New Prospects for the Application of Om-85: A Literature Review

The bacterial lysate OM-85 is a well-studied immunomodulator with a favorable safety profile. Its efficacy in the prevention and combination therapy of recurrent respiratory infections in children has been confirmed by numerous clinical trials, which have demonstrated a reduction in infection frequency, antibiotic use, and disease duration. Mechanistically, OM-85 induces interferon synthesis, enhances secretory IgA production, and modulates the T-helper (Th) balance by promoting a Th1-skewed response and activating regulatory T cells. These immunomodulatory properties open up prospects for its use as part of combination therapy in T2-mediated conditions, including bronchial asthma, allergic rhinitis, and atopic dermatitis. Promising directions for further research include evaluating the efficacy of extended OM-85 courses lasting up to 6–9 months, as well as investigating its role in the primary prevention of allergic diseases. Thus, the potential of OM-85 is not limited to the prevention of respiratory infections and may extend to the development of novel approaches for managing a broad range of immune-mediated disorders.

1. Ostraya respiratornaya virusnaya infektsiya (ORVI): Clinical guidelines. Union of Pediatricians of Russia. Moscow; 2022. 42 p. (In Russ). Доступно по: https://cr.minzdrav.gov.ru/preview-cr/25_2. Ссылка активна на 20.11.2025.

2. Ostrye respiratornye zabolevaniya u detei: lechenie i profilaktika: lechenie i profilaktika: Manual for doctors. Baranov AA, ed. Moscow: Mezhdunarodnyi Fond okhrany zdorov’ya materi i rebenka; 2002. 70 p. (In Russ).

3. Safiri S, Mahmoodpoor A, Kolahi AA, et al. Global burden of lower respiratory infections during the last three decades. Front Public Health. 2023;10:1028525. doi: https://doi.org/10.3389/fpubh.2022.1028525

4. Rossi GA, Pohunek P, Feleszko W, et al. Viral infections and wheezing-asthma inception in childhood: is there a role for immunomodulation by oral bacterial lysates? Clin Transl Allergy. 2020;10:17. doi: https://doi.org/10.1186/s13601020-00322-1

5. Renz H, Holt PG, Inouye M, et al. An exposome perspective: Earlylife events and immune development in a changing world. J Allergy Clin Immunol. 2017;140(1):24–40. doi: https://doi.org/10.1016/j.jaci.2017.05.015

6. Olin A, Henckel E, Chen Y, et al. Stereotypic Immune System Development in Newborn Children. Cell. 2018;174(5):1277–1292. e14. doi: https://doi.org/10.1016/j.cell.2018.06.045

7. Groves HE, Piché-Renaud PP, Peci A, et al. The impact of the COVID-19 pandemic on influenza, respiratory syncytial virus, and other seasonal respiratory virus circulation in Canada: A populationbased study. Lancet Reg Health Am. 2021;1:100015. doi: https://doi.org/10.1016/j.lana.2021.100015

8. Ryan FJ, Hope CM, Masavuli MG, et al. Long-term perturbation of the peripheral immune system months after SARS-CoV-2 infection. BMC Med. 2022;20(1):26. doi: https://doi.org/10.1186/s12916021-02228-6

9. L’vov DK, Burtseva EI, Kolobukhina LV, et al. Peculiarities of the influenza and ARVI viruses during epidemic season 2019–2020 in some regions of Russia. Problems of Virology = Voprosy Virusologii. 2020;65(6):335–349. (In Russ). doi: https://doi.org/10.36233/0507-4088-202065-6-4

10. Corsello A, Milani GP, Picca M, et al. Recurrent upper respiratory tract infections in early childhood: a newly defined clinical condition. Ital J Pediatr. 2024;50(1):30. doi: https://doi.org/10.1186/s13052-024-01600-5

11. Collaro AJ, McElrea MS, Marchant JM, et al. The effect of early childhood respiratory infections and pneumonia on lifelong lung function: a systematic review. Lancet Child Adolesc Health. 2023;7(6):429–440. doi: https://doi.org/10.1016/S2352-4642(23)00030-5

12. Mukozheva RA, Kulichenko TV, Vilchanskaya TV, et al. Outpatient Management of Acute Respiratory Infections in Children. Pediatricheskaya farmakologiya — Pediatric pharmacology. 2021;18(5):359–366. (In Russ). doi: https://doi.org/10.15690/pf.v18i5.2298]

13. Del-Rio-Navarro BE, Espinosa Rosales F, Flenady V, SienraMonge JJ. Immunostimulants for preventing respiratory tract infection in children. Cochrane Database Syst Rev. 2006;(4):CD004974. doi: https://doi.org/10.1002/14651858.CD004974.pub2

14. Di Gioacchino M, Santilli F, Pession A. Is There a Role for Immunostimulant Bacterial Lysates in the Management of Respiratory Tract Infection? Biomolecules. 2024;14(10):1249. doi: https://doi.org/10.3390/biom14101249

15. Rozy A, Chorostowska-Wynimko J. Bacterial immunostimulants--mechanism of action and clinical application in respiratory diseases. Pneumonol Alergol Pol. 2008;76(5):353–359.

16. Zhu LL, Wang YH, Feng JH, et al. Oral Bacterial Lysate OM-85: Advances in Pharmacology and Therapeutics. Drug Des Devel Ther. 2024;18:4387–4399. doi: https://doi.org/10.2147/DDDT.S484897

17. Esposito S, Cassano M, Cutrera R, et al. Expert consensus on the role of OM-85 in the management of recurrent respiratory infections: A Delphi study. Hum Vaccin Immunother. 2022;18(6):2106720. doi: https://doi.org/10.1080/21645515.2022.2106720

18. Luan H, Zhang Q, Wang L, et al. OM85-BV induced the productions of IL-1β, IL-6, and TNF-α via TLR4and TLR2-mediated ERK1/2/ NFB pathway in RAW264.7 cells. J Interferon Cytokine Res. 2014;34(7):526–536. doi: https://doi.org/10.1089/jir.2013.0077

19. Parola C, Salogni L, Vaira X, et al. Selective activation of human dendritic cells by OM-85 through a NF-kB and MAPK dependent pathway. PLoS One. 2013;8(12):e82867. doi: https://doi.org/10.1371/journal.pone.0082867

20. Cardinale F, Lombardi E, Rossi O, et al. Epithelial dysfunction, respiratory infections and asthma: the importance of immunomodulation. A focus on OM-85. Expert Rev Respir Med. 2020;14(10):1019– 1026. doi: https://doi.org/10.1080/17476348.2020.1793673

21. Rahman MM, Grice ID, Ulett GC, Wei MQ. Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer. J Immunol Res. 2024;2024:4312908. doi: https://doi.org/10.1155/2024/4312908

22. Huber M, Mossmann H, Bessler WG. Th1-orientated immunological properties of the bacterial extract OM-85-BV. Eur J Med Res. 2005;10(5):209–217.

23. Dang AT, Pasquali C, Ludigs K, Guarda G. OM-85 is an immunomodulator of interferon-β production and inflammasome activity. Sci Rep. 2017;7:43844. doi: https://doi.org/10.1038/srep43844

24. Yin J, Xu B, Zeng X, Shen K. Broncho-Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta-analysis. Int Immunopharmacol. 2018;54:198–209. doi: https://doi.org/10.1016/j.intimp.2017.10.032

25. Esposito S, Soto-Martinez ME, Feleszko W, et al. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol. 2018;18(3):198209. doi: https://doi.org/10.1097/ACI.0000000000000433

26. Schaad UB. OM-85 BV, an immunostimulant in pediatric recurrent respiratory tract infections: a systematic review. World J Pediatr. 2010;6(1):5–12. doi: https://doi.org/10.1007/s12519-010-0001-x

27. Steurer-Stey C, Lagler L, Straub DA, et al. Oral purified bacterial extracts in acute respiratory tract infections in childhood: a systematic quantitative review. Eur J Pediatr. 2007;166(4):365–376. doi: https://doi.org/10.1007/s00431-006-0248-3

28. De la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, et al. Comparative metaanalysis of immunoestimulant agents used in pediatric patients in Mexico. Rev Alerg Mex. 2005;52(1):25–38.

29. Cao C, Wang J, Li Y, et al. Efficacy and safety of OM-85 in paediatric recurrent respiratory tract infections which could have a possible protective effect on COVID-19 pandemic: A meta-analysis. Int J Clin Pract. 2021;75(5):e13981. doi: https://doi.org/10.1111/ijcp.13981

30. Esposito S, Bianchini S, Bosis S, et al. A randomized, placebocontrolled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections. J Transl Med. 2019;17(1):284. doi: https://doi.org/10.1186/s12967-019-2040-y

31. Esposito S, Ballarini S, Argentiero A, et al. Microbiota profiles in pre-school children with respiratory infections: Modification induced by the oral bacterial lysate OM-85. Front Cell Infect Microbiol 2022;12:789436. doi: https://doi.org/10.3389/fcimb.2022.789436

32. Foshina EP, Kostinov MP, Poddubikov AV. Influence of bacterial vaccines on the nasopharyngeal microbiocenosis state and evaluation of their clinical efficacy in children with chronic rhinosinusitis and tonsillopharyngitis. Pediatria. Journal n.a. G.N. Speransky. 2018;97(2):129–133. (In Russ). doi: https://doi.org/10.24110/0031-403X-2018-97-2-129-133

33. Chuvirova AG, Yartsev MN. Clinical and immunological characteristic of children with recurrent episodes of acute laryngotracheitis, acute respiratory infections, otorhinolaryngological deseases. Allergology and Immunology in Paediatrics. 2023;(2):33–43. (In Russ). doi: https://doi.org/10.53529/2500-1175-2023-2-33-43

34. Buendía JA, Patiño DG, Lindarte EF. OM-85 BV in pediatric recurrent respiratory tract infections: a cost-utility analysis. BMC Pulm Med. 2022;22(1):465. doi: https://doi.org/10.1186/s12890-02202264-9

35. Shamsheva OV, Kladova OV, El’shina GA. Profilaktika grippa i ostrykh respiratornykh zabolevanii sochetannym vvedeniem vaktsiny Inflyuvak i bakterial’nogo lizata IRS-19. Detskie infektsii. 2002;(1):65–67. (In Russ).

36. Kalyuzhin OV. OM-85 in the prevention/treatment of respiratory infections and exacerbations of chronic lung diseases: selection criteria, mechanisms and evidence. Lechaschi Vrach. 2018;(3):77–82. (In Russ).

37. Zagar S, Löfler-Badzek D. Broncho-Vaxom in children with rhinosinusitis: a double-blind clinical trial. ORL J Otorhinolaryngol Relat Spec. 1988;50(6):397–404. doi: https://doi.org/10.1159/000276020

38. Berber AC, Del-Rio-Navarro BE. Use of Broncho-Vaxom in private practice: phase IV trial in 587 children. Clin Ther. 1996;18(6):1068– 1079. doi: https://doi.org/10.1159/000276020.10.1016/s0149-2918(96)80062-2

39. Liu YW, Dong SH, Zhan GY, et al. Analysis of the effect of bacterial lysate and the immunologic mechanism in treating infant bronchiolitis. Eur Rev Med Pharmacol Sci. 2017;21(14):3332–3336.

40. Shen Y. Effect and mechanism of Broncho-Vaxom in the treatment of recurrent respiratory tract infections in children. J Pediatr Pharm. 2014;20(1):32–34.

41. Zhu H, Zhang H, Hu W. Clinical observation on 60 cases of recurrent respiratory tract infections in children treated by Bronchovaxom combined with routine treatment. China Prac Med. 2015;10(7):140–141.

42. Chang Y, Liu L, Wang J, et al. Clinical effect of bacterial lysates in the treatment of children with repeated respiratory infections. Int J Pediatr. 2017;44(10):710–713.

43. Kalyuzhin OV, Gorelov AV, Malyavin AG, et al. Efficacy and safety of bacterial lysate OM-85 in the treatment of uncomplicated acute respiratory infections: a double-blind, placebocontrolled, multicenter, randomized trial. Terapevticheskii Arkhiv. 2023;95(10):850–858. (In Russ). doi: https://doi.org/10.26442/00403660.2023.10.202464

44. Tsuge M, Ikeda M, Tsukahara H. Novel Lung Growth Strategy with Biological Therapy Targeting Airway Remodeling in Childhood Bronchial Asthma. Children (Basel). 2022;9(8):1253. doi: https://doi.org/10.3390/children9081253

45. Lu Y, Li Y, Xu L, et al. Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. Pharmacology. 2015;95(3-4):139–144. doi: https://doi.org/10.1159/000377683

46. Han L, Zheng CP, Sun YQ, et al. A bacterial extract of OM-85 Broncho-Vaxom prevents allergic rhinitis in mice. Am J Rhinol Allergy. 2014;28(2):110–116. doi: https://doi.org/10.2500/ajra.2013.27.4021

47. Yao S, Qin R, Song X, et al. Bacterial lysate add-on therapy in adult and childhood asthma: a systematic review and meta-analysis. J Thorac Dis. 2023;15(6):3143–3157. doi: https://doi.org/10.21037/jtd-22-1469

48. de Boer GM, Żółkiewicz J, Strzelec KP, et al. Bacterial lysate therapy for the prevention of wheezing episodes and asthma exacerbations: a systematic review and meta-analysis. Eur Respir Rev. 2020;29(158):190175. doi: https://doi.org/10.1183/16000617.0175-2019

49. Christopoulou ME, Panteli LS, Moisidis JA, et al. Oral Bacterial Lysate OM-85 Prevents Respiratory Tract Infections in Asthma: The OMRIA RWE Study. J Asthma Allergy. 2025;18:891–902. doi: https://doi.org/10.2147/JAA.S517194

50. Huang X, Zhang X, Zhang Z, et al. Bacterial lysates in allergic rhinitis and chronic rhinosinusitis: Mechanisms and clinical evidence. Sci Prog. 2025;108(2):368504251355373. doi: https://doi.org/10.1177/00368504251355373

51. Meng Q, Li P, Li Y. Broncho-vaxom alleviates persistent allergic rhinitis in patients by improving Th1/Th2 cytokine balance of nasal mucosa. Rhinology. 2019;57(6):451–459. doi: https://doi.org/10.4193/Rhin19.161

52. Yan H, Hong J, Zeng C, et al. The impact of bacterial lysate (OM85) on clinical and immunological parameters in children with allergic rhinitis. Eur Arch Otorhinolaryngol. 2025;282(11):5703–5709. doi: https://doi.org/10.1007/s00405-025-09728-8

53. Bodemer C, Guillet G, Cambazard F, et al. Adjuvant treatment with the bacterial lysate (OM-85) improves management of atopic dermatitis: a randomized study. PLoS One. 2017;12(3):e0161555. doi: https://doi.org/10.1371/journal.pone.0161555

54. Stein MM, Hrusch CL, Gozdz J, et al. Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children. N Engl J Med. 2016;375(5):411–421. doi: https://doi.org/10.1056/NEJMoa1508749

55. Rahbek-Hansen SH, Mikkelsen M, Stokholm J, et al. Preventive effects of prenatal administration of OM-85/BV on asthma and respiratory infection risk in the offspring: A review of animal models. Pediatr Allergy Immunol. 2024;35(6):e14184. doi: https://doi.org/10.1111/pai.14184

56. Mincham KT, Scott NM, Lauzon-Joset JF, et al. Transplacental immune modulation with a bacterial-derived agent protects against 4869. doi: https://doi.org/10.1172/JCI122631

57. Maggi L, Mazzoni A, Capone M, et al. The dual function of ILC2: From host protection to pathogenic players in type 2 asthma. Mol Aspects Med. 2021;80:100981. doi: https://doi.org/10.1016/j.mam.2021.100981

58. Zou W, Ma D, Sun F, et al. Maternal OM-85 administration alleviates offspring allergic airway inflammation by downregulating IL-33/ILC2 axis. Pediatr Allergy Immunol. 2025;36(2):e70044. doi: https://doi.org/10.1111/pai.70044

59. Kazy Z, Czeizel E. A population-based case-control study of broncho-vaxom use during pregnancy. Orv Hetil. 2005;146(46):2359–2361.