Advances in Therapy

, Volume 18, Issue 4, pp 151–162 | Cite as

Efficacy of a polyvalent bacterial lysate in children with recurrent respiratory tract infections

  • Samuel Bentes Ruah
  • Carlos Ruah
  • Antje van Aubel
  • Stephan Abel
  • Ulrich Elsasser


Respiratory tract infections (RTIs) are the most frequent infections in humans, particularly in children. In addition to intervention, increasing interest is focusing on immunomodulatory therapy for recurrent RTIs, which indicate a reduced defense capacity of the respiratory mucosa. LW 50020, an oral immunomodulator that contains the antigens of seven bacteria common in RTIs, has reduced the number, duration, and severity of RTIs in children and adults. This 56-week placebocontrolled, double-blind study in 188 children investigated whether the efficacy of the standard schedule (immunization cycle + one booster cycle) would be enhanced by additional booster cycles. Efficacy and safety over the long term were also assessed. The rate of infection was reduced by 50% with the standard schedule and could not be further decreased by two consecutive booster cycles. With both schedules, this reduction was sustained during a 28-week treatmentfree observation period that followed the 28-week treatment period. The number of adverse drug reactions was low, and all were transient, expected, and nonserious. These results confirm that LW 50020 is an effective and safe strategy for RTIs.


respiratory tract infections oral immunomodulator bacterial lysate mucosa-associated lymphoid tissue 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Bellanti JA. Recurrent respiratory tract infections in pediatric patients.Drugs. 1997;54:1–4.CrossRefPubMedGoogle Scholar
  2. 2.
    Towns S, Wong M. Assessment of the child with recurrent respiratory infections.Aust Fam Physician. 2000;29:741–746.PubMedGoogle Scholar
  3. 3.
    Wassermann RL, Sorensen RU. Evaluating children with respiratory tract infections: the role of immunization with bacterial polysaccharide vaccine.Pediatr Infect Dis J. 1999;18:157–163.CrossRefGoogle Scholar
  4. 4.
    Korppi M. Recurrent respiratory infections in children: a practical approach for clinical work.Pediatr Pulmonol. 1997;16:144–145.Google Scholar
  5. 5.
    Nafstad P, Hagen JA, Oie L, Magnus P, Jaakkola JJK. Day care centers and respiratory health.Pediatrics. 1999;103:753–758.CrossRefPubMedGoogle Scholar
  6. 6.
    Ferrari M, Tardivo S, Zanolin ME, et al. Serious childhood respiratory infections and asthma in adult life. A population based study.Ann Allergy Asthma Immunol. 1999;83:391–396.PubMedCrossRefGoogle Scholar
  7. 7.
    Paoletti P, Prediletto R, Carrozzi L, et al. Effects of childhood and adolescence-adulthood respiratory infections in a general population.Eur Respir J. 1989;2:428–436.PubMedGoogle Scholar
  8. 8.
    Celedon JC, Litonjua AA, Weiss ST, Gold DR. Day care attendance in the first year of life and illnesses of the upper and lower respiratory tract in children with a familial history of atopy.Pediatrics. 1999;104:495–500.CrossRefPubMedGoogle Scholar
  9. 9.
    Jedrychowski W, Maugeri U, Flak E, Mroz E, Bianchi I. Predisposition to acute respiratory infections among overweight preadolescent children: an epidemiologic study in Poland.Public Health. 1998;112:189–195.PubMedGoogle Scholar
  10. 10.
    Van Cauwenberge PB, Belussi L, Maw AR, Paradise JL, Solow B. The adenoid as a key factor in upper airway infections.Int J Pediatr Otorhinolaryngol. 1995;32(suppl.):71–80.CrossRefGoogle Scholar
  11. 11.
    Lundbäck B. Epidemiology of rhinitis and asthma.Clin Exp Allergy. 1998;28:3–10.PubMedGoogle Scholar
  12. 12.
    Bolte G, Mielck A, Meyer I, Stiller-Winkler R, Heinrich J. Inverse social gradient of secondary immune response parameters in children.Rev Environ Health. 1999;14:135–143.PubMedGoogle Scholar
  13. 13.
    Shapiro ED. Epidemiology of acute respiratory infections.Semin Pediatr Infect Dis. 1998;9:31–36.CrossRefGoogle Scholar
  14. 14.
    Latal Hajnal B, Braun-Fahrländer C, Grize L, et al. Effect of environmental tobacco smoke exposure on respiratory symptoms in children.Schweiz Med Wochenschr. 1999;129:723–730.Google Scholar
  15. 15.
    Jedrychowski W, Flak E. Maternal smoking during pregnancy and postnatal exposure to environmental tobacco smoke as predisposition factors to acute respiratory infections.Environ Health Perspect. 1997;105:302–306.CrossRefPubMedGoogle Scholar
  16. 16.
    Drummond PD, Hewson-Bower B. Increased psychological stress and decreased mucosal immunity in children with recurrent upper respiratory tract infections.J Psychosom Res. 1997; 43:271–278.CrossRefPubMedGoogle Scholar
  17. 17.
    Helmberg A, Böck G, Wolf H, Wick G. An orally administered bacterial immunomodulator primes rabbit neutrophils for increased oxidative burst in response to opsonized zymosan infection.Immunology. 1989;57:3576–3580.Google Scholar
  18. 18.
    Ruedl CH, Albin B, Böck G, Wick G, Wolf H. Oral administration of a bacterial immunomodulator enhances murine intestinal lamina propria and Peyer’s patch lymphocyte traffic to the lung: possible implications for infectious disease prophylaxis and therapy.Int Immunol. 1993;5:29–36.CrossRefPubMedGoogle Scholar
  19. 19.
    Ruedl CH, Frühwirt M, Wick G, Wolf H. Immune response in the lungs following oral immunization with bacterial lysates of respiratory pathogens.Clin Diagn Lab Immunol. 1994;1:150–154.PubMedGoogle Scholar
  20. 20.
    Van Daal GJ, Beusenberg FD, So KL, et al. Protection against influenza virus infection in mice by oral immunization with a polyvalent bacterial lysate.Int J Immunol. 1991;13:831–840.CrossRefGoogle Scholar
  21. 21.
    Van Daal GJ, van’t Veen A, So KL, et al. Oral immunization with polyvalent bacterial lysate and infection withStreptococcus pneumoniae: influence on interferon-gamma and PMN-elastase concentrations in murine bronchoalveolar lavage fluid.Int Immunol. 1993;5:29–36.CrossRefGoogle Scholar
  22. 22.
    Wichels R, Wolfschaffner F, Guggenbichler JP. Prophylaxis of infections.TW Pädiatrie. 1996;9: 421–423.Google Scholar
  23. 23.
    Riedl-Seifert RJ, van Aubel A, Kämmereit A, et al. Recurrent infections during childhood: are they still a “crux medicorum”? [in German].J Pharmacol Ther. 1992;2:108–117.Google Scholar
  24. 24.
    Rutishauser M, Pitzke P, van Aubel A, Elsasser U, Grevers G, Kämmereit A. Use of a polyvalent bacterial lysate in patients with recurrent respiratory tract infections.Adv Ther. 1998;15:330–341.PubMedGoogle Scholar
  25. 25.
    Gooch WM. Potential infectious disease complications of upper respiratory tract infections.Pediatr Infect Dis J. 1998;17:79–82.CrossRefGoogle Scholar
  26. 26.
    Openshaw PJ, Lemanske RF. Respiratory viruses and asthma: can the effects be prevented?Eur Respir J. 1998;12(suppl 27):35S-39S.Google Scholar
  27. 27.
    Mushatt DM. Advances in antimicrobial therapy for respiratory tract infections.Curr Opin Pulm Med. 2000;6:250–253.CrossRefPubMedGoogle Scholar
  28. 28.
    Staats HF, McGhee JR. Application of basic principles of mucosal immunity to vaccine development. In: Kiyono H, Ogra PL, McGhee JR, eds.Mucosal Vaccines. San Diego, Calif: Academic Press; 1996: 17–39.Google Scholar
  29. 29.
    Stead RH, Bienenstock J. Development of new oral vaccines and immunomodulators. In: Riedl-Seifert RJ, ed.Mucosal Immunology. Munich: Zuckschwerdt Verlag; 1998:119–128.Google Scholar
  30. 30.
    Walker RI. New strategies for using mucosal vaccination to achieve more effective immunization.Vaccine. 1994;12:387–400.CrossRefPubMedGoogle Scholar
  31. 31.
    Monto AS, Sullivan KM. Acute respiratory illness in the community. Frequency of illness and the agents involved.Epidemiol Infect. 1993;110:145–160.PubMedCrossRefGoogle Scholar
  32. 32.
    Jones NS. Current concepts in the management of pediatric rhinosinusitis.J Laryngol Otol. 1999; 113:1–9.PubMedGoogle Scholar
  33. 33.
    Stögmann W. Das infektanfällige Kind.Tägl Pract. 1992;3:283–294.Google Scholar
  34. 34.
    Grevers G, Aldrey O, Rodriguez B, Abel S, van Aubel A. Treatment of recurrent respiratory tract infections with a polyvalent bacterial lysate: results of an open, prospective, multinational study.Adv Ther. 2000;7:103–116.Google Scholar
  35. 35.
    Büchner KR.Treatment of Out-Patients With Recurrent Respiratory Tract Infections. Bayreuth, Germany: PCO Publisher; 1994.Google Scholar

Copyright information

© Health Communications Inc 2001

Authors and Affiliations

  • Samuel Bentes Ruah
    • 1
  • Carlos Ruah
    • 1
  • Antje van Aubel
    • 2
  • Stephan Abel
    • 2
  • Ulrich Elsasser
    • 2
  1. 1.Universidade NovaLisbonPortugal
  2. 2.Sankyo Pharma GmbHMunichGermany

Personalised recommendations