Exploratory Use of CMV Immunoglobulin in High Risk (D+R-) Transplant Recipients at the End of Antiviral Prophylaxis to Decrease the Risk of Late CMV Infection

This research study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help people with a high risk for developing late CMV disease post-transplant.

Cytomegalovirus (CMV) is a very common virus and in the same family as the viruses that cause herpes, chickenpox, and mononucleosis. Most people become infected with the virus when they come in direct contact with an infected person's bodily fluids. People with a normal immune system who become infected with CMV can have no symptoms or have symptoms similar to the common cold; people with a normal immune system rarely have any major complications from the virus. Once someone is infected with CMV, the virus remains inactive, or dormant, in the body for life; sometimes the virus can become active again and cause symptoms or severe disease, especially in people who are sick or have a weak immune system.

Individuals who receive an organ transplant are more likely to get an active CMV infection because of the medications required to prevent the immune system from attacking the transplanted organ. The immune system might recognize the organ transplant as a threat because it is not made of the same cells as the rest of the body. Anti-rejection medications help to reduce the immune system from attacking and damaging a new organ but also make it harder to fight off CMV and other infections. CMV is one of the most common infections after transplant.

Transplant teams test for CMV when someone is listed for an organ transplant and right before surgery. Both donors and recipients are tested for a CMV antibody which determines if someone has ever been infected with CMV. An antibody is created by the immune system and helps fight dangerous invaders like bacteria, fungus, or a virus, like CMV. People develop an antibody if the virus has been present in their body at any point in their life. CMV is so common that healthy people who test positive for CMV can still be organ donors; about half of all American adults have previous CMV infections.

The transplant team looks at the CMV antibody test results from both a donor and recipient at the time of the transplant surgery to determine the level of possible risk for CMV disease occurring in the recipient. Below is information regarding the level of potential risk to the recipient based on the presence (+) or absence (-) of antibodies. Other factors can influence someone's risk of CMV disease after transplant and can include age (of donor and recipient), other health problems, type and dosage of certain anti-rejection medications taken after transplant, and symptoms of transplant rejection.