Viral Load Assay Employed for Phase III CMV Vaccine Trial
Astellas Pharma is to use Abbott’s RealTime cytomegalovirus (CMV) assay to monitor viral load in patients enrolled in a Phase III trial evaluating use of the DNA vaccine ASP0113, (TransVax™) in the prevention of cytomegalovirus reactivation in transplant patients. ASP0113 is an investigational vaccine licensed by Astrellas from Vical.
Under terms of the deal Abbott’s RealTime CMV assay, carried out on the Abbott m2000 system, will be used to assess vaccine efficacy in terms of viral load. “Abbott’s investigational CMV test will be used as an important aid in assessing the efficacy of this promising vaccine which could significantly improve the overall outcome of transplant procedures,” comments John Coulter, head of Abbott’s molecular diagnostics business.
Astellas Pharma negotiated exclusive worldwide rights to develop and commercialize TransVax from Vical in July 2011, for use in the prevention and control of CMV infection in immunocompromised patients, including transplant recipients and donors.
Abbott’s real-time PCR m2000 system is a fully automated system for infectious disease molecular diagnostics. The firm currently markets the system and a broad menu of assays globally, including viral load assays for HIV, HBV, HCV, and a combination test for chalmydia and gonorrhea. The RealTime CMV assay is available in countries that recognize the CE mark.