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Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in h…
2021
A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65 y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60–64 y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60 y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60 y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180 d after vaccinat…
Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in De…
2020
Background: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. Objective: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. Methods: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. Results: O…
Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study
2016
Purpose The PRAME tumour antigen is expressed in several tumour types but in few normal adult tissues. A dose-escalation phase I/II study (NCT01149343) assessed the safety, immunogenicity and clinical activity of the PRAME immunotherapeutic (recombinant PRAME protein (recPRAME) with the AS15 immunostimulant) in patients with advanced melanoma. Here, we report the phase I dose-escalation study segment. Patients and methods Patients with stage IV PRAME-positive melanoma were enrolled to 3 consecutive cohorts to receive up to 24 intramuscular injections of the PRAME immunotherapeutic. The RecPRAME dose was 20, 100 or 500 µg in cohorts 1, 2 and 3, respectively, with a fixed dose of AS15. Advers…
Safety and immunogenicity of the therapeutic vaccine TG1050 in chronic hepatitis B patients: a phase 1b placebo-controlled trial
2020
Funding: Transgène; International audience; Treatment of chronic hepatitis B (CHB) typically requires life-long administration of drugs. Cohort and pre-clinical studies have established the link between a functional T-cell-mounted immunity and resolution of infection. TG1050 is an adenovirus 5-based vaccine that expresses HBV polymerase and domains of core and surface antigen and has shown immunogenicity and antiviral effects in mice. We performed a phase 1 clinical trial to assess safety and explore immunogenicity and early efficacy of TG1050 in CHB patients. This randomized, double blind, placebo-controlled study included two sequential phases: one single dose cohort (SD, n = 12) and one …
Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b vaccine; Infanrix™ hexa: T…
2014
Infant vaccination using 2-dose priming at 3 and 5 mo of age with a booster at 11–12 mo of age was pioneered in Italy. The 3-5-11 schedule is now used in a growing number of European countries. Infanrix™ hexa (DTPa-HBV-IPV/Hib, GlaxoSmithKline Vaccines) was first licensed for use in 2000 and has been the only pediatric hexavalent vaccine available since 2005. We reviewed available clinical trial data describing the immunogenicity of DTPa-HBV-IPV/Hib when administered at 3, 5, and 11 mo of age, and conducted an analysis of safety using global and Italian post-marketing surveillance data. In Italy, DTPa-HBV-IPV/Hib has a demonstrated safety record extending over a decade of use, it has been a…
Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multi…
2018
BACKGROUND: The aim of the study was to evaluate the achievement of 'no evidence of disease activity' (NEDA) over a 12-month period in a large multicenter population with relapsing remitting multiple sclerosis (RRMS) treated with delayed-release dimethyl fumarate (DMF) and teriflunomide (TRF) using a propensity-score adjustment. METHODS: A time-to-event method was used to determine the percentages of patients with RRMS (pwRRMS) in both groups achieving NEDA 3 (no relapses, no 12-week confirmed disability progression, and no new T2/gadolinium-enhancing brain lesions). We described the safety profile of the investigated drugs. RESULTS: Of the 587 pwRRMS treated with DMF and the 316 pwRRMS tre…
Kaunokirjallisuuden käyttö ja merkitys sanaston kehittymisessä : lukumummit ja -vaarit lukemassa kahdestaan S2-oppijoiden kanssa
2016
Maisterintutkielmassani tutkin, miten S2-oppijoiden sanavarasto kehittyy kaunokirjallisuutta lukemalla. Sanasto jää usein kielenopetuksessa sivurooliin, vaikka suppeaa sanavarastoa pidetään sekä kielen oppimisen että käyttämisensuurimpana esteenä. Tutkimus on osa Niilo Mäki Instituutin laajempaa Kielellisten taitojen ja lukemisen tukeminen -hankkeen (RAY) pilottivaihetta, jossa vapaaehtoiset seniorit lukevat kahdestaan kahdeksan S2-oppijan kanssa lastenkirjaa Palokunnan arvoitus(2015) kerran viikossa 20 minuutin ajan. Lukuinterventio kestää 8–10 viikkoa, ja jokaisella lukutuokiolla käytetään erilaisia sananselitystekniikoita. Mukana on myös kahdeksan S2-oppijan kontrolliryhmä, jolle opettaj…
Värit Sylvia Plathin runoudessa
1999
Estudio de la heterogeneidad fenotípica del sarcoma de Ewing en xenotrasplantes
2019
Los Tumores de la Familia del Sarcoma de Ewing (TFSE) son neoplasias malignas de hueso y de partes blandas, poco frecuentes (entre el 6-8% de los tumores malignos primarios de hueso) y que afectan principalmente a pacientes en edad de crecimiento, adolescentes y adultos jóvenes (1, 2). El término engloba a tres tumores que durante años han sido considerados por separado por su morfología característica, pero que forman un espectro morfológico, de biología e histogénesis comunes (3). Dichos tumores son los Sarcomas de Ewing clásicos, los atípicos y los tumores neuroectodérmicos primitivos periféricos (PNET). Desde el punto de vista morfológico son neoplasias constituidas por células pequeñas…
Combined effect of sauna bathing and cardiorespiratory fitness on the risk of sudden cardiac deaths in Caucasian men : a long-term prospective cohort…
2018
Both cardiorespiratory fitness (CRF) and frequency of sauna bathing (FSB) are each strongly and independently associated with sudden cardiac death (SCD) risk. However, the combined effect of CRF and FSB on SCD risk has not been previously investigated. We evaluated the joint impact of CRF and FSB on the risk of SCD in the Kuopio Ischemic Heart Disease prospective cohort study of 2291 men aged 42–61 years at recruitment. Objectively measured CRF and self-reported sauna bathing habits were assessed at baseline. CRF was categorized as low and high (median cutoffs) and FSB as low and high (defined as ≤2 and 3–7 sessions/week respectively). Multivariable adjusted hazard ratios (HRs) with confide…