[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunocompromised-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunocompromised-patients":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,70,94,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100584495","optimizing-the-diagnosis-of-pneumocystis-in-immunocompromised-patients-100584495",false,"NCT06890078","Optimizing the Diagnosis of Pneumocystis in Immunocompromised Patients","Optimisation du Diagnostic de Pneumocystose Chez Les Patients Immunodéprimés","OPTIJIROVEC","Inclusion Criteria:\n\n* adult patients with suspected pneumocystis\n* with an indication for bronchial fibroscopy for BAL or induced sputum\n* no opposition to the research from the adult patient or his or her next of kin research for patients unable to express their non-opposition\n\nExclusion Criteria:\n\n* Pneumocystis treated for more than 72 hours\n* pregnancy\u002Fbreast-feeding\n* adult patients deprived of liberty, protected",true,"ALL","18 Years",{"count":21,"type":22},240,"ESTIMATED","OBSERVATIONAL","Evaluate new diagnostic methods using qPCR on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (PcP) in immunocompromised patients",[26,27],"Pneumocystis","Immunocompromised Patients",[29,30],"immunocompromised patients","pneumocystis","RECRUITING","2026-04-22",{"date":34,"type":35},"2026-04-23","ACTUAL",{"date":37,"type":35},"2025-07-08",{"date":39,"type":22},"2027-07-08",{"name":41,"class":42},"Assistance Publique - Hôpitaux de Paris","OTHER",4,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100617683","immunogenicity-efficacy-and-safety-of-recombinant-herpes-zoster-vaccine-in-frail-patients-100617683","NCT07321808","Immunogenicity, Efficacy and Safety of Recombinant Herpes Zoster Vaccine in Frail Patients","Immunogenicity, Efficacy and Safety of Recombinant Herpes Zoster Vaccine (RZV) in Frail Patients: Multicentric Prospective Study","AID4FRAIL_RZV","3.1.1. Adult population (longitudinal study) General inclusion criteria Age ≥ 18 years Eligibility for RZV vaccination Written informed consent\n\nInclusion criteria for specific sub-groups:\n\nRheumatologic patients:\n\n* rheumatoid arthritis diagnosis according to classification criteria of 1987 and\u002For 2018\n* eligibility or in therapy with JAKis o CTLA4-Ig (monotherapy or DMARD combination)\n\nOncologic patients:\n\n* confirmed histological diagnosis of solid tumour (any type)\n* life expectancy ≥ 6 months\n* Patients with cancer who have to start immunotherapy with or without chemotherapy\u002Ftargeted therapy\n\nHematologic patients:\n\n* Patients with haematological malignancy treated with drugs (chemotherapy, new drugs, target therapies) other than antibodies.\n* Patients treated with anti-CD19 or CD20 or CD22 or CD30 or anti-PD1 antibodies with or without chemotherapy\n* Patients receiving autologous or allogeneic transplantation or CAR-T cells\n\nNeurologic patients:\n\n* Multiple sclerosis (MS) diagnosis according to McDonald criteria 2017\n* Eligibility or in therapy with first- or second-line immunosuppressive treatments\n\nGeneral Exclusion criteria No informed consent Previous HZ vaccination Documented reactions or allergies against vaccines Severe infections during the previous 3 months\n\n3.1.2. Pediatric population (cross-sectional study) Inclusion criteria Written informed consent from parents legal tutor and child assent (depending on age) Serology for VZV positive\n\nHematologic patients:\n\n* Patients with haematological malignancies treated with chemotherapy including experimental drugs and target therapies;\n* Patients with haematological malignancies undergoing B-cell depleting treatments, e.g. CAR-T cell therapy or anti-CD20, antiCD22, anti-CD30, anti-CD19 monoclonal or bispecific antibodies\n* Patients with haematological malignancies receiving allogeneic transplantation due to malignant or non-malignant diseases, including primary immunodeficiencies, hemoglobinopathies and acquired or inherited bone marrow failure syndrome.\n\nRheumatologic patients:\n\n1. patients with connective tissue diseases (including systemic lupus erythematosus, SLE, juvenile dermathomyositis, JDM, and scleroderma) treated with B cell depleting therapies (anti-CD20);\n2. patients with juvenile idiopathic arthritis (JIA) treated with TNF inhibitors. The corresponding disease control populations will be patients with the same diseases listed above, who are not receiving anti-CD20 or TNF inhibitors, respectively.",{"count":53,"type":22},300,"Herpes zoster (HZ) is a serious health problem whose incidence and severity increase with the decline of cell-mediated immunity (CMI) because of age and immunocompromised (IC) status. Subclinical reactivation are described and may boost the adaptive specific immunity. T cells play a major role in preventing reactivation of Varicella Zoster virus (VZV), with a contribution of both CD4 and CD8 T cells. Accordingly, the suppression of VZV-specific T cells preceded the occurrence of HZ. Moreover, several observations support a role of B cells in contributing to the overall protection against HZ as patients with primary antibody deficiency, common variable immunodeficiency, or patients treated with B-cell depleting therapies or Janus Kinase inhibitors (JAKis) show a higher risk of HZ. The functional effectiveness of CMI can be significantly affected by different diseases (e.g. cancer and immune-mediated inflammatory diseases, IMIDs) and\u002For by ongoing immune-targeted therapy, giving these patients at high risk for VZV reactivation. The new recombinant zoster vaccine (RZV) reduces the risk of HZ, and vaccination is encouraged in IC individuals, including those with cancer and IMIDs. Despite the efficacy and safety of RZV in healthy adults, data on IC patients are scarce. In particular, the immunogenicity of the new vaccine in frail subjects is not fully understood. On the one hand, immunosuppressive treatments can compromise the residual immunity to VZV but also the response to RZ . Several therapies are known to affect B cell response such as Rituximab or CAR T cells; other treatments reduce the T cell functionality, such as T-cell inhibitors (Cytotoxic T-lymphocyte Antigen 4-Immunoglobulin, CTLA4-Ig; abatacept), the JAK is, as well as by chemotherapy. To date, the vaccination is not approved in paediatric patients. However, the investigation of the VZV-specific immunological profile in frail paediatric patients could represent a valuable tool for understanding the potential vaccination strategies in these categories.\n\nThe study and definition of an immune profile associated with a high risk of viral in RZV vaccinated patients with IC can be useful for identifying patients' candidates for preventive antiviral treatments.\n\nThis is an observational multicentric prospective cohort study. The general objective is to assess the immunogenicity of RZV vaccination in terms of the induction of humoral and cell-mediated immune responses in selected frail (altered immunocompetence) populations, including rheumatologic, oncologic, neurologic and hematologic patients.\n\nPrimary Objective: To define the overall rate of humoral responders patients after the second dose of RZV administration.\n\nPrimary Endpoint: The rate of \"humoral responders\" will be defined as the percentage of patients showing ≥ 4 times of gE-specific IgG response (IU\u002FmL) after the second dose (T1m) respect to baseline (T0) Secondary Objective 2.1: To define the overall increase of humoral response after the second dose of RZV administration.\n\nSecondary Objective 2.2: To characterize the immunogenicity induced by RZV vaccine in the different study cohorts (rheumatologic, oncologic, neurologic and hematologic patients) Secondary Objective 2.3: To evaluate the kinetics of humoral response during the first year after the vaccination Secondary Objective 2.4: To characterize gE-specific T cell mediated response elicited by RZV vaccination in overall patients Secondary Objective 2.5: Evaluation of the incidence of adverse reactions (AR) to the RZV vaccine, local and systemic, solicited and unsolicited, within the period of four weeks after the second dose of RZV.\n\nSecondary Objective 2.6: Evaluation of the incidence of reactivation of VZV cases after the second dose of RZV.",[27],[57,58,59],"vaccination","varicella zoster","immunogenicity","2026-03-03",{"date":62,"type":35},"2026-03-05",{"date":64,"type":35},"2023-05-16",{"date":66,"type":22},"2027-05",{"name":68,"class":42},"Fondazione IRCCS Policlinico San Matteo di Pavia",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":69},"100622125","personalized-immunological-score-for-the-prediction-of-severe-infectious-events-in-immunocompromised-patients-and-tailored-management-periscope-100622125","NCT07379554","Personalized Immunological Score for the Prediction of Severe Infectious Events in Immunocompromised Patients and Tailored Management (PERISCOPE)","PERISCOPE","Inclusion Criteria:\n\nadult hematopoietic stem cell transplant recipients (a-HSCTR)\n\n* pediatric hematopoietic stem cell transplant recipients (p-HSCTR)\n* solid organ transplant recipients (SOTR), including kidney, heart and lung transplanted patients.\n\nWritten informed consent\n\nExclusion Criteria:\n\n* no written informed consent",{"count":78,"type":22},150,"Transplants have improved clinical conditions for many patients with haematological diseases and end-stage organ diseases. However, immunosuppressive therapies that are necessary for avoiding organ rejection have a crucial impact in the occurrence of opportunistic infections. Despite the development of effective antimicrobial agents, infectious diseases are still related to mortality and morbidity in immunocompromised patients. Immune function assays can be adopted for monitoring T-cell function and eventually modify immunosuppression. Given the inverse relationship between cellular immune reconstitution and risk of infection, many transplant centers prospectively monitor immune recovery post-transplant. Some basic methods are useful, including white blood cells and T-lymphocyte subsets count. Given the complexity of immune responses required to resolve infections, functional assays are necessary and the only available FDA-approved one is Cyclex-Immuknow. Viral infections are common in patients with T-cell deficiencies and are of particular concern in those receiving high dose steroids. Opportunistic infections are common during the period of highest immunosuppression while community acquired infections, including fungal and respiratory viruses infections, have to be considered in the long-term period. Reduced CD4+ and CD8+ T-lymphocyte counts correlate with risk of opportunistic infection, including human cytomegalovirus (HCMV). Moreover, a decrease in human Rhinovirus (HRV) load in pediatric hematopoietic stem cell transplant recipients (HSCTRs) was associated with a significant increase in T-CD4+, T-CD8+ and NK lymphocytes, suggesting that cellular immunity have a crucial role in viral clearance and infectious control. A recent study showed that poor NK-cell cytotoxic activity is associated with increased risk for severe infections in kidney-graft recipients, suggesting that assessment of NK-cell function may be used as a predictor of infection in immunocompromised patients. Moreover, it has been recently reported that NKG2C genotype influences receptor function and NKG2C+ NK cell number in HCMV seropositive subjects. In detail, NKG2C genotype is significantly associated with HCMV viremia frequency and related disease after lung transplant and with symptomatic CMV infection after kidney transplant. Beside the use of non-specific immunological markers, the lack of standardized quantitative measures of protective immune functions specific for different opportunistic pathogens represents a challenge for clinicians. Overall, a comprehensive approach based on the use of combined non-specific and pathogen-specific immune assays may help in the definition of a composite immune risk profile of immunocompromised patients. The ultimate goal of this research is the definition of algorithms of infectious risk in immunocompromised patients, leading to a more adherent administration of immunosuppressive and antimicrobial therapies as well as to a personalized strategy of patients' management. Moreover, the design of new immunological assays that can be standardized and used in the clinical practice will be obtained.\n\nCurrently, even if an immunological monitoring of immunocompromised patients is recommended, no standardized assays and protocols are available, especially for the use of antigen-specific or functional assays. The introduction of diagnostics algorithms will be useful for the stratification of patients at high risk of infections that will be monitored more frequently in order to prevent severe infections. Similarly, the administration of immunosuppressive drugs or ad hoc therapies might be tailored according to the risk of infections or complications. Objective is to identify a composite immune score measured either before or one month after transplant\u002Fchemotherapy able to define the risk for clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) during the following three months.\n\nPrimary endpoint:\n\nTo identify a composite immune score measured either before or one month after transplant\u002Fchemotherapy able to define the risk for clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) during the following three months.\n\nSecondary endpoints:\n\n* To evaluate the prognostic effect of the immunological score measured before or at first month after transplant\u002Fchemotherapy on the risk of severe infection during the following 6-12 months\n* To compare the role of the composite immunological score with specific assays against each pathogen.\n* To develop simple and rapid assays using whole blood to evaluate specific pathogen responses",[27,81,82],"Transplant Patients","Infections",[84,85],"Immunological score","severe infections","2026-01-23",{"date":88,"type":35},"2026-01-30",{"date":90,"type":35},"2024-04-04",{"date":92,"type":22},"2026-06",{"name":68,"class":42},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":69},"100615663","analysis-of-the-specificity-and-persistence-of-nasal-immune-responses-to-respiratory-viral-antigens-in-immunocompromised-and-healthy-cohorts-100615663","NCT07295535","Analysis of the Specificity and Persistence of Nasal Immune Responses to Respiratory Viral Antigens in Immunocompromised and Healthy Cohorts","Inclusion Criteria:\n\n* Informed Consent: Participants must have signed an informed consent form.\n* Age Range: Participants aged between 18 and 90 years.\n* Healthy Immunocompetent Donors: no underlying medical conditions declared, no clinical history of immunodeficiency or use of immunosuppressive medications.\n* Immunocompromised Patients: subjects with medical conditions or treatments associated with significant impairment of the immune system. This may include organ or stem cell transplants, ongoing immunosuppressive therapies, documented genetic immunosuppression.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Individuals unable to provide informed consent","90 Years",{"count":102,"type":22},40,"The goal of this observational study is to characterize nasal mucosal immunity to respiratory viruses, such as SARS-CoV-2, in immunocompromised individuals and healthy volunteers.\n\nThe study involves adults of any sex, between 18 and 90 years old, including both immunocompromised patients with medical conditions or treatments that can affect immune cell functions and healthy controls with no underlying medical conditions declared, no clinical history of immunodeficiency or use of immunosuppressive medications.\n\nResearchers will compare immunocompromised participants to healthy volunteers to determine how underlying immunodeficiency and related treatments affect immune cell composition and virus-specific responses.",[105,106,27,107,108],"Immuno-modulation","Immuno-suppression","Healthy Subjects","Oncological Patients","2025-12-16",{"date":111,"type":35},"2025-12-19",{"date":113,"type":35},"2025-09-01",{"date":115,"type":22},"2027-09-30",{"name":68,"class":42},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100568646","evaluation-of-direct-antiviral-treatments-against-sars-cov-2-in-immunocompromised-patients-with-covid-19-a-g2i-study-national-multicenter-observational-and-retrospective-from-june-2023-to-april-2024-100568646","NCT06683937","Evaluation of Direct Antiviral Treatments Against SARS-CoV-2 in Immunocompromised Patients With Covid-19. A G2i Study, National Multicenter Observational and Retrospective From June 2023 to April 2024","COV-ID","Inclusion Criteria:\n\n* Adult patients with SARS-CoV-2 in France, treated in a center participating in the study\n* Symptomatic patients for Covid-19 who have received mono- or dual therapy with nirmatrelvir\u002Fritonavir or remdesivir\n* SARS-CoV-2 positive by PCR on nasopharyngeal swab, ECBC or bronchoalveolar fluid\n* Hospitalization in a ward or day hospital for SARS-CoV-2 infection\n* Patients at very high risk of severe form of SARS-CoV-2\n\n  * Aggressive lymphomas (all types)\n  * Acute lymphocytic leukemia\n  * Acute myeloid leukemia\n  * Acute promyelocytic leukemia\n  * T-cell prolymphocytic leukemia\n  * Primary lymphoma of the central nervous system\n  * Stem cell transplant\n  * Light chain amyloidosis\n  * Chronic lymphocytic leukemia\n  * Multiple myeloma\n  * Hematopoietic stem cell transplant\n  * Solid organ transplant\n  * Being on the waiting list for an organ transplant\n  * Primary immunodeficiency;\n  * HIV patients with CD4 \\\u003C200\u002Fmm3 or with a detectable viral load\n  * Lymphopenia \\\u003C200\u002Fmm3\n  * Neutropenia \\\u003C1000\u002Fmm3 for \\> 1 week\n  * Patients receiving long-term immunosuppressive treatment (period of at least 3 months during treatment during infection) with:\n* anti-CD20 antibodies\n* anti-JAK\n* BTK inhibitors\n* azathioprine\n* cyclophosphamide\n* methotrexate\n* mycophenolate mofetil\n* CAR-T cell gene therapy\n* bi-phenotypic therapeutic antibodies\n* tacrolimus\n* sirolimus\n* long-term corticosteroids (prednisone equivalent dose \\>5mg for 3 months)\n\nExclusion Criteria:\n\n* Opposition formulated (following receipt of the study information note)\n* Patients who received convalescent plasma as first-line treatment for SARS-CoV-2 infection",{"count":53,"type":22},"Due to the lower virulence of circulating Omicron variants and the high seroprevalence of anti-SARS-CoV-2 antibodies, the incidence of cases and deaths related to the SARS-CoV-2 virus has significantly decreased in recent months worldwide. However, these infections remain a major public health problem in severely immunocompromised patients, who have decreased vaccine efficacy and are at higher risk of persistent SARS-CoV-2 viral shedding, relapses, secondary invasive fungal infection, intensive care unit hospitalization, and death than non-immunocompromised patients.\n\nThe research concerns adult patients at very high risk of severe SARS-CoV-2 disease, suffering from SARS-CoV-2 having resulted in hospitalization in a center participating in the study in France between June 1, 2023 and April 1, 2024 and having received mono- or dual therapy with nirmatrelvir\u002Fritonavir or remdesivir in order to carry out an evaluation of direct antiviral treatments against SARS-CoV-2 in these immunocompromised patients suffering from Covid-19.\n\nThe study consists of collecting patient care data from the medical record. Patients will be identified by practitioners at each participating French center.",[27,127],"SARS-CoV-2 Disease",[129,130,131],"Immunocompromised patients","SARS-CoV-2 disease","Mono- or dual therapy with nirmatrelvir\u002Fritonavir or remdesivir","NOT_YET_RECRUITING","2025-09-05",{"date":135,"type":35},"2025-09-12",{"date":137,"type":22},"2025-12-01",{"date":139,"type":22},"2026-06-01",{"name":41,"class":42},16]