[Preparation of a specific anti-cytomegalovirus immunoglobulin for intravenous injection]

In the industrialised countries of Europe about 60-70% of adults possess antibodies against cytomegalovirus. Primary infections or exacerbations of a latent infection are in most cases clinically asymptomatic in healthy patients. By way of contrast, attenuations in the immunological defence system: prematureness, pregnancy, the presence of malignant disease, immunosuppressive therapy, as well as massive transfusions of blood, are the commonest causes of a raised incidence of CMV infections often combined with severe clinical overt illness. Because a critical level of antibody is needed to prevent infection and disseminating, we have produced cytomegalovirus hyperimmune globulin for intravenous administration. They are prepared from plasmas of healthy blood donors on the basis of a high antibody level against cytomegalovirus. About 6% are selected by an ELISA procedure. Immunoglobulins, treated to ensure excellent intravenous acceptability, are lyophilized. The final product is found to have an anti-CMV antibody titer of 25 600, by the ELISA test, at a protein concentration of 5%. This CMV-immunoglobulin I.V. has 8 fold higher antibody content than do conventional immunoglobulin preparations. The first trials of prophylaxis and treatment of clinically apparent CMV infections are under study.