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1.
Lancet Reg Health West Pac ; 29: 100586, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2031544

ABSTRACT

Background: BNT162b2, an mRNA vaccine against COVID-19, is being utilised worldwide, but immunogenicity and safety data in Chinese individuals are limited. Methods: This phase 2, randomised, double-blind, placebo-controlled trial included healthy or medically stable individuals aged 18-85 years enrolled at two clinical sites in China. Participants were stratified by age (≤55 or >55 years) and randomly assigned (3:1) by an independent randomisation professional to receive two doses of intramuscular BNT162b2 30 µg or placebo, administered 21 days apart. Study participants, study personnel, investigators, statisticians, and the sponsor's study management team were blinded to treatment assignment. Primary immunogenicity endpoints were the geometric mean titers (GMTs) of neutralising antibodies to live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seroconversion rates (SCR) 1 month after the second dose. Safety assessments included reactogenicity within 14 days of vaccination, adverse events (AEs), and clinical laboratory parameters. Randomised participants who received at least one dose were included in the efficacy and safety analyses on a complete case basis (incomplete/missing data not imputed). Results up to 6 months after the second dose are reported. Findings: Overall, 959 participants (all of Han ethnicity) who were recruited between December 5th, 2020 and January 9th, 2021 received at least one injection (BNT162b2, n=720; placebo, n=239). At 1 month after the second dose, the 50% neutralising antibody GMT was 294.4 (95% CI; 281.1-308.4) in the BNT162b2 group and 5.0 (95% CI; 5.0-5.0) in the placebo group. SCRs were 99.7% (95% CI; 99.0%-100.0%) and 0% (95% CI; 0.0%-1.5%), respectively (p<0.0001 vs placebo). Although the GMT of neutralising antibodies in the BNT162b2 group was greatly reduced at 6 months after the second dose, the SCR still remained at 58.8%. BNT162b2-elicited sera neutralised SARS-CoV-2 variants of concern. T-cell responses were detected in 58/73 (79.5%) BNT162b2 recipients. Reactogenicity was mild or moderate in severity and resolved within a few days after onset. Unsolicited AEs were uncommon at 1 month following vaccine administration, and there were no vaccine-related serious AEs at 1 month or 6 months after the second dose. Interpretation: BNT162b2 vaccination induced a robust immune response with acceptable tolerability in Han Chinese adults. However, follow-up duration was relatively short and COVID-19 rates were not assessed. Safety data collection is continuing until 12 months after the second dose. Funding: BioNTech - sponsored the trial. Shanghai Fosun Pharmaceutical Development Inc. (Fosun Pharma) - conducted the trial, funded medical writing. ClinicalTrialsgov registration number: NCT04649021. Trial status: Completed.

2.
BMC Public Health ; 22(1): 1584, 2022 08 20.
Article in English | MEDLINE | ID: covidwho-2002156

ABSTRACT

BACKGROUND: The Kingdom of Morocco approved BBIBP-CorV (Sinopharm) COVID-19 vaccine for emergency use on 22 January 2021 in a two-dose, three-to-four-week interval schedule. We conducted a retrospective cohort study to determine real-world BBIBP-CorV vaccine effectiveness (VE) against serious or critical hospitalization of individuals RT-PCR-positive for SARS-CoV-2 during the first five months of BBIBP-CorV use in Morocco. METHODS: The study was conducted among adults 18-99 years old who were tested by RT-PCR for SARS-CoV-2 infection between 1 February and 30 June 2021. RT-PCR results were individually linked with outcomes from the COVID-19 severe or critical hospitalization dataset and with vaccination histories from the national vaccination registration system. Individuals with partial vaccination (< 2 weeks after dose two) or in receipt of any other COVID-19 vaccine were excluded. Unadjusted and adjusted VE estimates against hospitalization for serious or critical illness were made by comparing two-dose vaccinated and unvaccinated individuals in logistic regression models, calculated as (1-odds ratio) * 100%. RESULTS: There were 348,190 individuals able to be matched across the three databases. Among these, 140,892 were fully vaccinated, 206,149 were unvaccinated, and 1,149 received homologous BBIBP-CorV booster doses. Unadjusted, full-series, unboosted BBIBP-CorV VE against hospitalization for serious or critical illness was 90.2% (95%CI: 87.8-92.0%). Full-series, unboosted VE, adjusted for age, sex, and calendar day of RT-PCR test, was 88.5% (95%CI: 85.8-90.7%). Calendar day- and sex-adjusted VE was 96.4% (95%CI: 94.6-97.6%) for individuals < 60 years, and was 53.3% (95%CI: 39.6-63.9%) for individuals 60 years and older. There were no serious or critical illnesses among BBIBP-CorV-boosted individuals. CONCLUSIONS: Effectiveness of Sinopharm's BBIBP-CorV was consistent with phase III clinical trial results. Two doses of BBIBP-CorV was highly protective against COVID-19-associated serious or critical hospitalization in working-age adults under real-world conditions and moderately effective in older adults. Booster dose vaccination was associated with complete protection, regardless of age, although only a small proportion of subjects received booster doses.


Subject(s)
COVID-19 , Influenza Vaccines , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Critical Illness , Humans , Middle Aged , Morocco/epidemiology , Retrospective Studies , SARS-CoV-2 , Young Adult
4.
Adv Ther ; 39(8): 3789-3798, 2022 08.
Article in English | MEDLINE | ID: covidwho-1906546

ABSTRACT

INTRODUCTION: BNT162b1 is a lipid nanoparticle-formulated, nucleoside-modified mRNA SARS-CoV-2 vaccine. Here, we report safety and immune persistence data following a primary two-dose vaccination schedule administered 21 days apart. METHODS: Immune persistence was determined at month 3 in 72 younger participants (aged 18-55 years) and at month 6 in 70 younger and 69 older participants (aged 65-85 years). RESULTS: In younger participants, neutralizing antibody (nAb) geometric mean titers (GMTs) for the 10 and 30 µg dose levels declined from 233 and 254 (21 days after dose 2) to 55 and 87 at month 3, respectively, and to 16 and 27 at month 6, respectively. In older participants, nAb GMTs declined from 80 and 160 (21 days after dose 2) to 10 and 21 at month 6. Overall, higher antibody titers were observed in younger participants, and the 30 µg dose induced higher levels of nAb, which declined more slowly by month 6. No serious adverse events were reported in the vaccine group. CONCLUSION: This study showed BNT162b1 maintains a favorable safety profile in younger and older participants in the 6 months after vaccination. This study further extends our understanding of immune persistence and the safety of the BNT162b1 vaccine as a candidate vaccine in the BioNTech pipeline. TRIAL REGISTRATION NUMBER: NCT04523571, registered August 21, 2020.


Subject(s)
BNT162 Vaccine , COVID-19 , Vaccines , Adult , Aged , Antibodies, Neutralizing , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , China , Double-Blind Method , Humans , Liposomes , Nanoparticles , RNA, Messenger , SARS-CoV-2 , Vaccination
5.
Lancet Respir Med ; 10(8): 739-748, 2022 08.
Article in English | MEDLINE | ID: covidwho-1852285

ABSTRACT

BACKGROUND: Due to waning immunity and protection against infection with SARS-CoV-2, a third dose of a homologous or heterologous COVID-19 vaccine has been proposed by health agencies for individuals who were previously primed with two doses of an inactivated COVID-19 vaccine. METHODS: We did a randomised, open-label, controlled trial to evaluate the safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in Chinese adults (≥18 years old) who had previously received two doses of an inactivated SARS-CoV-2 vaccine-Sinovac CoronaVac. Eligible participants were randomly assigned (1:1:1) to receive a heterologous booster vaccination with a low dose (1·0 × 1011 viral particles per mL; 0·1 mL; low dose group), or a high dose (1·0 × 1011 viral particles per mL; 0·2 mL; high dose group) aerosolised Ad5-nCoV, or a homologous intramuscular vaccination with CoronaVac (0·5 mL). Only laboratory staff were masked to group assignment. The primary endpoint for safety was the incidence of adverse reactions within 14 days after the booster dose. The primary endpoint for immunogenicity was the geometric mean titres (GMTs) of serum neutralising antibodies (NAbs) against live SARS-CoV-2 virus 14 days after the booster dose. This study was registered with ClinicalTrials.gov, NCT05043259. FINDINGS: Between Sept 14 and 16, 2021, 420 participants were enrolled: 140 (33%) participants per group. Adverse reactions were reported by 26 (19%) participants in the low dose group and 33 (24%) in the high dose group within 14 days after the booster vaccination, significantly less than the 54 (39%) participants in the CoronaVac group (p<0·0001). The low dose group had a serum NAb GMT of 744·4 (95% CI 520·1-1065·6) and the high dose group had a GMT of 714·1 (479·4-1063·7) 14 days after booster dose, significantly higher than the GMT in the CoronaVac group (78·5 [60·5-101·7]; p<0·0001). INTERPRETATION: We found that a heterologous booster vaccine with an orally administered aerosolised Ad5-nCoV is safe and highly immunogenic in adults who have previously received two doses of CoronaVac as the primary series vaccination. FUNDING: National Natural Science Foundation of China and Jiangsu Provincial Key Research and Development Program.


Subject(s)
COVID-19 Vaccines , COVID-19 , Adolescent , Adult , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Research , SARS-CoV-2 , Vaccination
6.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-335174

ABSTRACT

ABSTRACT The Kingdom of Morocco approved BBIBP-CorV (Sinopharm) COVID-19 vaccine for emergency use on 22 January 2021 in a two-dose, three-to-four-week interval schedule. We conducted a case-control study to determine real-world BBIBP-CorV vaccine effectiveness (VE) against serious or critical hospitalization of individuals RT-PCR-positive for SARS-CoV-2 during the first five months of BBIBP-CorV use in Morocco. The study was conducted among adults 18-99 years old who were tested by RT-PCR for SARS-CoV-2 infection between 1 February and 30 June 2021. RT-PCR results were individually linked with outcomes from the COVID-19 severe or critical hospitalization dataset and with vaccination histories from the national vaccination registration system. Individuals with partial vaccination (<2 weeks after dose two) or in receipt of any other COVID-19 vaccine were excluded. Unadjusted and adjusted VE estimates against hospitalization for serious or critical illness were made by comparing two-dose vaccinated and unvaccinated individuals in logistic regression models, calculated as (1-odds ratio) * 100%. There were 348,190 individuals able to be matched across the three databases. Among these, 140,892 were fully vaccinated, 206,149 were unvaccinated, and 1,149 received homologous BBIBP-CorV booster doses. Unadjusted, full-series, unboosted BBIBP-CorV VE against hospitalization for serious or critical illness was 90.2% (95%CI: 87.8% - 92.0%). Full-series, unboosted VE, adjusted for age, sex, and calendar day of RT-PCR test, was 88.5% (95%CI: 85.8% - 90.7%). Calendar day- and sex-adjusted VE ranged from 93.9% to 100% for individuals <60 years, and was 53.3% for individuals 60 years and older. There were no serious or critical illnesses among BBIBP-CorV-boosted individuals. Effectiveness of Sinopharm’s BBIBP-CorV was consistent with phase III clinical trial results. Two doses of BBIBP-CorV was highly protective against COVID-19-associated serious or critical hospitalization in working-age adults under real-world conditions and moderately effective in older adults. Booster dose VE should be evaluated, as booster doses of BBIBP-CorV are recommended and are being used.

7.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-325403

ABSTRACT

An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Data from the U.S. NCT04368728 and German EudraCT 2020-001038-36 vaccine trials was recently reported, showing the safety, tolerability, and antibody response of the BNT162b1 vaccine candidate. BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain and is one of several RNA-based SARS-CoV-2 vaccine candidates under study. Here, we report preliminary results from a Phase I trial testing BNT162b1 in 144 healthy Chinese participants. The safety profile was broadly comparable to that seen in the American and German trials, with fever the only Grade 3 adverse event reported. Prime-boost vaccination with 10 µg or 30 µg BNT162b1 induced robust antibody responses in both younger (18 to 55 years of age) and older (65 to 85) Chinese adults, and interferon-γ T-cell responses to RBD antigen challenge were significantly higher in participants receiving BNT162b1 than those in placebo groups. The 30 µg dose induced increased reactogenicity as well as a more favorable vaccine-elicited virus-neutralizing response than the 10 µg dose in both younger and older Chinese adults. In conclusion, this first report of an mRNA vaccine in an Asian population showed similar results to BNT162b1 trials. This trial was funded by Fosun and BioNTech and registered under ChiCTR2000034825 and NCT04523571.

8.
Nat Med ; 27(6): 1062-1070, 2021 06.
Article in English | MEDLINE | ID: covidwho-1199302

ABSTRACT

An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Here, we assess the preliminary safety, tolerability and immunogenicity data from an ongoing single-center (in Jiangsu province, China), parallel-group, double-blind phase 1 trial of the vaccine candidate BNT162b1 in 144 healthy SARS-CoV-2-naive Chinese participants. These participants are randomized 1:1:1 to receive prime and boost vaccinations of 10 µg or 30 µg BNT162b1 or placebo, given 21 d apart, with equal allocation of younger (aged 18-55 years) and older adults (aged 65-85 years) to each treatment group (ChiCTR2000034825). BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) and is one of several messenger RNA-based vaccine candidates under clinical investigation. Local reactions and systemic events were generally dose dependent, transient and mild to moderate. Fever was the only grade 3 adverse event. BNT162b1 induced robust interferon-γ T cell responses to a peptide pool including the RBD in both younger and older Chinese adults, and geometric mean neutralizing titers reached 2.1-fold (for younger participants) and 1.3-fold (for the older participants) that of a panel of COVID-19 convalescent human sera obtained at least 14 d after positive SARS-CoV-2 polymerase chain reaction test. In summary, BNT162b1 has an acceptable safety profile and produces high levels of humoral and T cell responses in an Asian population.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Spike Glycoprotein, Coronavirus/immunology , Vaccines, Synthetic/immunology , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Neutralizing/immunology , Antibodies, Neutralizing/therapeutic use , Antibodies, Viral/genetics , Antibodies, Viral/immunology , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/adverse effects , China/epidemiology , Female , Humans , Male , Middle Aged , Pandemics , RNA, Messenger/genetics , RNA, Messenger/immunology , SARS-CoV-2/drug effects , SARS-CoV-2/pathogenicity , Spike Glycoprotein, Coronavirus/genetics , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/genetics , Young Adult
9.
Chin Med J (Engl) ; 134(8): 935-943, 2021 Apr 20.
Article in English | MEDLINE | ID: covidwho-1195742

ABSTRACT

BACKGROUND: Since 2019, a novel coronavirus named 2019 novel coronavirus (2019-nCoV) has emerged worldwide. Apart from fever and respiratory complications, acute kidney injury has been observed in a few patients with coronavirus disease 2019. Furthermore, according to recent findings, the virus has been detected in urine. Angiotensin-converting enzyme II (ACE2) has been proposed to serve as the receptor for the entry of 2019-nCoV, which is the same as that for the severe acute respiratory syndrome. This study aimed to investigate the possible cause of kidney damage and the potential route of 2019-nCoV infection in the urinary system. METHODS: We used both published kidney and bladder cell atlas data and new independent kidney single-cell RNA sequencing data generated in-house to evaluate ACE2 gene expression in all cell types in healthy kidneys and bladders. The Pearson correlation coefficients between ACE2 and all other genes were first generated. Then, genes with r values larger than 0.1 and P values smaller than 0.01 were deemed significant co-expression genes with ACE2. RESULTS: Our results showed the enriched expression of ACE2 in all subtypes of proximal tubule (PT) cells of the kidney. ACE2 expression was found in 5.12%, 5.80%, and 14.38% of the proximal convoluted tubule cells, PT cells, and proximal straight tubule cells, respectively, in three published kidney cell atlas datasets. In addition, ACE2 expression was also confirmed in 12.05%, 6.80%, and 10.20% of cells of the proximal convoluted tubule, PT, and proximal straight tubule, respectively, in our own two healthy kidney samples. For the analysis of public data from three bladder samples, ACE2 expression was low but detectable in bladder epithelial cells. Only 0.25% and 1.28% of intermediate cells and umbrella cells, respectively, had ACE2 expression. CONCLUSION: This study has provided bioinformatics evidence of the potential route of 2019-nCoV infection in the urinary system.


Subject(s)
Angiotensin-Converting Enzyme 2/metabolism , COVID-19 , Kidney/metabolism , Single-Cell Analysis , Urinary Bladder/metabolism , Gene Expression , Humans , SARS-CoV-2 , Sequence Analysis, RNA
10.
Iran J Public Health ; 50(3): 531-539, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1175818

ABSTRACT

BACKGROUND: To explore the intervention degree and improvement effect of group reminiscence therapy in combination with physical exercise on spiritual well-being of the elderly after the outbreak of the COVID-19 epidemic. METHODOLOGY: In 2020, overall, 130 elderly people were selected from communities in Xiangtan City and Changsha City of Hunan Province, China and randomly divided into two groups, with 65 people in each group. One group was the experimental group that participated in the exercise intervention for 8 weeks as the objects of group reminiscence therapy intervention in combination with physical exercise. The other group was the control group that listened to 4 routine health lectures. Spirituality Index of Well-Being, ULS Loneliness Scale and Brief Resilience Scale were used to evaluate the effect of the intervention. RESULTS: Before the intervention, there was no significant difference between the experimental group and the control group, but after 8 weeks of exercise intervention, the score of loneliness was lower in the experimental group than in the control group (P<0.05), the scores of spiritual well-being and resilience were significantly higher in the experimental group than in the control group (P<0.05); and the differences before and after the intervention were significantly higher in the experimental group than the control group (P<0.05). CONCLUSION: Group reminiscence therapy in combination with physical exercise could improve spiritual well-being and mental health of the elderly.

11.
Environ Sci Technol ; 55(9): 5721-5730, 2021 05 04.
Article in English | MEDLINE | ID: covidwho-1164780

ABSTRACT

Despite the large reduction in anthropogenic activities due to the outbreak of COVID-19, air quality in China has witnessed little improvement and featured great regional disparities. Here, by combining observational data and simulations, this work aims to understand the diverse air quality response in two city clusters, Yangtze River Delta region (YRD) and Pearl River Delta region (PRD), China. Though there was a noticeable drop in primary pollutants in both the regions, differently, the maximum daily 8 h average ozone (O3) soared by 20.6-76.8% in YRD but decreased by 15.5-28.1% in PRD. In YRD, nitrogen oxide (NOx) reductions enhanced O3 accumulation and hence increased secondary aerosol formation. Such an increment in secondary organic and inorganic aerosols under stationary weather reached up to 36.4 and 10.2%, respectively, which was further intensified by regional transport. PRD was quite the opposite. The emission reductions benefited PRD air quality, while regional transport corresponded to an increase of 17.3 and 9.3% in secondary organic and inorganic aerosols, respectively. Apart from meteorology, the discrepancy in O3-VOCs-NOx relationships determined the different O3 responses, indicating that future emission control shall be regionally specific, instead of one-size-fits-all cut. Overall, the importance of regionally coordinated and balanced control strategy for multiple pollutants is highly emphasized.


Subject(s)
Air Pollutants , Air Pollution , COVID-19 , Ozone , Air Pollutants/analysis , China , Cities , Communicable Disease Control , Environmental Monitoring , Humans , Ozone/analysis , SARS-CoV-2 , Seasons
12.
Rev Cardiovasc Med ; 21(4): 635-641, 2020 12 30.
Article in English | MEDLINE | ID: covidwho-1005370

ABSTRACT

To investigate the right heart function in coronavirus disease 2019 (COVID-19) patients with acute respiratory distress syndrome (ARDS), a retrospective analysis of 49 COVID-19 patients with ARDS was performed. Patients were divided into severe group and critically-severe group according to the severity of illness. Age-matched healthy volunteers were recruited as a control group. The cardiac cavity diameters, tricuspid annular plane systolic excursion (TAPSE), tricuspid valve regurgitation pressure gradient biggest (TRPG), pulmonary arterial systolic pressure (PASP), maximum inferior vena cava diameter (IVCmax) and minimum diameter (IVCmin), and inferior vena cava collapse index (ICV-CI) were measured using echocardiography. We found that the TAPSE was significantly decreased in pneumonia patients compared to healthy subjects (P < 0.0001), and it was significantly lower in critically-severe patients (P = 0.0068). The TAPSE was less than 17 mm in three (8.6%) severe and five (35.7%) critically-severe patients. In addition, the TAPSE was significantly decreased in severe ARDS patients than in mild ARDS patients. The IVCmax and IVCmin were significantly increased in critically-severe patients compared to healthy subjects and severe patients (P < 0.01), whereas the ICV-CI was significantly decreased (P < 0.05). COVID-19 patients had significantly larger right atrium and ventricle than healthy controls (P < 0.01). The left ventricular ejection fraction (LVEF) in critically-severe patients was significantly lower than that in severe patients and healthy controls (P < 0.05). Right ventricular function was impaired in critically-severe COVID-19 patients. The assessment and protection of the right heart function in COVID-19 patients should be strengthened.


Subject(s)
COVID-19/complications , Heart Ventricles/physiopathology , Pandemics , Ventricular Dysfunction, Right/etiology , Ventricular Function, Right/physiology , COVID-19/epidemiology , Echocardiography, Doppler , Female , Follow-Up Studies , Heart Ventricles/diagnostic imaging , Humans , Male , Middle Aged , Retrospective Studies , Ventricular Dysfunction, Right/diagnosis , Ventricular Dysfunction, Right/physiopathology
13.
Atmospheric and Oceanic Science Letters ; : 100015, 2020.
Article in English | ScienceDirect | ID: covidwho-973822

ABSTRACT

The explosive spread of the 2019 novel coronavirus (COVID-19) provides a unique chance to rethink the relationship between human activity and air pollution. Though related studies have revealed substantial reductions in primary emissions, obvious differences do exist in the responses of secondary pollutants, like ozone (O3) pollution. However, the regional disparities of O3 responses and their causes have still not been fully investigated. To better elucidate the interrelationship between anthropogenic emissions, chemical production, and meteorological conditions, O3 responses caused by lockdowns over different regions were comprehensively explored at a global scale. Observational signals of air-quality change were derived from multi-year surface measurements and satellite retrievals. With similar substantial drops in nitrogen dioxide (NO2), ozone shows rising signals in most areas of both East Asia and Europe, even up to ∼14 ppb, while a non-negligible declining signal exists in North America, by about 2–4 ppb. Furthermore, the drivers behind the different O3 responses are discussed based on meteorological analysis and O3 sensitivity diagnosis. On the one hand, O3 responses to NO2 declines can be affected by the primary dependence on its precursors. On the other hand, it is also highly dependent on meteorological factors, especially temperature. Our study further highlights the great importance of taking into consideration both the regional disparities and synergistic effects of precursor reductions and meteorological influence for scientific mitigation of O3 pollution. 摘要: 疫情期间全球各地一次排放大幅削减, 而臭氧等二次污染的响应则存在着区域间差异.结合地面和卫星观测发现, 同在氮氧化物大幅下降的情况下,臭氧在东亚和欧洲呈现出可达14ppb的上升信号, 而北美则下降为主 (约2-4ppb) .我们结合气象分析和臭氧敏感性进一步讨论了臭氧响应差异性的原因, 一方面受臭氧与前体物间关系的影响;另一方面来自于气象, 尤其是温度.研究明晰了人为排放,化学和气象三者的内在关联, 强调了在臭氧控制过程中考虑前体物削减和气象条件协同的重要性.

14.
Lancet Infect Dis ; 21(2): 181-192, 2021 02.
Article in English | MEDLINE | ID: covidwho-939389

ABSTRACT

BACKGROUND: With the unprecedented morbidity and mortality associated with the COVID-19 pandemic, a vaccine against COVID-19 is urgently needed. We investigated CoronaVac (Sinovac Life Sciences, Beijing, China), an inactivated vaccine candidate against COVID-19, containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for its safety, tolerability and immunogenicity. METHODS: In this randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, healthy adults aged 18-59 years were recruited from the community in Suining County of Jiangsu province, China. Adults with SARS-CoV-2 exposure or infection history, with axillary temperature above 37·0°C, or an allergic reaction to any vaccine component were excluded. The experimental vaccine for the phase 1 trial was manufactured using a cell factory process (CellSTACK Cell Culture Chamber 10, Corning, Wujiang, China), whereas those for the phase 2 trial were produced through a bioreactor process (ReadyToProcess WAVE 25, GE, Umea, Sweden). The phase 1 trial was done in a dose-escalating manner. At screening, participants were initially separated (1:1), with no specific randomisation, into two vaccination schedule cohorts, the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and within each cohort the first 36 participants were assigned to block 1 (low dose CoronaVac [3 µg per 0·5 mL of aluminium hydroxide diluent per dose) then another 36 were assigned to block 2 (high-dose Coronavc [6 µg per 0·5 mL of aluminium hydroxide diluent per dse]). Within each block, participants were randomly assigned (2:1), using block randomisation with a block size of six, to either two doses of CoronaVac or two doses of placebo. In the phase 2 trial, at screening, participants were initially separated (1:1), with no specific randomisation, into the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and participants were randomly assigned (2:2:1), using block randomisation with a block size of five, to receive two doses of either low-dose CoronaVac, high-dose CoronaVac, or placebo. Participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after injection in all participants who were given at least one dose of study drug (safety population). The primary immunogenic outcome was seroconversion rates of neutralising antibodies to live SARS-CoV-2 at day 14 after the last dose in the days 0 and 14 cohort, and at day 28 after the last dose in the days 0 and 28 cohort in participants who completed their allocated two-dose vaccination schedule (per-protocol population). This trial is registered with ClinicalTrials.gov, NCT04352608, and is closed to accrual. FINDINGS: Between April 16 and April 25, 2020, 144 participants were enrolled in the phase 1 trial, and between May 3 and May 5, 2020, 600 participants were enrolled in the phase 2 trial. 743 participants received at least one dose of investigational product (n=143 for phase 1 and n=600 for phase 2; safety population). In the phase 1 trial, the incidence of adverse reactions for the days 0 and 14 cohort was seven (29%) of 24 participants in the 3 ug group, nine (38%) of 24 in the 6 µg group, and two (8%) of 24 in the placebo group, and for the days 0 and 28 cohort was three (13%) of 24 in the 3 µg group, four (17%) of 24 in the 6 µg group, and three (13%) of 23 in the placebo group. The seroconversion of neutralising antibodies on day 14 after the days 0 and 14 vaccination schedule was seen in 11 (46%) of 24 participants in the 3 µg group, 12 (50%) of 24 in the 6 µg group, and none (0%) of 24 in the placebo group; whereas at day 28 after the days 0 and 28 vaccination schedule, seroconversion was seen in 20 (83%) of 24 in the 3 µg group, 19 (79%) of 24 in the 6 µg group, and one (4%) of 24 in the placebo group. In the phase 2 trial, the incidence of adverse reactions for the days 0 and 14 cohort was 40 (33%) of 120 participants in the 3 µg group, 42 (35%) of 120 in the 6 µg group, and 13 (22%) of 60 in the placebo group, and for the days 0 and 28 cohort was 23 (19%) of 120 in the 3 µg group, 23 (19%) of 120 in the 6 µg group, and 11 (18%) of 60 for the placebo group. Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 µg group, 117 (98%) of 119 in the 6 µg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 µg group, 118 (100%) of 118 in the 6 µg group, and none (0%) of 59 in the placebo group. INTERPRETATION: Taking safety, immunogenicity, and production capacity into account, the 3 µg dose of CoronaVac is the suggested dose for efficacy assessment in future phase 3 trials. FUNDING: Chinese National Key Research and Development Program and Beijing Science and Technology Program.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunogenicity, Vaccine , SARS-CoV-2/immunology , Vaccines, Inactivated/adverse effects , Vaccines, Inactivated/immunology , Adolescent , Adult , Antibodies, Neutralizing/immunology , Antibodies, Viral , COVID-19/epidemiology , COVID-19 Vaccines/administration & dosage , China/epidemiology , Female , Healthy Volunteers , Humans , Immunization Schedule , Immunoglobulin G , Immunoglobulin M , Male , Middle Aged , Seroconversion , Vaccination , Vaccines, Inactivated/administration & dosage , Young Adult
15.
Proc Assoc Inf Sci Technol ; 57(1): e397, 2020.
Article in English | MEDLINE | ID: covidwho-919802

ABSTRACT

In this poster, we report the preliminary results of an inventory of 149 publicly accessible active COVID-19 tracking systems. Key findings include the frequency distribution of the systems' web domain names, the countries where the systems were created, the languages they support, the visual display format, the map platforms, and the data sources. These findings help to advance the knowledge of the data characteristics and design of pandemic surveillance/tracking systems.

16.
Natl Sci Rev ; 8(2): nwaa137, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-603591

ABSTRACT

To control the spread of the 2019 novel coronavirus (COVID-19), China imposed nationwide restrictions on the movement of its population (lockdown) after the Chinese New Year of 2020, leading to large reductions in economic activities and associated emissions. Despite such large decreases in primary pollution, there were nonetheless several periods of heavy haze pollution in eastern China, raising questions about the well-established relationship between human activities and air quality. Here, using comprehensive measurements and modeling, we show that the haze during the COVID lockdown was driven by enhancements of secondary pollution. In particular, large decreases in NOx emissions from transportation increased ozone and nighttime NO3 radical formation, and these increases in atmospheric oxidizing capacity in turn facilitated the formation of secondary particulate matter. Our results, afforded by the tragic natural experiment of the COVID-19 pandemic, indicate that haze mitigation depends upon a coordinated and balanced strategy for controlling multiple pollutants.

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