Prevention of cytomegalovirus infection by prophylaxis with an intravenous, hyperimmune, native, unmodified cytomegalovirus globulin. Randomized trial in bone marrow transplant recipients

Abstract

We have completed a randomized trial to evaluate the safety and effectiveness of hyperimmune cytomegalovirus intravenous human globulin in prevention of cytomegalovirus infection and related problems in bone marrow transplant recipients. Prophylactic intravenous administration of this native, intact, hyperimmune, cytomegalovirus IgG, at a dose of 200 mg/kg 25, 50, and 75 days following transplant resulted in complete protection against cytomegalovirus infection during the 120 days covered by the treatment (p = 0.009). There was no interstitial pneumonia or mortality in the group receiving the hyperimmune IgG. This is significant at the p = 0.014 when compared with the supporting treatment control group. In bone marrow transplant recipients, prophylaxis with a total dosage of 0.6 g/kg of an intravenous hyperimmune cytomegalovirus globulin was safe and afforded effective protection against cytomegalovirus infection and interstitial pneumonia in this high-risk population.