Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 43
Filter
1.
Prev Med Rep ; 34: 102276, 2023 Aug.
Article in English | MEDLINE | ID: covidwho-20241192

ABSTRACT

The purpose of the systematic review was to evaluate the efficacy and safety of interleukin-6 receptor (IL-6) antagonists (tocilizumab, sarilumab) in adult patients with severe or critical COVID-19. A systematic review of the literature was conducted in Medline, Cochrane and Embase databases, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov from the inception dates to10 January 2023. Randomized clinical trials comparing IL-6 receptor antagonists (tocilizumab, sarilumab) with a placebo or usual care treatment for adult patients with severe or critical COVID-19 were identified. Two independent reviewers performed the assessment and selection of eligible studies, assessed study quality and extracted data. Relative risk (RR), mean difference (MD), and 95% confidence interval (CI) with random-effects models was performed in meta-analysis. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the quality of the evidence. The search retrieved a total of 11 RCTs involving 5028 participants were eligible for meta-analysis. Our findings suggest that as the new drug used in adult patients with severe or critical COVID-19, IL-6 antagonists (tocilizumab, sarilumab) may reduce the length of ICU stay and hospital stay. However, they did not significantly increase the risks of serious adverse events and did not reduce all-cause mortality (28-day, 14-day, and 7-day).

2.
Trials ; 24(1): 323, 2023 May 11.
Article in English | MEDLINE | ID: covidwho-2314176

ABSTRACT

BACKGROUND: This protocol is for a multi-centre randomised controlled trial to determine whether the computer-aided system ENDOANGEL-GC improves the detection rates of gastric neoplasms and early gastric cancer (EGC) in routine oesophagogastroduodenoscopy (EGD). METHODS: Study design: Prospective, single-blind, parallel-group, multi-centre randomised controlled trial. SETTINGS: The computer-aided system ENDOANGEL-GC was used to monitor blind spots, detect gastric abnormalities, and identify gastric neoplasms during EGD. PARTICIPANTS: Adults who underwent screening, diagnosis, or surveillance EGD. Randomisation groups: 1. Experiment group, EGD examinations with the assistance of the ENDOANGEL-GC; 2. Control group, EGD examinations without the assistance of the ENDOANGEL-GC. RANDOMISATION: Block randomisation, stratified by centre. PRIMARY OUTCOMES: Detection rates of gastric neoplasms and EGC. SECONDARY OUTCOMES: Detection rate of premalignant gastric lesions, biopsy rate, observation time, and number of blind spots on EGD. BLINDING: Outcomes are undertaken by blinded assessors. SAMPLE SIZE: Based on the previously published findings and our pilot study, the detection rate of gastric neoplasms in the control group is estimated to be 2.5%, and that of the experimental group is expected to be 4.0%. With a two-sided α level of 0.05 and power of 80%, allowing for a 10% drop-out rate, the sample size is calculated as 4858. The detection rate of EGC in the control group is estimated to be 20%, and that of the experiment group is expected to be 35%. With a two-sided α level of 0.05 and power of 80%, a total of 270 cases of gastric cancer are needed. Assuming the proportion of gastric cancer to be 1% in patients undergoing EGD and allowing for a 10% dropout rate, the sample size is calculated as 30,000. Considering the larger sample size calculated from the two primary endpoints, the required sample size is determined to be 30,000. DISCUSSION: The results of this trial will help determine the effectiveness of the ENDOANGEL-GC in clinical settings. TRIAL REGISTRATION: ChiCTR (Chinese Clinical Trial Registry), ChiCTR2100054449, registered 17 December 2021.


Subject(s)
COVID-19 , Stomach Neoplasms , Adult , Humans , Computers , Multicenter Studies as Topic , Pilot Projects , Prospective Studies , SARS-CoV-2 , Single-Blind Method , Stomach Neoplasms/diagnosis , Treatment Outcome
4.
Biosensors (Basel) ; 13(1)2022 Dec 26.
Article in English | MEDLINE | ID: covidwho-2246528

ABSTRACT

Infectious pathogens cause severe threats to public health due to their frightening infectivity and lethal capacity. Rapid and accurate detection of pathogens is of great significance for preventing their infection. Gold nanoparticles have drawn considerable attention in colorimetric biosensing during the past decades due to their unique physicochemical properties. Colorimetric diagnosis platforms based on functionalized AuNPs are emerging as a promising pathogen-analysis technique with the merits of high sensitivity, low-cost, and easy operation. This review summarizes the recent development in this field. We first introduce the significance of detecting pathogens and the characteristics of gold nanoparticles. Four types of colorimetric strategies, including the application of indirect target-mediated aggregation, chromogenic substrate-mediated catalytic activity, point-of-care testing (POCT) devices, and machine learning-assisted colorimetric sensor arrays, are systematically introduced. In particular, three biomolecule-functionalized AuNP-based colorimetric sensors are described in detail. Finally, we conclude by presenting our subjective views on the present challenges and some appropriate suggestions for future research directions of colorimetric sensors.


Subject(s)
Biosensing Techniques , Metal Nanoparticles , Gold/chemistry , Metal Nanoparticles/chemistry , Colorimetry/methods , Biosensing Techniques/methods
5.
Environ Res ; 216(Pt 2): 114575, 2023 01 01.
Article in English | MEDLINE | ID: covidwho-2068954

ABSTRACT

The COVID-19 pandemic has further increased income inequality. This work is aimed to explore the impact of income inequality on the environmental Kuznets curve (EKC) hypothesis. To this end, income inequality is set as the threshold variable, economic growth is set as the explanatory variable, while carbon emission is set as the explained variable, and the threshold panel model is developed using the data of 56 countries. The empirical results show that income inequality has changed the relationship between economic growth and carbon emissions from an inverted U-shaped to an N-shaped, which means that income inequality redefines the environmental Kuznets curve and increases the complexity of the decoupling of economic growth and carbon emissions. Specifically, economic growth significantly increases carbon emissions during periods of low income inequality, however, as income inequality increases, economic growth in turn suppresses carbon emissions. In the period of high income inequality, economic growth inhibits the increase of carbon emissions. However, with the increase of income inequality, the impact of economic growth on carbon emission changes from inhibiting to promoting. Panel regressions for robustness tests show that this phenomenon is more pronounced in high-income countries. We therefore contend that the excessive income inequality is bad for the win-win goal of economic growth without carbon emission growth, and the income distribution policy should be included in the carbon neutral strategy.


Subject(s)
COVID-19 , Data Analysis , Humans , Carbon Dioxide , Pandemics , COVID-19/epidemiology , Economic Development , Income , Carbon
6.
Front Microbiol ; 13: 922393, 2022.
Article in English | MEDLINE | ID: covidwho-2065588

ABSTRACT

Coronavirus disease 2019 (COVID-19) has been a pandemic disease reported in almost every country and causes life-threatening, severe respiratory symptoms. Recent studies showed that various environmental selection pressures challenge the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infectivity and, in response, the virus engenders new mutations, leading to the emergence of more virulent strains of WHO concern. Advance prediction of the forthcoming virulent SARS-CoV-2 strains in response to the principal environmental selection pressures like temperature and solar UV radiation is indispensable to overcome COVID-19. To discover the UV-solar radiation-driven genomic adaption of SARS-CoV-2, a curated dataset of 2,500 full-grade genomes from five different UVindex regions (25 countries) was subjected to in-depth downstream genome-wide analysis. The recurrent variants that best respond to UV-solar radiations were extracted and extensively annotated to determine their possible effects and impacts on gene functions. This study revealed 515 recurrent single nucleotide variants (rcntSNVs) as SARS-CoV-2 genomic responses to UV-solar radiation, of which 380 were found to be distinct. For all discovered rcntSNVs, 596 functional effects (rcntEffs) were detected, containing 290 missense, 194 synonymous, 81 regulatory, and 31 in the intergenic region. The highest counts of missense rcntSNVs in spike (27) and nucleocapsid (26) genes explain the SARS-CoV-2 genomic adjustment to escape immunity and prevent UV-induced DNA damage, respectively. Among all, the most commonly observed rcntEffs were four missenses (RdRp-Pro327Leu, N-Arg203Lys, N-Gly204Arg, and Spike-Asp614Gly) and one synonymous (ORF1ab-Phe924Phe) functional effects. The highest number of rcntSNVs found distinct and were uniquely attributed to the specific UVindex regions, proposing solar-UV radiation as one of the driving forces for SARS-CoV-2 differential genomic adaptation. The phylogenetic relationship indicated the high UVindex region populating SARS-CoV-2 as the recent progenitor of all included samples. Altogether, these results provide baseline genomic data that may need to be included for preparing UVindex region-specific future diagnostic and vaccine formulations.

7.
Chronic Dis Transl Med ; 8(3): 149-153, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2030954
8.
Adv Med Educ Pract ; 13: 993-1002, 2022.
Article in English | MEDLINE | ID: covidwho-2022200

ABSTRACT

Introduction: Conferences are an important avenue for dissemination of knowledge, research and provide networking opportunities for career development. The COVID-19 pandemic has prompted adoption of virtual platforms for delivery of these conferences. The aim of the study was to determine the utility and educational impact of a student-led virtual webinar to deliver an undergraduate cardiovascular conference compared to a traditional in-person conference. Methods: We conducted a two-day virtual conference using the Zoom platform in June 2021. The conference consisted of cardiology subspecialty lectures, and workshops were conducted by a junior doctor, senior cardiology trainees and consultants. The conference also outlaid a virtual poster hall and oral presentation session while networking opportunities were encouraged using breakout rooms and poster hall chat function. A 38-item self-administered online questionnaire was designed and disseminated at the end of the conference to all attending delegates. All data analysis and data visualisation strategies were conducted on R statistical programming. Results: Eight-hundred and forty students from 55 countries attended the event. Four hundred and ninety participants (58.5% response rate, 55.9% female) completed the questionnaire. Factors such as weekend conference (84.9%), student-led or organised (84.1%), environmental/sustainable (82.3%), appropriate level for me (81.5%) and comfort to present (80.8%) were deemed to be at least equal to traditional in-person conference. The conference also increased participants' interest, their core cardiology knowledge and improved their critical analysis and basic echocardiography skills [median 4 (IQR 3-5) for all parameters]. Overall, participants also found it easy to use the virtual platform [median 5 (IQR 5-5)] and easier to ask questions compared to in-person conferences [median 5 (IQR 4-5) vs median 4 (IQR 3-5), p < 0.001]. Conclusion: Our virtual conference provided opportunities to students that the COVID-19 pandemic would have otherwise affected; however, its utility and educational impact will need to be assessed within its individual context of delivery.

9.
Frontiers in microbiology ; 13, 2022.
Article in English | EuropePMC | ID: covidwho-1998868

ABSTRACT

Coronavirus disease 2019 (COVID-19) has been a pandemic disease reported in almost every country and causes life-threatening, severe respiratory symptoms. Recent studies showed that various environmental selection pressures challenge the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infectivity and, in response, the virus engenders new mutations, leading to the emergence of more virulent strains of WHO concern. Advance prediction of the forthcoming virulent SARS-CoV-2 strains in response to the principal environmental selection pressures like temperature and solar UV radiation is indispensable to overcome COVID-19. To discover the UV-solar radiation-driven genomic adaption of SARS-CoV-2, a curated dataset of 2,500 full-grade genomes from five different UVindex regions (25 countries) was subjected to in-depth downstream genome-wide analysis. The recurrent variants that best respond to UV-solar radiations were extracted and extensively annotated to determine their possible effects and impacts on gene functions. This study revealed 515 recurrent single nucleotide variants (rcntSNVs) as SARS-CoV-2 genomic responses to UV-solar radiation, of which 380 were found to be distinct. For all discovered rcntSNVs, 596 functional effects (rcntEffs) were detected, containing 290 missense, 194 synonymous, 81 regulatory, and 31 in the intergenic region. The highest counts of missense rcntSNVs in spike (27) and nucleocapsid (26) genes explain the SARS-CoV-2 genomic adjustment to escape immunity and prevent UV-induced DNA damage, respectively. Among all, the most commonly observed rcntEffs were four missenses (RdRp-Pro327Leu, N-Arg203Lys, N-Gly204Arg, and Spike-Asp614Gly) and one synonymous (ORF1ab-Phe924Phe) functional effects. The highest number of rcntSNVs found distinct and were uniquely attributed to the specific UVindex regions, proposing solar-UV radiation as one of the driving forces for SARS-CoV-2 differential genomic adaptation. The phylogenetic relationship indicated the high UVindex region populating SARS-CoV-2 as the recent progenitor of all included samples. Altogether, these results provide baseline genomic data that may need to be included for preparing UVindex region-specific future diagnostic and vaccine formulations.

10.
11.
Sichuan Da Xue Xue Bao Yi Xue Ban ; 53(4): 597-601, 2022 Jul.
Article in Chinese | MEDLINE | ID: covidwho-1964620

ABSTRACT

Objective: To discuss the characteristics of physician trainee outcomes after completion of the job-transfer subspecialty training in pediatrics, a program designed to increase the number of pediatricians, in Sichuan Province and to provide countermeasures for alleviating the shortage of pediatricians. Methods: We collected with questionnaire surveys information on changes in the workload and salaries experienced by physicians who completed the job-transfer subspecialty training program in pediatrics between February 2017 and May 2020 in Sichuan Province. Then, we compared the characteristics of physicians who successful became pediatricians and those who did no. Results: A total of 208 physicians completed the job-transfer subspecialty training program in pediatrics. Among them, 178, accounting for 85.6%, completed the questionnaire survey, and 120, accounting for 67.4%, had a background in other subspecialties than pediatrics. The majority (>90%) of physicians who participated in the training program came from secondary or lower levels of hospitals from the cities and prefectures all over Sichuan Province. In this study, we found that the rate of successful job transfer from being a physician to being a pediatrician in Sichuan Province in the past four years was 85.0% (102/120), with the year-by-year results being 88.2% (15/17) in 2017, 72.7% (16/22) in 2018, 86.7% (39/45) in 2019, and 94.% (32/34) in 2020. There was no significant difference between physicians who had successful job transfer and became pediatricians and those who failed to do so in terms of gender, age, hospital level, specialization prior to the job transfer, whether or not the hospital had a pediatrics department, amount of support for the pediatrics department, whether or not the physician was working at a new hospital after the job transfer, salaries, and changes of responsibilities during COVID-19 (all P>0.05). There was significant difference in the change of workload after completion of the training program between physicians who had successful job transfer and became pediatricians and those who failed to do so ( χ 2=9.037, P=0.003), and 78.4% of the trainees stated that their workload had increased after the job transfer. There was a moderate correlation between successful job transfer and changes in workload after the transfer (|Phi[ψ] |=0.729). Conclusions: The policy of government-supported job-transfer subspecialty training in pediatrics has played an active and important role in the swift resolution of the shortage of pediatricians. However, finding the root cause of and addressing the problem of the overwhelming workload of pediatricians remain challenging issues to be resolved.


Subject(s)
COVID-19 , Child , Humans , Surveys and Questionnaires
12.
Bioeng Transl Med ; 5(3): e10177, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-1898553

ABSTRACT

The Coronavirus-2019 (COVID-19) pandemic has put tremendous strain on healthcare systems worldwide. It is challenging for clinicians to differentiate COVID-19 from other acute respiratory tract infections via clinical symptoms because those who are infected display a wide range of symptoms. An effective, point-of-care (POC) diagnostic tool could mitigate healthcare system strain, protect healthcare professionals, and support quarantine efforts. We believe that a POC tool can be developed that would be rapid, easy to use, and inexpensive. It could be used in the home, in resource-limited areas, and even in clinical settings. In this article, we summarize the current state of COVID-19 diagnostic methods and make a case for an all-in-one, highly sensitive POC assay that integrates antibody detection, protein detection, and serum cytokine detection to diagnose COVID-19 infection. We believe this article will provide insights into the current state of diagnostics for COVID-19, and promote additional research and tool development that could be exceptionally impactful.

13.
Heart ; 108(Suppl 1):A59, 2022.
Article in English | ProQuest Central | ID: covidwho-1891868

ABSTRACT

80 Figure 1ConclusionOur virtual conference provided opportunities to students that the COVID-19 pandemic would have otherwise affected, however its utility and educational impact will need to be assessed within its individual context of delivery.Conflict of InterestNil

14.
Can J Physiol Pharmacol ; 100(7): 702-711, 2022 Jul 01.
Article in English | MEDLINE | ID: covidwho-1832563

ABSTRACT

Since the coronavirus disease 2019 (COVID-19) Delta variant was discovered in India in October 2020, it has rapidly triggered a second outbreak globally. However, the effects of the COVID-19 Delta variant on mental health in survivors and healthcare workers are unclear. The aim of this study is to assess mental health among the COVID-19 Delta variant survivors and healthcare workers, and analyze the possible impact factors. This survey-based, cross-sectional study used the Symptom Check List-90 Revised questionnaire to evaluate psychological status among 60 COVID-19 Delta variant survivors, 162 nurses, and 72 hygienists in Nanjing, China. Three indices and nine dimensions were compared for job, education level, gender, age, and marriage classification. Data were analyzed using SPSS 25.0. Mental distress among participants was not very serious in general. The survivors presented the highest score, followed by the hygienists, and the lowest score was in nurses. Low-educated individuals and women showed significant increase. No significant difference was noted in age and marriage classification. In this survey study of COVID-19 Delta variant survivors and healthcare workers in Nanjing, China, the survivors needed psychological support immediately. Meanwhile, healthcare workers warranted more attention, especially the lower education levels and women. A comprehensive emergency response plan was warranted.


Subject(s)
COVID-19 , COVID-19/epidemiology , China/epidemiology , Cross-Sectional Studies , Disease Outbreaks , Female , Health Personnel/psychology , Humans , Mental Health , SARS-CoV-2 , Survivors
15.
BMJ Open ; 12(4): e058686, 2022 04 22.
Article in English | MEDLINE | ID: covidwho-1822073

ABSTRACT

INTRODUCTION: Existing studies have shown that mobile-based mindfulness meditation (MMM) can have a certain impact on nurses' mental health problems, but its specific effect and the effect on specific mental health problems such as stress, anxiety, depression, mindfulness, well-being and resilience are not clear. METHODS AND ANALYSIS: This study protocol follows the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols guidelines. Electronic search through PubMed, Web of Science, EBSCO, Cochrane Library, CINAHL, PsycINFO, ERIC, Embase and three Chinese databases namely CNKI, Wan Fang and Chinese Biology Medicine disc. The inclusion criteria follow the PICO principle, which is defined translate the question into a searchable and answerable question . P (patient/population): clinical characteristics of patients; I (intervention or exposure): treatment measures or exposure factors of concern; C (comparison): control measure.; O (outcome): outcome indicator of concern. Registered nurses, preregistered nurses, midwives and nursing students will all be included, studies using MMM as intervention to improve mental health of nurses, compared with waitlist controls or traditional methods groups, outcomes assessment of stress, anxiety, depression, mindfulness, well-being and resilience will meet the inclusion criteria. Studies designed randomised controlled trails (RCTs) of quasiexperimental and written in English or Chinese will be eligible. Search time was from inception of each database to July 2022. Two reviewers screen and assess studies for inclusion and extract data independently; any dispute will be settled through discussion. If the discussion still fails, the third author will make a decision. For RCT, risk of bias will be assessed using Cochrane risk-of-bias tool for randomised trials (RoB 2), and for non-RCT studies, risk of bias in non-randomised studies of interventions (ROBINS-I) tool will be performed. Meta-analysis will be performed using RevMan software if sufficient number of comparable studies are retrieved. ETHICS AND DISSEMINATION: This is a study protocol of meta-analysis; no primary data will be collected, and no ethics assessment is required. The study results will be presented in a peer-reviewed scientific publication. PROSPERO REGISTRATION NUMBER: CRD42021277932.


Subject(s)
Meditation , Mindfulness , Humans , Mental Health , Meta-Analysis as Topic , Mindfulness/methods , Systematic Reviews as Topic
16.
Bioengineering (Basel) ; 9(4)2022 Mar 25.
Article in English | MEDLINE | ID: covidwho-1809683

ABSTRACT

OBJECTIVE: Pulmonary function parameters play a pivotal role in the assessment of respiratory diseases. However, the accuracy of the existing methods for the prediction of pulmonary function parameters is low. This study proposes a combination algorithm to improve the accuracy of pulmonary function parameter prediction. METHODS: We first established a system to collect volumetric capnography and then processed the data with a combination algorithm to predict pulmonary function parameters. The algorithm consists of three main parts: a medical feature regression structure consisting of support vector machines (SVM) and extreme gradient boosting (XGBoost) algorithms, a sequence feature regression structure consisting of one-dimensional convolutional neural network (1D-CNN), and an error correction structure using improved K-nearest neighbor (KNN) algorithm. RESULTS: The root mean square error (RMSE) of the pulmonary function parameters predicted by the combination algorithm was less than 0.39L and the R2 was found to be greater than 0.85 through a ten-fold cross-validation experiment. CONCLUSION: Compared with the existing methods for predicting pulmonary function parameters, the present algorithm can achieve a higher accuracy rate. At the same time, this algorithm uses specific processing structures for different features, and the interpretability of the algorithm is ensured while mining the feature depth information.

17.
Antimicrob Agents Chemother ; 66(3): e0204521, 2022 03 15.
Article in English | MEDLINE | ID: covidwho-1759274

ABSTRACT

Recombinant human severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibody JS016 showed neutralizing and therapeutic effects in preclinical studies. The clinical efficacy and safety of the therapy needed to be evaluated. In this phase 2/3, multicenter, randomized, open-label, controlled trial, hospitalized patients with moderate or severe coronavirus disease 2019 (COVID-19) were randomly assigned in a 1:1 ratio to receive standard care or standard care plus a single intravenous infusion of JS016. The primary outcome was a six-level ordinal scale of clinical status on day 28 since randomization. Secondary outcomes include adverse events, 28-day mortality, ventilator-free days within 28 days, length of hospital stay, and negative conversion rate of SARS-CoV-2 nucleic acid on day 14. A total of 199 patients were randomized, and 197 (99 in the JS016 group and 98 in the control group) were analyzed. Most patients, 95 (96%) in the JS016 group and 97 (99%) in the control group were in the best category on day 28 since randomization. The odds ratio of being in a better clinical status was 0.31 (95% confidence interval [CI], 0.03 to 3.19; P = 0.33). Few adverse events occurred in both groups (3% in the JS016 group and 1% in the control group, respectively; P = 0.34). SARS-CoV-2 neutralizing antibody JS016 did not show clinical efficacy among hospitalized Chinese patients with moderate to severe COVID-19 disease. Further studies are needed to assess the efficacy of the neutralizing antibody to prevent disease deterioration and its benefits among groups of patients specified by disease course and severity. (This study has been registered at ClinicalTrials.gov under identifier NCT04931238.).


Subject(s)
COVID-19 Drug Treatment , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing/therapeutic use , China , Humans , SARS-CoV-2 , Treatment Outcome
18.
Signal Transduct Target Ther ; 7(1): 61, 2022 02 25.
Article in English | MEDLINE | ID: covidwho-1758178

ABSTRACT

Variants are globally emerging very quickly following pandemic prototypic SARS-CoV-2. To evaluate the cross-protection of prototypic SARS-CoV-2 vaccine against its variants, we vaccinated rhesus monkeys with three doses of prototypic SARS-CoV-2 inactivated vaccine, followed by challenging with emerging SARS-CoV-2 variants of concern (VOCs). These vaccinated animals produced neutralizing antibodies against Alpha, Beta, Delta, and Omicron variants, although there were certain declinations of geometric mean titer (GMT) as compared with prototypic SARS-CoV-2. Of note, in vivo this prototypic vaccine not only reduced the viral loads in nasal, throat and anal swabs, pulmonary tissues, but also improved the pathological changes in the lung infected by variants of Alpha, Beta, and Delta. In summary, the prototypic SARS-CoV-2 inactivated vaccine in this study protected against VOCs to certain extension, which is of great significance for prevention and control of COVID-19.


Subject(s)
Antibodies, Neutralizing/biosynthesis , Antibodies, Viral/biosynthesis , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Cross Protection , SARS-CoV-2/drug effects , Vaccination/methods , Vaccines, Inactivated/administration & dosage , Anal Canal/virology , Animals , B-Lymphocytes/immunology , B-Lymphocytes/virology , COVID-19/immunology , COVID-19/virology , Humans , Immunogenicity, Vaccine , Lung/virology , Macaca mulatta , Male , Nasal Cavity/virology , Pharynx/virology , SARS-CoV-2/growth & development , SARS-CoV-2/pathogenicity , T-Lymphocytes/immunology , T-Lymphocytes/virology , Viral Load/drug effects
20.
Clin Infect Dis ; 73(11): e3949-e3955, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1561940

ABSTRACT

BACKGROUND: We evaluated an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine for immunogenicity and safety in adults aged 18-59 years. METHODS: In this randomized, double-blinded, controlled trial, healthy adults received a medium dose (MD) or a high dose (HD) of the vaccine at an interval of either 14 days or 28 days. Neutralizing antibody (NAb) and anti-S and anti-N antibodies were detected at different times, and adverse reactions were monitored for 28 days after full immunization. RESULTS: A total of 742 adults were enrolled in the immunogenicity and safety analysis. Among subjects in the 0, 14 procedure, the seroconversion rates of NAb in MD and HD groups were 89% and 96% with geometric mean titers (GMTs) of 23 and 30, respectively, at day 14 and 92% and 96% with GMTs of 19 and 21, respectively, at day 28 after immunization. Anti-S antibodies had GMTs of 1883 and 2370 in the MD group and 2295 and 2432 in the HD group. Anti-N antibodies had GMTs of 387 and 434 in the MD group and 342 and 380 in the HD group. Among subjects in the 0, 28 procedure, seroconversion rates for NAb at both doses were both 95% with GMTs of 19 at day 28 after immunization. Anti-S antibodies had GMTs of 937 and 929 for the MD and HD groups, and anti-N antibodies had GMTs of 570 and 494 for the MD and HD groups, respectively. No serious adverse events were observed during the study period. CONCLUSIONS: Adults vaccinated with inactivated SARS-CoV-2 vaccine had NAb as well as anti-S/N antibody and had a low rate of adverse reactions. CLINICAL TRIALS REGISTRATION: NCT04412538.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Antibodies, Neutralizing , Antibodies, Viral , COVID-19 Vaccines , Double-Blind Method , Humans , Immunogenicity, Vaccine
SELECTION OF CITATIONS
SEARCH DETAIL