Phase I clinical trial in healthy adults of a nasal vaccine candidate containing recombinant hepatitis B surface and core antigens

SummaryBackgroundThe nasal vaccine candidate (NASVAC), comprising hepatitis B virus (HBV) surface (HBsAg) and core antigens (HBcAg), has been shown to be highly immunogenic in animal models.MethodsA phase I double-blinded, placebo-controlled randomized clinical trial was carried out in 19 healthy male adults with no serologic markers of immunity/infection to HBV. This study was aimed at exploring the safety and immunogenic profile of nasal co-administration of both HBV recombinant antigens. The trial was performed according to Good Clinical Practice guidelines. Participants ranged in age from 18 to 45 years and were randomly allocated to receive a mixture of 50μg HBsAg and 50μg HBcAg or 0.9% physiologic saline solution, as a placebo, via nasal spray in a five-dose schedule at 0, 7, 15, 30, and 60 days. A total volume of 0.5ml was administered in two dosages of 125μl per nostril. Adverse events were actively recorded 1h, 6h, 12h, 24h, 48h, 72h, 7 days and 30 days after each dose. Anti-HBs and anti-HBc titers were evaluated using corresponding ELISA kits at days 30 and 90.ResultsThe vaccine candidate was safe and well tolerated. Adverse reactions included sneezing (34.1%), rhinorrhea (12.2%), nasal stuffiness (9.8%), palate itching (9.8%), headache (9.8%), and general malaise (7.3%). These reactions were all self-limiting and mild in intensity. No severe or unexpected events were recorded during the trial. The vaccine elicited anti-HBc seroconversion in 100% of subjects as early as day 30 of the immunization schedule, while a seroprotective anti-HBs titer (≥10IU/l) was at a maximum at day 90 (75%). All subjects in the placebo group remained seronegative during the trial.ConclusionThe HBsAg–HBcAg vaccine candidate was safe, well tolerated and immunogenic in this phase I study in healthy adults. To our knowledge, this is the first demonstration of safety and immunogenicity for a nasal vaccine candidate comprising HBV antigens

Latin American consumption of major food groups: Results from the ELANS study

Background The Latin American (LA) region is still facing an ongoing epidemiological transition and shows a complex public health scenario regarding non-communicable diseases (NCDs). A healthy diet and consumption of specific food groups may decrease the risk of NCDs, however there is a lack of dietary intake data in LA countries. Objective Provide updated data on the dietary intake of key science-based selected food groups related to NCDs risk in LA countries. Design ELANS (Latin American Study of Nutrition and Health) is a multicenter cross-sectional study assessing food consumption from an urban sample between15 to 65 years old from 8 LA countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Peru, and Venezuela). Two 24-HR were obtained from 9, 218 individuals. The daily intake of 10 food groups related to NCDs risk (fruits; vegetables; legumes/beans; nuts and seeds; whole grains products; fish and seafood; yogurt; red meat; processed meats; sugar-sweetened beverages (ready-to-drink and homemade)) were assessed and compared to global recommendations. Results Only 7.2% of the overall sample reached WHO's recommendation for fruits and vegetables consumption (400 grams per day). Regarding the dietary patterns related to a reduced risk of NCDs, among the overall sample legumes and fruits were the food groups with closer intake to the recommendation, although much lower than expected (13.1% and 11.5%, respectively). Less than 3.5% of the sample met the optimal consumption level of vegetables, nuts, whole grains, fish and yogurt. Largest country-dependent differences in average daily consumption were found for legumes, nuts, fish, and yogurt. Mean consumption of SSB showed large differences between countries. Conclusion Diet intake quality is deficient for nutrient-dense food groups, suggesting a higher risk for NCDs in the urban LA region in upcoming decades. These data provide relevant and up-to-date information to take urgent public health actions to improve consumption of critically foods in order to prevent NCDs. Copyright

NEOTROPICAL XENARTHRANS: a data set of occurrence of xenarthran species in the Neotropics

Xenarthrans – anteaters, sloths, and armadillos – have essential functions for ecosystem maintenance, such as insect control and nutrient cycling, playing key roles as ecosystem engineers. Because of habitat loss and fragmentation, hunting pressure, and conflicts with 24 domestic dogs, these species have been threatened locally, regionally, or even across their full distribution ranges. The Neotropics harbor 21 species of armadillos, ten anteaters, and six sloths. Our dataset includes the families Chlamyphoridae (13), Dasypodidae (7), Myrmecophagidae (3), Bradypodidae (4), and Megalonychidae (2). We have no occurrence data on Dasypus pilosus (Dasypodidae). Regarding Cyclopedidae, until recently, only one species was recognized, but new genetic studies have revealed that the group is represented by seven species. In this data-paper, we compiled a total of 42,528 records of 31 species, represented by occurrence and quantitative data, totaling 24,847 unique georeferenced records. The geographic range is from the south of the USA, Mexico, and Caribbean countries at the northern portion of the Neotropics, to its austral distribution in Argentina, Paraguay, Chile, and Uruguay. Regarding anteaters, Myrmecophaga tridactyla has the most records (n=5,941), and Cyclopes sp. has the fewest (n=240). The armadillo species with the most data is Dasypus novemcinctus (n=11,588), and the least recorded for Calyptophractus retusus (n=33). With regards to sloth species, Bradypus variegatus has the most records (n=962), and Bradypus pygmaeus has the fewest (n=12). Our main objective with Neotropical Xenarthrans is to make occurrence and quantitative data available to facilitate more ecological research, particularly if we integrate the xenarthran data with other datasets of Neotropical Series which will become available very soon (i.e. Neotropical Carnivores, Neotropical Invasive Mammals, and Neotropical Hunters and Dogs). Therefore, studies on trophic cascades, hunting pressure, habitat loss, fragmentation effects, species invasion, and climate change effects will be possible with the Neotropical Xenarthrans dataset

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

The effects of microstructure heterogeneities and casting defects on the mechanical properties of high-pressure die-cast AlSi9Cu3(Fe) alloys

Detailed investigations of the salient microstructural features and casting defects of the high-pressure die-cast (HPDC) AlSi9Cu3(Fe) alloy are reported. These characteristics are addressed to the mechanical properties and reliability of separately HPDC tensile bars. Metallographic and image analysis techniques have been used to quantitatively examine the microstructural changes throughout the tensile specimen. The results indicate that the die-cast microstructure consists of several microstructural heterogeneities such as positive eutectic segregation bands, externally solidified crystals (ESCs) cold flakes, primary Fe-rich intermetallics (sludge) and porosities. In addition, it results that sludge particles, gas porosity, as well as ESCs and cold flakes are concentrated toward the casting centre while low porosity and fine-grained structure is observed on the surface layer of the castings bars. The local variation of the hardness along the cross section as well as the change of tensile test results as a function of gauge diameter of the tensile bars seem to be ascribed to the change of porosity content, eutectic fraction and amount of sludge. Further, this behavior reflects upon the reliability of the die-cast alloy, as evidenced by the Weibull statistics