Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.

The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Lung transplant recipients in Strasbourg University Hospital between 30 June 2018 and 31 December 2022

Male or female patients, age over 18 years

Patient having provided informed written consent to take part in the study

Patient affiliated to Social Security

Disqualifiers

Patient deprived of liberty, by judicial or administrative decision

Patient under legal guardianship

Impossibility to give complete information about this study to the patient

Trial population

Lung transplant recipients between 30 June 2018 and 31 December 2022 at the University Hospital of Strasbourg

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transplant patients

    Genetic

    Study the specific immunity against Polyomavirus

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

BKV viral load in urine (viruria) and in plasma (viremia)

In cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.

Time frame
3 years

Secondary outcomes

1

Quantification of anti-BKV neutralizing antibodies

Time frame
3 years

Other outcomes

1

Quantification of BKV specific T lymphocytes

Time frame
3 years
2

TTV viral load in plasma

Evaluation of the viral load of TTV (reflection of global immunosuppression) or its genotype (established by sequencing).

Time frame
3 years

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: