Use of OM-85 BV in primary prevention of acute respiratory tract infections in children in orphanages

Abstract

A multicenter, open-label clinical trial was conducted to assess the safety and efficacy of OM-85 BV in the primary prevention of acute respiratory tract infections (ARTIs) in children residing in orphanages. Seventy-four children (42 boys and 32 girls; median age, 9 years [2 to 12 years]) received one capsule (3.5 mg) of OM-85 BV once daily for 10 days a month during 3 consecutive months. The incidence of ARTIs was reduced significantly from the month before treatment to the final month of treatment, as were the number of days absent from school and the number of antibiotic treatments. In patients experiencing an ARTI, the time to clinical improvement and the convalescent time decreased from the month before treatment to the final month of treatment; both changes were statistically significant. Serum immunoglobulin G levels increased significantly from before treatment to after the end of treatment; serum immunoglobulin M levels increased significantly during the same period. No significant changes were detected in serum immunoglobulin A levels. No adverse events related to the administration of OM-85 BV were reported. This study shows that OM-85 BV may induce significant primary prevention of ARTI in children living in close contact.