Broncho-Vaxom Research Articles

Effect of Broncho-Vaxom (OM-85) on the frequency of chronic obstructive pulmonary disease (COPD) exacerbations

BackgroundEfforts have been made to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations using a variety of measures. Broncho-Vaxom (BV) is an immunomodulating agent that has shown potential benefit by balancing between immune stimulation and regulation in patients with COPD. In this study, we evaluated the clinical efficacy of BV for reducing the risk of COPD exacerbations.MethodsThis study was based on the Korean National Health Insurance database, which contains reimbursement information for almost the entire population of South Korea. We extracted data from 2016 to 2019 for patients started on BV during 2017–2018. We collected baseline data on demographics, comorbidities, inhaler use, hospital type, and insurance type 1 year before starting BV. We also analyzed exacerbation history, starting from the year before BV initiation.ResultsIn total, 238 patients were enrolled in this study. Their mean age was 69.2 ± 9.14 years, 79.8% were male, and 45% experienced at least one exacerbation. BV reduced the risk of moderate (odds ratio [OR] = 0.59, 95% confidence interval [CI]: 0.38–0.91) and moderate-to-severe exacerbations compared to pre- and post-BV (OR = 0.571, 95% CI: 0.37–0.89). BV use also reduced the incidence of moderate and moderate-to-severe exacerbations (incidence rate ratio [IRR] = 0.75, p = 0.03; and IRR = 0.77, p = 0.03, respectively). The use of BV was significantly delayed moderate exacerbations (hazard ratio = 0.68, p = 0.02), but not with moderate-to-severe or severe exacerbations.ConclusionThe use of BV was associated with fewer moderate and moderate-to-severe exacerbations. Additionally, BV was associated with a delay in moderate COPD exacerbations.

Broncho-Vaxom bacterial lysate prevents asthma via acetate enhancement in mouse model.

Broncho-Vaxom (BV) is known to attenuate allergic airway inflammation and chronic bronchitis in humans, but the underlying mechanism of this gut-mediated immunity remains unclear. This study investigated the effects of an oral BV on gut and systemic short-chain fatty acids (SCFAs) and immune responses. Oral BV was administered daily for 15 days prior to commencing the study in an asthma mouse model. Asthma was induced by ovalbumin (OVA) sensitization followed by a challenge with 1% OVA by inhalation. Asthmatic phenotypes, gut- and systemic- immune responses, and SCFAs in the cecum and blood were then investigated. Airway hyperresponsiveness, total immunoglobulin E production, and pulmonary inflammation were all significantly suppressed by BV. The interleukin-13 level was also suppressed, whereas TGF-β expression was increased, in the lungs of the BV-treated mice. The regulatory T (Treg) cell numbers were increased in the small intestine, and the acetate level was increased in the cecum and serum after BV treatment. The levels of acetate in the cecum and serum were negatively correlated with airway hyperresponsiveness and with the eosinophil numbers in the BAL fluid of the OVA-induced mice. There was a positive correlation between the acetate levels in the feces and serum and the lung expression of TGF-β in the asthma mice. Oral BV administration appears to prevent allergic inflammation by enhancing Treg cell proliferation and acetate production in an asthmatic mouse model.

Innate Immune Training with Bacterial Extracts Enhances Lung Macrophage Recruitment to Protect from Betacoronavirus Infection

Training of the innate immune system with orally ingested bacterial extracts was demonstrated to have beneficial effects on infection clearance and disease outcome. The aim of our study was to identify cellular and molecular processes responsible for these immunological benefits. We used a murine coronavirus (MCoV) A59 mouse model treated with the immune activating bacterial extract Broncho-Vaxom (BV) OM-85. Tissue samples were analysed with qPCR, RNA sequencing, histology, and flow cytometry. After BV OM-85 treatment, interstitial macrophages accumulated in lung tissue leading to a faster response of type I interferon (IFN) signalling after MCoV infection resulting in overall lung tissue protection. Moreover, RNA sequencing showed that lung tissue from mice receiving BV OM-85 resembled an intermediate stage between healthy and viral infected lung tissue at day 4, indicating a faster return to normal tissue homoeostasis. The pharmacologic effect was mimicked by adoptively transferring naive lung macrophages into lungs from recipient mice before virus infection. The beneficial effect of BV OM-85 was abolished when inhibiting initial type I IFN signalling. Overall, our data suggest that BV OM-85 enhances lung macrophages allowing for a faster IFN response towards a viral challenge as part of the oral-induced innate immune system training.

Broncho-vaxom alleviates persistent allergic rhinitis in patients by improving Th1/Th2 cytokine balance of nasal mucosa.

Probiotics are mainly distributed in the mucosal system and have the ability to enhance mucosal barrier function and regulate immune responses. Broncho-Vaxom (BV), as a probiotic, has been applied to patients suffering from respiratory tract infections, but its potential effectiveness in allergic rhinitis (AR) has not been evaluated in human. This study aimed to investigate the clinical efficacy of BV in patients with persistent AR and to elucidate the underlying cellular mechanisms. Sixty patients with AR were enrolled to this study and were randomly assigned to the BV group (n=30) and the placebo group (n=30). Changes of clinical symptoms and laboratory parameters of allergic inflammation were measured at baseline visit, immediately after BV treatment, four weeks, and eight weeks after the BV treatment. After BV treatment, medication score in the BV group was significantly decreased compared with placebo group, along with a significant drop of the total nasal symptom score and the individual nasal symptom scores (itching score: 23.72±5.32%; nasal rhinorrhea score: 18.59±4.83%; sneezing score: 23.08±4.98%). The levels of IL-4 and IL-13 in nasal lavage were diminished remarkably while the level of INF-γ was markedly increased in the BV group. This rendered a significant reduction of the ratio of IL-4/INF-γ. Moreover, a decrease of eosinophils in nasal smear was observed after BV treatment. The BV-induced favorable changes sustained for at least four to eight weeks post BV treatment. Oral administration of BV offers remarkable and sustained efficacy in alleviating AR symptoms and may be considered as an alternative therapeutic strategy for patients with persistent AR. BV acts by improving the overall mucosal immunity via restoring and maintaining the normal Th1/Th2 cytokine balance as an underlying cellular/signaling mechanism.

Broncho Vaxom (OM-85) modulates rhinovirus docking proteins on human airway epithelial cells via Erk1/2 mitogen activated protein kinase and cAMP.

BackgroundBronchial epithelial cells (BEC) are primary target for Rhinovirus infection through attaching to cell membrane proteins. OM-85, a bacterial extract, improves recovery of asthma and COPD patients after viral infections, but only part of the mechanism was addressed, by focusing on defined immune cells.ObjectiveWe therefore determined the effect of OM-85 on isolated primary human BEC of controls (n = 8), asthma patients (n = 10) and COPD patients (n = 9).MethodsBEC were treated with OM-85 alone (24 hours) or infected with Rhinovirus. BEC survival was monitored by manual cell counting and Rhinovirus replication by lytic activity. Immuno-blotting and ELISA were used to determine the expression of Rhinovirus interacting proteins: intracellular adhesion molecule (ICAM), major histocompatibility complex class II (MHC-2), complement component C1q receptor (C1q-R), inducible T-Cell co-stimulator (ICOS), its ligand ICOSL, and myeloid differentiation primary response gene 88 (Myd88); as well as for signal transducers Erk1/2, p38, JNK mitogen activated protein kinases MAPK), and cAMP.ResultsOM-85 significantly reduced Rhinovirus-induced BEC death and virus replication. OM-85 significantly increased the expression of virus interacting proteins C1q-R and β-defensin in all 3 probes and groups, which was prevented by either Erk1/2 MAPK or cAMP inhibition. In addition, OM-85 significantly reduced Rhinovirus induced expression of ICAM1 involving p38 MAPK. In BEC OM-85 had no significant effect on the expression of ICOS, ICOSL and MHC-2 membrane proteins nor on the adaptor protein MyD88.ConclusionThe OM-85-induced increased of C1q-R and β-defensin, both important for antigen presentation and phagocytosis, supports its activity in host cell’s defence against Rhinovirus infection.

Bacterial Lysate Increases the Percentage of Natural Killer T Cells in Peripheral Blood and Alleviates Asthma in Children

Aims: To assess the efficacy of conventional treatment combined with bacterial lysate [OM-85 Broncho-Vaxom (BV)] in the prevention of asthma in children as well as its influence on the number of natural killer T (NKT) cells and their cytokine production. Materials and Methods: Sixty children diagnosed with asthma were divided into either a BV-treated group (with oral OM-85 BV) or a conventional inhaled corticosteroid (ICS) group. The numbers of NKT cells and CD4+ NKT cells were measured in the peripheral blood by flow cytometry. The levels of IFN-γ, IL-4, and IL-10 after the blood cells had been cultured with an NKT cell agonist were detected by ELISA. Results: After therapy, asthma attacks were significantly decreased compared with before therapy in both groups. However, after therapy, respiratory tract infections were reduced compared with before therapy in the BV-treated group only. Additionally, the frequency of asthma attacks and use of antibiotics in the BV-treated group were lower than in the ICS group. With BV treatment, the numbers of peripheral blood NKT cells and CD4+ NKT cells were higher after therapy than before therapy. After therapy, the ratio of IFN-γ/IL-4 and IL-10 levels were increased in the BV-treated group, whereas IL-4 was reduced in the BV-treated group compared with the ICS group. Conclusion: BV combined with conventional asthma treatment can prevent recurrent respiratory tract infections and suppress the severity of asthma attacks, possibly by altering the rates and cytokines of NKT cells.

The analysis of the influence of the adenoiditis treatment by different methods on the nasopharyngeal microbiocenosis in the children

The objective of the present study was to analyze the quality of nasopharyngeal sanation during the treatment of the children presenting with exacerbations of chronic adenoiditis with the use of different methods. Another objective was to estimate the influence of individual methods on the indigenous microflora. The study has revealed the prevailing groups of microflora in the nasopharynx, nasal cavity, and palatine tonsils of 2.228 patients. The clinical examination and comparative analysis of the results of the bacteriological study of nasopharyngeal discharge involved 170 children at the mean age of 5.06±2.6 years presenting with exacerbations of chronic adenoiditis. The patients of group 1 (n=60, control group) underwent nasopharyngeal sanation by means of the low-frequency ultrasound treatment, those of group 2 (n=53) were given an oral antibiotics (amoxicillin/clavulanic acid) at an age-based dose during 7-10 days. The patients of group 3 (n=57) were treated with bacterial lysate OM-85 BV (Broncho-Vaxom) (a 3.5 mg capsule once daily in the morning hours under the fasting condition for 3 months (during 10 days of every month). The amount of anaerobic bacteria in the control cultures from the patients of group 1decreased six-fold and that of pneumococci by 3 times. In the children comprising group 2 all pathogenic species persisted despite the treatment whereas in group 3 the number of those species largely decreased whose lysates were contained in the medication. In the patients treated with Broncho-Vaxom the beneficial results of therapy 1 and 3 months after its onset were more apparent than in the children of two other groups. Moreover, this preparation did not affect the indigenous microflora.

FEATURES OF BACTERIAL IMMUNOMODULATORS INFLUENCE ON IMMUNOREGULATORY MECHANISMS IN PATIENTS WITH RESPIRATORY ALLERGIES

Recovering from bacterial infections in the first years of life reduces further risk of allergic diseases. Effects of bacterial immunomodulator Broncho Vaxom on immune system to certain extent repeats the immune response that occurs during penetration of the pathogen in the body. Bacterial antigens orchestrate cellular and humoral immune responses, stimulate innate immunity, normalize cytokine balance, and are promising in the treatment of respiratory allergic diseases.

Clinical observation of broncho VAXOM combined with acupoint application in the treatment of children with recurrent respiratory tract infection

Objective To study clinical effect of broncho VAXOM combined with acupoint application in the treatment of children with recurrent respiratory tract infection.Methods 60 children with recurrent respiratory tract infection in department of pediatrics of our hospital from February 2011 to December 2013 were randomly divided into two groups,30 cases in each group.Control group received routine drug combined with acupoint application therapy,experimental group received broncho VAXOM combined with acupoint application therapy based on routine drug.Results Time of duration of cough,fever and other clinical symptoms in experimental group were shorter than those in control group (P ＜ 0.05),type and service time of antibiotic were significantly less than those in control group (P ＜ 0.05); IgG,IgA,IgM and CD3+,CD4+,CD8+,CD4+/ CD8+significantly improved after treatment in both two groups (P ＜ 0.05).Conclusions Broncho VAXOM combined with acupoint application in the treatment of children with recurrent respiratory tract infection can significantly improve cough,fever and other clinical symptoms,enhance humoral and cellular immune function,and enhance the ability of anti-infection in children,worthy of promotion and application in clinical practice. Key words: Children; Recurrent respiratory tract infection; Broncho VAXOM; Acupoint application; Curative effect

Broncho-Vaxom Attenuates Allergic Airway Inflammation by Restoring GSK3β-Related T Regulatory Cell Insufficiency

BackgroundOral administration of bacterial extracts (eg, Broncho-Vaxom (BV)) has been proposed to attenuate asthma through modulating Treg cells. However, the underlying mechanism has not been fully characterized. This study sought to assess the effects of oral administration of BV on GSK-3β expression and Treg cells in ovalbumin (OVA)-induced asthmatic mice models.MethodAsthmatic mice models were established with OVA challenge and treated with oral administration of BV. Next, infiltration of inflammatory cells including eosinophil and neutrophils, mucous metaplasia, levels of Th1/Th2/Treg-typed cytokines and expression of GSK3β and Foxp3 were examined in asthmatic mice models by histological analysis, Bio-Plex and western blot, respectively. Moreover, the frequencies of Treg cells were evaluated in cultured splenocytes by flow cytometry in the presence of BV or GSK3β siRNA interference.ResultsWe found significant decrease of infiltrated inflammatory cells in bronchoalveolar lavage fluid (BALF) in asthmatic mice models after oral administration of BV. Oral administration of BV was shown to significantly suppress mucus metaplasia, Th2-typed cytokine levels and GSK3β expression while increasing Foxp3 production in asthmatic mice models. Moreover, BV significantly enhanced GSK3β-related expansion of Treg cells in cultured spleen cells in vitro.ConclusionOur findings provide evidence that oral administration of BV is capable of attenuating airway inflammation in asthmatic mice models, which may be associated with GSK3β-related expansion of Treg cells.

A Bacterial Extract of OM-85 Broncho-Vaxom Prevents Allergic Rhinitis in Mice

According to the hygiene hypothesis, bacterial infections during early life contribute to a reduced incidence of asthma in animals. However, the effects of microbial products at a safe dose and within a rational time course on the prevention of allergic rhinitis (AR) have been inconclusive. This study investigated the immunomodulatory effects of oral administration of a bacterial extract, OM-85 Broncho-Vaxom (BV), with a low dose and general time course, which is currently used for respiratory infections in humans, on AR inflammation in mice. We developed a mouse model of ovalbumin (OVA)-induced AR allergic inflammation in the nose mucosa of mice. Low doses of OM-85 BV were orally administered for 3 months (long term) before sensitization. We evaluated nasal symptoms, pathology in the nose, inflammatory cells, and the levels of T helper 1 (Th1)/Th2 cytokines in the nasal lavage fluids, and the serum levels of specific IgE and IgG1. We also observed enhanced effects of OM-85 BV with 1 month (short term) of treatment. We found that long-term pretreatment with OM-85 BV protected the mice from the majority of allergy-specific symptoms; specifically, OM-85 BV suppressed nasal symptoms, inhibited eosinophil infiltration in the nose, inhibited inflammatory infiltrates and the Th2 response by reducing cytokines (IL-4, IL-5, or IL-13) in the nasal lavage fluids, and reduced IgE and IgG1 levels. Furthermore, short-term treatment with OM-85 BV decreased the levels of Th2 cytokines and IgE. Taken together, our data suggested that OM-85 BV is a low-cost alternative candidate to prevent AR with simple oral administration.

The role of OM-85 BV (Broncho-Vaxom) in preventing recurrent acute tonsillitis in children

ObjectiveTo evaluate the efficacy of an immunostimulant (bacterial lysate) Broncho-Vaxom in the management of children with recurrent acute tonsillitis. MethodsA 5-year retrospective cohort study of 177 children presenting with a diagnosis of recurrent acute tonsillitis. Patients’ demographics and laboratory studies at presentation were retrieved. For patients given Broncho-Vaxom, we defined response as a decrease in the frequency of acute tonsillitis episodes after 3 months of therapy (partial: by ≤50% and total: by >50%). Patients showing response to Broncho-Vaxom were further followed until study-end or need for tonsillectomy. ResultsThe median age of patients was 4.5 years (range: 1–15 years) with 63.8% being males. 131 (74%) patients received Broncho-Vaxom as initial therapy, and 99 (75.6%) showed response (51.2% total and 24.4% partial response). A normal ESR level was the only predictor of total compared with no response (OR: 3.53, 95% CI: 1.03–12.07); while both normal ESR (OR: 7.15-times, 95% CI: 1.18–43.39) and normal CRP (OR: 12.66, 95% CI: 1.43–111.86) levels were independent predictors of total over partial response. None of the patients showing total response required tonsillectomy on long-term follow up while in those with partial response 34.4% required subsequent tonsillectomy (median follow-up: 9 months). ConclusionsA considerable proportion of children receiving Broncho-Vaxom for recurrent acute tonsillitis show a decrease in the frequency of episodes in the short term, and very few patients eventually require tonsillectomy on long-term follow up.

The oral administration of bacterial extracts prevents asthma via the recruitment of regulatory T cells to the airways.

The prevalence of asthma has steadily increased during the last decade, probably as the result of changes in the environment, including reduced microbial exposure during infancy. Accordingly, experimental studies have shown that deliberate infections with live pathogens prevent the development of allergic airway diseases in mice. Bacterial extracts are currently used in children suffering from repeated upper respiratory tract infections. In the present study, we have investigated whether bacterial extracts, commercially available as Broncho-Vaxom (BV), could prevent allergic airway disease in mice. Oral treatment with BV suppressed airway inflammation through interleukin-10 (IL-10)-dependent and MyD88 (myeloid differentiation primary response gene (88))-dependent mechanisms and induced the conversion of FoxP3 (forkhead box P3)(-) T cells into FoxP3(+) regulatory T cells. Furthermore, CD4(+) T cells purified from the trachea of BV-treated mice conferred protection against airway inflammation when adoptively transferred into sensitized mice. Therefore, treatment with BV could possibly be a safe and efficient strategy to prevent the development of allergic diseases in children.

OM-85 BV, an immunostimulant in pediatric recurrent respiratory tract infections: a systematic review

This study was conducted to assess the efficacy of OM-85 BV (Broncho-Vaxom) in the prevention of pediatric recurrent respiratory tract infections (RTIs). Available evidence suggests that defining recurrent RTIs as >or=3 infections per fall-winter semester is both medically and epidemiologically justified. Therefore, this criterion was chosen as a primary endpoint. Trials were identified through consultation of bibliographic databases and other channels. Eleven non-blinded studies plus one dealing with primary prevention were excluded and eight randomized controlled trials were included in the meta-analysis. The data were compared at 6 months, which represented the end of most studies. The complete database was examined according to the guidelines of the Cochrane collaboration. The mean age of children and the number of RTIs in the preceding year were comparable at admission. Of the patients in the OM-85 BV treated population (n=435), 32% had recurrent RTIs (that is, >or=3 RTIs/6 months) vs. 58.2% in the placebo treated population (n=416; P<0.001). Sensitivity analysis showed that this was not driven by any particular trial. The results of this review were also positive for the active treatment regarding the secondary variables, which were represented by the number of patients with at least one RTI and the mean number of RTIs. This meta-analysis shows, as observed in several individual trials, that the population treated with OM-85 BV had significantly and consistently fewer cases of recurrent RTIs. The data suggest that the effect is greater in patients at increased risk of recurrent RTIs.

Oral purified bacterial extracts in acute respiratory tract infections in childhood: a systematic quantitative review.

Recurrent acute respiratory tract infections (ARTI) are a common problem in childhood. Some evidence suggests a benefit regarding the prevention of ARTI in children treated with the immunomodulator OM-85 BV (Bronchovaxom). We summarised the evidence on the effectiveness of the immunomodulator OM-85 BV in the prevention of ARTI in children. We searched randomised comparisons of oral purified bacterial extracts against inactive controls in children with respiratory tract diseases in nine electronic databases and reference lists of included studies. We extracted salient features of each study, calculated relative risks (RR) or weighted mean differences (WMD) and performed meta-analyses using random-effects models. Thirteen studies (2,721 patients) of low to moderate quality tested OM-85 BV. Patients and outcomes differed substantially, which impeded pooling results of more than two trials. Two studies (240 patients) reporting on the number of patients with less than three infections over 6 month of follow-up in children not in day care showed a trend for benefit RR 0.82 (95% CI, 0.65-1.02). One out of two studies examining the number of children not in day care without infections over 4-6 month reported a significant RR of 0.42 (95% CI, 0.21-0.82) whereas the smaller, second study did not [RR 0.92 (95% CI, 0.58-1.46)]. Two studies reporting the number of antibiotic courses indicated a benefit for the intervention arm [WMD 2.0 (95% CI, 1.7-2.3)]. Two out of the three studies showed a reduction of length of episodes of 4-6 days whereas a third study showed no difference between the two groups. Evidence in favour of OM-85 BV in the prevention of ARTI in children is weak. There is a trend for fewer and shorter infections and a reduction of antibiotic use.

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.

Oral Bacterial Vaccine Broncho-Vaxom Interferes Zinc Metabolism in Mononuclear Cells of Peripheral Blood of Patients With Chronic Non-Obstructive Bronchitis

Metalloregulation of immune response and unique role of zinc in induction of numerous cell and humoral dependent immune reactions were documented «in recent years (A.Koudrine. J. Trace Elements in Biol. Med.. 1998. 12: 65–76).The objective of this study was to test the capacity of widely used preventive oral bacterial vaccine Broncho-Vaxom (BV) (Laboratoires OM. Sw itzerland) to selectively up-regulate zinc metabolism in mononuclear cells of patients affected by non-obstructive chronic bronchitis.The group of 50 patients with a mean age of 34.2 years was exposed to BV administration according to conventional scheme. Mononuclear cells and lymphocytes were isolated by sedimentation of blood in ficoll-verografin gradient. Zinc content in both types of cells was examined by an atomic absorption spectroscopy before BV administration and every 10th day in 3 consecutive months of the treatment.A significant enhancement of zinc content in mononuclear cells on 10th day of 1st month (0.424 +/− 0.02 μg/107 cells respectively, p<0.01) was observed. During the following period dramatic reduction of this value was noted (0.352 +/− 0.02 μg/107 cell). There was no statistically significant change of zinc content in lymphocytes.These results indicate that BV may provide specific accumulation of zinc in mononuclear cells and could be used in nutrition models pro\\iding long-lasting immunomodulating and antitoxic effect. Further studies of this BV capacity are required for elucidation of the roles of gut- and broncho-associated lymphoid tissue in formation of zinc-dependent link.

Adherence of Staphylococcus aureus, Klebsiella pneumoniae from healthy persons and HIV carriers, under the influence of Broncho Vaxom in vitro and ascorbic acid in vivo

We examined the in vitro effect of Broncho Vaxom (BV) (an immunobiotherapeutic preparation containing a lysate made from bacteria often involved in respiratory tract infections) on adherence of Staphylococcus aureus, Klebsiella pneumoniae and Candida albicans to human buccal epithelial cells (BEC) of healthy volunteers and HIV carriers. We also examined the ex vivo effect of ascorbic acid on the adherence of the same microorganisms to BEC of HIV carriers. The study reached the following conclusions: The presence of BV in vitro significantly reduces the adherence of the tested strains to BEC from healthy persons and HIV carriers. No significant difference was observed between healthy persons and HIV carriers regarding the adherence of the tested strains to BEC. Significant difference in the adherence of the tested strains to BEC was observed between HIV carriers who had been taking ascorbic acid over a 3-month period and those who had not. There was no further reduction in the adherence of the tested strains to BEC from HIV carriers who had been taking ascorbic acid in the presence of BV in vitro.

Inhibition of spontaneous pulmonary metastases of Lewis lung carcinoma by oral treatment with Respivax and Broncho-Vaxom.

The antimetastatic activity of orally administered polybacterial vaccines, Broncho-Vaxom (BV) and Respivax (RV) was examined in C57BL/6 mice, bearing implants of Lewis lung carcinoma (3LL) in the footpad. The oral administration of BV or RV for 10 consecutive days before or after surgery caused significant reduction of the number and volume of lung metastases. In addition, the therapeutic potential of BV and RV was examined in combination with chemotherapy to determine if there is additive activity. In animals bearing pulmonary micrometastases, treatment with a combination of cyclophosphamide at 50-150 mg/kg with BV or RV was found to be more effective than each of these treatments alone. In immune function studies it was established that the oral administration of BV and RV induced an increase in the number of cells, recovered by broncho-alveolar lavage, and alveolar macrophages were dominant in these cell populations. Furthermore, oral treatment of mice with these vaccines rendered their alveolar macrophages tumoricidal for syngeneic metastatic 3LL cells in vitro. These results show that pulmonary macrophages induced by oral administration of BV and RV played a key role in the inhibition of metastasis in 3LL-bearing mice.

Activation of natural killer cells and cytokine production in humans by bacterial extracts (OM-85 BV).

The influence of Broncho-Vaxom (BV) on different immune parameters was investigated in vitro on human peripheral blood mononuclear cells (PBMC). It was found that BV enhances the natural killer (NK) activity of PBMC and increases their spontaneous and phytohemagglutin (PHA)-induced production of tumor-necrosis factor--alpha and interleukin-2 as well as the PHA-stimulated production of interferon-gamma. These immunostimulating actions of BV on NK activity and cytokine production can contribute to the understanding of the enhancement of the body's defense mechanisms against respiratory tract infections.