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There is a paucity of data on COVID-19 vaccines in people living with HIV-1, who could be at increased risk of severe illness and death from COVID-19. We evaluated the safety and immunogenicity of a Matrix-M adjuvanted recombinant spike protein nanoparticle COVID-19 vaccine (NVX-CoV2373; Novavax) in HIV-negative people and people living with HIV-1.In this randomised, observer-blinded, multicentre, placebo-controlled phase 2A/B trial in South Africa, participants aged 18-84 years, with and without underlying HIV-1, were enrolled from 16 sites and randomly assigned (1:1) to receive two intramuscular injections of NVX-CoV2373 or placebo, 21 days apart. People living with HIV-1 were on stable antiretroviral therapy and had an HIV-1 viral load of less than 1000 copies per mL. Vaccine dosage was 5 μg SARS-CoV-2 recombinant spike protein with 50 μg Matrix-M adjuvant, whereas 0·9% saline was used as placebo injection (volume 0·5 mL each). All study staff and participants remained masked to study group assignment. We previously reported an interim analysis on the efficacy and safety of the NVX-CoV2373 vaccine (coprimary endpoints). In this Article, we present an expanded safety analysis for the full cohort of participants and report on the secondary objective of vaccine immunogenicity in the full cohort of people living with HIV-1 and in HIV-negative individuals overall and stratified by baseline SARS-CoV-2 serostatus. This trial is registered with ClinicalTrials.gov, NCT04533399, and the Pan-African Clinical Trials Registry, PACTR202009726132275.Participants were enrolled between Aug 17 and Nov 25, 2020. The safety analysis set included 4164 HIV-negative participants (2089 in the intervention group and 2075 in the placebo group) and 244 people living with HIV-1 (122 in the intervention group and 122 in the placebo group). 1422 (34·1%) of 4164 HIV-negative people and 83 (34·0%) of 244 people living with HIV-1 were categorised as baseline SARS-CoV-2-positive (ie, anti-spike IgG reactive at enrolment or had a reactive SARS-CoV-2 nucleic acid amplification test by 14 days after the second study vaccination). In the NVX-CoV2373 group, solicited local and systemic adverse events were more common in HIV-negative participants (427 [30·6%] local and 401 [28·7%] systemic) than in people living with HIV-1 (20 [25·3%] local and 20 [25·3%] systemic) among those who were baseline SARS-CoV-2-seronegative (naive). Of the serious adverse events that occurred among HIV-negative people (of whom, two [0·1%] were baseline SARS-CoV-2-negative and four [0·6%] were baseline SARS-CoV-2-positive) and people living with HIV-1 (for whom there were no serious adverse events) in the NVX-CoV2373 group, none were assessed as related to the vaccine. Among participants who were baseline SARS-CoV-2-negative in the NVX-CoV2373 group, the anti-spike IgG geometric mean titres (GMTs) and seroconversion rates (SCRs) were lower in people living with HIV-1 (n=62) than in HIV-negative people (n=1234) following the first vaccination (GMT: 508·6 vs 1195·3 ELISA units [EU]/mL; SCR: 51·6% vs 81·3%); and similarly so 14 days after the second vaccination for GMTs (14 420·5 vs 31 631·8 EU/mL), whereas the SCR was similar at this point (100·0% vs 99·3%). In the NVX-CoV2373 group, anti-spike IgG GMTs 14 days after the second vaccination were substantially higher in those who were baseline SARS-CoV-2-positive than in those who were baseline SARS-CoV-2-seronegative for HIV-negative participants (100 666·1 vs 31 631·8 EU/mL) and for people living with HIV-1 (98 399·5 vs 14 420·5 EU/mL). This was also the case for angiotensin-converting enzyme 2 receptor-binding antibody and neutralising antibody titres.The safety of the NVX-CoV2373 vaccine in people living with HIV-1 was similar to that in HIV-negative participants. However, people living with HIV-1 not previously exposed to SARS-CoV-2 had attenuated humoral immune responses to NVX-CoV2373 compared with their HIV-negative vaccine counterparts, but not so if they were baseline SARS-CoV-2-positive.Novavax and the BillMelinda Gates Foundation; investigational vaccine manufacturing support was provided by the Coalition for Epidemic Preparedness Innovations.

Herein we describe a new fertilizer delivery system made of a thermoplastic starch composite used to control the release of nitrogen in greenhouse trials. The innovative approach in this work is to use a natural matrix to disperse the N source using one extrusion processing step that is easily scalable. The extrudate was formed into a continuous strand using a rod die and was subsequently air-cooled and pelletized. The extrusion process yielded homogeneous pellets with high nitrogen content that could be applied directly to the soil. Melamine changed the structure of composites and increased the N final content of the fertilizers. Soil incubation experiments showed a more controlled N release by the matrix whereby the same proportion of N from urea was achieved after 28 days. Greenhouse trials revealed that melamine plays an important role as a structure modifier, increasing the effective use of available N from urea for maize in pot experiments. It was also verified that the Nmelamine was not available during the first 60 days of the trial experiment, showing that the lower amount of nitrogen released (only from urea) was better utilized by the plants treated with the composite material. The pelletized composite could be a prospective system for smart fertilization processing based on a renewable source (e.g. starch).

Made available in DSpace on 2018-12-11T17:20:45Z (GMT). No. of bitstreams: 0 Previous issue date: 2018-09-01 Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Universidade Estadual Paulista Polymeric hydrogels are important biomaterials with potential for various applications including the controlled release of drugs. Clay and zeolite nanostructures can enhance the absorption and release properties of hydrogels. In our previous work, a procedure was optimized for making hydrogel beads. The objectives of this study were to use the optimized bead forming procedure to prepare clay and zeolite nanocomposite hydrogel beads and characterize their microstructure, thermal and chemical properties. The hydrogels were prepared by dripping solutions of either sodium alginate or sodium alginate/nanostructure (clay and/or zeolite) into beakers containing different concentrations of CaCl2 at 25 °C. Fourier transform infrared spectroscopy (FTIR) analysis detected the presence of functional groups associated with alginate, clay and zeolite. The microstructure of the alginate beads was somewhat rough with small protrusions. Flakes were visible in micrographs of beads containing nanoclay. The elemental composition of the hydrogels was investigated by energy dispersive X-ray spectrometry (EDX). EDX spectra revealed magnesium, sodium, aluminum, silicon and increased the levels of oxygen in the nanoclay compositions. The incorporation of nanoclays decreased the percentage of organic matter lost as detected by thermogravimetric analysis (TG). TG was also able to detect the incorporation of nanoclay in hydrogels. The nanoclays proved to be more effective than zeolites in producing alginate hydrogels with satisfactory swelling characteristics. Grupo de Compósitos e Nanocompósitos Híbridos (GCNH) Department of Physics and Chemistry Programa de Pós-Graduação em Ciência dos Materiais São Paulo State University (Unesp) School of Engineering, Ilha Solteira Bioproduct Research Unit USDA-ARS WRRC Grupo de Compósitos e Nanocompósitos Híbridos (GCNH) Department of Physics and Chemistry Programa de Pós-Graduação em Ciência dos Materiais São Paulo State University (Unesp) School of Engineering, Ilha Solteira FAPESP: 2013/03643-0 CNPq: 405680/2016-3

Herein we describe the interaction of starch, urea, and melamine (C3N6H6) in composite materials for use as controlled-release plant fertilizer. Slow-release fertilizers are important in minimizing nutrient losses due to run-off, leaching, and other factors. Urea is an effective plasticizer for starch and is an important nitrogen fertilizer throughout the world. Melamine also has high nitrogen content and could be combined with urea-starch composites to provide enhanced controlled-release fertilizer. This study reports the structural interaction and the performance gain of melamine addition to starch-urea composites. Composites were characterized by spectroscopic techniques (FT-Raman and 13C NMR) detailing the interaction between melamine, urea, and starch. These interactions helped facilitate extrusion processing by lowering viscosity and processing temperatures suggesting an enhanced starch plasticizing effect of starch-urea-melamine composites. Further research into the co-plasticization of starch by urea and melamine could be exploited for improved controlled-release fertilizer products. Further research into the co-plasticization of starch by urea and melamine could be exploited for improved controlled-release fertilizer products.

Controlled-release formulations of bioactive agents are of increasing interest for effective pest control. Volatile 2-heptanone is a bioactive agent that has shown potential as a pesticide. The aim of this study was to investigate the kinetics of release of 2-heptanone incorporated into lipid films or composite solid lipid particle (SLP) films.Effective 2-heptanone diffusivity was estimated to be between 0.1 and 2.5 mm(2) day(-1) during the first week and between 0.05 and 0.1 mm(2) day(-1) during the next 5 weeks. The films that showed better retention of 2-heptanone were the paraffin lipid films. Inclusion of SLPs into paraffin films increased the release rate of 2-heptanone, mainly owing to a decrease in the film firmness as the composite SLP film became less crystalline and more brittle. In contrast, SLPs decreased the kinetics of 2-heptanone release in Acetem films owing to an increase in the film firmness.The results indicated that the use of SLPs as a method for controlled release can improve the delivery of the natural pesticide 2-heptanone if the SLPs have good compatibility with the matrix, leading to an increase in firmness of the films without increasing their porosity. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.