[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-response\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-response":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,83,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100619680","study-of-the-serotype-and-genotype-of-bk-virus-in-kidney-transplant-recipients-and-their-donors-to-identify-individuals-at-risk-of-nephropathy-100619680",false,"NCT07347769","Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy","TYPIK","Inclusion Criteria:\n\n* Kidney transplant patients with a first positive BK virus viral load in urine. - BK virus viral load in urine \\> 3 log copies\u002FmL.\n* More than 3 months post-transplant and less than 2 years post-transplant.\n* Men or women aged 18 years and older.\n* Followed up at Grenoble Alpes University Hospital.\n* Affiliated with social security or beneficiary of such a scheme.\n* Patients who are not opposed to the TYPIK study.\n\nExclusion Criteria:\n\n* Expected renal graft survival is \\\u003C 6 months, estimated by an eGFR \\\u003C 15 mL\u002Fmin\u002F1.73 m² at the time of BKPyV viruria\n* Patients who object to the use of their data and\u002For samples for research purposes\n* Subjects who are excluded from another study\n* Subjects under administrative or judicial supervision","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","The aim of this observational study is to characterize the urinary replication of BK polyomavirus (BKV) in kidney transplant recipients. Although BKV reactivation after transplantation is well established, the origin of the replicating virus remains uncertain. Current evidence suggests that BKV detected in recipients may originate either from the transplanted kidney (donor-derived) or from viral reactivation in the recipient. The evaluation of new biomarkers to predict BKV replication are needed.\n\nThis study seeks to address the following key questions:\n\n* Origin of the replicating virus: Is the BKV detected in the recipient identical to the virus originating from the donor kidney?\n* Host immune response and viral genotype: Is there an association between the recipient's immune response and the genotype of the replicating BKV?\n* Differences in immune response according to viral replication profile: Does the immune response differ between patients presenting isolated BKV viruria and those with both viruria and viremia?\n* Can new biomarkers help predict BKV replication and viremia?\n\nPatients will be grouped according to their BKV replication profile:\n\nGroup 1: patients with BKV viruria without viremia Group 2: patients with both BKV viruria and viremia Comparisons between these two groups will help identify whether different viral genotypes or immune responses are associated with systemic dissemination (viremia).\n\nKidney transplant recipients will be included if they present BKV viruria during their post-transplant follow-up. Additional blood samples will be collected during scheduled follow-up visits at the university hospital. These visits are part of routine clinical care, and no extra visits will be required specifically for the study.",[24,25,26,27,28,29,30,31,32],"Nephropathy","Opportunistic Viral Infection","Polyoma Virus Nephropathy","BK Nephropathy","BK Viremia; BKV DNAemia","BK Virus Infection","BK Polyomavirus","Immune Response","Neutralizing Antibodies",[34,35,36,37,38,39,40],"TTV","BK polyomavirus","neutralizing antibodies","ELISPOT BKV","genotype","miRNA BKV","urinary chimiokine","RECRUITING","2026-05-22",{"date":44,"type":45},"2026-05-27","ACTUAL",{"date":47,"type":45},"2026-03-11",{"date":49,"type":20},"2030-09-11",{"name":51,"class":52},"University Hospital, Grenoble","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":53},"100583449","study-of-the-cellular-response-induced-after-vaccination-against-the-hepatitis-b-virus-100583449","NCT06876467","Study of the Cellular Response Induced After Vaccination Against the Hepatitis B Virus","Etude de la réponse Cellulaire Induite Post-vaccination Contre le Virus de l'hépatite B","HBVax","Inclusion Criteria:\n\n* Adults ≥18 years\n* Pre-vaccination HBV serology carried out within 4 weeks prior to vaccination\n* Collection of no objection\n\nExclusion Criteria:\n\n* Opposition of the person or inability to give opposition\n* Pregnant or breast-feeding women\n* Chronic illnesses affecting the individual's immune system (asplenia; hyposplenia; haematological cancer; auto-immune disease requiring immunosuppressive treatment, HIV infection).\n* Non-affiliation with a social security scheme, Universal Medical Coverage or any equivalent scheme",true,{"count":64,"type":20},115,"296 million people worldwide are infected with the hepatitis B virus (HBV), despite the existence of an effective prophylactic vaccine. Current treatments (nucleoside analogues and pegylated interferon-α) do not prevent chronic hepatitis B (CHB) patients from developing liver fibrosis or hepatocellular carcinoma.\n\nVaccination is the best way to prevent HBV infection. The first generation of plasma-based vaccines, introduced in the 1980s, has now been superseded by protein vaccines, which are the only ones authorized in France. They are safe and effective. After an initial series of three out of four doses, protective levels of antibodies to the HBV surface antigen (anti-HBsAg; ≥10 IU\u002FmL) are achieved in over 95% of infants, children and young adults.\n\nHBV antigen (Ag)-specific CD4+ and CD8+ T lymphocytes play a major role in the control of HBV infection, contributing to viral clearance and the pathophysiology of acute hepatitis B. However, during HBC, these HBV-specific T cells develop a dysfunctional phenotype and become 'exhausted'. T lymphocytes directed against surface protein antigens (HBsAg) are the most affected by depletion mechanisms - these disappear completely in chronically infected patients, suggesting an important role for these T lymphocytes in infection control. Interestingly, recent studies of rare patients undergoing functional recovery from chronic infection following antiviral treatment have shown a re-emergence of T lymphocytes directed against HBsAg, confirming the importance of these cells in controlling viral replication. Although the protection induced by hepatitis B vaccination has mainly been attributed to the humoral response, a few studies have documented the presence of HBsAg-specific T lymphocytes. These could contribute to the maintenance of a long-term post-vaccination humoral response. The aim of this study is therefore to determine the frequency of healthy individuals receiving HBV vaccination who have a detectable HBsAg-specific T-cell response post-vaccination. We will also study the potential correlation between the frequency of HBsAg-specific T lymphocytes and the level of serum anti-HBsAg antibodies, and we will finely characterize the functional phenotype of these cells using cutting-edge methods and technologies (spectral cytometry, sequencing of mRNA and TCRs). These data will contribute to a better understanding of the biological mechanisms associated with HBV vaccine-induced protection.",[67,31,68],"Hepatitis B Vaccination","T Cells",[70,71,72,73],"PBMCs isolation","Serology","Spectral cytometry","RNA sequencing","2026-04-22",{"date":76,"type":45},"2026-04-23",{"date":78,"type":45},"2025-08-11",{"date":80,"type":20},"2028-12-11",{"name":82,"class":52},"Assistance Publique - Hôpitaux de Paris",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100628895","phase-2-combination-of-high-and-low-dose-radiotherapy-with-immune-therapy-and-tki-in-advanced-colorectal-cancer-a-phase-ii-study-100628895","NCT07467590","Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal Cancer: A Phase II Study","Efficacy of Combined High and Low-Dose Radiotherapy With Immune Therapy and Tyrosine Kinase Inhibitors (TKI) as a Second-Line or Later Treatment Strategy for Advanced Colorectal Cancer: A Single-Arm, Open-Label Phase II Study","TRIUNITE-07","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent form.\n2. Age 18-80 years, male or female.\n3. Histologically confirmed microsatellite stable (MSS) \u002F proficient mismatch repair (pMMR) colorectal adenocarcinoma.\n4. Clinical stage IV disease confirmed by systemic imaging. At least two measurable metastatic lesions per RECIST 1.1, including:\n\n   At least one lesion ≥2 cm in diameter and at least one lesion \\\u003C2 cm in diameter;\n\n   For lesions within the same organ, at least one lesion ≥2 cm and one lesion \\\u003C2 cm must be located within independent, non-overlapping radiation fields;\n\n   For lesions in different organs, high-dose and low-dose radiotherapy should preferably be delivered to lesions in different organs.\n\n   Second-line or later treatment setting, defined as disease progression after prior platinum- and irinotecan-based chemotherapy, including:\n5. Failure after first-line triplet chemotherapy containing platinum and irinotecan; Or failure after first-line platinum-based chemotherapy followed by second-line irinotecan-based chemotherapy.\n6. Ability to swallow oral medication.\n7. ECOG performance status 0-1.\n8. Adequate organ function as defined by laboratory criteria.\n\nExclusion Criteria:\n\nDiffuse miliary liver or lung metastases, or bulky metastatic lesions ≥10 cm in diameter.\n\nPresence of brain metastases.\n\n1. History of severe hypersensitivity to monoclonal antibodies or anti-angiogenic agents.\n2. Prior exposure to immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., targeting ICOS, CD40, CD137, GITR, OX40), or any prior cancer immunotherapy.\n3. Active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on stable hormone replacement therapy may be eligible). Patients with psoriasis or childhood asthma\u002Fallergy that has completely resolved and requires no adult intervention may be eligible; patients requiring bronchodilator therapy are excluded.\n4. History of immunodeficiency, including positive HIV test, congenital or acquired immunodeficiency, prior organ transplantation, or allogeneic bone marrow transplantation.\n5. Uncontrolled cardiovascular disease, including:\n\n   NYHA class II or higher heart failure;\n6. Unstable angina;\n7. Myocardial infarction within 1 year;\n8. Clinically significant uncontrolled supraventricular or ventricular arrhythmias.\n9. Severe infection (CTCAE grade \\>2) within 4 weeks prior to first study treatment, including severe pneumonia, bacteremia, or infection requiring hospitalization. Active pulmonary inflammation on baseline imaging, signs or symptoms of infection within 14 days before treatment requiring systemic antibiotics (except prophylactic antibiotics), or active tuberculosis (current or within 1 year without adequate treatment).\n10. Active hepatitis B (HBV DNA ≥2000 IU\u002FmL) or active hepatitis C (positive HCV antibody with detectable HCV RNA above the lower limit of detection).\n11. Diagnosis of another malignancy within 5 years prior to first study treatment, except for malignancies with low risk of metastasis or death (5-year survival rate \\>90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n12. Pregnant or breastfeeding women.","80 Years",{"count":93,"type":20},33,"INTERVENTIONAL",[96],"PHASE2","The goal of this clinical trial is to learn whether a high- and low-dose radiotherapy regimen followed by anti-angiogenic TKI and anti-PD-1 antibody therapy works to treat advanced metastatic colorectal cancer. It will also evaluate long-term survival outcomes and explore potential biomarkers associated with tumor response and immune modulation.\n\nThe main questions it aims to answer are:\n\nDoes the high- and low-dose radiotherapy regimen followed by sequential anti-angiogenic TKI and anti-PD-1 therapy improve the objective response rate (ORR) in patients with advanced metastatic colorectal cancer?\n\nWhat are the disease control rate (DCR) and survival outcomes following this treatment strategy?\n\nAre tumor response and long-term survival associated with specific biomarkers related to systemic immune modulation induced by radiotherapy to different metastatic organs?\n\nHow does this radiotherapy pattern affect tumor immune infiltration in metastatic lesions?\n\nThis is a single-arm, single-center, prospective Phase II clinical study designed to evaluate the efficacy of a high- and low-dose radiotherapy regimen targeting metastatic lesions followed by sequential anti-angiogenic TKI and anti-PD-1 antibody therapy in patients with advanced metastatic colorectal cancer.\n\nParticipants will:\n\nReceive high- and low-dose radiotherapy to metastatic lesions. Subsequently receive anti-angiogenic TKI combined with anti-PD-1 antibody therapy.\n\nUndergo regular clinical assessments and imaging evaluations to determine tumor response.\n\nProvide blood and tumor samples for biomarker and immune infiltration analysis. Be followed for survival outcomes and disease progression.",[99,100,31],"Refractory Colorectal Cancer","Radiotherapy-Induced Immune Priming","NOT_YET_RECRUITING","2026-03-09",{"date":104,"type":45},"2026-03-12",{"date":106,"type":20},"2026-04-01",{"date":108,"type":20},"2029-04-01",{"name":110,"class":52},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":53},"100352963","post-vaccination-biological-collection-100352963","NCT03875703","Post-Vaccination Biological Collection","Biological Collection for Studying Vaccine-induced Immune Responses","BioCol-VIR","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Informed and consented\n* Need to be vaccinated for routine care\n\nExclusion Criteria:\n\n* Person under guardianship or safeguards\n* Pregnant or breastfeeding woman\n* No affiliation to a health insurance scheme",{"count":120,"type":20},1200,"Introduction: Vaccination is a powerful weapon in the fight against infectious diseases, which has led to dramatic reduction in mortality and complications from some diseases. In this respect, vaccination is a real worldwide public health challenge (WHO). Thus, vaccine research benefits from an exponential development of knowledge in immunology and biotechnology. In particular, the advent of recent tools (\"omics\", new cytometric assays) and the description of new categories of immune cells (Tfh, BReg...) have revolutionized the characterization of immune responses, particularly post-vaccination. To study of the immune response following vaccination remains essential in order to define the immunological correlates to vaccine protection. This response also varies according to parameters related to the vaccine (type, adjuvant, dose, regimen…) and to the vaccinated host (genetics, age, morbidity, treatment …). Analyzing with new generation immune assays, new data on immunological responses post-vaccination from a clinical cohort is therefore essential to better define these correlates.\n\nObjective: To develop new vaccines (HIV, emerging infectious diseases) the investigators use a \"System vaccinology\" method to decipher the mechanisms of immune responses set up against vaccines currently being developed or marketed, specifically in specific populations (patients with primary immune deficiency, sickle cell patients, solid organ transplanted patients, COPD).\n\nMethod: Description of the genetic, molecular and cellular mechanisms of the immune response to vaccines recommended for adults, in particular influenza and pneumococcal vaccines, but also other mandatory vaccines (MMR,...) or vaccine for travelers (yellow fever, ...) as part of routine care in different population categories (healthy subjects, HIV+ subjects, COPD patients, …), using qualitative and quantitative immunological assays: transcriptional analysis of the dynamic innate immune response, analysis of the lymphocytes B \\& T responses (phenotype, repertoire analysis, functional analysis including T reg and TFH populations, antibody response), genetic analysis in the context of primary immune deficiencies) Conclusion: The data generated will allow the best possible analysis of vaccine responses according to vaccines and vaccinated populations, providing important information for the research developed within the department.",[123,31],"Vaccination",[125,123,126],"Biological Collection","Active Immune Response","2020-12-11",{"date":129,"type":45},"2020-12-14",{"date":131,"type":45},"2019-09-01",{"date":133,"type":20},"2030-02-01",{"name":82,"class":52}]