CMV Viral Loads in Seropositive Renal Transplant Recipients
Conditions
Keywords
CYTOF, CMV, PCR, HLA
Brief summary
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (\>/=60 years) and young (20-40 years) renal transplant recipients who are cytomegalovirus (CMV) seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after release from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. In addition, clinical data will be collected at the time points indicated, particularly renal function and the presence/absence of acute rejection.
Detailed description
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (\>/=60 years) and young (20-40 years) renal transplant recipients who are CMV seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after release from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. Blood from 10 patients in each age group will be studied, to collect virologic and immune response data: * CYTOF (broad array of measurements) * Tetramer assays (requires recipient HLA type of A1, A2, B7) * CMV viral load PCR * Response to pneumococcal antigens and inactivated influenza virus In addition, clinical data will be collected at the time points indicated,particularly renal function and the presence/absence of acute rejection.
Interventions
OTHERCMV viral load
Sponsors
University of Nebraska
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults young age 20-40 years and old \>/= 60 years 2. Anticipate renal transplant within 2 weeks 3. CMV sero-positive renal transplant recipients 4. HLA type of A1, A2, B7 of recipient
Exclusion criteria
1. Pediatric recipients 2. Multi-organ transplant recipients 3. Highly sensitized (antigen level) recipients 4. Prior organ transplant recipients 5. Patients who do not wish to participate in study, or who cannot consent to research 6. Patients with active CMV infection 7. Seronegative 8. HLA Type of organ recipient not corresponding to A1,A2, B7
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy | 1 year | CMV viral loads in younger (age 20-40) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy |
| CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy | 1 year | CMV viral loads in older (age \>/= 60) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy |
Countries
United States
Outcome results
None listed