Phase 3 Study of Safety and Immunogenicity of Gbp510 Vaccine Adjuvanted with As03 in Adults

Intro: GBP510 contains the self-assembling recombinant nanoparticle displaying SARS-CoV-2 Spike protein receptor binding domain and is adjuvanted with AS03. We report interim Phase 3 study (NCT05007951) results up to 4 weeks post-dose 2 (Data-cut: March-18-2022), where immunogenicity to the D614G ancestral strain and safety of 25mug GBP510/AS03 candidate was compared to ChAdOx1-S (Vaxzevria). Method(s): This Phase 3 randomized, active-controlled, observer-blind, parallel- group study in adults was conducted in 6 countries. Cohort1: 1,895 subjects (naive to COVID-19 vaccination and infection) randomized at 2:1 ratio (GBP510/AS03:ChAdOx1-S) to assess immunogenicity and safety;Cohort 2: 2,141 subjects at 5:1 ratio, regardless of their serostatus at screening for safety assessment. Subjects were vaccinated twice at a 4-week interval with 0.5 mL of the test vaccine (GBP510/AS03) or active control (ChAdOx1-S) in deltoid muscle. The primary objective was to demonstrate the superiority of geometric mean titer (GMT) and non-inferiority in seroconversion rate (SCR: >=4-fold rise from baseline) of neutralizing antibodies over ChAdOx1-S by live-virus neutralization assay (FRNT). Finding(s): At 2 weeks post-dose 2, GMT ratio of the two groups (Test vaccine/Active control) was 2.93 [95% CI: 2.63, 3.27], satisfying the hypothesis of superiority (95% CI lower limit> 1). The SCR difference (Test vaccine - Active control) was 10.76% [95% CI: 7.68, 14.32], satisfying the hypothesis of non- inferiority (95% CI lower limit> -5%). Good cell-mediated immune responses for Th1 cytokines were also observed with the test vaccine (FluoroSpot). The AE incidence rate for the test vaccine was higher than the active control for solicited local AEs (56.69% vs 49.20%), and comparable for solicited systemic AEs (51.21% vs 53.51%) and unsolicited AEs (13.34% vs 14.66%) after any vaccination. Conclusion(s): Higher immune responses were observed with GBP510/AS03 compared to ChAdOx1-S against D614G strain after 2 weeks post-dose 2. GBP510/AS03 showed a clinically acceptable safety profile;no safety concerns were identified during the study period.Copyright © 2023

A feasibility study on a digital device, SAT-008, as an influenza vaccine adjuvant

Background: Viral infections such as influenza and COVID-19 pose a serious threat to human health, which increases the demand for a new approach to enhance the host immunity. Previous studies showed that exercise activities could enhance the anti-viral neutralizing antibody titers after vaccination. We developed a novel digital device, SAT-008, as a mobile application based on an algorithm to regulate physical activity which are related to boosting innate and adaptive immune systems against virus. SAT-008 aimed to improve the activity of immune cells and the immune response in the body, which can be induced by software -designed -intensity levels of daily physical activities. Method(s): A randomized, open-label, and controlled study was conducted for 13 weeks (Oct 20 to Jan 21). A total of 42 healthy adults aged 24 to 46 years were recruited for this study and 32 among them served for analysis. Subjects were administered a single-dose quadrivalent influenza vaccine. The control group maintained daily life without using SAT-008, while the experimental group used SAT-008 during the study. Result(s): Compared to the control group, the experimental group showed a significant increase in neutralizing antibody titers of antigen subtype B Yamagata lineage after 4 weeks of vaccination and antigen subtype B Victoria lineage after 12 weeks of vaccination (P < 0.05), whereas the controls did not reach a significant level in any antibody titer. In the case of type 'A' influenza, there was no significant difference in neutralizing antibody titers between control and experimental groups. Stimulated NK cells of subjects in the control group decreased significantly between 4 weeks and 12 weeks after the vaccination (P < 0.05) while the subjects in the experimental group slightly increase the NK activity between 4 weeks and 12 weeks after the vaccination, however, there was no significance. The interaction effect was observed between control and experimental groups at weeks 4 and 12 by subsequent analysis (P < 0.05). Conclusion(s): We conclude that a novel approach using the digital device may play an important role to enhance the host immune system to act as a vaccine adjuvant against viral diseases such as influenza.

National trends in suicide-related behaviors among youths between 2005-2020, including COVID-19: a Korean representative survey of one million adolescents.

OBJECTIVE: It is difficult to conclude that COVID-19 is associated with a decrease in the suicide attempts rate by comparing only a short-term period. Therefore, it is necessary to examine attempted suicide rates through a trend analysis over a longer period. This study aimed to investigate an estimated long-term trend regarding the prevalence of suicide-related behaviors among adolescents in South Korea from 2005 to 2020, including COVID-19. SUBJECTS AND METHODS: We sourced data from a national representative survey (Korea Youth Risk Behavior Survey) and analyzed one million Korean adolescents aged 13 to 18 years (n=1,057,885) from 2005 to 2020. The 16-year trends regarding the prevalence of sadness or despair and suicidal ideation and attempt and the trend changes before and during COVID-19. RESULTS: Data of 1,057,885 Korean adolescents was analyzed (weighted mean age, 15.03 years; males, 52.5%; females, 47.5%). Although the 16-year trend in the prevalence of sadness or despair and suicide ideation and attempt consistently decreased (prevalence of sadness or despair between 2005-2008, 38.0% with 95% confidence interval [CI], 37.7 to 38.4 vs. prevalence in 2020, 25.0% [24.5 to 25.6]; suicide ideation between 2005-2008, 21.9% [21.6 to 22.1] vs. prevalence in 2020, 10.7% [10.3 to 11.1]; and suicide attempt between 2005-2008, 5.0% [4.9 to 5.2] vs. prevalence in 2020, 1.9% [1.8 to 2.0]), the downward slope decreased during COVID-19 (ßdiff in sadness, 0.215 with 95% CI 0.206 to 0.224; ßdiff in suicidal ideation, 0.245 [0.234 to 0.256]; and ßdiff in suicide attempt, 0.219 [0.201 to 0.237]) compared with pre-pandemic period. CONCLUSIONS: This study found that the observed risk of suicide-related behaviors during the pandemic was higher than expected through long-term trend analysis of the prevalence of sadness/despair and suicidal ideation and attempts among South Korean adolescents. We need a profound epidemiologic study of the change in mental health due to the pandemic's impact and the establishment of prevention strategies for suicide ideation and attempt.

Trends in body mass index changes among Korean adolescents between 2005-2020, including the COVID-19 pandemic period: a national representative survey of one million adolescents.

OBJECTIVE: The impact of the coronavirus disease 2019 (COVID-19) pandemic on weight gain in children and adolescents remains unknown. We aimed to identify an estimated 15-year trend in mean body mass index (BMI) changes and prevalence of obesity and overweight among Korean adolescents from 2005 to 2020, including the period of the COVID-19 pandemic. PATIENTS AND METHODS: We analyzed data taken from a nationwide survey (Korea Youth Risk Behavior Survey), between 2005 and 2020. Representative samples of one million Korean adolescents aged 13-18 years (n=1,057,885) were examined. The 15-year trends in mean BMI and proportion of obesity or overweight, and the changes due to the COVID-19 pandemic were analyzed. RESULTS: The data of 1,057,885 Korean adolescents were analyzed (mean age: 14.98 years; females, 48.4%). The estimated weighted mean BMI was 20.5 kg/m2 [95% confidence interval (CI), 20.4-20.5] from 2005 to 2008 and 21.5 kg/m2 (95% CI, 21.4-21.6) in 2020 (during the COVID-19 pandemic). Although the 15-year trend of mean BMI gradually increased, the change in mean BMI before and during the pandemic significantly lessened (ßdiff, -0.027; 95% CI, -0.028 to -0.026). The 15-year (2005-2020) trend changes in the prevalence of obesity and overweight were similar (obesity prevalence from 2005-2008, 3.2%; 95% CI, 3.1-3.3 vs. obesity prevalence in 2020, 8.6%; 95% CI, 8.2-9.0; ßdiff, -0.309; 95% CI, -0.330 to -0.288). CONCLUSIONS: The 15-year trend of overall mean BMI and obesity and overweight prevalence demonstrated a significant increase; however, its slope decreased during the pandemic. These landmark results suggest the need for the development of precise strategies to prevent pediatric obesity and overweight during the COVID-19 pandemic.

Public purchasing in the EU during the COVID-19 pandemic

The COVID-19 has affected all countries worldwide including the European Union and its Member States. The impact of the pandemic is huge where the death toll is higher and the intensive care units are sparser. With the rise of the contagion, the healthcare sector across Europe has struggled with its healthcare supplies. This is when public purchasing plays a vital in combating the struggles that arise from the pandemic. The unprecedented demand for healthcare supplies is not only faced by the EU and its Member States but also throughout the world. The EU has been put to test in its roles of cooperation in the pandemic response of its Member States. It is at this juncture that the EU roles and the Member States’ roles somehow conflicted as some Member States tackle the pandemic through its national preference and political legitimacy. The Chapter will discuss the existing legislation and governance mechanism in the EU and its Member States, the response of the EU and its Member States, the adoption of EU guidance of public procurement relating to the pandemic and its Member States’ response, the assistance and cooperation between Member States’ and lastly on the joint procurement and centralisation effort on vaccine procurement in the EU and its Member States. © The Editors and Contributors Severally 2021.

The emotional landscape of online teaching: An autoethnographic exploration of vulnerability and emotional reflexivity

In this autoethnography, I share my lived experiences of emotions in online teaching. Employing the notion of vulnerability, I explore my feelings as I negotiated the specific structural conditions of online teaching and the challenges presented by social interactions, student participation, and by my own sense of my teacher-educator identity, mediated by my background as an Asian female, non-native English speaker. My reflection on my own sense of vulnerability brought to the forefront various dimensions of my personal and professional identity. I felt marginalized further in online teaching due to the lack of direct social interactions and my self-doubt about online pedagogy, which accentuates, rather than subdues, my status as a non-native speaker and deepens my emotional struggles in negotiating and reinventing my teacher identity. In stepping back and looking at my own sense of increasing vulnerability and at the same time re-living past experiences, I not only came to understand my own emotions, but also was able to develop sensitivity to students' emotions through a closer attention towards their silence and (non) participation. I end the autoethnography emphasizing the importance of emotional reflexivity in grappling with challenges in teaching, enabling both personal growth and professional transformation.

Blockchain Meets COVID-19: A Framework for Contact Information Sharing and Risk Notification System

COVID-19 is a severe global epidemic in human history. Even though there are particular medications and vaccines to curb the epidemic, tracing and isolating the infection source is the best option to slow the virus spread and reduce infection and death rates. There are three disadvantages to the existing contact tracing system: 1. User data is stored in a centralized database that could be stolen and tampered with, 2. User's confidential personal identity may be revealed to a third party or organization, 3. Existing contact tracing systems [1] [2] only focus on information sharing from one dimension, such as location-based tracing, which significantly limits the effectiveness of such systems. We propose a global COVID-19 information sharing and risk notification system that utilizes the Blockchain, Smart Contract, and Bluetooth. To protect user privacy, we design a novel Blockchain-based platform that can share consistent and non-tampered contact tracing information from multiple dimensions, such as location-based for indirect contact and Bluetooth-based for direct contact. Hierarchical smart contract architecture is also designed to achieve global agreements from users about how to process and utilize user data, thereby enhancing the data usage transparency. Furthermore, we propose a mechanism to protect user identity privacy from multiple aspects. More importantly, our system can notify the users about the exposure risk via smart contracts. We implement a prototype system to conduct extensive measurements to demonstrate the feasibility and effectiveness of our system.

Clinical Presentation and Outcomes of Middle East Respiratory Syndrome in the Republic of Korea

Background: From May to July 2015, the Republic of Korea experienced the largest outbreak of Middle East respiratory syndrome (MERS) outside the Arabian Peninsula. A total of 186 patients, including 36 deaths, had been diagnosed with MERS-coronavirus (MERS-CoV) infection as of September 30th, 2015. Materials and Methods: We obtained information of patients who were confirmed to have MERS-CoV infection. MERS-CoV infection was diagnosed using real-time reverse-transcriptase polymerase chain reaction assay. Results: The median age of the patients was 55 years (range, 16 to 86). A total of 55.4% of the patients had one or more coexisting medical conditions. The most common symptom was fever (95.2%). At admission, leukopenia (42.6%), thrombocytopenia (46.6%), and elevation of aspartate aminotransferase (42.7%) were observed. Pneumonia was detected in 68.3% of patients at admission and developed in 80.8% during the disease course. Antiviral agents were used for 74.7% of patients. Mechanical ventilation, extracorporeal membrane oxygenation, and convalescent serum were employed for 24.5%, 7.1%, and 3.8% of patients, respectively. Older age, presence of coexisting medical conditions including diabetes or chronic lung disease, presence of dyspnea, hypotension, and leukocytosis at admission, and the use of mechanical ventilation were revealed to be independent predictors of death. Conclusion: The clinical features of MERS-CoV infection in the Republic of Korea were similar to those of previous outbreaks in the Middle East. However, the overall mortality rate (20.4%) was lower than that in previous reports. Enhanced surveillance and active management of patients during the outbreak may have resulted in improved outcomes. FAU - Choi, Won Suk