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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504309-35-00
Acronym
BK-VAX
Enrollment
70
Registered
2023-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention viral infection (BKV) poliamavirus after kidney trasplantation

Brief summary

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

Detailed description

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, Differences Between Groups in Memory B Cell Response producer of specific IgG against BKV immunogenic proteins, Differences between specific neutralizing antibodies (NAb), by using a system based on pseudovirions that express genotypes I-IV virus capsid proteins, 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)., Differences in TCR signaling efficiency of cells Specific T against BKV

Interventions

DRUGMyfortic 360 mg Comprimidos gastrorresistentes
DRUGMyfortic 180 mg comprimidos gastrorresistentes

Sponsors

Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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, Differences Between Groups in Memory B Cell Response producer of specific IgG against BKV immunogenic proteins, Differences between specific neutralizing antibodies (NAb), by using a system based on pseudovirions that express genotypes I-IV virus capsid proteins, 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)., Differences in TCR signaling efficiency of cells Specific T against BKV

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026