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2.
Inquiry ; 59: 469580211055621, 2022.
Article in English | MEDLINE | ID: covidwho-1784978

ABSTRACT

By September 20, 2021, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been pandemic in 237 countries and regions, resulting in 228,506,698 confirmed cases and 4,692,361 deaths. At the same time, a total of 1123 cases of COVID-19 had been confirmed in Beijing, China. Peking University Shougang Hospital has 4 community hospitals with 174 staff members, covering 230,000 residents in Shijingshan district, Beijing. The community hospitals were the basic units of China's healthcare system for public health services, as the main battlefield for screening and controlling of COVID-19. We reported our experience about the prevention of SARS-CoV-2. We suggest that community hospitals should change their process for admitting patients. While the screening of suspected cases of COVID-19 is vital, patients with suspected infections should be isolated immediately.


Subject(s)
COVID-19 , Beijing/epidemiology , China/epidemiology , Hospitals, Community , Humans , SARS-CoV-2
3.
Front Psychiatry ; 13: 780807, 2022.
Article in English | MEDLINE | ID: covidwho-1779962

ABSTRACT

Although the World Health Organization (WHO) has issued guidelines for managing to contain, mitigate, and limit of the COVID-19. However, it is more essential to highlight the urgency and importance of evaluating social functioning and mental health status during the pandemic. College students have experienced serious problems and have had to overcome many negative situations brought about by the pandemic. Accordingly, the present study intended to use Chinese college students as sample to examine the positive adoption and changes during the ongoing COVID-19. Guided by literatures in this filed, we explored the internal mechanism of post-traumatic growth affecting psychological resilience, and considered about mediation roles of positive coping styles and cognitive reappraisal. A total of 463 college students from universities in China effectively completed online questionnaires. The result indicated that these four variables were positively correlated with each other (ps < 0.001). More importantly, our findings proved a direct and positive effect on psychological resilience. Positive coping styles and cognitive reappraisal, respectively, mediated the relationship between post-traumatic growth and psychological resilience. Over all, the hypothesized serial model conclusively fits the data: students with high-level post-traumatic growth tended to report increased use of positive coping strategies, which further facilitated their cognitive reappraisal, and subsequently, promoted their psychological resilience. The findings obtained in this study will provide a theoretical basis and possible viable strategies for both targeted crisis intervention and psychological trauma recovery plans.

4.
Psych J ; 2022 Apr 06.
Article in English | MEDLINE | ID: covidwho-1772829

ABSTRACT

Repeated outbreaks of coronavirus disease 2019 (COVID-19) have forced people to shift most of their work and life activities from offline to online, leading to a growing problem of Internet dependence and even Internet addiction. However, the mechanism of the association between COVID-19-related intolerance of uncertainty (COVID-19 IU) and Internet addiction during the second wave of COVID-19 is still unclear. The current study explored the association between COVID-19 IU and Internet addiction as mediated by depression and risk perception based on the Uncertainty-Depression-Perception-Addiction model (UDPA). A total of 1,137 adult participants were recruited, and COVID-19 IU, depression, risk perception, Internet addiction, and demographic variables were analyzed. The results showed that COVID-19 IU was significantly and positively associated with Internet addiction and that this relationship was mediated in parallel by depression and risk perception. Our findings further extend the Interaction of Person-Affect-Cognition-Execution (I-PACE) model from the perspective of applicability in the unique context of COVID-19. Furthermore, the study suggests that individuals could decrease their dependence on the Internet to prevent Internet addiction during the second wave of the pandemic through effective interventions that include lowering COVID-19 IU, improving emotion regulation, and developing reasonable perceptions of risk.

5.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-331897

ABSTRACT

Large-scale populations in the world have been vaccinated with COVID-19 vaccines, however, breakthrough infections of SARS-CoV-2 are still growing rapidly due to the emergence of immune-evasive variants, especially Omicron. It is urgent to develop effective broad-spectrum vaccines to better control the pandemic of these variants. Here, we present a mosaic-type trimeric form of spike receptor-binding domain (mos-tri-RBD) as a broad-spectrum vaccine candidate, which carries the key mutations from Omicron and other circulating variants. Tests in rats showed that the designed mos-tri-RBD, whether used alone or as a booster shot, elicited potent cross-neutralizing antibodies against not only Omicron but also other immune-evasive variants. Neutralizing antibody titers induced by mos-tri-RBD were substantially higher than those elicited by homo-tri-RBD (containing homologous RBDs from prototype strain) or the inactivated vaccine BBIBP-CorV. Our study indicates that mos-tri-RBD is highly immunogenic, which may serve as a broad-spectrum vaccine candidate in combating SARS-CoV-2 variants including Omicron.

6.
Elife ; 112022 03 24.
Article in English | MEDLINE | ID: covidwho-1761116

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infects cells through binding to angiotensin-converting enzyme 2 (ACE2). This interaction is mediated by the receptor-binding domain (RBD) of the viral spike (S) glycoprotein. Structural and dynamic data have shown that S can adopt multiple conformations, which controls the exposure of the ACE2-binding site in the RBD. Here, using single-molecule Förster resonance energy transfer (smFRET) imaging, we report the effects of ACE2 and antibody binding on the conformational dynamics of S from the Wuhan-1 strain and in the presence of the D614G mutation. We find that D614G modulates the energetics of the RBD position in a manner similar to ACE2 binding. We also find that antibodies that target diverse epitopes, including those distal to the RBD, stabilize the RBD in a position competent for ACE2 binding. Parallel solution-based binding experiments using fluorescence correlation spectroscopy (FCS) indicate antibody-mediated enhancement of ACE2 binding. These findings inform on novel strategies for therapeutic antibody cocktails.


Subject(s)
SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Angiotensin-Converting Enzyme 2/chemistry , COVID-19 , Humans , Protein Domains , Spike Glycoprotein, Coronavirus/chemistry
7.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-329783

ABSTRACT

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants with immune escape ability raises the urgent need for developing cross-neutralizing vaccines against the virus. NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluated the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in adults previously vaccinated with the inactivated vaccine BBIBP-CorV in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates ( NCT05069129 ). Three groups of healthy adults over 18 years of age (600 participants per group) who had administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, were vaccinated with either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The primary outcome was immunogenicity and safety of booster vaccinations. The exploratory outcome was cross-reactive immunogenicity against multiple SARS-CoV-2 variants of concerns (VOCs). The incidence of adverse reactions was low in both booster vaccinations, and the overall safety profile of heterologous boost was quite similar to that of homologous boost. Heterologous NVSI-06-08 booster was immunogenically superior to homologous booster of BBIBP-CorV. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster were significantly higher than by the booster of BBIBP-CorV against not only SARS-CoV-2 prototype strain but also multiple VOCs. Especially, the neutralizing activity induced by NVSI-06-08 booster against the immune-evasive Beta variant was no less than that against the prototype strain, and a considerable level of neutralizing antibodies against Omicron (GMT: 367.67;95%CI, 295.50-457.47) was induced by heterologous booster, which was substantially higher than that boosted by BBIBP-CorV (GMT: 45.03;95%CI, 36.37-55.74). Our findings showed that NVSI-06-08 was safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which was immunogenically superior to homologous boost with another dose of BBIBP-CorV. Our study also indicated that the design of hybrid antigen may provide an effective strategy for broad-spectrum vaccine developments.

8.
Cell Discov ; 8(1): 17, 2022 Feb 15.
Article in English | MEDLINE | ID: covidwho-1692628

ABSTRACT

The continuous emergence of SARS-CoV-2 variants highlights the need of developing vaccines with broad protection. Here, according to the immune-escape capability and evolutionary convergence, the representative SARS-CoV-2 strains carrying the hotspot mutations were selected. Then, guided by structural and computational analyses, we present a mutation-integrated trimeric form of spike receptor-binding domain (mutI-tri-RBD) as a broadly protective vaccine candidate, which combined heterologous RBDs from different representative strains into a hybrid immunogen and integrated immune-escape hotspots into a single antigen. When compared with a homo-tri-RBD vaccine candidate in the stage of phase II trial, of which all three RBDs are derived from the SARS-CoV-2 prototype strain, mutI-tri-RBD induced significantly higher neutralizing antibody titers against the Delta and Beta variants, and maintained a similar immune response against the prototype strain. Pseudo-virus neutralization assay demonstrated that mutI-tri-RBD also induced broadly strong neutralizing activities against all tested 23 SARS-CoV-2 variants. The in vivo protective capability of mutI-tri-RBD was further validated in hACE2-transgenic mice challenged by the live virus, and the results showed that mutI-tri-RBD provided potent protection not only against the SARS-CoV-2 prototype strain but also against the Delta and Beta variants.

9.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-324495

ABSTRACT

Background: The novel coronavirus disease 2019 (COVID-19) spreads rapidly among people and causes a global pandemic. It is of great clinical significance to identify COVID-19 patients with high risk of death. Results: Of the 2,169 COVID-19 patients, the median age was 61 years and male patients accounted for 48%. A total of 646 patients were diagnosed with severe illness, and 75 patients died. Obvious differences in demographics, clinical characteristics and laboratory examinations were found between survivors and non-survivors. A decision tree classifier, including three biomarkers, neutrophil-to-lymphocyte ratio, C-reactive protein and lactic dehydrogenase, was developed to predict death outcome in severe patients. This model performed well both in train dataset and test dataset. The accuracy of this model was 0.98 and 0.98, respectively. Conclusion: The machine learning model was robust and effective in predicting the death outcome in severe COVID-19 patients.

10.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-324245

ABSTRACT

Background: Recently the 2019-nCov pneumonia outbreak in China then the world. Search Query performs well in forecasting the epidemics. It is still a suspense whether search query can forecast the drift and the inflexion in 2019-nCov pneumonia. Based on the Baidu Search Index, we propose three prediction models: composite Index, composite Index with filtering (Fourier Transform) and suspected NCP(Novel Coronavirus Pneumonia) cases. With the trained models, we predict the new confirmed cases of 2019-nCov of forecast-period from Feb. 3rd to 9th. Attempting to identify the next peak period, we further estimate 10 day out-of-sample of the new confirmed cases from Feb. 10th to 19th. Results: : We select 16 search queries related to NCP and calculate the correlation coefficient. The maximum correlation coefficient of search queries is above 0.8. The composite Index performs 10 days ahead of the new confirmed cases. With the In-sample prediction, the result demonstrates that the predictive model of composite index with filtering performs the best with MAPE 24.98% and RMSE 192.71. By contract, the predictive model of the suspected NCP cases is calculated with the prediction error of MAPE 8.82% and RMSE 368.51(almost twice the best model). With the Out-of-sample prediction, we monitor that there might be a peak value in Feb. 16th to 17th in the next ten days. Conclusion: With noise filtering, the predictive model can forecast the new confirmed NCP cases more accurately. However, the filtering eliminates the violent fluctuations of the series and cannot capture the rising and declining details of the predicted values. On contrast, the prediction accuracy based on search composite index is sensitive to prediction of peak and valley although its prediction error is larger. These two predictive models can be combined: monitoring the further volatility trend with filtering model while identifying the inflexion with composite model.

11.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-323719

ABSTRACT

The SARS-CoV-2 has led to a worldwide health crisis. The ACE2 has been identified as the entry receptor in a species-specific manner. Classic laboratory mice were insusceptible since the virus cannot use murine ACE2 orthologue. Animal models rely on gene modification on the virus or the host. However, these mice were restricted in limited genetic backgrounds and did not support natural infection. Here we showed two wild-type inbred lines (CAST and FEW) from Genetic Diversity mice supported authentic SARS-CoV-2 infection, and developed mild to moderate interstitial pneumonia, along with infiltrating inflammatory cells. Particularly, FEW featured age-dependent damages, while CAST charactered by pulmonary fibrosis. Genome and transcriptome comparative analysis suggested the mutated ACE2 was not responsible for SARS-CoV-2 infection in CAST and FEW, and the differential gene expressions in immune response and immune cell may be risk factors for the infection. In summary, the GD mice, derived from the multi-parental panel, provided promising murine models for exploring sophisticated pathogenesis in SARS-CoV-2.

12.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-322464

ABSTRACT

Objective: this study aimed to explore the impacts of myocardial injury on the clinical severity and outcomes in patients with Coronavirus Disease 2019 (COVID-19). Methods: : we analyzed the electronic medical records of 1646 COVID-19 inpatients in Wuhan Huoshenshan Hospital. Results: : 327 (19.9%) developed into severe cases, 23 (1.4%) died. In comparison to common cases, severe cases showed older age, more comorbidities, abnormal immune responses, as well as liver, renal, cardiac and coagulation disorders. Multivariable logistic regression identified that older age , combining with arrhythmia, abnormal lymphocyte percentage, elevated hypersensitive C reactive protein (hs-CRP) and myocardial injury were the independent risk factors for the incidence of severe cases. Moreover, Kaplan-Meier survival analysis showed that patients with myocardial injury had increasing risks of mortality, incidence of severe cases, acute respiratory distress syndrome (ARDS), and intensive care unit (ICU) admission. Particularly, myocardial injury patients co-existed with any other risk factor further deteriorated the clinical outcomes. Conclusion: The presence of myocardial injury and its co-existing with older age, arrhythmia, abnormal lymphocyte percentage, or elevated hs-CRP were greatly associated with the incidence of severe patients and poor clinical outcomes.

13.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-321366

ABSTRACT

Background: Treatment of severe Corona Virus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC‑MSCs) to treat patients with severe COVID-19 with lung damage, based on our phase 1 data.Methods: In this randomised, double-blind, and placebo-controlled trial, we recruited 101 eligible patients with severe COVID-19 with lung damage aged between 18–74 years from two hospitals. Enrolled patients were randomly assigned at a 2:1 ratio to receive either UC-MSCs (4 × 107 cells per infusion) or placebo on day 0, 3, and 6. We excluded patients with malignant tumours, shock, or other organ failure. The primary endpoint was an altered proportion of whole lung lesion areas from baseline to day 28, measured by chest computed tomography. Other imaging outcomes, 6-minute walk test, maximum vital capacity, diffusing capacity, plasma biomarkers, and adverse events were recorded and analysed. Primary analysis was done in the modified intention-to-treat (mITT) population and safety analysis was done in all patients who started their assigned treatment. Findings: From March 5, 2020, to March 28, 2020, 100 patients were finally enrolled and received either UC-MSCs (n = 65) or placebo (n = 35). During follow-up, the patients receiving UC-MSCs exhibited a trend of numerical improvement in whole lung lesions from baseline to day 28 compared with the placebo cases. UC-MSCs administration significantly reduced the proportions of consolidation lesions from baseline to day 28 in the treated patients compared with the placebo subjects. The 6-minute walk test showed an increased distance in patients treated with UC-MSCs. Notably, UC-MSCs delivery was well tolerated, with no serious adverse events.Interpretation: UC-MSCs treatment is a safe and potentially effective therapeutic approach for patients with severe COVID‑19. The trial suggests that UC-MSCs administration might benefit patients with COVID-19 with lung damage at the convalescent stage as well as the progression stage.Trial Registration: This trial is registered with ClinicalTrials.gov, number NCT04288102.Funding Statement: This trial was supported by The National Key R&D Program of China (2020YFC0841900, 2020YFC0844000, 2020YFC08860900);The Innovation Groups of the National Natural Science Foundation of China (81721002);The National Science and Technology Major Project (2017YFA0105703).Declaration of Interests: All authors declare no competing interests.Ethics Approval Statement: Ethical approval was obtained from the institutional review boards of each participating hospital. Written informed consent was obtained from all the enrolled patients or their legal representatives if they were unable to provide consent.

14.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-315327

ABSTRACT

Background: : Coronavirus disease 2019 (COVID-19), a highly infectious disease, has been rapidly spreading all over the world and remains a great threat to global public health. Patients diagnosed with severe or critical cases have a poor prognosis. Hence, it is crucial for us to identify potentially severe or critical cases early, and give timely treatments for targeted patients. In the clinical practice of treating patients with COVID-19, we have observed that the neutrophil-to-lymphocyte ratio (NLR) of severe patients is higher than that in mild patients. We performed this systematic review and meta-analysis to evaluate the predictive values of NLR on disease severity and mortality in patients with COVID-19. Methods: : We searched PubMed, EMBASE, China National Knowledge Infrastructure (CNKI) and Wanfang databases to identify eligible studies (up to August 11, 2020). Two authors independently screened studies and extracted data. The methodological quality of the included studies was assessed by Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Results: : Thirteen studies involving 1579 patients reported the predictive value of NLR on disease severity. The pooled sensitivity (SEN), specificity (SPE) and area under curve (AUC) were 0.78 (95% CI 0.70-0.84), 0.78 (95% CI 0.73-0.83) and 0.85 (95% CI 0.81-0.88), respectively. Ten studies involving 2967 patients reported the predictive value of NLR on mortality. The pooled SEN, SPE and AUC were 0.83 (95% CI 0.75-0.89), 0.83 (95% CI 0.74-0.89) and 0.90 (95% CI 0.87-0.92), respectively. Conclusions: : NLR has good predictive values on disease severity and mortality in patients with COVID-19 infection. Evaluating NLR can help clinicians identify potentially severe cases early, conduct early triage and initiate effective management in time, which may reduce the overall mortality of COVID-19. Trial registration: This meta-analysis was prospectively registered on PROSPERO database (Registration number: CRD42020203612).

15.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-315249

ABSTRACT

Aim: Coronavirus disease 2019 (COVID-19) has caused an unprecedented healthcare crisis. We aim to develop and validate a nomogram for predicting disease progression based on a large cohort of hospitalized COVID-19 patients. Methods: This is a multicenter retrospective cohort study, with a total of 4,086 hospitalized COVID-19 patients enrolled from two hospitals in Wuhan, China between February 3 rd and Apr 10 th . Nomogram was developed based on a cohort of 3, 022 patients from one hospital, and externally validated in another cohort of 1,064 patients from the other hospital. The calibration was assessed by a calibration plot and the HL test to evaluate the goodness of fit, and the Area under the ROC Curve (AUROC) as a measure of discriminative ability. Results: Six independent predictors, including age, dyspnea, platelet count, lactate dehydrogenase, D-dimer and cardiovascular disease, were finally identified for construction of the nomogram for predicting disease progression of COVID-19 patients during hospitalization. The AUROC was 0.877 and 0.817 for development cohort and validation cohort, respectively. The calibration plots AND Hosmer-Lemeshow test showed optimal agreement between nomogram prediction and actual observation. The decision curve analysis showed the performance of the nomograms were better than all univariable models, and had greater net benefit. Next, a predictive nomogram for disease severity on admission was formulated and the six independent factors used were similar to that of the nomogram for disease progression, which indicates that those factors play important roles in determining disease severity and the risk of disease progression. Conclusion: In the current study, a nomogram was developed based on generally readily available variables at hospital admission to help predict disease progression of COVID-19.

16.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-315166

ABSTRACT

Background: Previous studies have found some evidence of association between changes in lipids and lipoprotein and viral pneumonia. No data are available about the effect of coronavirus disease 2019 (Covid-19) on lipids. The aim of this study was to investigate the relationships between lipid profiles and inflammation markers among patients with Covid-19. Methods: : In this retrospective analysis, Covid-19 patients in Jin-yin-tan Hospital and healthy individuals from Daping Hospital were enrolled. The clinical and biochemical characteristics of Covid-19 patients and healthy controls were compared. We correlated lipid parameters to disease severity and inflammatory markers. The severity of Covid-19 for all patients were stipulated according to the diagnostic and treatment guideline for Covid-19 issued by Chinese National Health Committee (the 7th edition). Results: : A total of 242 Covid-19 patients and 242 sex-age matched controls were enrolled. Compared with controls, Covid-19 patients had lower lymphocyte counts as well as total cholesterol (TC), high density lipoprotein (HDL-c), low density lipoprotein cholesterol (LDL-c), non-high density lipoprotein cholesterol (non-HDL-c) and apoA-I levels on admission. Whereas apolipoprotein B (apoB) and apoB/apoA-I ratio were slightly higher in patients with Covid-19. There was no difference in lipid levels between the moderate and severe groups. The total lymphocytes were weakly positively associated with TC, LDL-c and apoA-I. Conclusion: Patients with Covid-19 are associated with decreased lipid and lipoprotein levels. Covid-19 infection induced inflammation response and cytokine storm were associated with a shift of lipids, lipoproteins toward a more atherogenic lipid profile.

17.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-312679

ABSTRACT

Less aligned emphasis has been given to the COVID-19 infodemic coordinating with the COVID-19 outbreak. Global profusion of tangled monikers and hashtags has found their ways in daily communication and contributed to backlash against Chinese. Official naming efforts against infodemic should be meet with a fair share of identification. Based on brief critical reviews on previous multifarious naming practices, we punctuate heuristic introspection in scientific conventions and sociocultural paradigms. Infodemiological analysis promises to articulate that people around the globe are divided in their favor stigmatized monikers in the public and scientific communities because of perceptual bias. There is no positive correlation between the degree of infection in their territories and collective perceptual bias to COVID-19. The official portfolio “COVID-19”and “SARS-CoV-2”has not become de facto standard usages, but full-fledged official names are excepted to duly contribute to the resilience of negative perceptual bias and collective behavioral propensities.

18.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-312180

ABSTRACT

Background: The aim of the study was to establish and validate nomograms to predict the mortality risk of patients with COVID-19 using routine clinical indicators. Method: This retrospective study included a development cohort enrolled 2119 hospitalized COVID-19 patients and a validation cohort included 1504 COVID-19 patients. The demographics, clinical manifestations, vital signs and laboratory test results of the patients at admission and outcome of in-hospital death were recorded. The independent factors associated with death were identified by a forward stepwise multivariate logistic regression analysis and used to construct two prognostic nomograms. The models were then tested in an external dataset. Results: Nomogram 1 is a full model included nine factors identified in the multivariate logistic regression and nomogram 2 is built by selecting four factors from nine to perform as a reduced model. Nomogram 1 and nomogram 2 established showed better performance in discrimination and calibration than the MuLBSTA score in training. In validation, Nomogram 1 performed better than nomogram 2 for calibration. Conclusion: Nomograms we established performed better than the MuLBSTA score. We recommend the application of nomogram 1 in general hospital which provide robust prognostic performance but more cumbersome;nomogram 2 in mobile cabin hospitals which depend on less laboratory examinations and more convenient. Both nomograms can help clinicians in identifying patients at risk of death with routine clinical indicators at admission, which may reduce the overall mortality of COVID-19.

19.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-311929

ABSTRACT

Background: The COVID-19 vaccine for children and adolescents, who are indispensable populations to curb the pandemic, would protect this population against rare severe COVID-19 and infectious conditions. Here we aimed to assess the safety, tolerability and immunogenicity of a candidate COVID-19 vaccine, CoronaVac, containing inactivated SARS-CoV-2, in children and adolescents aged 3-17 years old. Methods: We did a randomised, double-blind, placebo-controlled phase 1/2 clinical trial of CoronaVac in healthy children and adolescents aged 3-17 years old in Zanhuang (Hebei, China). Vaccine (in 0 ·5ml aluminum hydroxide adjuvant) or placebo (adjuvant only) was given by intramuscular injection in two doses (day 0 and day 28). We conducted phase 1 trial in 71 participants with an age de-escalation in tree groups and dose-escalation in two blocks (1.5ug or 3ug per injection). Within each block, participants were randomly assigned (3:1) using block randomisation to receive CoronaVac or placebo. In phase 2, participants were randomly assigned (2:2:1) using block randomisation to receive either CoronaVac at 1.5ug or 3ug per dose, or placebo. The primary safety endpoint was adverse reactions within 28 days after each injection in all participants who received at least one dose. The primary immunogenicity endpoint was seroconversion rate at 28 days after the second injection and its GMT as the secondary endpoint. This study is ongoing and is registered with ClinicalTrials.gov (NCT04551547).Findings: Between October 31 and December 2, 2020, 72 participants were enrolled in phase 1, and between December 12 and December 30, 2020, 480 participants were enrolled in phase 2. 500 participants received at least one dose of vaccine or placebo (n=71 for phase 1 and n=479 for phase 2;safety population). In the combined safety profile of phase 1 and phase 2, any adverse reactions within 28 days after injection occurred in 56 (26%) of 219 participants in the 1·5ug group, 63 (29%) of 217 in the 3ug group and 27 (24%) of 114 in the placebo group, without significant difference. Most adverse reactions were mild and moderate in severity and injection site pain (73[13%]) of 550 participants was the most frequently reported event. As of March 12, 2021, only one serious adverse event has been reported, which was considered unrelated to vaccination. In phase 1, seroconversion after the second dose was observed in 27 of 27 participants (100·0% [95%CI 87·3-100·0]) in the 1·5ug groups and 26 of 26 participants (100·0% [86·8-100·0]) in the 3ug group, with the geometric mean titers of 55·0 (95%CI 38·9-77·9) and 117·4 (87·8-157·0). In phase 2, seroconversion was seen in 180 of 186 participants (96·8% [93·1-98·8]) in the 1·5ug group and 180 of 180 participants (100·0% [98·0-100·0]) in the 3ug group, with the geometric mean titers of 86·4 (73·9-101·0) and 142·2 (124·7-162·1). There were no detectable antibody responses in the placebo groups. Interpretation: CoronaVac was well tolerated and induced strong neutralising antibody responses in children and adolescents aged 3-17 years. The study has provided solid safety and immunogenicity data to support the further study and use of CoronaVac in children and adolescents.Trial Registration: NCT04551547Funding Statement: Chinese National Key Research and Development Program and Beijing Science and Technology Program.Declaration of Interests: QG and XL are employees of Sinovac Life Sciences Co., Ltd. YS, WY and LW are employees of Sinovac Biotech Ltd. All other authors declare no competing interests.Ethics Approval Statement: The clinical trial protocol and informed consent form were approved by the Ethics Committee of Hebei CDC (IRB2020-005).

20.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-309016

ABSTRACT

The SARS-CoV-2 virus continues to spread and resurge globally with signs of a second wave, despite actions by governments to curb the COVID-19 pandemic. However, evidence-based strategies to combat COVID-19 recurrence are poorly documented. To reveal how governments and individuals should act to effectively cope with future waves, this study proposed a preventive model of COVID-19 epidemic resurgence. To verify the model, we conducted an online questionnaire survey assessing government intervention, perceived efficacy, positive emotions, posttraumatic growth (PTG) and protective behaviors among 1137 residents in Beijing, where the epidemic reoccurred. Data analysis revealed that during COVID-19 epidemic resurgence, government intervention could directly and indirectly influence protective behaviors through individual factors (i.e., perceived efficacy, positive emotions), and PTG could mediate the indirect pathway to protective behaviors. These findings implied that government intervention needs to be integrated with individual factors to effectively control repeated COVID-19 outbreaks.

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