Astellas to use Abbott's CMV assay for vaccine trial

US health care major Abbott Laboratories (NYSE: ABT) says that it has signed an agreement to collaborate with Japan’s Astellas Pharma  TYO: 4503) in a Phase III clinical trial for ASP0113 (TransVax), an investigational vaccine licensed from Vical last year for preventing cytomegalovirus (CMV) reactivation in transplant patients (The Pharma Letter July 18, 2011).

Under the accord, Abbott's RealTime CMV assay, which is performed on the Abbott m2000 System and intended for investigational use only, will be used to monitor patients for CMV viral load in order to assess the vaccine's efficacy. Viral load is a measure of the severity of a viral infection or the amount of active virus in the blood.

A herpes virus, CMV infects half of all adults by age 40 and is the most common viral infection in transplant recipients. After primary infection, CMV establishes lifelong latency without causing symptoms. The virus is often dormant in those who are healthy but can cause illness in immunocompromised people, such as those undergoing stem cell or organ transplants. Hematopoietic cell transplant patients and other individuals with depressed immune systems are vulnerable to severe complications from CMV infection, including CMV disease and death.