RESUMEN
The objective of this study was to evaluate and compare the safety, tolerability and immunogenicity for two seasonal influenza subunit vaccines, one with MF59 adjuvant (Fluad) and one without an adjuvant (Agrippal). A total of 195 subjects aged > or = 65 years were enrolled to receive one dose of vaccine intramuscularly, 96 were vaccinated with Fluad, 99 received Agrippal. Blood samples were taken from all subjects in order to assess their antibody titre by the haemagglutination inhibition assay (HI), before (Time 0) and after (Time 1: 28 +/- 7 days) vaccination, against the A/H3N2 (A/Moscow/10/99), A/H1N1 (A/New Caledonia/20/99) and B/Shandong/7/97 antigens contained in the influenza vaccine in the 2002/2003 influenza season for the northern hemisphere. A good humoral antibody response was detected for both vaccines, meeting all the criteria of EMEA. The number of subjects in whom > or = 4-fold increase in antibody titre was recorded, in comparison with the pre-vaccination value, proved to be lower in the group vaccinated with AgrippaPl than in those vaccinated with the adjuvated preparation. Fluad" exhibited better immunogenicity than Agrippal. This difference was probably linked to the potentiated immune stimulation exerted by the adjuvant molecules. These results take on a particular importance if we consider that the immune system is weaker in the elderly; the administration of an adjuvated vaccine in such subjects is clearly preferable in that it provides greater and more prolonged protection. Both vaccines were generally well tolerated; no severe adverse events occurred in any of the subjects vaccinated, confirming the excellent safety profile of Fluad and Agrippal.
Asunto(s)
Vacunas contra la Influenza/administración & dosificación , Gripe Humana/prevención & control , Adyuvantes Inmunológicos/administración & dosificación , Adyuvantes Inmunológicos/efectos adversos , Anciano , Anciano de 80 o más Años , Anticuerpos Antivirales/sangre , Femenino , Humanos , Subtipo H1N1 del Virus de la Influenza A/inmunología , Subtipo H3N2 del Virus de la Influenza A/inmunología , Virus de la Influenza B/inmunología , Vacunas contra la Influenza/efectos adversos , Vacunas contra la Influenza/inmunología , Gripe Humana/inmunología , Masculino , Vacunas/administración & dosificación , Vacunas/efectos adversos , Vacunas/inmunología , Vacunas de Subunidad/administración & dosificación , Vacunas de Subunidad/efectos adversos , Vacunas de Subunidad/inmunologíaRESUMEN
INTRODUCTION AND METHODS: Two real time one-step RT-PCR assays were developed for simultaneous detection and typing of influenza A and B viruses and detection of Respiratory Syncytial Virus (RSV). As regard influenza, primers were designed to amplify specific sequences of gene M of A/H1N1, A/H3N2, A/H5N1, A/H7N7 and A/H9N2 viruses and of gene NP of type B viruses belonging both Yamagata and Victoria lineage. Specificity, analytical and clinical sensitivity, dynamic range, linearity of the new assays were evaluated. RESULTS: Dynamic ranges for Influenza A and B, and RSV were at least five logs and linearity was conserved. In order to evaluate the specificity, 80 nasopharyngeal swabs resulting Influenza and RSV negative by multiplex nested PCR and cell culture, were tested and 79 resulted negative. The detection limits for influenza A and B, calculated by 95% probit, was 0.008 and 0.09 PFU, respectively, resulting more sensible than nested PCR. A total of 75 specimens (10 A/H1N1, 3 A/H1N2, 8 A/H3N2 Johannesburg/94-like, 10 A/H3N2 Panama/2007/99-like, 10 A/H3N2 Fuijian/411/02-like, 2 A/H5N1, 2 A/H7N7 and 2 A/H9N2, 15 B/Yamagata-like and 13 B/Victoria-like) collected between 1994 and 2004 or received by WHO Influenza Centre, London, were chosen as representative of the circulating strains and tested. All samples resulted positive although one B/Victoria sample was not clear typed. Thirty swabs nested RT-PCR positive for RSV collected during the four seasons, were also analysed by realtime PCR, resulting positive. To evaluate the performance of the new assay on fresh material, 250 specimens, collected during the 2004/05 seasons, were tested by nested-PCR, cell culture and real-time PCR. DISCUSSION AND CONCLUSION: The new assays provide accurate and sensitive diagnosis of influenza and RSV infection and they represent a sensitive tool for virological surveillance and management of patient with ILI.
Asunto(s)
Virus de la Influenza A/genética , Virus de la Influenza A/aislamiento & purificación , Gripe Humana/virología , ARN Viral/análisis , Infecciones por Virus Sincitial Respiratorio/virología , Virus Sincitiales Respiratorios/genética , Virus Sincitiales Respiratorios/aislamiento & purificación , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/normas , Animales , Antivirales/síntesis química , Antivirales/uso terapéutico , Aves , Técnicas de Cultivo de Célula , Enfermedades Transmisibles Emergentes/prevención & control , Enfermedades Transmisibles Emergentes/virología , Humanos , Subtipo H1N1 del Virus de la Influenza A/genética , Subtipo H1N1 del Virus de la Influenza A/aislamiento & purificación , Subtipo H3N2 del Virus de la Influenza A/genética , Subtipo H3N2 del Virus de la Influenza A/aislamiento & purificación , Virus de la Influenza A/efectos de los fármacos , Gripe Aviar/epidemiología , Gripe Aviar/virología , Gripe Humana/epidemiología , Filogenia , ARN Viral/genética , Infecciones por Virus Sincitial Respiratorio/epidemiología , Virus Sincitiales Respiratorios/efectos de los fármacos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/métodos , Sensibilidad y Especificidad , Vigilancia de GuardiaRESUMEN
In this study of influenza vaccination, 37 human immunodeficiency virus (HIV)-1-seropositive patients were randomized to receive either a vaccine with a conventional subunit or one adjuvanted with MF59. Blood samples were collected at the time of vaccination, and then 30 and 180 days later, to evaluate immunogenicity, CD4+ T-lymphocyte count and HIV-1 RNA levels. Seroconversion rates against the three viral strains included in the vaccine ranged between 44% and 72% and 53% and 68% for the adjuvanted vaccine and the subunit vaccine, respectively. Other criteria of the European Medicines Evaluation Agency were also met. Vaccination was not associated with serious adverse events. Local and systemic effects were mild and of short duration. CD4+ T-lymphocyte counts and viraemia levels were not negatively affected by vaccination. These results confirmed the safety and immunogenicity of these currently available vaccines in HIV-1-seropositive patients, thus supporting the recommendation for influenza immunization in this high-risk category.
Asunto(s)
Adyuvantes Inmunológicos/farmacología , Vacunas contra la Influenza/uso terapéutico , Polisorbatos/farmacología , Escualeno/farmacología , Carga Viral , Adolescente , Adulto , Anciano , Anticuerpos Antivirales/análisis , Recuento de Linfocito CD4 , Linfocitos T CD4-Positivos/citología , Femenino , Seropositividad para VIH , VIH-1/genética , Humanos , Masculino , Persona de Mediana Edad , ARN Viral/sangre , Riesgo , Seguridad , Factores de Tiempo , Viremia/sangreAsunto(s)
Carcinoma de Células Escamosas/diagnóstico , Enfermedades de la Uña/diagnóstico , Uñas/patología , Neoplasias Cutáneas/diagnóstico , Biopsia , Carcinoma de Células Escamosas/epidemiología , Diagnóstico Diferencial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedades de la Uña/epidemiología , Neoplasias Cutáneas/epidemiologíaRESUMEN
OBJECTIVE: To develop a flow chart indicting which tests to perform with the aim of helping physicians with the diagnosis, management and treatment of lichen simplex chronicus. STUDY DESIGN: We reviewed the data on vulvar lichen simplex chronicus patients to delineate proper management. RESULTS: Patch test should be added to the series of tests performed to ascertain the causes of vulvar lichen simplex chronicus. CONCLUSION: Among the stimuli that may trigger vulvar lichen simplex chronicus, not only infections and irritating factors but also sensitization must be kept in mind, especially in long-lasting disease.
Asunto(s)
Árboles de Decisión , Dermatitis Alérgica por Contacto/diagnóstico , Neurodermatitis/diagnóstico , Vulvitis/diagnóstico , Dermatitis Alérgica por Contacto/patología , Dermatitis Alérgica por Contacto/terapia , Diagnóstico Diferencial , Femenino , Humanos , Neurodermatitis/patología , Neurodermatitis/terapia , Pruebas del Parche , Vulvitis/patología , Vulvitis/terapiaRESUMEN
Alteration of T cell suppression function has been recognized in patients with systemic lupus erythematosus (SLE). Recently, CD8(+) T suppressor lymphocytes (CD8(+) Ts) have been generated in vitro by incubating purified CD8(+) T cells with IL-2 and GM-CSF. Using this method, we generated CD8(+) Ts from patients affected by SLE. No major differences were found in the CD8(+) Ts phenotype between SLE patients and healthy subjects. CD8(+) Ts from SLE patients with active disease did not inhibit the anti-CD3 mAb-induced proliferation of autologous PBMC, whereas CD8(+) Ts from SLE patients in remission exerted an inhibitory activity comparable to normal subjects. The inhibitory effect of CD8(+) Ts cells was neither mediated by cytotoxic activity nor by apoptosis induction. Two cytokines, IFN-gamma and IL-6, were found to be responsible for the function of CD8(+) TS: In fact, counteraction of CD8(+) Ts suppression activity was obtained by blocking IFN-gamma with a specific Ab or by inhibiting CD8(+) Ts-mediated IL-6 secretion by an antisense oligonucleotide. Interestingly, CD8(+) Ts from SLE patients showed a peculiar cytokine pattern characterized by an impaired secretion of IL-6 and an increased secretion of IL-12. Thus, it appears that an altered balance between inhibitory (IL-6) and stimulatory (IL-12) cytokines might be responsible for the functional impairment of CD8(+) Ts in SLE patients.
Asunto(s)
Lupus Eritematoso Sistémico/inmunología , Lupus Eritematoso Sistémico/patología , Linfocitos T Reguladores/inmunología , Linfocitos T Reguladores/patología , Adulto , Anticuerpos Monoclonales/farmacología , Complejo CD3/inmunología , Sistema Libre de Células/inmunología , Células Cultivadas , Técnicas de Cocultivo , Citocinas/biosíntesis , Regulación hacia Abajo/inmunología , Femenino , Humanos , Inmunofenotipificación , Interleucina-12/biosíntesis , Interleucina-6/antagonistas & inhibidores , Interleucina-6/biosíntesis , Células K562 , Leucocitos Mononucleares/inmunología , Activación de Linfocitos/inmunología , Masculino , Persona de Mediana Edad , Solubilidad , Factores Supresores Inmunológicos/fisiología , Linfocitos T Reguladores/metabolismo , Regulación hacia Arriba/inmunologíaAsunto(s)
Dermatitis Alérgica por Contacto/etiología , Dermatitis Profesional/etiología , Dermatosis de la Mano/inducido químicamente , Exposición Profesional/efectos adversos , Conservadores Farmacéuticos/efectos adversos , Tiazoles/efectos adversos , Niño , Cromatografía Líquida de Alta Presión , Humanos , Aceites Industriales/efectos adversos , Aceites Industriales/análisis , Masculino , Espectrometría de Masas , Pruebas del Parche , Tiazoles/análisisRESUMEN
Patients affected by chronic dermatoses are at high risk for the development of sensitization to corticosteroids. This study was carried out to evaluate contact hypersensitivity to corticosteroids in a selected group of patients affected by longlasting cutaneous dermatoses. Sixty subjects underwent the GIRDCA series. The Italian GIRDCA series we applied had the following substances in addition to the European standard series: imidazolidinyl urea 2% pet, thiomersal 0.1% pet, disperse yellow 31% pet, disperse red 1% pet, 4'4-diaminodiphenylmethane 0.5% pet, ammoniated mercury 1% pet. The patients were tested with our corticosteroids series and some of them also with their own steroid products. Allergic reactions to corticosteroids were observed in 8/60 (13.3%) patients; budesonide was the main sensitizer (7 positives) followed by hydrocortisone-17-butyrate and betamethasone-17-valerate (2 and 1 positives, respectively). One patient also reacted to methylprednisolone aceponate contained in her own cream. 4/8 positives were certainly related to previous drug-exposure. This study showed a very high percentage of sensitization to corticosteroids. In our opinion, this value may be due both to our selection-standards and to the wide employment of a well known sensitizer like budesonide in our country. Although a corticosteroids series like ours seems to be adequate for the detection of sensitized patients, patch tests with individual compounds and/or steroids corresponding to local prescription habits are recommended, especially in unresponsive chronic dermatoses.
Asunto(s)
Corticoesteroides/efectos adversos , Hipersensibilidad a las Drogas/etiología , Eccema Dishidrótico/tratamiento farmacológico , Eccema Dishidrótico/inmunología , Administración Tópica , Corticoesteroides/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Enfermedad Crónica , Dermatitis Alérgica por Contacto/diagnóstico , Dermatitis Alérgica por Contacto/etiología , Hipersensibilidad a las Drogas/diagnóstico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pruebas del Parche , Pronóstico , Medición de RiesgoRESUMEN
Acrylic anaerobic sealants are widely used in engineering and electronic industries. They may induce allergic contact dermatitis of the first three fingers and onycholysis. We report a case of allergic contact dermatitis due to anaerobic sealants and we underline some practical problems connected with the frequency of sensitization, patch-testing and material safety data sheet availability.