Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years

AbstractBackgroundStockpiling vaccine for deployment in the event of an influenza pandemic is an important mitigation strategy. A necessary aspect of stockpiling is to determine the shelf-life of the stored vaccine.MethodsIn this Phase II, open-label study we assessed the immunogenicity and safety of H5N1 A/Indonesia/5/2005 vaccine adjuvanted with AS03A. The AS03A-H5N1 vaccine was prepared from bulk antigen that had been stored for 4 years, and adjuvant that had been stored for 2.5 years. Both the antigen and adjuvant were filled in separate multi-dose vials within 4 months of use, and on the day of vaccination, the contents of antigen and adjuvant vials were mixed. Seventy-eight adults aged 18–64 years were scheduled to receive two doses of hemagglutinin-antigen (3.75μg) given 21 days apart. Antibody responses were assessed by hemagglutination-inhibition (HI) assay according to age (18–30 years, 31–40 years, 41–50 years, and 51–64 years). Reactogenicity was assessed for 7 days after each vaccination, and safety was assessed for 385 days post-vaccination (NCT01416571).ResultsThe vaccine was immunogenic. Twenty-one days after the second dose of vaccine in the overall population, the HI seroconversion rate and seroprotection rate (SPR; titer ≥1:40) was 96.0% and 98.7%, respectively. At Day 182 after vaccination, the SPR was 76.7% in the overall population. Injection site pain was the most frequent solicited adverse event (91.0%), and no safety concerns were raised.ConclusionThe immunogenicity and safety observed with AS03A-H5N1 vaccine formulated with bulk antigen which had been stockpiled before vialing and administration was consistent with that previously observed with newly manufactured AS03A-H5N1 vaccine. This suggests that stockpiling bulk antigen for 4 years does not compromise the immunogenicity or reactogenicity of the vaccine

Efficacy, Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine in Adults Aged 60 Years and Older: Results From the ZOE-50 and ZOE-70 Efficacy Studies

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As atitudes dos professores do 1º, 2º e 3º ciclos do ensino básico face à inclusão de alunos com a síndrome de Asperger no ensino regular

A incessante procura de conhecer e perceber o Ser Humano, leva os cientistas a descobrir os processos psicológicos do Homem. A Síndrome de Asperger é uma categoria recente da investigação científica e ainda existe pouca informação relativamente a este assunto. As crianças/jovens com a Síndrome de Asperger não apresentam qualquer atraso no desenvolvimento da fala ou cognitivo porém é importante que esta receba uma educação especializada o mais cedo possível. (Teixeira, s.d.) Actualmente, uma das metas da escola, é levar aos alunos a aprender as normas da cultura onde encontram-se inseridos (solidariedade, respeito, cooperação…) mas também deve dar condições para que construam e interiorizem tais valores. O direito a uma igualdade de oportunidades exige da escola as melhores condições possíveis e profissionais cada vez mais qualificados para a formação de alunos que necessitam de uma educação especial. Assim é necessário conhecer as estratégias de ensino individual e transmitir aos alunos certas ferramentas para que estes recebam um ensino adequado à sua patologia. Os professores têm um papel importante neste processo, pois são os responsáveis na formação do indivíduo, são estes que fornecem-lhe as ferramentas/conhecimentos necessários para o convívio em sociedade. (Guimarães, s.d.) O presente estudo propõe-se descrever as atitudes dos professores do 1º, 2º e 3º ciclos do ensino básico face à inclusão de alunos com a Síndrome de Asperger no ensino regular. O objectivo do trabalho consiste em saber quais as variáveis que influenciam as atitudes dos professores face à inclusão de alunos com a Síndrome de Asperger, tentando relacionar o nível de ensino (1º, 2º e 3º ciclos) com as atitudes mais ou menos favoráveis apresentadas pelos docentes

A circular mapping catheter is not mandatory for isolating pulmonary veins during paroxysmal atrial fibrillation ablation with radiofrequency.

PURPOSE: In this study, we evaluated the feasibility, efficacy, and safety of radiofrequency ablation of paroxysmal atrial fibrillation (AF) with the use of an ablation catheter only (non-CMC group) by retrospectively comparing its procedural success and recurrence rates at 1 year to ablation performed with the help of a circular mapping catheter (CMC group). METHODS: We compared the success and recurrence rates between 226 patients and 251 patients who underwent index ablation with and without the use of CMC, respectively. RESULTS: Freedom from recurrence was defined as a 1-year absence of AF/atrial tachycardia (AT) episodes > 30 s, beyond the 3-month blanking period. There was no significant difference between the number of pulmonary vein isolations, recurrence rate of AF/AT, and the use of antiarrhythmic drugs after 1 year of ablation. The procedure and fluoroscopy times were lower in the non-CMC group compared with the CMC group (106 ± 33 vs. 125 ± 32 min, p < 0.0001; 2.2 ± 1.9 vs. 2.7 ± 2.3 min, p = 0.0002, respectively). CONCLUSIONS: Pulmonary vein isolation without the use of a CMC is feasible; moreover, the material costs, procedure time, and radiation exposure were reduced compared with the CMC group. Freedom of recurrence was similar between groups. Optimized use of 3D electro-anatomical mapping systems could reduce the radiation exposure for both the patient and physician

3D navigation system allows remarkable reduction in fluoroscopy use during cavo-tricuspid isthmus ablation.

PURPOSE: Typical atrial flutter (AFL) is one of the most common supraventricular arrhythmias. Its treatment mainly relies on cavo-tricuspid isthmus (CTI) ablation, which can be performed either using conventional fluoroscopy, still mainly used, or 3D navigation system to track the position of the catheter. The aim of this study is to show that the use of a 3D navigation system allows a dramatic reduction of fluoroscopy use during CTI ablation, without any loss of efficacy, time, or safety. METHODS: In this single-center study, we retrospectively compared 134 cases of CTI ablation performed for typical AFL without a 3D navigation system with 95 cases of CTI ablation performed with such a 3D system. We compared the rates of procedural success (defined as obtaining a bidirectional electrical conduction block), freedom from AFL recurrence at 1-year follow-up, procedural time and safety, and fluoroscopy use. RESULTS: Compared to conventional fluoroscopy, the use of a 3D navigation system significantly decreased the duration of fluoroscopy use (2 min 13 s ± 2 min 16 s versus 14 min 41 s ± 10 min 39 s, p < 0.0001) and dose-area products (1567.9 ± 1329.5 mGy cm2 versus 8263.3 ± 8636.6 mGy cm2, p < 0.0001). Procedure success rates, duration, and safety were not different between groups. CONCLUSIONS: The use of 3D navigation during CTI ablation substantially reduces fluoroscopy use duration, without reducing the success rates and safety or prolonging the procedure duration, as compared to conventional fluoroscopy. We therefore suggest the generalization of this navigation system

Method, safety, and outcomes of persistent AF ablation without a circular mapping catheter: 3 years experience of a Belgian Tertiary Centre.

We aimed to share our methods and experience of persistent AF ablation without a circular mapping catheter (CMC), thereby avoiding femoral venous and transseptal punctures, decreasing the cost of the procedure, and possibly reducing the duration of the procedure and fluoroscopy time. We report our experience with 261 persistent AF ablations performed without a CMC over the past 3 years. The procedures were performed with no apparent loss of efficacy or safety. Freedom from recurrence was defined as a 1-year absence of AF/atrial flutter (AFL) episodes >30 s, beyond the 3-month blanking period. At 1 year, 72% of the patients were free from arrythmias. Persistent AF ablation is feasible without a CMC, reducing the need for venous and transseptal punctures and the cost of the procedure. We suggest that prospective studies should aim to characterise the reduction in procedure and fluoroscopy times as a result of this technique