Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months


      Acute respiratory tract infections (ARTIs) are among the main causes of morbidity and mortality in children. The bacterial extract OM-85 BV (bronchovaxom) has shown protective effect for ARTIs on children. We report a double-blind, placebo-controlled, parallel, prospective clinical trial to assess the safety and efficacy of two courses of OM-85 BV in the prevention of ARTIs in susceptible children during 12 months.


      Fifty-four susceptible children from 1 to 12 years of age living in the metropolitan area of Chihuahua City were selected. They were randomized to receive either OM-85 BV or placebo (one capsule a day for 10 days a month for 3 consecutive months) at the beginning of the trial and 6 months later with the same schedule. Patients were followed up for 12 months, including the administration period. The trial began in July 1997 and ended in April 1999.


      The number (mean ± SD) of ARTIs was 5.04 ± 1.99 (median, 5.0) in the OM-85 BV group vs 8.0 ± 2.55 (median, 8.0) in the placebo group, with a mean difference of − 2.96 (95% confidence interval [CI],−4.22 to − 1.7). The number of antibiotic courses was 2.46 ± 2.08 (median, 1.5) in the treatment group vs 4.46 ± 2.08 (median, 4.0) in the control group, a difference of − 2.0 (95% CI,− 3.14 to − 0.86). The total duration of ARTIs was 35.23 ± 17.64 days (median, 30.5 days) in the OM-85 BV group vs 60.75 ± 25.44 days (median, 55.0 days) in the placebo group, ie, a difference of − 25.52 days (95% CI, − 37.56 to − 13.47 days),p < 0.001 by Student’s t test and Mann-Whitney U test for all the items. Four patients in the OM-85 BV group had five adverse events. Only one episode of skin rash was related to the medication intake. Six patients in the control group had six adverse events.


      OM-85 BV had a preventive effect on ARTI in the susceptible children for 12 months with an important reduction on the antibiotic requirements and the number of days of suffering ARTIs.

      Key words


      ANOVA (analysis of variance), ARTI (acute respiratory tract infection), CI (confidence interval), IL (interleukin), RTI (respiratory tract infection)
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        • World Health Organization
        Acute respiratory infections: the forgotten pandemic.
        Bull WHO. 1998; 76: 101-103
        • Haskins R
        • Kotch J
        Day care and illness: evidence, costs, and public policy.
        Pediatrics. 1986; 77: 951-982
        • Bell DM
        • Gleiber DW
        • Mercer AA
        • et al.
        Illness associated with child day care: a study of incidence and cost.
        Am J Public Health. 1989; 79: 479-484
        • Luotonen M
        • Uhari M
        • Aitola L
        • et al.
        A nation-wide, population-based survey of otitis media and school achievement.
        Int J Pediatr Otorhinolaryngol. 1998; 43: 41-51
        • Teele DW
        • Klein JO
        • Chase C
        • et al.
        Otitis media in infancy and intellectual ability, school achievement, speech, and language at age 7 years: Greater Boston Otitis Media Study Group.
        J Infect Dis. 1990; 162: 685-694
        • Luotonen M
        • Uhari M
        • Aitola L
        • et al.
        Recurrent otitis media during infancy and linguistic skills at the age of nine years.
        Pediatr Infect Dis J. 1996; 15: 854-858
        • Henderson FW
        • Collier AM
        • Sanyal MA
        • et al.
        A longitudinal study of respiratory viruses and bacteria in the etiology of acute otitis media with effusion.
        N Engl J Med. 1982; 306: 1377-1383
        • Heikkinen T
        • Thint M
        • Chonmaitree T
        Prevalence of various respiratory viruses in the middle ear during acute otitis media.
        N Engl J Med. 1999; 340: 260-264
        • Sazawal S
        • Black RE
        • Jalla S
        • et al.
        Zinc supplementation reduces the incidence of acute lower respiratory infections in infants and preschool children: a double-blind, controlled trial.
        Pediatrics. 1998; 102: 1-5
        • Grimm W
        • Müller HH
        A randomized controlled trial of the effect of fluid extract of Echinacea purpurea on the incidence and severity of colds and respiratory infections.
        Am J Med. 1999; 106: 138-143
        • Heikkinen T
        • Ruohola A
        • Ruuskanen O
        • et al.
        Intranasally administered immunoglobulin for the prevention of rhinitis in children.
        Pediatr Infect Dis J. 1998; 17: 367-372
        • Uhari M
        • Kontiokari T
        • Niemelä M
        A novel use of xylitol sugar in preventing acute otitis media.
        Pediatrics. 1998; 102: 879-884
        • Bessler WG
        • Sedelmeir E
        Biological activity of bacterial cell wall components.
        Arzneim-Forsch/Drug-Res. 1993; 43: 502-507
        • Marchant A
        • Goldman M
        OM-85 BV upregulates the expression of adhesion molecules on phagocytes through a CD14-independent pathway.
        Int J Immunopharmacol. 1996; 18: 259-262
        • Baladi S
        • Kantengwa S
        • Donati YRA
        • et al.
        Effects of the bacterial extract OM-85 on phagocyte functions and the stress response.
        Med Inflamm. 1994; 3: 143-148
        • Keul R
        • Roth M
        • Papakonstantinou E
        • et al.
        Induction of interleukin 6 and interleukin 8 expression by broncho-vaxom (OM-85 BV) via C-Fos/serum responsive element.
        Thorax. 1996; 51: 150-154
        • Roth M
        • Keul R
        • Papakonstantinou E
        • et al.
        Characterization of intracellular signaling transduction and transcription factors involved in broncho-vaxom (OM-85 BV)-induced expression of interleukin-6 and interleukin-8 in human pulmonary fibroblasts.
        Eur Respir Rev. 1996; 6: 171-175
        • Broug-Holub E
        • Persoons JHA
        • Schornagel K
        • et al.
        Changes in cytokine and nitric oxide secretion by rat alveolar macrophages after oral administration of bacterial extracts.
        Clin Exp Immunol. 1995; 101: 302-307
        • Broug-Holub E
        • Kraal G
        Cytokine production by alveolar macrophages after oral administration of OM-85 BV in a rat model.
        Eur Respir Rev. 1996; 6: 163-165
        • Jacquier-Sarlin MR
        • Dreher D
        • Polla BS
        Selective induction of the glucose-regulated protein grp78 in human monocytes by bacterial extract (OM-85): a role for calcium as second messenger.
        Biochem Biophys Res Comm. 1996; 226: 166-171
        • Girard JP
        • Fleury S
        Analyze comparative du lévamisole et d'un lysat bactérien sur la réponse lymphocytaire in vitro.
        Med Hyg. 1979; 37: 2519-2526
        • Maestroni GJ
        • Losa GA
        Clinical and immunobiological effects of an orally administered bacterial extract.
        Int J Immunopharmacol. 1984; 6: 111-117
        • Puigdollers JM
        • Serna GR
        • Hernández del Rey I
        • et al.
        Immunoglobulin production in man stimulated by orally administered bacterial lysate.
        Respiration. 1980; 40: 142-149
        • Emmerich B
        • Emslander HP
        • Pachmann K
        • et al.
        Local immunity in patients with chronic bronchitis and the effects of a bacterial extract, broncho-vaxom, on T lymphocytes, macrophages, γ-interferon and secretory immunoglobulin A in bronchoalveolar lavage fluid and other variables.
        Respiration. 1990; 57: 90-99
        • Lusuardi M
        • Capelli A
        • Carli S
        • et al.
        Local airways immune modifications induced by oral bacterial extracts in chronic bronchitis.
        Chest. 1993; 103: 1783-1791
        • Cvoriscec B
        • Ustar M
        • Pardon R
        • et al.
        Oral immunotherapy of chronic bronchitis: a double-blind placebo-controlled multicenter study.
        Respiration. 1989; 55: 129-135
        • Djuric O
        • Mihailovic-Vucinic V
        • Stojcic V
        Effect of broncho-vaxom on clinical and immunological parameters in patients with chronic obstructive bronchitis: a double-blind, placebo-controlled study.
        Int J Immunother. 1989; V: 139-V143
        • Collet J-P
        • Ducruet T
        • Kramer MS
        • et al.
        Stimulation of nonspecific immunity to reduce the risk of recurrent infections in children attending day-care centers.
        Pediatr Infect Dis J. 1993; 12: 648-652
        • Field J
        • Gómez-Barreto D
        • Del-Rio-Navarro BE
        • et al.
        Use of OM-85 BV in the primary prevention of acute respiratory tract infections in children in orphan ages.
        Cur Ther Res. 1998; 59: 407-418
        • Paupe J
        Immunotherapy with an oral bacterial extract (OM-85 BV) for upper respiratory infections.
        Respiration. 1991; 58: 150-154
        • Gutiérrez-Tarango MD
        • Berber A
        Efficacy of a bacterial extract (OM-85 BV) in preventing recurrent respiratory tract infections in susceptible children.
        Clin Drug Invest. 1997; 13: 76-84
        • Quezada A
        • Maggi L
        • Pérez MA
        • et al.
        Effect of bacterial antigen lysate on IgG and IgA levels in children with recurrent infections and hypogammaglobulinemia.
        J Invest Allergol Clin Immunol. 1999; 9: 178-182
        • Litzman J
        • Lokaj J
        • Gerylovova A
        Orally administered bacterial lysate broncho-vaxom for the treatment of common variable immunodeficiency.
        Allerg Immunol (Paris). 1996; 28: 81-85
        • Selwyn BJ
        The epidemiology of acute respiratory tract infection in young children: comparison of findings from several developing countries.
        Rev Infect Dis. 1990; 12: S870-S888
        • Jara-Pérez JV
        • Berber A
        Primary prevention of acute respiratory tract infections in children using a bacterial immunostimulant: a double-masked, placebo-controlled clinical trial.
        Clin Ther. 2000; 22: 748-759
        • Dixon RE
        Economic costs of respiratory tract infections in the United States.
        Am J Med. 1985; 78: 45-51
        • Gates GA
        Cost-effectiveness considerations in otitis media treatment.
        Otolaryngol Head Neck Surg. 1996; 114: 525-530