Background: Patients with immunoglobulin (Ig)A and/or IgG subclass deficiency may be asymptomatic or may have recurrent, mainly respiratory infections.Objective: This study compared the clinical efficacy and tolerability of prophylactic therapy with either the oral immunomodulator bacterial extract OM-85 BV or benzathine penicillin G (BPG) in the prevention of recurrent infections in symptomatic patients.Methods: In this 26-month, prospective, randomized study conducted at the Department of Pediatric Immunology, Ege University (Izmir, Turkey), children aged 1 to 12 years with recurrent infections and IgA and/or IgG subclass deficiency were enrolled. After an initial 12-month control period, patients were randomized to receive OM-85 BV or BPG. OM-85 BV (3.5-mg capsule) was given once daily for the first 10 days of each month for the first 3 months of the study. IM injections of BPG were given at a dose of 1.2 million units (for patients with body weight Ͼ27 kg) or at a half-dose (for patients with body weight Յ27 kg) every 3 weeks for 12 months. In nonresponders (ie, those who continued to have recurrent infections at 12-month follow-up), IV immunoglobulin (IVIG) replacement therapy at 400 mg/kg body weight was given every 4 weeks for an additional 12 months. The results of IVIG therapy were assessed by the authors using clinical observation. Adverse effects and adverse drug reactions were documented by the authors for each vaccine, prophylactic therapy, and IVIG.Results 52] months; P ϭ 0.036) and had lower serum IgG (P Ͻ 0.001), IgG1 (P ϭ 0.006), IgG2 (P ϭ 0.003), IgG3 (P ϭ 0.035), and IgM (P ϭ 0.008) levels and antibody responses to tetanus toxoid and Haemophilus influenzae type b (Hib) vaccines (P ϭ 0.036 and 0.013, respectively). At 12-month follow-up, a protective effect of the prophylactic IVIG therapy was seen, with a statistically significant reduction in the number of infections to 3.3 (2.4) and in the number of antibiotic courses to 2.7 (2.5) (both P ϭ 0.005).
Conclusions:In this study population of children with recurrent infections and IgA and/or IgG subclass deficiency, prophylactic therapy with either OM-85 BV or an antibiotic significantly decreased the number of infections per year. In addition, nonresponders benefited from IVIG replacement therapy. (Curr Ther Res Clin Exp. 2003;64:600-615)