PREDICT Cytomegalovirus (CMV)

Cytomegalovirus (CMV) is a common virus. The virus is spread from one person to another
through infected body fluids. In those with a normal immune system, CMV does not cause much
of a problem. The immune system keeps the virus under control so most people do not have any
symptoms. Once infected, the virus usually stays dormant (inactive) in the body for a
person's entire life. This means some of the cells in the body are infected and the virus can
become active again.

Lung transplant recipients take anti-rejection medicines to prevent the body from rejecting
the transplanted lung(s). Although anti-rejection medications help protect the transplanted
lung(s) from the body's immune system, these medications also decrease the body's ability to
fight infections. This reduces the immune system's ability to control viruses like CMV. Many
transplant recipients take an antiviral medication early after transplant to help the body
control the CMV virus. This is the time that risk of infection would be highest. Sometimes
recipients get an active CMV infection after stopping these medicines. If this happens, the
infection is treated and monitored.

In this study, investigators are trying to determine whether a blood test can predict
development of active CMV infection in lung transplant recipients. Specifically, the clinical
research study will prospectively assess the performance of an immune signature based on the
"ex vivo" measurement of T cell CMV specific immunity in predicting freedom from future CMV
infections among recipient positive (R+) lung transplant participants receiving standard
durations of valganciclovir prophylaxis.

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study
participants:

- Must be able to understand and provide written informed consent;

- Anticipated listing for lung transplantation OR listed for lung transplant OR is
within 45 days of having received a single or bilateral cadaveric donor lung
transplant;

- Undergoing first lung transplant operation;

- Transplant surgery to be performed or performed at enrolling center;

- Concurrent participation in CTOT-20 (Clinical Trials.gov ID: NCT02631720); and

- CMV-seropositive lung transplant recipient, using methods in accordance with current
local organ procurement organization policies.

- Note: Concurrent participation in immune monitoring studies or interventional
device trials are permitted.

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for enrollment as study
participants:

- Unwilling to enroll in CTOT-20 (Clinical Trials.gov ID: NCT02631720);

- Multi-organ recipient;

- Prior recipient of any solid organ transplant, including prior lung transplant;

- Prior or concurrent recipient of bone marrow transplant;

- Human Immunodeficiency Virus (HIV) infection;

- Pregnant or planned pregnancy;

- Any condition that, in the investigator's opinion, would make it unlikely for the
recipient to complete follow up procedures or complete the study; or

- Participation in an investigational drug trial at the time of enrollment visit.