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NCT ID: NCT05215327 Recruiting - Influenza Clinical Trials

High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients

Start date: November 7, 2022
Phase: Phase 2
Study type: Interventional

Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine. This early post-transplant period is when immunity is most desirable, since influenza disease during this time frame is associated with adverse consequences. Thus, strategies to reduce severe influenza disease in this highly susceptible population are critical. No trials in lung transplant recipients have evaluated two doses of HD-IIV within the same influenza season as a strategy to improve immunogenicity and durability of influenza prevention. Furthermore, no influenza vaccine trials have focused on enrollment of subjects at early post-transplant timepoints. Very few studies have been performed in solely lung allograft recipients. Immunosuppression intensity is highest in lung patients, thereby limiting comparisons to recipients of heart, liver, and kidney transplants. Therefore, studies to assess both HD-IIV and two-dose strategies in the same influenza season in post-lung transplant recipients are greatly needed. The central hypothesis of our proposal is that lung allograft recipients who are 1-35 months post-transplant and receiving two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have higher HAI geometric mean titers (GMT) to influenza antigens compared to those receiving two doses of SD-QIV. To test this hypothesis and address the above critical knowledge gaps, we propose to conduct a phase II, multi-center, randomized, double-blind, controlled immunogenicity and safety trial comparing the administration of two doses of HD-QIV to two doses of SD-QIV in lung allograft recipients 1-35 months post-transplant. The results of this clinical trial will address significant knowledge gaps regarding influenza vaccine strategies (e.g., one vs. two doses and HD-QIV vs. SD-QIV) and immune responses in lung transplant recipients and will guide vaccine recommendations during the post-transplant period.

NCT ID: NCT05198570 Recruiting - Oncology Clinical Trials

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Start date: September 15, 2021
Phase:
Study type: Observational

- Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality. - Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals. - Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection. - Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection. - Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children. - Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.

NCT ID: NCT05193058 Recruiting - Clinical trials for Transplantation Infection

Description of Lung Transplant Patients With Microbiologically Documented Stenotrophomonas Maltophilia Pneumonia and Impact of Treatment on Outcome

STENO_SOT
Start date: November 22, 2021
Phase:
Study type: Observational

Stenotrophomonas maltophilia is a multi-resistant Gram-negative bacillus and is an opportunistic pathogen. Stenotrophomonas maltophilia infections are associated with a significant morbidity and mortality, particularly in immunocompromised patients. The mortality of infections (bacteremia, pneumonia) related to Stenotrophomonas maltophilia is variable and is estimated between 21 and 69%. Stenotrophomonas maltophilia pneumopathies have been mainly described in patients hospitalized in intensive care and benefiting from mechanical ventilation. The existence of immunosuppression seems to be a risk factor for the transition from Stenotrophomonas maltophilia pulmonary colonization to Stenotrophomonas maltophilia pulmonary infection. The reference treatment for Stenotrophomonas maltophilia-associated pneumonia is the combination of trimethoprim and sulfamthoxazole, a molecule that lung transplant patients routinely receive as a preventive treatment for Pneumocysitis jirovecii infection. There is no consensus on the value of routine dual-antibiotic therapy, and it varies from one center to another and from one country to another. The main objective is to compare the clinical-microbiological evolution of lung transplant patients treated for Stenotrophomonas maltophilia pneumopathy according to the prescription of a mono- or bi-antibiotherapy. The secondary objective is to evaluate the resistance rate of Stenotrophomonas maltophilia strains isolated from respiratory samples according to the anti-pneumocystis prophylactic molecule received by the patient.

NCT ID: NCT04613206 Recruiting - Influenza Clinical Trials

High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients

Start date: January 11, 2021
Phase: Phase 2
Study type: Interventional

The influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. The first study compared HD-IIV vs. SD-IIV in adult SOT and noted HD-IIV was safe and reported higher immunogenicity; however, the median post-transplant period was 38 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV a month apart compared to one-dose SD-IIV revealed increased immunogenicity, with a median post-transplantation period of 18 months. Therefore, these studies lack evaluation in the early post-transplantation period in this vulnerable population when influenza disease is most severe. The administration of two-doses of HD-IIV in the same influenza season has also not been studied in SOT recipients. Moreover, the vast majority of SOT influenza vaccinations studies have not substantively evaluated prolonged immunogenicity. Thus, the optimal immunization strategy for SOT recipients less than 12 months post-transplant is poorly-defined. In addition, the immunologic predictors and correlates of influenza vaccine immunogenicity in SOT recipients have not been defined. The investigators hypothesize that adult solid organ transplant recipients that are 1-11 months out from transplant and are receiving high-dose inactivated influenza vaccine will have higher hemagglutination inhibition (HAI) geometric mean titers to influenza A antigens compared to adult SOT recipients receiving standard-dose inactivated influenza vaccine. To test this hypothesis and address the above critical knowledge gaps, The investigators propose to conduct a phase II multicenter randomized controlled trial comparing either two doses HD-IIV, two doses of SD-IIV, or one-dose of HD-IIV in adult kidney, heart, and liver SOT recipients 1-11 months post-transplantation. The results of this study will address significant gaps in knowledge regarding influenza vaccine strategies and immune responses in adult SOT recipients and will guide vaccine recommendations in this vulnerable population.

NCT ID: NCT04579471 Recruiting - Covid19 Clinical Trials

Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study

COVITRA
Start date: July 1, 2020
Phase:
Study type: Observational

This project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.

NCT ID: NCT04336735 Recruiting - Vaccination Clinical Trials

Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Vaccine preventable infections are a serious complication following pediatric solid organ transplant. Immunizations are a minimally invasive and cost-effective was to reduce these infections. Despite the importance of pre-transplant vaccination, the majority of pediatric solid organ transplant recipients are not up-to-date on age-appropriate immunizations at the time of transplant. The goal of this study is to pilot a novel health information technology immunization tool to improve immunization rates in pediatric solid organ transplant candidates.

NCT ID: NCT04320303 Recruiting - Clinical trials for Transplantation Infection

CMV Infection and Immune Intervention After Transplantation

Start date: March 23, 2020
Phase: N/A
Study type: Interventional

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective or even the only way to cure blood malignant diseases. Cytomegalovirus (CMV) infection is a serious early complication of allo-HSCT. Its high incidence and poor prognosis can cause a series of terminal organ diseases such as CMV pneumonia, encephalitis, and enteritis,which seriously affecting the prognosis of patients post allo-HSCT. Our data show that rapid reconstruction of NK cells after transplantation can reduce the incidence of CMV infection. Patients with a rapid reconstruction of NKG2C after transplantation have a low CMV infection rate, and patients with strong secretion of IFN-gamma of NK after transplantation have low CMV infection. Our previous research showed that trophoblast cells transfected with IL-21 and 4-1BBL can achieve a large number of clinical-grade expansion of NK cells (mIL-21 / 4-1BBL NK cells), and mIL-21 / 4-1BBL NK cells It is safe to treat patients with minimal residual disease (MRD) positive AML after transplantation, and can induce MRD to turn negative. Previous studies have shown that adoptive infusion of expanded NK cells after haplotype transplantation is safe and can improve the functional reconstruction of NK cells. Therefore, we hypothesized that the infusion of NK cells can improve the antiviral capacity of NK cells, thereby effectively reducing the CMV infection. Incidence.

NCT ID: NCT01515605 Recruiting - Kidney Diseases Clinical Trials

Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

MoMoTxRes
Start date: January 1, 2011
Phase:
Study type: Observational

Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue from patients after kidney transplantation. In the present study the investigators examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after transplantation. Routine clinical and laboratory data from serum and urine are evaluated at baseline and after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase), TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques. Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected genes are analyzed using standard techniques. Data are analyzed by descriptive statistics. Differences between groups were analyzed using Mann-Whitney test or Kruskal-Wallis-test and Dunn's multiple comparison post-test, as appropriate. Associations between variables are analyzed using regression analyses. Contingency tables are analyzed using Fisher's exact test.