CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients

Who can take part

• < 18 years of age at the time of pre-transplant enrollment
• Potential subject is undergoing evaluation or is currently listed for isolated heart, kidney, or liver transplantation at a participating transplant center OR is anticipated to undergo living-donor kidney or liver transplantation
• Anticipated to receive ≤ 200 days of antiviral chemoprophylaxis; Note: Subjects who are consented, enrolled, and undergo transplantation at <18 years of age will remain in the study and be followed post-transplant according to the study plan after they turn 18 years of age. Subjects will be re-consented to remain in the study at their first study visit after turning 18 years of age

Who cannot take part

• Exclusion Criteria pre-transplant
• Prior history of any organ transplant
• Prior history of hematopoietic cell transplant
• Anticipated to receive more than one organ at the time of transplant
• Anticipated to receive > 200 days of CMV antiviral chemoprophylaxis as part of the local transplant center's standard CMV prevention protocol
• Infants <12 months will be considered seronegative regardless of their CMV IgG status (whether or not this testing was obtained by the local transplant center) UNLESS the infant has a positive pre-transplant CMV culture (from urine) or a positive pre-transplant CMV PCR (from urine, saliva, or blood). Infants <12 months of age without evidence of prior CMV infection (as defined by these preceding criteria) will be excluded from post-transplant follow up IF they receive an organ from a CMV seronegative donor due to low risk for post-transplant CMV infection. Infants <12 months of age with evidence of prior CMV infection (as defined above) will remain in the study following transplantation
• Subjects who are enrolled at <18 years of age but are not transplanted prior to their 18th birthday will be removed from the study and will not have further pre- or post-transplant follow up
• History of underlying primary (genetic) T cell immune deficiency
• Exclusion Criteria post-enrollment A) Removal from study due to minimal risk for CMV infection
• CMV seronegative children >= 12 months of age will be enrolled pre-transplant but will subsequently be excluded from the study IF they receive an organ from a CMV seronegative donor (CMV D-/R-)
• Removal from study due to age