Hyperimmune globulin

Abstract: We undertook a prospective randomized trial to examine whether an intravenous cytomegalovirus (CMV) immune globulin would prevent primary CMV disease in renal-transplant recipients. Fifty-nine CMV-seronegative patients who received kidneys from donors who had antibodies against CMV were assigned to receive either intravenous CMV immune globulin or no treatment. The immune globulin was administered in multiple doses over the first four months after transplantation. The incidence of virologically confirmed CMV-associated syndromes was reduced from 60 percent in controls to 21 percent in recipients of CMV immune globulin (P less than 0.01). Fungal or parasitic superinfections were not seen in globulin recipients but occurred in 20 percent of controls (P = 0.05). Only 4 percent of globulin recipients had marked leukopenia (reflecting serious CMV disease), as compared with 37 percent of the controls (P less than 0.01). There was a concomitant but not statistically significant reduction in the incidence of CMV pneumonia (17 percent of controls as compared with 4 percent of globulin recipients). A significant reduction in serious CMV-associated disease was observed even when patients were stratified according to therapy for transplant rejection (P = 0.04). We observed no effect of immune globulin on rates of viral isolation or seroconversion, suggesting that treated patients often harbored the virus but that clinically evident disease was much less likely to develop in them. We conclude that CMV immune globulin provides effective prophylaxis in renal-transplant recipients at risk for primary CMV disease.

Abstract: Background Congenital infection with human cytomegalovirus (CMV) is a major cause of morbidity and mortality. In an uncontrolled study published in 2005, administration of CMV-specific hyperimmune globulin to pregnant women with primary CMV infection significantly reduced the rate of intrauterine transmission, from 40% to 16%. Methods We evaluated the efficacy of hyperimmune globulin in a phase 2, randomized, placebo-controlled, double-blind study. A total of 124 pregnant women with primary CMV infection at 5 to 26 weeks of gestation were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid. The primary end point was congenital infection diagnosed at birth or by means of amniocentesis. Results A total of 123 women could be evaluated in the efficacy analysis (1 woman in the placebo group withdrew). The rate of congenital infection was 30% (18 fetuses or infants ...

Abstract: Approximately 1 % of all newborn infants reportedly have congenital cytomegalovirus (CMV) infection. The disorder is symptomatic in approximately one in 10 infants, and clinically significant neurologic sequelae develop in nearly half of them. Neurologic defects eventually develop in as many as 13% of newborn infants who lack symptoms. This prospective study evaluated hyperimmune globulin for treating or preventing fetal CMV infection. Participants were pregnant women with primary CMV infection. Women with primary infection for longer than 6 weeks were offered amniocentesis and treatment with 200 U/kg of intravenous hyperimmune globulin if CMV DNA was identified in amniotic fluid. If necessary, subsequent doses of 400 U/kg were given intravenously or into the umbilical cord or amniotic fluid. Women who declined amniocentesis were offered preventive treatment (100 U/kg of hyperimmune globulin per month). Untreated women served as control subjects. Of women with documented fetal infection, only one of 31 given hyperimmune globulin delivered an infant with CMV disease compared with 7 of 14 untreated women. On logistic regression analysis, treatment significantly lowered the risk of congenital disease. For prevention of fetal infection, 37 women received monthly infusions of hyperimmune globulin 2 to 11 weeks after presumed maternal seroconversion. Of these, 6 (16%) delivered an infected infant compared with 19 of 47 (40%) of untreated women. Treatment was the only factor that predicted a significant reduction in the risk of congenital infection. Treatment, whether therapeutic or preventive, correlated significantly with increased titers of CMV-specific immunoglobulin G. The percentage of total natural killer cells was significantly less in women receiving hyperimmune globulin. No adverse events were observed. Intravenous treatment with CMV-specific hyperimmune globulin is safe and may be effective both in preventing congenital infection and treating established infection.