Evaluation and promotion of specific adaptative immunity against polyomavirus (BKV) to prevent viral infection after kidney transplantation (BK-VAX project)

Phase 1

Conditions: Prevention viral infection (BKV) poliamavirus after kidney trasplantation
MedDRA version: 20.0Level: PTClassification code: 10010185Term: Complications of transplanted kidney Class: 100000004863
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]

Registration Number: CTIS2023-504309-35-00

Lead Sponsor: Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

The patient must be at least 18 years old., The patient must be able to give informed consent in writing, Patient receiving a kidney transplant., The patient must have a maintenance immunosuppressive regimen based on tacrolimus + MMF/MPS + corticosteroids or tacrolimus + rapamycin + corticosteroids., Patient with viral load detectable by PCR in peripheral blood against the BK-virus, Kidney transplant patient at Vall d'Hebron Hospital at most 12 months before viral load detection., Stable renal function with an estimated glomerular filtration rate = 35 ml/min/1.73 m2, Urine protein/creatinine ratio value less than 1 g/g

Exclusion Criteria

Prior diagnosis of T cell-mediated or antibody-mediated rejection., Active cancer excluding non-melanocytic skin cancer, Potentially Fertile Women who do not agree to use measures reliable contraceptives during the trial, who are pregnant, in period of breast-feeding or who present a positive pregnancy test at the time of their inclusion in the study, Patients presenting with another severe systemic infection at the time of randomization., Patients with positive HIV serology

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the role of adaptive immunity against to BKV and its modulation according to different immunosuppressive regimens used routinely in kidney transplantation, including mTor-i drugs.;Secondary Objective: T/B cell association specific against BKV and serological immunity through neutralizing antibodies (NAb) before and after transplantation and its relationship with the risk of developing BKV infection in a prospective cohort of renal transplant patients who receive standard IS or an mTor-i-based regimen.;Primary end point(s): changes in immune response virus-specific at different biological levels, of patients who develop infection virus by the BK virus through the changes in BK virus viral load in peripheral blood of patients

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Differences between groups of the specific effector polyfunctional T (IFN-y/IL2, IL-2, IFN-y, IL6, IL-4) response against different proteins VBK (LT-1, VP1) using FluorSPOT technique;Secondary end point(s):Differences Between Groups in Memory B Cell Response producer of specific IgG against BKV immunogenic proteins;Secondary end point(s):Differences between specific neutralizing antibodies (NAb), by using a system based on pseudovirions that express genotypes I-IV virus capsid proteins;Secondary end point(s):Differences in the specific immunophenotype by FACS multiparameter spectral analysis (AURORA, CyTEX Bioscience) of cells CD8+, CD4+ and NKT with special interest in exhaustion phenotypes that could be induced by using mTor-i (CD45RA and CD27; CD85j, CD161, CD16, CD56 CD161 and CD94 and KLRG1; or PD-1, TIM-3, LAG3, and DNAM-1).;Secondary end point(s):Differences in TCR signaling efficiency of cells Specific T against BKV