HHV8 and Solid Organ Transplantation

Study Overview
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Brief Summary
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Solid organ transplant candidates will undergo serological screening for HHV8 at time of listing and transplantation. In the event of a recipient/donor mismatch R-/D+ or in the presence of a seropositive recipient (R+), blood levels of HHV8 DNA will be monitored together with specific IGRA for HHV8.

Detailed Description
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Patients on the waiting list for solid organ transplantation will undergo serological screening for HHV8 (lytic and latent antigens) in the pre-transplant phase, both at time of listing and then at the time of transplantation; if seropositivity is found, further investigations will be performed, i.e. blood levels of HHV8 DNA and specific Elispot for HHV8. As for donors, serological testing for HHV8 (lytic and latent antigens) will be performed. AFTER SOLID ORGAN TRANSPLANTATION Patients found HHV8 seropositive in the pretransplant phase (R +), being at risk of HHV8 reactivation, will be monitored monthly in terms of viremia (HHV8 DNA) and specific IGRA for HHV8 for the first 6 months after transplantation and subsequently every 3 months up to 12 months post transplant. In case of patients who were found HHV8 seronegative at time of transplantation, donor serology will be evaluated. In case of R-/D+ mismatch, SOT recipients will receive the same monitoring of R + patients (blood levels of HHV8 DNA and specific IGRA for HHV8 monthly for the first 6 months and then every 3 months up to 12 months after transplantation). With reference to lung transplant patients, in cases of R + or R- / D +, HHV8 DNA will also be searched on the BAL obtained during surveillance bronchoscopies (usually at 3, 6 and 12 months after transplantation).

Official Title
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Screening for HHV8 Infection in Solid Organ Transplantation Donors, Candidates and Recipients

Conditions
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Lung Transplant; Complications, HHV8, HHV8 Infection, HHV8-Related Malignant Neoplasm, Kaposi Sarcoma, Liver Transplant; Complications, Kidney Transplant; Complications, Castleman Disease

Intervention / Treatment
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* Diagnostic Test: Diagnostic test for HHV8 exposure


Participation Criteria
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Eligibility Criteria
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SOT DONORS: Inclusion Criteria: all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation Exclusion Criteria: None SOT CANDIDATES RECIPIENTS: Inclusion Criteria: All patients listed for solid organ transplantation (lung, liver and kidney) Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SOT Donors<br>Solid organ transplantation donors | Diagnostic Test: Diagnostic test for HHV8 exposure<br>* Venipuncture for blood sampling<br>|
| LuTx candidates and recipients<br>Lung transplant candidates and recipients | Diagnostic Test: Diagnostic test for HHV8 exposure<br>* Venipuncture for blood sampling<br>|
| LTx candidates and recipients<br>Liver transplant candidates and recipients | Diagnostic Test: Diagnostic test for HHV8 exposure<br>* Venipuncture for blood sampling<br>|
| KTx candidates and recipients<br>Kidney transplant candidates and recipients | Diagnostic Test: Diagnostic test for HHV8 exposure<br>* Venipuncture for blood sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HHV8 seropositivity among SOT donors and recipients | Incidence of HHV8 seropositivity among solid organ transplantations donors, candidates and recipients | 2021-2024 | 
| Incidence of HHV8 mismatch between SOT donors and recipients | Incidence of HHV8 mismatch between solid organ transplantations donors and recipients | 2021-2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HHV8 related disease after solid organ transplantation | Incidence of HHV8 related disease after solid organ transplantation | 2021-2025 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HHV8, Solid organ transplant, Lung transplant, Liver transplant, Kidney transplant, Kaposi Sarcoma, Castleman Disease