Elsevier

The Journal of Pediatrics

Volume 123, Issue 5, November 1993, Pages 801-810
The Journal of Pediatrics

Bacterial polysaccharide immune globulin for prophylaxis of acute otitis media in high-risk children1,2

https://doi.org/10.1016/S0022-3476(05)80865-0Get rights and content

We evaluated the prevention of recurrences of acute otitis media (AOM) bybacterial polysaccharide immune globulin (BPIG), a hyperimmune human immune globulin prepared by immunizing donors with bacterial polysaccharide vaccines. We used a randomized, stratified, double-blind, placebo-controlied design. Children ≤24 months of age with 1 to 3 prior episodes of AOM received BPIG, 0.5 ml/kg, or saline placebo intramuscularly at entry and 30 days later. During the 120-day follow-up period, AOM was diagnosed by using clinical criferia and was confimed with tympanocentesis and culture of the middle ear exudates. Eighty-eight episodes of AOM were observed in 76 patients who completed the study. The incidence of AOM during the entire 120-day study period was similar in BPIG and placebo recipients. Pneumococcal AOM was significantly less frequent in BPIG reciplents (0.21 episode per patient) 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 stimulation of specific local immunity, may prevent infection of the middle ear. The use of immune globulin preparations for longer periods or at a higher dosage might decrease the incidence of recurrent AOM in otitis-prone children, and deserves further evaluation.

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    1

    Supported by grants (Nos. 1RO1 HD18753 01A1GT and A1 18125) from the National Institutes of Health.

    Presented in part at the 28th Interscience conference on Antimicrobial Agents and Chemotherapy, Los Angeles Calif., October 1988.

    2

    Reprints not available.

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