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1.
Gut ; 72(Suppl 1):A25-A28, 2023.
Article in English | ProQuest Central | ID: covidwho-20234065

ABSTRACT

IDDF2023-ABS-0045 Figure 1 IDDF2023-ABS-0045 Figure 2 IDDF2023-ABS-0045 Figure 3 IDDF2023-ABS-0045 Figure 4

2.
J Neurol Neurosurg Psychiatry ; 94(8): 605-613, 2023 Aug.
Article in English | MEDLINE | ID: covidwho-20238777

ABSTRACT

To explore the autoimmune response and outcome in the central nervous system (CNS) at the onset of viral infection and correlation between autoantibodies and viruses. METHODS: A retrospective observational study was conducted in 121 patients (2016-2021) with a CNS viral infection confirmed via cerebrospinal fluid (CSF) next-generation sequencing (cohort A). Their clinical information was analysed and CSF samples were screened for autoantibodies against monkey cerebellum by tissue-based assay. In situ hybridisation was used to detect Epstein-Barr virus (EBV) in brain tissue of 8 patients with glial fibrillar acidic protein (GFAP)-IgG and nasopharyngeal carcinoma tissue of 2 patients with GFAP-IgG as control (cohort B). RESULTS: Among cohort A (male:female=79:42; median age: 42 (14-78) years old), 61 (50.4%) participants had detectable autoantibodies in CSF. Compared with other viruses, EBV increased the odds of having GFAP-IgG (OR 18.22, 95% CI 6.54 to 50.77, p<0.001). In cohort B, EBV was found in the brain tissue from two of eight (25.0%) patients with GFAP-IgG. Autoantibody-positive patients had a higher CSF protein level (median: 1126.00 (281.00-5352.00) vs 700.00 (76.70-2899.00), p<0.001), lower CSF chloride level (mean: 119.80±6.24 vs 122.84±5.26, p=0.005), lower ratios of CSF-glucose/serum-glucose (median: 0.50[0.13-0.94] vs 0.60[0.26-1.23], p=0.003), more meningitis (26/61 (42.6%) vs 12/60 (20.0%), p=0.007) and higher follow-up modified Rankin Scale scores (1 (0-6) vs 0 (0-3), p=0.037) compared with antibody-negative patients. A Kaplan-Meier analysis revealed that autoantibody-positive patients experienced significantly worse outcomes (p=0.031). CONCLUSIONS: Autoimmune responses are found at the onset of viral encephalitis. EBV in the CNS increases the risk for autoimmunity to GFAP.


Subject(s)
Encephalitis , Epstein-Barr Virus Infections , Male , Humans , Female , Autoimmunity , Retrospective Studies , Herpesvirus 4, Human , Autoantibodies , Immunoglobulin G
3.
ACS Sens ; 8(6): 2309-2318, 2023 Jun 23.
Article in English | MEDLINE | ID: covidwho-20238622

ABSTRACT

We adapted an existing, spaceflight-proven, robust "electronic nose" (E-Nose) that uses an array of electrical resistivity-based nanosensors mimicking aspects of mammalian olfaction to conduct on-site, rapid screening for COVID-19 infection by measuring the pattern of sensor responses to volatile organic compounds (VOCs) in exhaled human breath. We built and tested multiple copies of a hand-held prototype E-Nose sensor system, composed of 64 chemically sensitive nanomaterial sensing elements tailored to COVID-19 VOC detection; data acquisition electronics; a smart tablet with software (App) for sensor control, data acquisition and display; and a sampling fixture to capture exhaled breath samples and deliver them to the sensor array inside the E-Nose. The sensing elements detect the combination of VOCs typical in breath at parts-per-billion (ppb) levels, with repeatability of 0.02% and reproducibility of 1.2%; the measurement electronics in the E-Nose provide measurement accuracy and signal-to-noise ratios comparable to benchtop instrumentation. Preliminary clinical testing at Stanford Medicine with 63 participants, their COVID-19-positive or COVID-19-negative status determined by concomitant RT-PCR, discriminated between these two categories of human breath with a 79% correct identification rate using "leave-one-out" training-and-analysis methods. Analyzing the E-Nose response in conjunction with body temperature and other non-invasive symptom screening using advanced machine learning methods, with a much larger database of responses from a wider swath of the population, is expected to provide more accurate on-the-spot answers. Additional clinical testing, design refinement, and a mass manufacturing approach are the main steps toward deploying this technology to rapidly screen for active infection in clinics and hospitals, public and commercial venues, or at home.


Subject(s)
COVID-19 , Nanostructures , Volatile Organic Compounds , Animals , Humans , Electronic Nose , Reproducibility of Results , COVID-19/diagnosis , Breath Tests/methods , Volatile Organic Compounds/analysis , Mammals
4.
Front Psychiatry ; 14: 1144413, 2023.
Article in English | MEDLINE | ID: covidwho-20245001

ABSTRACT

Background: Internet gaming disorder (IGD) has become a social problem in children. Evidence from previous studies has proven that anxiety is associated with IGD. However, IGD was always assessed as a whole based on total scores, and the fine-grained relationship between anxiety and IGD was hidden. Objective: The present study aims to investigate the fine-grained relationship between anxiety and IGD in elementary school students during the COVID-19 lockdown, and to identify potential targets for psychological interventions. Methods: During the lockdown caused by the COVID-19 pandemic, 667 children from a primary school in China were investigated by the Spence Children's Anxiety Scale-Short Version and Internet Gaming Disorder Scale. R4.1.1 software was used to construct a network model, assess bridge centrality, and test the robustness of the network and conduct a network. Results: There were 23 cross-community edges (weight ranged from -0.03 to 0.12), and each node of anxiety was connected to different nodes of IGD. The nodes with the top 80th percentile bridge expected influence were A2 "social phobia" (0.20), A3 "panic disorder" (0.21) and IGD5 "escape" (0.22). The robustness of the network was acceptable. Conclusion: From the perspective of network analysis, the present study explored the correlation pathways between anxiety and IGD in children and identified social phobia and panic disorder as the best targets for intervention to reduce IGD.

5.
Vaccines (Basel) ; 11(5)2023 May 04.
Article in English | MEDLINE | ID: covidwho-20242835

ABSTRACT

Several observational studies have confirmed that the severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) might substantially affect the gastrointestinal (GI) system by replicating in human small intestine enterocytes. Yet, so far, no study has reported the effects of inactivated SARS-CoV-2 virus vaccines on gut microbiota alterations. In this study, we examined the effects of the BBIBP-CorV vaccine (ChiCTR2000032459, sponsored by the Beijing Institute of Biological Products/Sinopharm), on gut microbiota. Fecal samples were collected from individuals whoreceived two doses of intramuscular injection of BBIBP-CorV and matched unvaccinated controls. DNA extracted from fecal samples was subjected to 16S ribosomal RNA sequencing analysis. The composition and biological functions of the microbiota between vaccinated and unvaccinated individuals were compared. Compared with unvaccinated controls, vaccinated subjects exhibited significantly reduced bacterial diversity, elevated firmicutes/bacteroidetes (F/B) ratios, a tendency towards Faecalibacterium-predominant enterotypes, and altered gut microbial compositions and functional potentials. Specifically, the intestinal microbiota in vaccine recipients was enriched with Faecalibacterium and Mollicutes and with a lower abundance of Prevotella, Enterococcus, Leuconostocaceae, and Weissella. Microbial function prediction by phylogenetic investigation of communities using reconstruction of unobserved states (PICRUSt) analysis further indicated that Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways involved in carbohydrate metabolism and transcription were positively associated with vaccine inoculation, whereas capacities in neurodegenerative diseases, cardiovascular diseases, and cancers were negatively affected by vaccines. Vaccine inoculation was particularly associated with gut microbiota alterations, as was demonstrated by the improved composition and functional capacities of gut microbiota.

6.
Virus Genes ; 2023 Jun 13.
Article in English | MEDLINE | ID: covidwho-20235198

ABSTRACT

SARS-CoV-2 mutation is minimized through a proofreading function encoded by NSP-14. Most estimates of the SARS-CoV-2 mutation rate are derived from population based sequence data. Our understanding of SARS-CoV-2 evolution might be enhanced through analysis of intra-host viral mutation rates in specific populations. Viral genome analysis was performed between paired samples and mutations quantified at allele frequencies (AF) ≥ 0.25, ≥ 0.5 and ≥ 0.75. Mutation rate was determined employing F81 and JC69 evolution models and compared between isolates with (ΔNSP-14) and without (wtNSP-14) non-synonymous mutations in NSP-14 and by patient comorbidity. Forty paired samples with median interval of 13 days [IQR 8.5-20] were analyzed. The estimated mutation rate by F81 modeling was 93.6 (95%CI 90.8-96.4], 40.7 (95%CI 38.9-42.6) and 34.7 (95%CI 33.0-36.4) substitutions/genome/year at AF ≥ 0.25, ≥ 0.5, ≥ 0.75 respectively. Mutation rate in ΔNSP-14 were significantly elevated at AF ≥ 0.25 vs wtNSP-14. Patients with immune comorbidities had higher mutation rate at all allele frequencies. Intra-host SARS-CoV-2 mutation rates are substantially higher than those reported through population analysis. Virus strains with altered NSP-14 have accelerated mutation rate at low AF. Immunosuppressed patients have elevated mutation rate at all AF. Understanding intra-host virus evolution will aid in current and future pandemic modeling.

7.
Organs-on-a-Chip ; 5:100030, 2023.
Article in English | ScienceDirect | ID: covidwho-20230626

ABSTRACT

Disease models that can accurately recapitulate human pathophysiology during infection and clinical response to antiviral therapeutics are still lacking, which represents a major barrier in drug development. The emergence of human Organs-on-a-Chip that integrated microfluidics with three-dimensional (3D) cell culture, may become the potential solution for this urgent need. Human Organs-on-a-Chip aims to recapitulate human pathophysiology by incorporating tissue-relevant cell types and their microenvironment, such as dynamic fluid flow, mechanical cues, tissue–tissue interfaces, and immune cells to increase the predictive validity of in vitro experimental models. Human Organs-on-a-Chip has a broad range of potential applications in basic biomedical research, preclinical drug development, and personalized medicine. This review focuses on its use in the fields of virology and infectious diseases. We reviewed various types of human Organs-on-a-Chip-based viral infection models and their application in studying viral life cycle, pathogenesis, virus-host interaction, and drug responses to virus- and host-targeted therapies. We conclude by proposing challenges and future research avenues for leveraging this promising technology to prepare for future pandemics.

8.
Journal of Building Engineering ; : 106807, 2023.
Article in English | ScienceDirect | ID: covidwho-2327353

ABSTRACT

The COVID-19 pandemic changed our lives, forcing us to reconsider our built environment. In some buildings with high traffic flow, infected individuals release viral particles during movement. The complex interactions between humans, building, and viruses make it difficult to predict indoor infection risk by traditional computational fluid dynamics methods. The paper developed a spatially-explicit agent-based model to simulate indoor respiratory pathogen transmission for buildings with frequent movement of people. The social force model simulating pedestrian movement and a simple forcing method simulating indoor airflow were coupled in an agent-based modeling environment. The impact of architectural and behavioral interventions on the indoor infection risk was then compared by simulating a supermarket case. We found that wearing a mask was the most effective single intervention, with all people wearing masks reducing the percentage of infections to 0.08%. Among the combined interventions, the combination of customer control is the most effective and can reduce the percentage of infections to 0.04%. In addition, the extremely strict combination of all the interventions makes the supermarket free of new infections during its 8-hour operation. The approach can help architects, managers, or the government better understand the effect of nonpharmaceutical interventions to reduce the infection risk and improve the level of indoor safety.

9.
BMC Nurs ; 22(1): 164, 2023 May 16.
Article in English | MEDLINE | ID: covidwho-2327359

ABSTRACT

BACKGROUND: The emergency of Omicron variants, spreading in China and worldwide, has sparked a new wave of the coronavirus disease 2019 (COVID-19) pandemic. The high infectivity and persistence of the pandemic may trigger some degrees of post-traumatic stress disorder (PTSD) for nursing students experiencing indirect trauma exposure to the epidemic, which hinders the role transition from students to qualified nurses and exacerbates the health workforce shortage. Thus, it's well worth an exploration to understand PTSD and its underlying mechanism. Specifically, PTSD, social support, resilience, and fear of COVID-19 were selected after widely literature review. This study aimed to investigate the relationship between social support and PTSD among nursing students during COVID-19, to address the mediating role of resilience and fear of COVID-19 between social support and PTSD, and to provide practical guidance for nursing students' psychological intervention. METHODS: From April 26 to April 30, 2022, 966 nursing students from Wannan Medical College were selected by the multistage sampling method to fill the Primary Care PTSD Screen for the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), Brief Resilience Scale, Fear of COVID-19 Scale, and Oslo 3 Items Social Support Scale. Data were analyzed by descriptive statistics, spearman's correlation analysis, regression analysis, and path analysis. RESULTS: 15.42% of nursing students had PTSD. There were significant correlations between social support, resilience, fear of COVID-19, and PTSD (r =-0.291 ~ 0.353, P <0.001). Social support had a direct negative effect on PTSD (ß =-0.216; 95% confidence interval, CI: -0.309~-0.117), accounting for 72.48% of the total effect. Analysis of mediating effects revealed that social support influenced PTSD through three indirect pathways: the mediated effect of resilience was statistically significant (ß =-0.053; 95% CI: -0.077~-0.031), accounting for 17.79% of the total effect; the mediated effect of fear of COVID-19 was statistically significant (ß =-0.016; 95% CI: -0.031~-0.003), accounting for 5.37% of the total effect; the chain mediating effect of resilience and fear of COVID-19 was statistically significant (ß =-0.013; 95% CI: -0.022~-0.006), accounting for 4.36% of the total effect. CONCLUSION: The social support of nursing students not only directly affects PTSD, but also indirectly affects PTSD through the separate and chain mediating effect of resilience and fear of COVID-19. The compound strategies targeted at boosting perceived social support, fostering resilience, and controlling fear of COVID-19 are warranted for reducing PTSD.

10.
J Infect Dis ; 2023 May 18.
Article in English | MEDLINE | ID: covidwho-2327151

ABSTRACT

BACKGROUND: An orally aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) has recently been authorized for boosting immunization in China. Our study aims to assess the environmental impact of the use of aerosolised Ad5-nCoV. METHODS: We collected air samples from rooms, swabs from the setting desks of the vaccine nebuliser, mask samples from participants and blood samples of nurses who administered the inoculation in the clinical trials. The viral load of adenovirus type-5 vector in the samples and the antibody levels against the wild-type SARS-CoV-2 strain in serum were detected. RESULTS: Only one (4.00%) air samples collected before the initiation of vaccination was positive, which were almost positive during and after the vaccination (97.96%, 100%, respectively). All nurses in the trial A showed at least four-fold increase of the neutralizing antibody against the SARS-CoV-2 after the initiation of the study. In trial B, the positive proportion of the mask samples was 72.97% at 30 minutes after vaccination, 8.11% at day 1, and 0% at days 3, 5, and 7, respectively. CONCLUSION: The vaccination with the orally aerosolised Ad5-nCoV could have some spillage of the vaccine vector viral particles in the environment and cause human exposure.

11.
Lancet Infect Dis ; 2023 May 19.
Article in English | MEDLINE | ID: covidwho-2327135

ABSTRACT

BACKGROUND: Heterologous boosting is suggested to be of use in populations who have received inactivated COVID-19 vaccines. We aimed to assess the safety and immunogenicity of a heterologous vaccination with the mRNA vaccine CS-2034 versus the inactivated BBIBP-CorV as a fourth dose, as well as the efficacy against the SARS-CoV-2 omicron (BA.5) variant. METHODS: This trial contains a randomised, double-blind, parallel-controlled study in healthy participants aged 18 years or older (group A) and an open-label cohort in participants 60 years and older (group B), who had received three doses of inactivated whole-virion vaccines at least 6 months before enrolment. Pregnant women and people with major chronic illnesses or a history of allergies were excluded. Eligible participants in group A were stratified by age (18-59 years and ≥60 years) and then randomised by SAS 9.4 in a ratio of 3:1 to receive a dose of the mRNA vaccine (CS-2034, CanSino, Shanghai, China) or inactivated vaccine (BBIBP-CorV, Sinopharm, Beijing, China). Safety and immunogenicity against omicron variants of the fourth dose were evaluated in group A. Participants 60 years and older were involved in group B for safety observations. The primary outcome was geometric mean titres (GMTs) of the neutralising antibodies against omicron and seroconversion rates against BA.5 variant 28 days after the boosting, and incidence of adverse reactions within 28 days. The intention-to-treat group was involved in the safety analysis, while all patients in group A who had blood samples taken before and after the booster were involved in the immunogenicity analysis. This trial was registered at the Chinese Clinical Trial Registry Centre (ChiCTR2200064575). FINDINGS: Between Oct 13, and Nov 22, 2022, 320 participants were enrolled in group A (240 in the CS-2034 group and 80 in the BBIBP-CorV group) and 113 in group B. Adverse reactions after vaccination were more frequent in CS-2034 recipients (158 [44·8%]) than BBIBP-CorV recipients (17 [21·3%], p<0·0001). However, most adverse reactions were mild or moderate, with grade 3 adverse reactions only reported by eight (2%) of 353 participants receiving CS-2034. Heterologous boosting with CS-2034 elicited 14·4-fold (GMT 229·3, 95% CI 202·7-259·4 vs 15·9, 13·1-19·4) higher concentration of neutralising antibodies to SARS-CoV-2 omicron variant BA.5 than did homologous boosting with BBIBP-CorV. The seroconversion rates of SARS-CoV-2-specific neutralising antibody responses were much higher in the mRNA heterologous booster regimen compared with BBIBP-CorV homologous booster regimen (original strain 47 [100%] of 47 vs three [18·8%] of 16; BA.1 45 [95·8%] of 48 vs two [12·5%] 16; and BA.5 233 [98·3%] of 240 vs 15 [18·8%] of 80 by day 28). INTERPRETATION: Both the administration of mRNA vaccine CS-2034 and inactivated vaccine BBIBP-CorV as a fourth dose were well tolerated. Heterologous boosting with mRNA vaccine CS-2034 induced higher immune responses and protection against symptomatic SARS-CoV-2 omicron infections compared with homologous boosting, which could support the emergency use authorisation of CS-2034 in adults. FUNDING: Science and Technology Commission of Shanghai, National Natural Science Foundation of China, Jiangsu Provincial Science Fund for Distinguished Young Scholars, and Jiangsu Provincial Key Project of Science and Technology Plan. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.

12.
Front Microbiol ; 14: 1157608, 2023.
Article in English | MEDLINE | ID: covidwho-2324430

ABSTRACT

Introduction: Coronaviruses (CoVs) are naturally found in bats and can occasionally cause infection and transmission in humans and other mammals. Our study aimed to build a deep learning (DL) method to predict the adaptation of bat CoVs to other mammals. Methods: The CoV genome was represented with a method of dinucleotide composition representation (DCR) for the two main viral genes, ORF1ab and Spike. DCR features were first analyzed for their distribution among adaptive hosts and then trained with a DL classifier of convolutional neural networks (CNN) to predict the adaptation of bat CoVs. Results and discussion: The results demonstrated inter-host separation and intra-host clustering of DCR-represented CoVs for six host types: Artiodactyla, Carnivora, Chiroptera, Primates, Rodentia/Lagomorpha, and Suiformes. The DCR-based CNN with five host labels (without Chiroptera) predicted a dominant adaptation of bat CoVs to Artiodactyla hosts, then to Carnivora and Rodentia/Lagomorpha mammals, and later to primates. Moreover, a linear asymptotic adaptation of all CoVs (except Suiformes) from Artiodactyla to Carnivora and Rodentia/Lagomorpha and then to Primates indicates an asymptotic bats-other mammals-human adaptation. Conclusion: Genomic dinucleotides represented as DCR indicate a host-specific separation, and clustering predicts a linear asymptotic adaptation shift of bat CoVs from other mammals to humans via deep learning.

13.
International Journal of Contemporary Hospitality Management ; 35(3):871-892, 2022.
Article in English | CAB Abstracts | ID: covidwho-2324620

ABSTRACT

Purpose: This study aims to investigate the effects of memorable dining experiences (MDEs) in the USA during the COVID-19 pandemic. Design/methodology/approach: A total of 530 valid survey responses were collected in the USA. Partial least squares structural equation modeling (PLS-SEM) was used to estimate inner and outer models. A two-stage approach was applied to test the moderating effects of restaurant safety measures. Additional analyses were conducted to compare electronic word of mouth (eWOM) intention and actual eWOM behavior. Findings: All five dimensions contributed to the overall memorability of a dining experience, with affect being the primary factor. Overall memorability was positively related to subjective well-being and actual eWOM behavior. Restaurant safety measures were positively related to the overall experience but did not moderate the relationship between any dimension and overall memorability. Research limitations/implications: Findings provide empirical support for the conceptualization of MDEs during a pandemic and underscore the importance of actual eWOM behavior in restaurant research. Practical implications: Results offer guidance for restaurant managers in designing MDEs. Originality/value: The restaurant industry is evolving from simply providing products and services to creating experiences. Yet the impacts of crafting MDEs are not well understood, especially during a pandemic. This study filled this gap by investigating MDEs and their effects on subjective well-being and eWOM behavior.

14.
Ear Nose Throat J ; : 1455613211000613, 2021 Mar 18.
Article in English | MEDLINE | ID: covidwho-2316522

ABSTRACT

We describe a case of spontaneous nasal septal abscess (NSA) in a 9-year-old child. We also reviewed the literatures in recent years and summarized the characteristics of NSA, such as gender, age, inducement, pathogenic bacteria, treatment, and prognosis. We found that this boy reported by us has the most extensive abscess. May be the delay of treatment was related to the recent fluctuation of COVID-19 epidemic in China. Fortunately, with the help of surgery and anti-infection treatment, the boy was discharged from the hospital without septal perforation or saddle nose.

15.
NPJ Vaccines ; 8(1): 64, 2023 May 02.
Article in English | MEDLINE | ID: covidwho-2316524

ABSTRACT

Coronavirus disease 2019 (COVID-19) vaccines are associated with several ocular manifestations. Emerging evidence has been reported; however, the causality between the two is debatable. We aimed to investigate the risk of retinal vascular occlusion after COVID-19 vaccination. This retrospective cohort study used the TriNetX global network and included individuals vaccinated with COVID-19 vaccines between January 2020 and December 2022. We excluded individuals with a history of retinal vascular occlusion or those who used any systemic medication that could potentially affect blood coagulation prior to vaccination. To compare the risk of retinal vascular occlusion, we employed multivariable-adjusted Cox proportional hazards models after performing a 1:1 propensity score matching between the vaccinated and unvaccinated cohorts. Individuals with COVID-19 vaccination had a higher risk of all forms of retinal vascular occlusion in 2 years after vaccination, with an overall hazard ratio of 2.19 (95% confidence interval 2.00-2.39). The cumulative incidence of retinal vascular occlusion was significantly higher in the vaccinated cohort compared to the unvaccinated cohort, 2 years and 12 weeks after vaccination. The risk of retinal vascular occlusion significantly increased during the first 2 weeks after vaccination and persisted for 12 weeks. Additionally, individuals with first and second dose of BNT162b2 and mRNA-1273 had significantly increased risk of retinal vascular occlusion 2 years following vaccination, while no disparity was detected between brand and dose of vaccines. This large multicenter study strengthens the findings of previous cases. Retinal vascular occlusion may not be a coincidental finding after COVID-19 vaccination.

16.
Emerg Microbes Infect ; 12(1): 2212806, 2023 Dec.
Article in English | MEDLINE | ID: covidwho-2319462

ABSTRACT

Monoclonal antibodies (mAbs) and the post-exposure prophylaxis (PEP) with mAbs represent a very important public health strategy against coronavirus disease 2019 (COVID-19). This study has assessed a new Anti-SARS-COV-2 mAb (SA58) Nasal Spray for PEP against COVID-19 in healthy adults aged 18 years and older within three days of exposure to a SARS-CoV-2 infected individual. Recruited participants were randomized in a ratio of 3:1 to receive SA58 or placebo. Primary endpoints were laboratory-confirmed symptomatic COVID-19 within the study period. A total of 1222 participants were randomized and dosed (SA58, n = 901; placebo, n = 321). Median of follow-up was 2.25 and 2.79 days for SA58 and placebo, respectively. Adverse events occurred in 221 of 901 (25%) and 72 of 321 (22%) participants with SA58 and placebo, respectively. All adverse events were mild in severity. Laboratory-confirmed symptomatic COVID-19 developed in 7 of 824 participants (0.22 per 100 person-days) in the SA58 group vs. 14 of 299 (1.17 per 100 person-days) in the placebo group, resulting in an estimated efficacy of 80.82% (95%CI 52.41%-92.27%). There were 32 SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) positives (1.04 per 100 person-days) in the SA58 group vs. 32 (2.80 per 100 person-days) in the placebo group, resulting in an estimated efficacy of 61.83% (95%CI 37.50%-76.69%). A total of 21 RT-PCR positive samples were sequenced and all were the Omicron variant BF.7. In conclusion, SA58 Nasal Spray showed favourable efficacy and safety in preventing symptomatic COVID-19 or SARS-CoV-2 infection in adults who had exposure to SARS-CoV-2 within 72 h.


Subject(s)
COVID-19 , Adult , Humans , COVID-19/prevention & control , SARS-CoV-2 , Nasal Sprays , Post-Exposure Prophylaxis , Single-Blind Method , Double-Blind Method , Antibodies, Viral
17.
EBioMedicine ; 91: 104586, 2023 May.
Article in English | MEDLINE | ID: covidwho-2295894

ABSTRACT

BACKGROUND: We assessed the safety and immunogenicity of a core-shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. METHODS: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25µg (n = 20), or SW-BIC-213-45µg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). FINDINGS: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 µg, n = 20, or 45 µg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 µg and 45 µg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45µg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. INTERPRETATION: SW-BIC-213, a core-shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. FUNDING: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai.


Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , Humans , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , SARS-CoV-2 , Antibodies, Viral , China , Antibodies, Neutralizing , Double-Blind Method
18.
Front Biosci (Landmark Ed) ; 28(4): 65, 2023 04 06.
Article in English | MEDLINE | ID: covidwho-2294387

ABSTRACT

BACKGROUND: The SARS-CoV-2 vaccine has been implemented in response to the 2019 Coronavirus Disease (COVID-19) pandemic worldwide. Dysregulation of gut metabolite is associated with COVID-19 patients. However, the effect of vaccination on the gut metabolite remains unknown, and it is critical to investigate the shifts in metabolic profiles following vaccine treatment. METHODS: In the present study, we conducted a case-control study to assess the fecal metabolic profiles between individuals who received two doses of intramuscular injection of an inactivated SARS-CoV-2 vaccine candidate (BBIBP-CorV) (n = 20), and matched unvaccinated controls (n = 20) using untargeted gas chromatography and time-of-flight mass spectrometry (GC-TOF/MS). RESULTS: Significant different metabolic profiles were observed between subjects receiving SARS-CoV-2 virus vaccines and the unvaccinated. Among a total of 243 metabolites from 27 ontology classes identified in the study cohort, 64 metabolic markers and 15 ontology classes were dramatically distinct between vaccinated and unvaccinated individuals. There were 52 enhanced (such as Desaminotyrosine, Phenylalanine) and 12 deficient metabolites (such as Octadecanol, 1-Hexadecanol) in vaccinated individuals. Along with altered metabolic compositions, multiple functional pathways in Small MoleculePathway Database (SMPDB) and Kyoto Encyclopedia of Genes and Genomes (KEGG) varied between groups. Our results indicated that urea cycle; alanine, aspartate, and glutamate metabolism; arginine and proline metabolism; phenylalanine metabolism and tryptophan metabolism were abundant after vaccination. Additionally, correlation analysis showed that intestinal microbiome was related to alteration in metabolite composition and functions. CONCLUSIONS: The present study indicated the alterations in the gut metabolome after COVID-19 vaccination and the findings provide a valuable resource for in-depth exploration of mechanisms between gut metabolite and SARS-CoV-2 virus vaccines.


Subject(s)
COVID-19 , Vaccines , Humans , COVID-19 Vaccines , SARS-CoV-2 , Case-Control Studies , COVID-19/prevention & control , Metabolome
19.
Animal Model Exp Med ; 4(1): 2-15, 2021 03.
Article in English | MEDLINE | ID: covidwho-2270129

ABSTRACT

Background: Cardiovascular diseases (CVDs) and diabetes mellitus (DM) are top two chronic comorbidities that increase the severity and mortality of COVID-19. However, how SARS-CoV-2 alters the progression of chronic diseases remain unclear. Methods: We used adenovirus to deliver h-ACE2 to lung to enable SARS-CoV-2 infection in mice. SARS-CoV-2's impacts on pathogenesis of chronic diseases were studied through histopathological, virologic and molecular biology analysis. Results: Pre-existing CVDs resulted in viral invasion, ROS elevation and activation of apoptosis pathways contribute myocardial injury during SARS-CoV-2 infection. Viral infection increased fasting blood glucose and reduced insulin response in DM model. Bone mineral density decreased shortly after infection, which associated with impaired PI3K/AKT/mTOR signaling. Conclusion: We established mouse models mimicked the complex pathological symptoms of COVID-19 patients with chronic diseases. Pre-existing diseases could impair the inflammatory responses to SARS-CoV-2 infection, which further aggravated the pre-existing diseases. This work provided valuable information to better understand the interplay between the primary diseases and SARS-CoV-2 infection.


Subject(s)
COVID-19/complications , COVID-19/physiopathology , Cardiovascular Diseases/complications , Cardiovascular Diseases/physiopathology , Diabetes Complications/physiopathology , Animals , Comorbidity , Diabetes Mellitus , Disease Models, Animal , Male , Mice , SARS-CoV-2
20.
Biomed Pharmacother ; 158: 114096, 2023 Feb.
Article in English | MEDLINE | ID: covidwho-2257259

ABSTRACT

BACKGROUND: Respiratory diseases mainly include asthma, influenza, pneumonia, chronic obstructive pulmonary disease, pulmonary hypertension, lung fibrosis, and lung cancer. Given their high prevalence and poor prognosis, the prevention and treatment of respiratory diseases are increasingly essential. In particular, the development for the novel strategies of drug treatment has been a hot topic in the research field. Ginsenosides are the major component of Panax ginseng C. A. Meyer (ginseng), a food homology and well-known medicinal herb. In this review, we summarize the current therapeutic effects and molecular mechanisms of ginsenosides in respiratory diseases. METHODS: The reviewed studies were retrieved via a thorough analysis of numerous articles using electronic search tools including Sci-Finder, ScienceDirect, PubMed, and Web of Science. The following keywords were used for the online search: ginsenosides, asthma, influenza, pneumonia, chronic obstructive pulmonary disease (COPD), pulmonary hypertension (PH), lung fibrosis, lung cancer, and clinical trials. We summarized the findings and the conclusions from 176 manuscripts on ginsenosides, including research articles and reviews. RESULTS: Ginsenosides Rb1, Rg1, Rg3, Rh2, and CK, which are the most commonly reported ginsenosides for treating of respiratory diseases, and other ginsenosides such as Rh1, Rk1, Rg5, Rd and Re, all primarily reduce pneumonia, fibrosis, and inhibit tumor progression by targeting NF-κB, TGF-ß/Smad, PI3K/AKT/mTOR, and JNK pathways, thereby ameliorating respiratory diseases. CONCLUSION: This review provides novel ideas and important aspects for the future research of ginsenosides for treating respiratory diseases.


Subject(s)
Asthma , Ginsenosides , Hypertension, Pulmonary , Influenza, Human , Lung Neoplasms , Panax , Pulmonary Disease, Chronic Obstructive , Pulmonary Fibrosis , Humans , Ginsenosides/pharmacology , Ginsenosides/therapeutic use , Ginsenosides/chemistry , Pulmonary Fibrosis/drug therapy , Hypertension, Pulmonary/drug therapy , Influenza, Human/drug therapy , Phosphatidylinositol 3-Kinases , Pulmonary Disease, Chronic Obstructive/drug therapy , Asthma/drug therapy , Lung Neoplasms/drug therapy , Panax/chemistry
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