Safety and immunogenicity profiles of an adjuvanted seasonal influenza vaccine in Guatemalan children.

INTRODUCTION: The efficacy of non-adjuvanted seasonal influenza vaccine in young children is considered to be suboptimal. This study compared the safety and immunogenicity profiles of MF59-adjuvanted, trivalent, influenza vaccine (ATIV) and non-adjuvanted, trivalent, influenza vaccine (TIV) in Guatemalan children (N = 360) between 6 and < 60 months of age. METHODOLOGY: Children received two doses of ATIV or TIV administered four weeks apart. Solicited adverse reactions were recorded for seven days after each vaccination. Serious adverse events were recorded throughout the entire study period. Antibody responses were assessed by hemagglutination inhibition (HI) assay at baseline, four weeks after administration of the first vaccine dose, and three weeks after administration of the second dose. RESULTS: Both ATIV and TIV were well tolerated, with similar rates of solicited reactions and adverse events observed in response to both vaccines. MF59-adjuvanted vaccine induced considerably higher antibody titers than did TIV. After two doses, the B strain-specific antibody response to TIV was insufficient to meet the Center for Biologics Evaluation and Research (CBER) licensure criterion for seroprotection, whereas responses to the MF59-adjuvanted vaccine met the seroprotection criterion against all three strains. Cross-reactive antibody responses to MF59-adjuvanted vaccine met the CBER seroprotection criterion against all three strains after two doses; B strain-specific heterologous responses to non-adjuvanted TIV were inadequate. CONCLUSIONS: The MF59-adjuvanted seasonal influenza vaccine was well-tolerated and highly immunogenic in children 6 to < 60 months of age, inducing seroprotective antibody titers against both the vaccine strains and antigenically distinct heterologous strains.

A prospective observational safety study on MF59(®) adjuvanted cell culture-derived vaccine, Celtura(®) during the A/H1N1 (2009) influenza pandemic.

BACKGROUND: The present study was a prospective observational study to evaluate the safety profile of Celtura(®), a monovalent, cell culture-derived, inactivated subunit influenza vaccine prepared from A/California/07/2009(H1N1) with the adjuvant MF59(®). Subjects were enrolled prospectively during the H1N1 2009 influenza pandemic at medical centres in Colombia, Chile, Switzerland, and Germany during the period December 2009 to June 2010. METHODS: Subjects ages 18 and older were followed for the occurrence of adverse events (AEs) for six months after vaccination. Adverse events of special interest (AESIs) were neuritis, convulsion (seizure), anaphylaxis, encephalitis, vasculitis, Guillain-Barre syndrome, demyelinating conditions, Bell's palsy, and laboratory-confirmed vaccination failure. RESULTS: Overall, 7348 AEs were reported in 2296 of 3989 enrolled subjects (57.6%). Only two AEs were considered related to injection site reactions. No laboratory-confirmed cases of influenza were reported. There were 108 medically confirmed serious adverse events (SAEs) reported among 73 subjects with 6 such SAEs described as possibly or probably related to vaccination. Three fatal cases were reported and assessed as not related to vaccination. Two AESIs classified as convulsion were reported and assessed as not related to vaccination. Both AESIs occurred well outside the pre-specified 7 day risk window representing the likely timeframe of the occurrence of seizure following vaccination. CONCLUSIONS: The results of this study support the overall good safety profile of MF59 adjuvanted cell culture-derived influenza vaccine as administered in adults during the 2009-2010 H1N1 influenza pandemic. No concern is raised regarding the occurrence of AESIs.

[Risk factors for therapeutic noncompliance of patients with epilepsies]. / Factores de riesgo para incumplimiento terapéutico en pacientes con epilepsias.

Inadequate compliance is a major contributor to unsuccessful treatment in epilepsies. To establish risk factors associated with therapeutic non-compliance in patients with epilepsy, we carried out a case-control study, nested into a cohort, with thirteen factors possibly implicated in therapeutic non-compliance. The patient's general characteristics, the illness, and patient-practitioner relationship were studied. Patients were followed during 6 months; during this time, serum levels and pill counts were registered. Of 150 patients, 66 were non-compliers and 84 were compliers. Seven of thirteen factors were statistically different with an odds ratio greater than 3 (p < 0.05). However, after log-lineal regression analysis, only the total number of pills per day and the subject's intellectual level were significant. These two factors increase 3.66 times the risk of non-compliance. We conclude that epileptic patients with a low intellectual level and more than three prescribed pills per day have a 3.66 times greater risk of non-compliance to anti epileptic treatment.

Factores de riesgo para incumplimiento terapéutico en pacientes con epilepsias / Risk factors for therapeutic noncompliance of patients with epilepsies

Inadequate compliance is a major contributor to unsuccessful treatment in epilepsies. To establish risk factors associated with therapeutic non-compliance in patients with epilepsy, we carried out a case-control study, nested into a cohort, with thirteen factors possibly implicated in therapeutic non-compliance. The patient's general characteristics, the illness, and patient-practitioner relationship were studied. Patients were followed during 6 months; during this time, serum levels and pill counts were registered. Of 150 patients, 66 were non-compliers and 84 were compliers. Seven of thirteen factors were statistically different with an odds ratio greater than 3 (p < 0.05). However, after log-lineal regression analysis, only the total number of pills per day and the subject's intellectual level were significant. These two factors increase 3.66 times the risk of non-compliance. We conclude that epileptic patients with a low intellectual level and more than three prescribed pills per day have a 3.66 times greater risk of non-compliance to anti epileptic treatment.

Concordancia entre observadores en la evaluación de protocolos de investigación clínica / The agreement between observators in evaluation of clinical research protocols

Objetivo: Determinar el nivel de concordancia entre los integrantes de la Unidad de Epidemiología Clínica en la evaluación de aspectos metodológicos de los protocolos de investigación clínica. Material y métodos: Se seleccionaron aleatoriamente 15 protocolos de investigación registrados durante 1992 en el Hospital General de México, y fueron evaluados por ocho observadores de la Unidad de Epidemiología Clínica siguiéndose un formato diseñado para el estudio. Cada protocolo fue calificado en tres escalas: 1) aprobado/rechazado, 2) escala ordinal de cuatro categorías de la calidad metodológica y 3) puntaje detallado que calificaba cada uno de los aspectos del estudio: Cada protocolo fue independientemente evaluado por todos los observadores. Análisis: Se calcularon coeficientes Kappa y Kappa ponderada entre las parejas de observadores y el coeficiente de correlación intraclase en las calificaciones de los protocolos. Resultados: Se observó una concordancia regular en las parejas de observadores al aprobar o rechazar un protocolo. Las concordancias en la escala de cuatro puntos fueron diversas: buena en cinco parejas y moderada a baja en 11. La concordancia del puntaje total fue excelente. Conclusiones: Los resultados preliminares sugieren que la evaluación objetiva y estandarizada de los protocolos de investigación, utilizando criterios de rigidez científica disminuiría sesgos del evaluador y mejorarían la calidad de presentación de los mismos

Tumores óseos craneofaciales: frecuencia y respuesta al tratamiento / Craniofacial bone tumours: frecuency and treatment resonse

En el periodo comprendido entre enero de 1985 y diciembre de 1989, se atendieron en el Servicio de Oncología del Hospital General de México, 112 pacientes con lesiones óseas de localización craneofacial de los cuales 76 (67.9 por ciento), correspondieron a lesiones malignas, de éstas 10 (8.9 por ciento, fueron primarias y 67 (59.8 por ciento) secundarias, los restantes 36 casos (32.1 por ciento) correspondieron a lesiones benignas. El promedio de edad para las lesiones malignas fue de 58.4 años y para las benignas fue de 32.7 años (p = 0.00000006) de las 76 neoplasias malignas 49 correspondieron a hombres y 27 a mujeres en tanto que de las 36 lesiones benignas 16 correspondieron a hombres y 20 a mujeres. De los 76 pacientes con lesiones malignas 61 recibieron diversas modalidades de tratamiento, cirugía, radioterapia, quimioterapia y combinaciones de las tres. De las lesiones benignas se trataron 33 de 36 con una sola modalidad que fue la cirugía. El seguimiento a un año sólo se logró en nueve pacientes

Estudio clinopatológico de los linfomas no Hodgkin de testículo / Clinical and pathological study of the testicle linphomas no Hodgkin type up to data papers

Para conocer la frecuencia de los linfomas no Hodgkin (LNH) con afección testicular y sus características clínicas y anatomopatológicas, se revisaron los archivos de Hematología y Patología de enero de 1975 a diciembre de 1984. En el servicio de Hematología se encontraron 479 casos de LNH, de los cuales 263 (54.9%) fueron del sexo masculino y de éstos, seis (2.3%) presentaron afección testicular. Un caso se consideró enfermedad primaria, tres enfermedad sistémica y dos complicación tardía. La edad promedio fue de 50 años. De acuerdo a la clasificación internacional (CI), cinco casos correspondieron a linfomas de linfocitos poco diferenciados con patrón difuso. La sobrevida mayor correspondió al caso primario, con 60 meses. El promedio de sobrevida del grupo fue de cinco meses. En la Unidad de Patología se encontraron 148 casos de autopsia con LNH, de éstos 92 (62.1%) fueron del sexo masculino, de los cuales 10 (10.8%) mostraron participación testicular. En dos de los 10 casos se conocía la participación testicular y en seis fue hallazgo de autopsia, en un caso se localizó en epidídimo y en otro en condones espermáticos. La edad promedio fue de 49 años. Cinco casos presentaron participación extraganglionar además de la testicular: tres en piel, un nasal y cuatro en sistema nervioso central. De acuerdo a la CI, uno correspondió a grado de malignidad bajo, seis a grado de malignidad intermedio y tres a grado de malignidad alto. De acuerdo a la clasificación de Rappaport tres fueron linfomas histiocíticos, tres de linfocitos poco diferenciados, uno de linfocitos bien diferenciados, un plasmocitoma, un sarcoma inmuno blásico y un caso de micosis fungoides .