BACTERIAL POLYSACCHARIDE IMMUNE GLOBULIN FOR PROPHYLAXIS OF ACUTE OTITIS-MEDIA IN HIGH-RISK CHILDREN

We evaluated the prevention of recurrences of acute otitis medio (AOM) by bacterial polysaccharide immune globulin (BPIG), a hyperimmune hum an immune globulin prepared by immunizing donors with bacterial polysa ccharide vaccines. We used a randomized, stratified, double-blind, pla cebo-controlled design. Children less-than-or-equal-to 24 months of ag e with 1 to 3 prior episodes of AOM received BPIG, 0.5 ml/kg, or salin e placebo intramuscularly at entry and 30 days later. During the 120-d ay follow-up period, AOM was diagnosed by using clinical criteria and was confirmed with tympanocentesis and culture of the middle ear exuda tes. Eighty-eight episodes of AOM were observed in 76 patients who com pleted the study. The incidence of AOM during the entire 120-day study period was similar in BPIG and placebo recipients. Pneumococcal AOM w as significantly less frequent in BPIG recipients (0.21 episode per pa tient) than in placebo recipients (0.45 episode per patient; p = 0.05) . Time spent free of AOM was significantly prolonged in recipients of BPIG, in comparison with placebo recipients (51 vs 35 days; p = 0.034) . This study demonstrated that circulating antibody, even without stim ulation of specific local immunity, may prevent infection of the middl e ear. The use of immune globulin preparations for longer periods or a t a higher dosage might decrease the incidence of recurrent AOM in oti tis-prone children, and deserves further evaluation.