A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections

Abstract

Background Over many years, OM-85, a lysate of 21 common bacterial respiratory pathogens, has been demonstrated to prevent respiratory recurrences in children. However, further studies are needed to explore the true importance of OM-85 in the prevention of respiratory tract infections (RTIs) in children. This study was planned to further contribute to the evaluation of the role played by OM-85 in prevention of recurrent RTIs in children. Methods This study was a randomized (3:3:1), placebo-controlled, double-blind, single-centre, phase IV trial carried out in Italy to assess the efficacy of OM-85 (Broncho-Vaxom ® ; Vifor Pharma; Meyrin 2/Geneva, Switzerland) in reducing the number of new RTI episodes in 288 children aged 1 to 6 years with a history of recurrent RTIs and to compare the efficacy of the standard 3-month regimen with that of administration of OM-85 for 6 months during a 6-month study period. Results The number of RTIs and of children who experienced at least one RTI were significantly lower among patients receiving OM-85 for 3 months than among those given placebo (33% vs 65.1%, p < 0.0001). Differences were statistically significant for upper RTIs (i.e., common cold/viral pharyngitis and acute otitis media; p < 0.0001 and p = 0.006, respectively). Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively). No difference was seen between children who received OM-85 for 3 and those who received OM-85 for 6 months. The prevalence of atopy as well as the history of recurrent wheezing and age of the study child did not influence the results. Benefit was maximally evident among children with a history of frequent recurrences. OM-85 was well tolerated and safe, even in children who received an influenza vaccination. Conclusions The use of OM-85 for 3 months in 3 series of 10 consecutive days each time reduces the risk of recurrent RTIs in children, with a favourable safety profile. The greater effect observed in children prone to several respiratory episodes than in non-prone children seems to indicate that this lysate should be administered especially to children with a proven high susceptibility to RTIs.

Paediatric Recurrent Ear, Nose and Throat Infections and Complications: Can We Do More?

“…These results show OM-85 may be administered with IIV to reduce rRTIs in this at-risk paediatric population and does not affect humoral immunity to the vaccine. Follow-up for 14 days after vaccination with IIV given with or without OM-85 showed that OM-85 administered with IIV was well tolerated in the short term [39]. Local and systemic adverse events were similar in both groups, and no serious adverse events were reported.…”

“…In a prospective study of children with IgA deficiency and febrile attacks, treatment with the immunomodulator OM-85 did not affect clinical or laboratory markers for autoimmunity [45], and it was effective and well tolerated in children with mild IgG deficiency [34]. OM-85 was also well tolerated when administered in combination with IIV, did not interfere with antibody titres of vaccine and had no observed effect on humoral immunity [39].…”

“…A randomised, double-blind, placebo-controlled study to assess the efficacy and safety of OM-85 in 288 children aged 1-6 years with rRTIs showed that OM-85 can significantly reduce the risk of new infections (primary endpoint) in these patients, thus limiting the total burden of these diseases regardless of atopy/allergy history [39]. During the study period, at least one new episode of RTI was diagnosed in over 65% of children who were given placebo and in only about one-third of those who received OM-85; efficacy was greater in children at high risk of RTIs (50% of placebo patients had at least three episodes of nasopharyngitis/pharyngitis compared with 21% of OM-85 patients), and recurrences in treated children were reduced by about 50% compared with untreated patients.…”

Silence of the Lambs: The Immunological and Molecular Mechanisms of COVID-19 in Children in Comparison with Adults

“…As already reported, children with COVID-19 show reduced serum cytokine levels and this contrasts with the hypothesis of an enhanced activation of the innate immune system. Moreover, results of studies have suggested that the BCG vaccine could provide protection against SARS-CoV-2 infection [ 57 ], and the use of a bacterial lysate can reduce the incidence, prevalence and/or duration of further infections in children with a history of recurrent respiratory tract infections [ 58 , 59 ]. Regarding the role of the BCG vaccine, it has been shown that the severity of COVID-19 is significantly lower in countries with universal BCG vaccination policies than in those without [ 60 , 61 ].…”

Recurrent respiratory infection protection in children: can we do anything more?

“…Далее профессор остановилась на двойном слепом исследовании, которое провели с целью подтверждения результатов предыдущих исследователей. В нем наблюдались дети в возрасте от 1 до 6 лет с рецидивирующими инфекционными заболеваниями верхних дыхательных путей [12]. Пациентов разделили на 3 группы: 1-я группа -получали ОМ-85 10 дней в месяц в течение 3 мес., затем еще 3 мес.…”