Prevention of CMV infection in newborns and foetuses -study design and epidemiological results of a phase III trial

Cytomegalovirus (CMV) disease is a widespread viral infection, which usually follows a harmless course with flu-like symptoms. However, if women become for the first time infected during pregnancy, fetal infection with malformation can occur. About 10% of CMV-infected neonates show postnatal symptoms like thrombocytopenic purpura, hearing impairment, retinitis, microcephaly and hepatosplenomegaly. About further 10-20% will exhibit clinical manifestations of the CMV infection later in life such as disorders of mental and motor development. Anti-CMV-Hyperimmunoglobulin (Cytotect®) treatment after early diagnosed infection in pregnancy is intended to prevent intrauterine CMV infection of the foetus (Nigro NEJM 2005). Thus, a multicenter Phase III study is ongoing since 2008 to establish therapy with the anti-CMV-Hyperimmunoglobulin study medication BT094 as the standard treatment for congenital CMV infections. Epidemiological data of CMV in pregnancy are prospectively evaluated in four European countries. Up to now more than 7,000 pregnant women have been screened for CMV IgG serostatus. About 4,200 (60%) of them were CMV-negative at the start of the pregnancy. Thirty-five (0.8%) of these CMV negative pregnant women became infected with cytomegalovirus during pregnancy. From the group of pregnant women infected, 30 children have to date been born and are being continually followed up to the age of 2 years to detect clinical manifestations of CMV disease. The efficacy results from newborns are promising and justify continuation of the study.