Modified immune globulin: its use in the prophylactic treatment of patients with immune deficiency.

Patients with antibody deficiency syndromes provide excellent models to study safety and efficacy of new immune globulin (IG) preparations for intravenous use. In a long term study of such patients we showed that a reduced and alkylated IG preparation given intravenously was as effective in preventing infections as Cohn fraction II given intramuscularly. Mild side effects occurred in 50% of infusions; addition of maltose reduced side effects to 3%. Adverse reactions appeared to be related to IG concentration: they were slightly higher if the IG concentration was increased from 5% to 10%. The striking effect of maltose may relate to the observation that maltose and other disaccharides, added to Cohn fraction II, prevent heat aggregation in vitro. The stabilizing effect of these sugars was most pronounced at pH 6-6.5. Thus, modified IG formulated as a 5% solution in 10% maltose seems to be safe, effective and suitable for rapid intravenous infusion.