OM-85 BV for primary prevention of recurrent airway infections: a pilot randomized, double-blind, placebo-controlled study / OM-85 BV para prevenção primária de infecções recorrentes das vias aéreas: estudo piloto, randomizado, duplo-cego, placebo-controlado

ABSTRACT Objective To compare the frequency of respiratory tract infections in children treated with OM-85 BV and placebo during the 3-month therapy period, and observation for a further 3 months after treatment. Methods A randomized, double-blind, placebo-controlled trial was conducted with 54 children (6 months to 5 years old) with no past history of recurrent respiratory infections attending daycare center. Family members were instructed to administer one capsule per day for 10 consecutive days, for 3 months of OM-85 BV or placebo. Telephone interviews were conducted every 30 days. Results There was no significant difference in the number of respiratory infections between the groups. The mean number of respiratory tract infection in the OM-85 BV Group in the first 3 months was 0.92±0.87, and in the Placebo Group was 0.74±1.02, and at 6 months it was 1.62±1.47 and 1.03±1.34, respectively. Conclusion OM-85 BV was not effective in the primary prevention of respiratory tract infections. Although most authors recommend the use of this immunostimulant in children with a history of recurrent respiratory infections, more studies are needed to define its usefulness in the primary prevention of respiratory infections in healthy children exposed to few risk factors.

RESUMO Objetivo Comparar a frequência de infecções do trato respiratório em crianças tratadas com OM-85 BV e placebo durante o período de terapia de 3 meses, e observação por mais 3 meses após o tratamento. Métodos Foi realizado estudo randomizado, duplo-cego, controlado por placebo com 54 crianças (6 meses a 5 anos) sem história prévia de infecções respiratórias recorrentes, que frequentavam creches. Os membros da família foram instruídos a administrar uma cápsula por dia durante 10 dias consecutivos, durante 3 meses, de OM-85 BV ou placebo. Entrevistas telefônicas foram realizadas a cada 30 dias. Resultados Não houve diferença significativa no número de infecções respiratórias entre os grupos. O número médio de infecções do trato respiratório no Grupo OM-85 BV nos primeiros 3 meses foi de 0,92±0,87 e, no Grupo Placebo, de 0,74±1,02, e aos 6 meses foi de 1,62±1,47 e 1,03±1,34, respectivamente. Conclusão O OM-85 BV não foi eficaz na prevenção primária de infecções do trato respiratório. Embora a maioria dos autores recomende o uso deste imunoestimulante em crianças com história de infecções respiratórias recorrentes, mais estudos são necessários para definir sua utilidade na prevenção primária de infecções respiratórias em crianças saudáveis expostas a poucos fatores de risco.

TAPCells, the Chilean dendritic cell vaccine against melanoma and prostate cancer

Here we summarize 10 years of effort in the development of a biomedical innovation with global projections. This innovation consists of a novel method for the production of therapeutic dendritic-like cells called Tumor Antigen Presenting Cells (TAPCells®). TAPCells-based immunotherapy was tested in more than 120 stage III and IV melanoma patients and 20 castration-resistant prostate cancer patients in a series of phase I and I/II clinical trials. TAPCells vaccines induced T cell-mediated memory immune responses that correlated with increased survival in melanoma patients and prolonged prostate-specific antigen doubling time in prostate cancer patients. Importantly, more than 60% of tested patients showed a Delayed Type Hypersensitivity (DTH) reaction against the lysates, indicating the development of anti-tumor immunological memory that correlates with clinical benefits. The in vitro analysis of the lysate mix showed that it contains damage-associated molecular patterns such as HMBG-1 protein which are capable to improve, through Toll-like receptor-4, maturation and antigen cross-presentation of the dendritic cells (DC). In fact, a Toll-like receptor-4 polymorphism correlates with patient clinical outcomes. Moreover, Concholepas concholepas hemocyanin (CCH) used as adjuvant proved to be safe and capable of enhancing the immunological response. Furthermore, we observed that DC vaccination resulted in a three-fold increase of T helper-1 lymphocytes releasing IFN-γ and a two-fold increase of T helper-17 lymphocytes capable of producing IL-17 in DTH+ with respect to DTH- patients. Important steps have been accomplished for TAPCells technology transfer, including patenting, packaging and technology assessment. Altogether, our results indicate that TAPCells vaccines constitute an exceptional Chilean national innovation of international value.

Glicoprotéinas de Klebsiella pneumoniae como coadyuvantes en la prevención de infecciones recurrentes respiratorias en niños de 1 a 6 años de edad / The extract of Klebsiella pneumoniae can be used as a coadyuvant in the treatment of pediatric patients with recurrent respiratory infections

Antecedentes. Las infecciones recurrentes de las vías respiratorias altas y bajas representan los padecimientos más comunes de la edad pediátrica. Material y método. Estudio doble ciego, pareado y en paralelo. Se comparó la mejoría clínica y de laboratorio con un grupo de 44 pacientes control, a quienes se administró placebo, con un diagnóstico semejante, lo mismo que edades y distribución por sexo. Resultados. En el grupo de estudio, comparado con el de control (p<0.001 en todos los parámetros), a los 6, 9 y 12 meses posteriores al inicio del tratamiento hubo una disminución estadísticamente significativa del número de infecciones por año, duración de éstas y días de ausencia escolar. No hubo cambios estadísticamente significativos en las concentraciones de complemento hemolítico, C3, C4 e inmunoglobulinas IgA, IgG, IgM e IgE, cuando se compararon los valores basales y a los seis meses de iniciado el tratamiento. No se reportó reacción adversa a la administración oral de la glicoproteína de Klebsiella pneumoniae. Conclusión. Estos resultados sugieren que ésta puede usarse como coadyuvante en la prevención y tratamiento de pacientes con infecciones respiratorias bajas y altas recurrentes