Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine.

BACKGROUND: Coronavirus-like particles (CoVLP) that are produced in plants and display the prefusion spike glycoprotein of the original strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are combined with an adjuvant (Adjuvant System 03 [AS03]) to form the candidate vaccine. METHODS: In this phase 3, multinational, randomized, placebo-controlled trial conducted at 85 centers, we assigned adults (≥18 years of age) in a 1:1 ratio to receive two intramuscular injections of the CoVLP+AS03 vaccine or placebo 21 days apart. The primary objective of the trial was to determine the efficacy of the CoVLP+AS03 vaccine in preventing symptomatic coronavirus disease 2019 (Covid-19) beginning at least 7 days after the second injection, with the analysis performed after the detection of at least 160 cases. RESULTS: A total of 24,141 volunteers participated in the trial; the median age of the participants was 29 years. Covid-19 was confirmed by polymerase-chain-reaction assay in 165 participants in the intention-to-treat population; all viral samples that could be sequenced contained variants of the original strain. Vaccine efficacy was 69.5% (95% confidence interval [CI], 56.7 to 78.8) against any symptomatic Covid-19 caused by five variants that were identified by sequencing. In a post hoc analysis, vaccine efficacy was 78.8% (95% CI, 55.8 to 90.8) against moderate-to-severe disease and 74.0% (95% CI, 62.1 to 82.5) among the participants who were seronegative at baseline. No severe cases of Covid-19 occurred in the vaccine group, in which the median viral load for breakthrough cases was lower than that in the placebo group by a factor of more than 100. Solicited adverse events were mostly mild or moderate and transient and were more frequent in the vaccine group than in the placebo group; local adverse events occurred in 92.3% and 45.5% of participants, respectively, and systemic adverse events in 87.3% and 65.0%. The incidence of unsolicited adverse events was similar in the two groups up to 21 days after each dose (22.7% and 20.4%) and from day 43 through day 201 (4.2% and 4.0%). CONCLUSIONS: The CoVLP+AS03 vaccine was effective in preventing Covid-19 caused by a spectrum of variants, with efficacy ranging from 69.5% against symptomatic infection to 78.8% against moderate-to-severe disease. (Funded by Medicago; ClinicalTrials.gov number, NCT04636697.).

Simulating cardiac disorders with a lumped parameter synergistic model.

A lumped parameter synergistic model of the human cardiovascular system (CVS) is proposed to integrate the heart's electrical activity with its mechanical activity. This model can represent the physiological condition of a patient in an effective way, whether it is considered normal or with some cardiac disorders. The electrical activity is coupled to the CVS model through electrocardiogram (ECG) signals in the suggested model. The variations in ECG morphology are detected by appropriate algorithms and changes parameters of the CVS model, such as systemic resistance and end-systolic pressure-volume relationship.Clinical relevance- It provides interpretation and analysis of physiological data of the cardiovascular system, both of electrical and mechanical cardiac behavior, evaluated together.

Accelerating simulations of cardiac electrical dynamics through a multi-GPU platform and an optimized data structure.

Simulations of cardiac electrophysiological models in tissue, particularly in 3D require the solutions of billions of differential equations even for just a couple of milliseconds, thus highly demanding in computational resources. In fact, even studies in small domains with very complex models may take several hours to reproduce seconds of electrical cardiac behavior. Today's Graphics Processor Units (GPUs) are becoming a way to accelerate such simulations, and give the added possibilities to run them locally without the need for supercomputers. Nevertheless, when using GPUs, bottlenecks related to global memory access caused by the spatial discretization of the large tissue domains being simulated, become a big challenge. For simulations in a single GPU, we propose a strategy to accelerate the computation of the diffusion term through a data-structure and memory access pattern designed to maximize coalescent memory transactions and minimize branch divergence, achieving results approximately 1.4 times faster than a standard GPU method. We also combine this data structure with a designed communication strategy to take advantage in the case of simulations in multi-GPU platforms. We demonstrate that, in the multi-GPU approach performs, simulations in 3D tissue can be just 4× slower than real time.

Effects of Gender and Body Weight on Children's Peer Choice During Physical Activities.

The present study investigated possible effects of gender and body weight on children's peer choices during physical activities. Twenty-four school-aged children (12 overweight and 12 non-overweight) were observed during 2 play sessions: the 1st session consisted of 2 tests that required agility (A) and 1 that required strength (S) in an A-S-A design; the 2nd session consisted of 2 strength tests and 1 agility in an S-A-S design. Before each session, 2 participants were asked to choose members for their teams. Results suggest that peer gender is a stronger predictor of children's playmate choices than their body weight. More specifically, children preferred to choose a peer of the same gender who was overweight rather than a peer of the opposite gender who was not overweight. However, when there was a choice between an overweight peer and a non-overweight peer of the same gender, the non-overweight child was favored.

Road safety impacts of the motorcycle in Brazil.

Brazil has had high indices of traffic injuries and deaths since the 1950s, mostly related to the increasing and irresponsible use of the automobile. Upon approval of the Brazilian Transit Code (CTB) in 1997, traffic injuries and deaths began to diminish, despite an increase in vehicle fleet size, a phenomenon that had never occurred previously. Concurrently, starting in 1991 and with a great intensity after 1996, there has been a sizeable increase in motorcycle production and use, facilitated and encouraged by public officials. Between 1995 and 2000 annual sales figures for motorcycles doubled and reached 2 million units in 2008. Traffic deaths associated with motorcycles increased exponentially, rising from 725 in 2006 to 10,143 in 2010, eliminating the advances gained by the CTB in reducing auto-related injuries. This article analyses the process and its impacts on road safety. The first part summarises the main public policy decisions related to the theme. Part two analyses changes in traffic safety after the introduction of this new technology. Part three looks at the possible political, economic and social motives that lie behind this process. The final part suggests solutions to the great prejudice caused to society and the nation.

Agrupamento de escolas rurais: alternativa para o impasse da educacao rural?

O agrupamento das escolas rurais em torno de novos nucleos, com o fim da multisseriacao e com a oferta de melhores condicoes de ensino, iniciou-se em Sao Paulo em 1989, tendo obtido rapida adesao de grande parte dos municipios. O artigo descreve o processo de discussao e de implantacao desses agrupamentos, com as suas caracteristicas tecnicas, dentro do contexto social, economico e politico do estado de Sao Paulo. Tambem sao descritas resumidamente as experiencias internacionais nesse campo, e comparadas a experiencia paulista. As vantagens e desvantagens do processo sao analisadas sob a otica da oferta de ensino para a populacao rural, bem como dos problemas encontrados e das possiveis formas de sua superacao. Conclui-se que o processo apresenta um grande potencial de melhoria das condicoes de ensino para a populacao rural, mas requer cuidados especiais sob varios aspectos.