, Vaccine'}], 'ancestors': [{'id': 'D000087506', 'term': 'Vaccine Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-07-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of vaccine " responder " according to serological results measured 6 months after liver transplantation', 'timeFrame': '6 months after liver transplantation', 'description': 'Vaccine immunogenicity will be assess by titration of specific antibodies by standard approved serological tests and patients will be considered if their antibody title exceed protection threshold defined by the WHO and support by the literature when available (for example for tetanus or diphtheria vaccines), or a 4-fold increase in antibody titers compared to antibodies titers measures before vaccination when a protection threshold is not formally defined (for example for pneumococcus vaccination)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications', 'Vaccination; Complications', 'Cirrhosis', 'Chronic Hepatitis']}, 'descriptionModule': {'briefSummary': 'Chronic hepatic disease, and especially cirrhosis, are associated to a global dysfunction of the immune system. Liver transplantation represents the only replacement therapy for end-stage liver disease and a curative means of localized hepatocellular carcinoma (HCC) but required immunosuppressive treatment to limit the risk of rejection. Candidates for liver transplantation are at an increased risk for severe infections, some of which can be prevented by vaccination. With regard to vaccine preventable diseases, these patients share the same pitfalls than all immunocompromised individuals: i) a theoretical or proven increased incidence and severity of certain infections warranting specific vaccine recommendations; ii) a decrease in immunogenicity of vaccine; iii) a risk of developing vaccine disease after administration of live attenuated vaccines. It is therefore recommended for all patients awaiting liver transplantation: i) updating the vaccinations recommended in general population (DTPw, MMR); ii) vaccination against viral hepatitis A and B to limit the risk of severe hepatitis; iii) vaccination against pneumococcal infection, influenza and chickenpox more common and more serious in this population. However, these recommendations are based on theoretical assessments and experts opinions; i) immunogenicity of vaccination in cirrhotic patients and persistence of post-transplant protection had been poorly assessed as well as their determinants; ii) there are only a few data regarding the tolerance of vaccinations in this population; iii) vaccination coverage of patients with end-stage liver disease is poorly known in France and; iv) the perception and acceptability of vaccinations have not been evaluated in this population.\n\nInvestigators hypothesis is that: the vaccination schedule currently recommended for liver transplantation does not provide adequate protection against vaccine targets 6 months after liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Liver transplantation candidates', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years old\n* patients waiting for liver transplantation referred by hepato-gastroenterology department as part of the pre-transplant evaluation to the infectiology consultation\n* patient who were informed of the study and did not object to participate\n\nExclusion Criteria:\n\n* patient candidate for multi-organ transplant\n* patient who received immunosuppressive therapy, biotherapy and/ or corticosteroid therapy at a dose greater than 10 mg / day of prednisone equivalent for more than 2 weeks within 3 months before vaccination (6 months of rituximab)\n* patient who received polyvalent immunoglobulins within the 6 months before the serological evaluation\n* patient who received systemic anti-cancer chemotherapy for solid tumor or hemopathy within 6 months preceding the start of vaccination\n* splenectomized patients\n* asplenic patients for a reason other than liver disease\n* chronic infection with the human immunodeficiency virus (HIV)\n* patient with any other hereditary immune deficiency or acquired which could compromise the vaccine response or interpretation of serological results\n* patient under legal protection measure or unable to consent to the study'}, 'identificationModule': {'nctId': 'NCT04446832', 'acronym': 'VacLit', 'briefTitle': 'VACcination of LIver Transplantation Candidates', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'VACcination of LIver Transplantation Candidates: Efficacy, Tolerance and Acceptability Prospective Cohort Study.', 'orgStudyIdInfo': {'id': '69HCL19_0752'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver transplantation candidates', 'interventionNames': ['Other: Vaccine immunogenicity']}], 'interventions': [{'name': 'Vaccine immunogenicity', 'type': 'OTHER', 'description': 'Evaluation of the vaccine immunogenicity by standard approved serological tests', 'armGroupLabels': ['Liver transplantation candidates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69317', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florent VALOUR, Dr', 'role': 'CONTACT', 'email': 'florent.valour@chu-lyon.fr', 'phone': '04 72 07 11 07', 'phoneExt': '+33'}], 'facility': 'Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Florent VALOUR, Dr', 'role': 'CONTACT', 'email': 'florent.valour@chu-lyon.fr', 'phone': '04 72 07 11 07', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}