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

Graft Rejection Clinical Trial

— BKV-Pneumo  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04164576
• Other study ID #: 7547
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: June 2027

Study information

• Verified date: November 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2027
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• Patient deprived of liberty, by judicial or administrative decision

• Patient under legal guardianship

• Impossibility to give complete information about this study to the patient

Related Conditions & MeSH terms

• Graft Rejection
• Infection Episodes
• Renal-urinary Impairment

Intervention

Genetic:
• Transplant patients
Study the specific immunity against Polyomavirus

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantification of BKV specific T lymphocytes		3 years
Other	TTV viral load in plasma	Evaluation of the viral load of TTV (reflection of global immunosuppression) or its genotype (established by sequencing).	3 years
Primary	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.	3 years
Secondary	Quantification of anti-BKV neutralizing antibodies		3 years