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17,675 result(s) for "Deen, A T"
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Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial
Children account for a substantial proportion of cases and deaths from Ebola virus disease. We aimed to assess the safety and immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a paediatric population in Sierra Leone. This randomised, double-blind, controlled trial was done at three clinics in Kambia district, Sierra Leone. Healthy children and adolescents aged 1–17 years were enrolled in three age cohorts (12–17 years, 4–11 years, and 1–3 years) and randomly assigned (3:1), via computer-generated block randomisation (block size of eight), to receive an intramuscular injection of either Ad26.ZEBOV (5 × 1010 viral particles; first dose) followed by MVA-BN-Filo (1 × 108 infectious units; second dose) on day 57 (Ebola vaccine group), or a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo (second dose) on day 57 (control group). Study team personnel (except for those with primary responsibility for study vaccine preparation), participants, and their parents or guardians were masked to study vaccine allocation. The primary outcome was safety, measured as the occurrence of solicited local and systemic adverse symptoms during 7 days after each vaccination, unsolicited systemic adverse events during 28 days after each vaccination, abnormal laboratory results during the study period, and serious adverse events or immediate reportable events throughout the study period. The secondary outcome was immunogenicity (humoral immune response), measured as the concentration of Ebola virus glycoprotein-specific binding antibodies at 21 days after the second dose. The primary outcome was assessed in all participants who had received at least one dose of study vaccine and had available reactogenicity data, and immunogenicity was assessed in all participants who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response. This study is registered at ClinicalTrials.gov, NCT02509494. From April 4, 2017, to July 5, 2018, 576 eligible children or adolescents (192 in each of the three age cohorts) were enrolled and randomly assigned. The most common solicited local adverse event during the 7 days after the first and second dose was injection-site pain in all age groups, with frequencies ranging from 0% (none of 48) of children aged 1–3 years after placebo injection to 21% (30 of 144) of children aged 4–11 years after Ad26.ZEBOV vaccination. The most frequently observed solicited systemic adverse event during the 7 days was headache in the 12–17 years and 4–11 years age cohorts after the first and second dose, and pyrexia in the 1–3 years age cohort after the first and second dose. The most frequent unsolicited adverse event after the first and second dose vaccinations was malaria in all age cohorts, irrespective of the vaccine types. Following vaccination with MenACWY, severe thrombocytopaenia was observed in one participant aged 3 years. No other clinically significant laboratory abnormalities were observed in other study participants, and no serious adverse events related to the Ebola vaccine regimen were reported. There were no treatment-related deaths. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine regimen were observed in 131 (98%) of 134 children aged 12–17 years (9929 ELISA units [EU]/mL [95% CI 8172–12 064]), in 119 (99%) of 120 aged 4–11 years (10 212 EU/mL [8419–12 388]), and in 118 (98%) of 121 aged 1–3 years (22 568 EU/mL [18 426–27 642]). The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen was well tolerated with no safety concerns in children aged 1–17 years, and induced robust humoral immune responses, suggesting suitability of this regimen for Ebola virus disease prophylaxis in children. Innovative Medicines Initiative 2 Joint Undertaking and Janssen Vaccines & Prevention BV.
Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial
The Ebola epidemics in west Africa and the Democratic Republic of the Congo highlight an urgent need for safe and effective vaccines to prevent Ebola virus disease. We aimed to assess the safety and long-term immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in Sierra Leone, a country previously affected by Ebola. The trial comprised two stages: an open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2. The study was done at three clinics in Kambia district, Sierra Leone. In stage 1, healthy adults (aged ≥18 years) residing in or near Kambia district, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) on day 1 (first dose) followed by an intramuscular injection of MVA-BN-Filo (1 × 108 infectious units) on day 57 (second dose). An Ad26.ZEBOV booster vaccination was offered at 2 years after the first dose to stage 1 participants. The eligibility criteria for adult participants in stage 2 were consistent with stage 1 eligibility criteria. Stage 2 participants were randomly assigned (3:1), by computer-generated block randomisation (block size of eight) via an interactive web-response system, to receive either the Ebola vaccine regimen (Ad26.ZEBOV followed by MVA-BN-Filo) or an intramuscular injection of a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo on day 57 (second dose; control group). Study team personnel, except those with primary responsibility for study vaccine preparation, and participants were masked to study vaccine allocation. The primary outcome was the safety of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen, which was assessed in all participants who had received at least one dose of study vaccine. Safety was assessed as solicited local and systemic adverse events occurring in the first 7 days after each vaccination, unsolicited adverse events occurring in the first 28 days after each vaccination, and serious adverse events or immediate reportable events occurring up to each participant's last study visit. Secondary outcomes were to assess Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second vaccine in a per-protocol set of participants (ie, those who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response) and to assess the safety and tolerability of the Ad26.ZEBOV booster vaccination in stage 1 participants who had received the booster dose. This study is registered at ClinicalTrials.gov, NCT02509494. Between Sept 30, 2015, and Oct 19, 2016, 443 participants (43 in stage 1 and 400 in stage 2) were enrolled; 341 participants assigned to receive the Ad26.ZEBOV and MVA-BN-Filo regimen and 102 participants assigned to receive the MenACWY and placebo regimen received at least one dose of study vaccine. Both regimens were well tolerated with no safety concerns. In stage 1, solicited local adverse events (mostly mild or moderate injection-site pain) were reported in 12 (28%) of 43 participants after Ad26.ZEBOV vaccination and in six (14%) participants after MVA-BN-Filo vaccination. In stage 2, solicited local adverse events were reported in 51 (17%) of 298 participants after Ad26.ZEBOV vaccination, in 58 (24%) of 246 after MVA-BN-Filo vaccination, in 17 (17%) of 102 after MenACWY vaccination, and in eight (9%) of 86 after placebo injection. In stage 1, solicited systemic adverse events were reported in 18 (42%) of 43 participants after Ad26.ZEBOV vaccination and in 17 (40%) after MVA-BN-Filo vaccination. In stage 2, solicited systemic adverse events were reported in 161 (54%) of 298 participants after Ad26.ZEBOV vaccination, in 107 (43%) of 246 after MVA-BN-Filo vaccination, in 51 (50%) of 102 after MenACWY vaccination, and in 39 (45%) of 86 after placebo injection. Solicited systemic adverse events in both stage 1 and 2 participants included mostly mild or moderate headache, myalgia, fatigue, and arthralgia. The most frequent unsolicited adverse event after the first dose was headache in stage 1 and malaria in stage 2. Malaria was the most frequent unsolicited adverse event after the second dose in both stage 1 and 2. No serious adverse event was considered related to the study vaccine, and no immediate reportable events were observed. In stage 1, the safety profile after the booster vaccination was not notably different to that observed after the first dose. Vaccine-induced humoral immune responses were observed in 41 (98%) of 42 stage 1 participants (geometric mean binding antibody concentration 4784 ELISA units [EU]/mL [95% CI 3736–6125]) and in 176 (98%) of 179 stage 2 participants (3810 EU/mL [3312–4383]) at 21 days after the second vaccination. The Ad26.ZEBOV and MVA-BN-Filo vaccine regimen was well tolerated and immunogenic, with persistent humoral immune responses. These data support the use of this vaccine regimen for Ebola virus disease prophylaxis in adults. Innovative Medicines Initiative 2 Joint Undertaking and Janssen Vaccines & Prevention BV.
Safety and immunogenicity of an Ad26.ZEBOV booster dose in children previously vaccinated with the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen: an open-label, non-randomised, phase 2 trial
Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a booster dose of the Ad26.ZEBOV vaccine in children who had been vaccinated with a two-dose regimen comprising Ad26.ZEBOV as dose one and MVA-BN-Filo as dose two. We conducted an open-label, non-randomised, phase 2 trial at one clinic in Kambia Town, Sierra Leone. Healthy children, excluding pregnant or breastfeeding girls, who had received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in a previous study, and were aged 1–11 years at the time of their first vaccine dose, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) and were followed up for 28 days. Primary outcomes were safety (measured by adverse events) and immunogenicity (measured by Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration) of the booster vaccine dose. Safety was assessed in all participants who received the booster vaccination; immunogenicity was assessed in all participants who received the booster vaccination, had at least one evaluable sample after the booster, and had no major protocol deviations that could have influenced the immune response. This trial is registered with ClinicalTrials.gov, NCT04711356. Between July 8 and Aug 18, 2021, 58 children were assessed for eligibility and 50 (27 aged 4–7 years and 23 aged 9–15 years) were enrolled and received an Ad26.ZEBOV booster vaccination, more than 3 years after receiving dose one of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. The booster was well tolerated. The most common solicited local adverse event during the 7 days after vaccination was injection site pain, reported in 18 (36%, 95% CI 23–51) of 50 participants. The most common solicited systemic adverse event during the 7 days after vaccination was headache, reported in 11 (22%, 12–36) of 50 participants. Malaria was the most common unsolicited adverse event during the 28 days after vaccination, reported in 25 (50%, 36–64) of 50 participants. No serious adverse events were observed during the study period. 7 days after vaccination, the Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration was 28 561 ELISA units per mL (95% CI 20 255–40 272), which was 44 times higher than the geometric mean concentration before the booster dose. 21 days after vaccination, the geometric mean concentration reached 64 690 ELISA units per mL (95% CI 48 356–86 541), which was 101 times higher than the geometric mean concentration before the booster dose. A booster dose of Ad26.ZEBOV in children who had received the two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen more than 3 years earlier was well tolerated and induced a rapid and robust increase in binding antibodies against Ebola virus. These findings could inform Ebola vaccination strategies in paediatric populations. Innovative Medicines Initiative 2 Joint Undertaking. For the French translation of the abstract see Supplementary Materials section.
Smart Homes for Elderly Healthcare—Recent Advances and Research Challenges
Advancements in medical science and technology, medicine and public health coupled with increased consciousness about nutrition and environmental and personal hygiene have paved the way for the dramatic increase in life expectancy globally in the past several decades. However, increased life expectancy has given rise to an increasing aging population, thus jeopardizing the socio-economic structure of many countries in terms of costs associated with elderly healthcare and wellbeing. In order to cope with the growing need for elderly healthcare services, it is essential to develop affordable, unobtrusive and easy-to-use healthcare solutions. Smart homes, which incorporate environmental and wearable medical sensors, actuators, and modern communication and information technologies, can enable continuous and remote monitoring of elderly health and wellbeing at a low cost. Smart homes may allow the elderly to stay in their comfortable home environments instead of expensive and limited healthcare facilities. Healthcare personnel can also keep track of the overall health condition of the elderly in real-time and provide feedback and support from distant facilities. In this paper, we have presented a comprehensive review on the state-of-the-art research and development in smart home based remote healthcare technologies.
Smartphone Sensors for Health Monitoring and Diagnosis
Over the past few decades, we have witnessed a dramatic rise in life expectancy owing to significant advances in medical science and technology, medicine as well as increased awareness about nutrition, education, and environmental and personal hygiene. Consequently, the elderly population in many countries are expected to rise rapidly in the coming years. A rapidly rising elderly demographics is expected to adversely affect the socioeconomic systems of many nations in terms of costs associated with their healthcare and wellbeing. In addition, diseases related to the cardiovascular system, eye, respiratory system, skin and mental health are widespread globally. However, most of these diseases can be avoided and/or properly managed through continuous monitoring. In order to enable continuous health monitoring as well as to serve growing healthcare needs; affordable, non-invasive and easy-to-use healthcare solutions are critical. The ever-increasing penetration of smartphones, coupled with embedded sensors and modern communication technologies, make it an attractive technology for enabling continuous and remote monitoring of an individual’s health and wellbeing with negligible additional costs. In this paper, we present a comprehensive review of the state-of-the-art research and developments in smartphone-sensor based healthcare technologies. A discussion on regulatory policies for medical devices and their implications in smartphone-based healthcare systems is presented. Finally, some future research perspectives and concerns regarding smartphone-based healthcare systems are described.
Fruit Quality Monitoring with Smart Packaging
Smart packaging of fresh produce is an emerging technology toward reduction of waste and preservation of consumer health and safety. Smart packaging systems also help to prolong the shelf life of perishable foods during transport and mass storage, which are difficult to regulate otherwise. The use of these ever-progressing technologies in the packaging of fruits has the potential to result in many positive consequences, including improved fruit quality, reduced waste, and associated improved public health. In this review, we examine the role of smart packaging in fruit packaging, current-state-of-the-art, challenges, and prospects. First, we discuss the motivation behind fruit quality monitoring and maintenance, followed by the background on the development process of fruits, factors used in determining fruit quality, and the classification of smart packaging technologies. Then, we discuss conventional freshness sensors for packaged fruits including direct and indirect freshness indicators. After that, we provide examples of possible smart packaging systems and sensors that can be used in monitoring fruits quality, followed by several strategies to mitigate premature fruit decay, and active packaging technologies. Finally, we discuss the prospects of smart packaging application for fruit quality monitoring along with the associated challenges and prospects.
SUCNR1-mediated chemotaxis of macrophages aggravates obesity-induced inflammation and diabetes
Aims/hypothesis Obesity induces macrophages to drive inflammation in adipose tissue, a crucial step towards the development of type 2 diabetes. The tricarboxylic acid (TCA) cycle intermediate succinate is released from cells under metabolic stress and has recently emerged as a metabolic signal induced by proinflammatory stimuli. We therefore investigated whether succinate receptor 1 (SUCNR1) could play a role in the development of adipose tissue inflammation and type 2 diabetes. Methods Succinate levels were determined in human plasma samples from individuals with type 2 diabetes and non-diabetic participants. Succinate release from adipose tissue explants was studied. Sucnr1 − /− and wild-type (WT) littermate mice were fed a high-fat diet (HFD) or low-fat diet (LFD) for 16 weeks. Serum metabolic variables, adipose tissue inflammation, macrophage migration and glucose tolerance were determined. Results We show that hypoxia and hyperglycaemia independently drive the release of succinate from mouse adipose tissue (17-fold and up to 18-fold, respectively) and that plasma levels of succinate were higher in participants with type 2 diabetes compared with non-diabetic individuals (+53%; p  < 0.01). Sucnr1 − /− mice had significantly reduced numbers of macrophages (0.56 ± 0.07 vs 0.92 ± 0.15 F4/80 cells/adipocytes, p  < 0.05) and crown-like structures (0.06 ± 0.02 vs 0.14 ± 0.02, CLS/adipocytes p  < 0.01) in adipose tissue and significantly improved glucose tolerance ( p  < 0.001) compared with WT mice fed an HFD, despite similarly increased body weights. Consistently, macrophages from Sucnr1 − /− mice showed reduced chemotaxis towards medium collected from apoptotic and hypoxic adipocytes (−59%; p  < 0.05). Conclusions/interpretation Our results reveal that activation of SUCNR1 in macrophages is important for both infiltration and inflammation of adipose tissue in obesity, and suggest that SUCNR1 is a promising therapeutic target in obesity-induced type 2 diabetes. Data availability The dataset generated and analysed during the current study is available in GEO with the accession number GSE64104, www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE64104 .
Insole-Based Systems for Health Monitoring: Current Solutions and Research Challenges
Wearable health monitoring devices allow for measuring physiological parameters without restricting individuals’ daily activities, providing information that is reflective of an individual’s health and well-being. However, these systems need to be accurate, power-efficient, unobtrusive and simple to use to enable a reliable, convenient, automatic and ubiquitous means of long-term health monitoring. One such system can be embedded in an insole to obtain physiological data from the plantar aspect of the foot that can be analyzed to gain insight into an individual’s health. This manuscript provides a comprehensive review of insole-based sensor systems that measure a variety of parameters useful for overall health monitoring, with a focus on insole-based PPD measurement systems developed in recent years. Existing solutions are reviewed, and several open issues are presented and discussed. The concept of a fully integrated insole-based health monitoring system and considerations for future work are described. By developing a system that is capable of measuring parameters such as PPD, gait characteristics, foot temperature and heart rate, a holistic understanding of an individual’s health and well-being can be obtained without interrupting day-to-day activities. The proposed device can have a multitude of applications, such as for pathology detection, tracking medical conditions and analyzing gait characteristics.
Preparation and Evaluation of Graphene-Agricultural Waste Biomass Nanocomposite for Removal of Cr(VI) Oxyanion from Aqueous Solutions
Adsorption is one of the promising techniques that use for removal of most toxic metals like chromium from industrial wastewater. Herein, the author concerned with the preparation of costly effective adsorbent for this process. A promising nanocomposite of reduced graphene oxide-sugarcane bagasse (rGOSC) was prepared for the first time using ultrasonic assisted method followed by freeze-drying technique. A facile and efficient modified Hummer method technique was used to prepare reduced graphene oxide (rGO). The prepared nanocomposite was characterized using different techniques such as; thermal gravimetric analysis (TGA), X-ray diffraction (XRD) and Fourier transforms infrared spectroscopy (FTIR). The morphological structure was also confirmed using transmission electron microscopy (TEM) and scanning electron microscopy (SEM). The data confirmed the successful formation of rGOSC nanocomposite. The effectiveness of rGO/SC as an adsorbent is assessed for Cr(VI) oxyanion elimination from aquatic solutions and industrial wastewater. Different experimental conditions were studied (pH, adsorbent dosage, Cr(VI) initial concentration, contact time and adsorption temperature). The kinetic models were applied for adsorption of Cr(VI) on rGOSC and the data is fit with Pseudo-second order model. Both Langmuir and D–R models gave the best fit with the equilibrium isothermal data among the four isotherm models applied. The topmost sorption ability of 26.7 mg/g was achieved on rGOSC at pH 2. The value of adsorption energy from (D–R) isothermal pattern showed ion exchange - sorption of Cr(VI) ions on rGOSC. The parameters of thermodynamic studies demonstrated random, spontaneous and endothermic removal process. Desorption of Cr(VI) from loaded rGOSC was studied at different pHs, indicating the maximum desorption that was achieved is 69.8% at pH 10. The result clarified that the economic feasibility of rGOSC-nanocomposite that is synthesized from purchasing graphene powder is higher than rGOSC-nanocomposite that is prepared in this research. Accordingly, the prepared low-cost rGOSC-nanocomposite adsorbent was used as an environmentally friendly material in treating polluted industrial water.
Information and communications technologies for elderly ubiquitous healthcare in a smart home
Over the past century, in most countries, there has been a continual increase in life expectancy primarily due to improvements in public health, nutrition, personal hygiene and medicine. However, these improvements are now coupled with aging population demographics and falling birth rates, which, when combined, are expected to significantly burden the socioeconomic well-being of many of these countries. In fact, never before in human history have we been confronted with such a large aging population, nor have we developed solid, cost-effective solutions for the well-being, healthcare and social needs of the elderly. One efficient and cost-effective solution to the problem of elderly/patient care is remote healthcare monitoring so they can continue to live at home rather than in nursing homes or hospitals that are very expensive and with limited spaces. These remote monitoring systems will allow medical personnel to keep track of important physiological signs with reduced human resources, at less cost and in real time. This paper introduces several low-cost, noninvasive, user-friendly sensing and actuating systems using information and communication technologies. Such systems can be used to create engineering solutions to some of the pressing healthcare problems in our society, especially as it pertains to the elderly. One example is the integration of sensors, wireless communications, low-power electronics and intelligent computing to determine health-related information using signals from walking patterns. Such a sensing system will be suitable for prolonged use in a home environment. It will be wearable, noninvasive and non-intrusive, similar to smart socks , smart wrist - bands or smart belts . Other examples such as a smart joint monitor and a smart sleeping environment will be discussed, and future perspectives and research challenges in smart home technologies will be described.