VOC

VOC
  • 文章类型: Journal Article
    二手烟暴露是一种新兴的公共卫生问题,仍未得到充分研究。在这项研究中,收集了ENDS用户(二手)和非ENDS用户(基线)的唾液和呼出排放物,使用自动ENDS气溶胶生成系统生成第一手排放物,该系统被编程为模拟从ENDS用户收集的膨化地形轮廓。表征了颗粒浓度和大小以及挥发性有机化合物。我们揭示了膨化地形指标作为第一手和二手粒子和化学暴露的潜在介体,以及代谢和呼吸健康结果。颗粒沉积模型显示,虽然二手排放显示出较小的沉积质量,总和肺颗粒沉积分数高于第一手沉积水平,可能是由于较小的二手发射粒子直径。最后,由第一手ENDS暴露引起的肺损伤的唾液生物标志物的非靶向代谢组学分析揭示了呼吸窘迫的潜在早期指标,这些指标也可能与暴露于二手烟的旁观者相关.通过利用系统毒理学,我们鉴定出10种代谢物,包括白三烯D4,可能作为ENDS使用的生物标志物,暴露估计,和电子烟相关疾病的预测。这项研究强调了vaping行为的表征是促进我们对ENDS用户和旁观者潜在健康影响的理解的重要组成部分。
    Secondhand vaping exposure is an emerging public health concern that remains understudied. In this study, saliva and exhaled emissions from ENDS users (secondhand) and non-ENDS users (baseline) were collected, firsthand emissions were generated using an automated ENDS aerosol generation system programmed to simulate puffing topography profiles collected from ENDS users. Particulate concentrations and sizes along with volatile organic compounds were characterized. We revealed puffing topography metrics as potential mediators of firsthand and secondhand particle and chemical exposures, as well as metabolic and respiratory health outcomes. Particle deposition modeling revealed that while secondhand emissions displayed smaller deposited mass, total and pulmonary particle deposition fractions were higher than firsthand deposition levels, possibly due to smaller secondhand emission particle diameters. Lastly, untargeted metabolomic profiling of salivary biomarkers of lung injury due to firsthand ENDS exposures revealed potential early indicators of respiratory distress that may also be relevant in bystanders exposed to secondhand vaping scenarios. By leveraging system toxicology, we identified 10 metabolites, including leukotriene D4, that could potentially serve as biomarkers for ENDS use, exposure estimation, and the prediction of vaping-related disease. This study highlights characterization of vaping behavior is an important exposure component in advancing our understanding of potential health effects in ENDS users and bystanders.
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  • 文章类型: Journal Article
    通过在包含与活火山活动相关的高焓热液系统的地区进行广泛的抽样调查,研究了在从不同的低源向地面的天然气起义期间影响非甲烷挥发性有机化合物(VOCs)的降解机制。富含CH4的沉积盆地和城市垃圾填埋场。对于一个全面的框架,还包括中高焓热液系统的已发布数据。所研究的系统的特点是独特的VOC套件,反映了遗传环境的条件,其中温度,有机物的含量,和天然气真空起到了重要作用。源(气体喷口和垃圾填埋气体)和土壤气体之间的VOC模式差异表明土壤中的VOC转化。相对于低分子量烷烃,在土壤中作用的过程优先降解高分子量烷烃。烯烃和环状物大致表现得像烷烃。噻吩相对于烷基化苯的降解程度更大,比苯更活泼。呋喃的降解程度低于其烷基化同系物。相对于二甲基硫醚,二甲基亚砜通常是有利的。柠檬烯和樟脑烯在有氧条件下相对不稳定,而α-pine烯是顽固性的。含O的有机化合物(即,醛类,酯类,酮,酒精,有机酸和苯酚)是土壤中正在进行的VOC降解的中间产物。没有观察到卤代化合物和苯并噻唑降解的证据。本研究指出了土壤降解过程是如何减少VOC排放的,以及物理化学和生物学参数对土壤有效VOC衰减能力的重要作用。
    Degradation mechanisms affecting non-methane volatile organic compounds (VOCs) during gas uprising from different hypogenic sources to the surface were investigated through extensive sampling surveys in areas encompassing a high enthalpy hydrothermal system associated with active volcanism, a CH4-rich sedimentary basin and a municipal waste landfill. For a comprehensive framework, published data from medium-to-high enthalpy hydrothermal systems were also included. The investigated systems were characterised by peculiar VOC suites that reflected the conditions of the genetic environments in which temperature, contents of organic matter, and gas fugacity had a major role. Differences in VOC patterns between source (gas vents and landfill gas) and soil gases indicated VOC transformations in soil. Processes acting in soil preferentially degraded high-molecular weight alkanes with respect to the low-molecular weight ones. Alkenes and cyclics roughly behaved like alkanes. Thiophenes were degraded to a larger extent with respect to alkylated benzenes, which were more reactive than benzene. Furan appeared less degraded than its alkylated homologues. Dimethylsulfoxide was generally favoured with respect to dimethylsulfide. Limonene and camphene were relatively unstable under aerobic conditions, while α-pinene was recalcitrant. O-bearing organic compounds (i.e., aldehydes, esters, ketones, alcohols, organic acids and phenol) acted as intermediate products of the ongoing VOC degradations in soil. No evidence for the degradation of halogenated compounds and benzothiazole was observed. This study pointed out how soil degradation processes reduce hypogenic VOC emissions and the important role played by physicochemical and biological parameters on the effective VOC attenuation capacity of the soil.
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  • 文章类型: Journal Article
    已从材料挤出3D打印中检测到超细颗粒和挥发性有机化合物(VOC),在非工业环境中广泛使用。这项研究使用标准化测试方法和各种3D打印场景,合并了来自腔室研究的447个颗粒排放和58个VOC排放评估的数据。对于颗粒,观察到的排放速率的四分位数范围为109-1011#/h,对于总VOC为0.2-1.0mg/h。印刷材料对颗粒和总VOC排放的变化有很大贡献,并确定了排放最多的VOC。印刷条件和灯丝规格,包括打印机品牌,打印温度和速度,建立板加热设置,灯丝品牌,颜色和复合,也影响了排放,并导致在排放曲线中观察到很大的变化。多元回归表明,与VOC排放相比,颗粒排放受各种印刷条件的影响更大。根据室内暴露建模,个人和住宅暴露场景更有可能导致高暴露水平,经常超过推荐的接触限值。3D打印通常排放的有害VOCs包括芳烃,醛类,酒精,酮,酯和硅氧烷,其中有各种致癌物,刺激物和发育和生殖毒素。因此,3D打印释放出超细颗粒和各种危险化学品的复杂混合物,暴露可能超过推荐的暴露限值并可能诱发急性,慢性,或根据暴露场景对用户的发育健康影响。
    Ultrafine particles and volatile organic compounds (VOCs) have been detected from material extrusion 3D printing, which is widely used in non-industrial environments. This study consolidates data of 447 particle emission and 58 VOC emission evaluations from a chamber study using a standardized testing method with various 3D printing scenarios. The interquartile ranges of the observed emission rates were 109-1011 #/h for particles and 0.2-1.0 mg/h for total VOC. Print material contributed largely to the variations of particle and total VOC emissions and determined the most abundantly emitted VOCs. Printing conditions and filament specifications, included printer brand, print temperature and speed, build plate heating setup, filament brand, color and composite, also affected emissions and resulted in large variations observed in emission profiles. Multiple regression showed that particle emissions were more impacted by various print conditions than VOC emissions. According to indoor exposure modeling, personal and residential exposure scenarios were more likely to result in high exposure levels, often exceeding recommended exposure limits. Hazardous VOCs commonly emitted from 3D printing included aromatics, aldehydes, alcohols, ketones, esters and siloxanes, among which were various carcinogens, irritants and developmental and reproductive toxins. Therefore, 3D printing emits a complex mixture of ultrafine particles and various hazardous chemicals, exposure to which may exceed recommended exposure limits and potentially induce acute, chronic, or developmental health effects for users depending on exposure scenarios.
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  • 文章类型: Journal Article
    据报道,一项由23个主题进行的可行性研究旨在评估如何使用从硅微反应器收集的呼出气样本的紫外线吸光度测量来检测COVID-19。硅微反应器技术化学选择性预浓缩呼出的羰基VOC,随后的甲醇洗脱提供了用于分析的样品。可行性研究的结果似乎支持了病毒感染会导致呼出气羰基增加的基本科学原理。数据表明,在235nm至305nm的波长范围内,健康和有症状的COVID-19阳性受试者之间测得的紫外线吸收值存在统计学上的显着差异。受试者年龄等因素被认为是潜在的混杂变量。
    A 23-subject feasibility study is reported to assess how UV absorbance measurements on exhaled breath samples collected from silicon microreactors can be used to detect COVID-19. The silicon microreactor technology chemoselectively preconcentrates exhaled carbonyl volatile organic compounds and subsequent methanol elution provides samples for analysis. The underlying scientific rationale that viral infection will induce an increase in exhaled carbonyls appears to be supported by the results of the feasibility study. The data indicate statistically significant differences in measured UV absorbance values between healthy and symptomatic COVID-19 positive subjects in the wavelength range from 235 nm to 305 nm. Factors such as subject age were noted as potential confounding variables.
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  • 文章类型: Journal Article
    在COVID-19大流行期间,具有特定特征的不同SARS-CoV-2变体(VOC)已经出现并在世界范围内传播。同时,临床医师在患者入院时和住院期间常规评估某些血液检查的结果,以评估疾病严重程度和患者总体状况.在本研究中,我们在受Alpha影响的患者中搜索了显著的血细胞计数和生物标志物差异,入场时的Delta和OmicronVOCs。检索了330名患者的年龄数据,性别,VOC,细胞血细胞计数结果(白细胞,Neut%,淋巴%,Ig%,PLT),常见的生物标志物(D-二聚体,尿素,肌酐,SGOT,SGPT,CRP,IL-6,suPAR),ICU入院和死亡。使用方差分析进行统计分析,Kruskal-Wallis测试,双向方差分析,卡方,T检验,适当时使用SPSSv.28和STATA14进行Mann-Whitney检验和逻辑回归.年龄和VOC与住院显著相关,而VOC组之间的WBC存在显著差异,PLT,Neut%,IL-6,肌酐,CRP,D-二聚体和suPAR。我们的分析表明,在当前的大流行中,不仅SARS-CoV-2VOCs,而且用于评估患者入院时状态的实验室参数也会发生变化。
    During the COVID-19 pandemic, different SARS-CoV-2 variants of concern (VOC) with specific characteristics have emerged and spread worldwide. At the same time, clinicians routinely evaluate the results of certain blood tests upon patient admission as well as during hospitalization to assess disease severity and the overall patient status. In the present study, we searched for significant cell blood count and biomarker differences among patients affected with the Alpha, Delta and Omicron VOCs at admission. Data from 330 patients were retrieved regarding age, gender, VOC, cell blood count results (WBC, Neut%, Lymph%, Ig%, PLT), common biomarkers (D-dimers, urea, creatinine, SGOT, SGPT, CRP, IL-6, suPAR), ICU admission and death. Statistical analyses were performed using ANOVA, the Kruskal-Wallis test, two-way ANOVA, Chi-square, T-test, the Mann-Whitney test and logistic regression was performed where appropriate using SPSS v.28 and STATA 14. Age and VOC were significantly associated with hospitalization, whereas significant differences among VOC groups were found for WBC, PLT, Neut%, IL-6, creatinine, CRP, D-dimers and suPAR. Our analyses showed that throughout the current pandemic, not only the SARS-CoV-2 VOCs but also the laboratory parameters that are used to evaluate the patient\'s status at admission are subject to changes.
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  • 文章类型: Journal Article
    背景/目标:在镰状细胞病(SCD)患者中,血管闭塞性危象(VOCs)是急性疼痛的反复发作和不可预测的发作。这些疼痛危机通常用镇痛药治疗,包括阿片类药物,与滥用和过量有关。这项研究的目的是检查VOC事件与阿片类药物使用之间的关联,并评估阿片类药物处方与SCD患者医疗保健资源利用之间的关联。方法:这是一项回顾性队列研究,使用2011年9月至2016年8月期间的德克萨斯州医疗补助医疗和处方索赔。索引日期是首次SCD诊断。患者(2-63岁)至少有一个住院或两个门诊SCD诊断,他们在索引后的12个月内连续注册,包括在研究中。主要结果是阿片类药物处方的数量,而自变量为VOC事件数。协变量包括年龄,性别,非阿片类药物的使用,非研究SCD相关药物(青霉素和叶酸)使用,输血的证据,SCD相关并发症的数量,与SCD相关的共病条件的数量,和Charlson合并症指数评分。负二项回归分析用于解决研究目标。结果:在3368名患者中,1978年(58.7%)至少有一个阿片类药物处方,平均值为4.2(SD=7.2)。总的来说,2071(61.5%)发生至少一次VOC事件,平均为2.9(SD=4.4)。负二项回归的结果表明,VOC事件的每增加一次,阿片类药物处方数量增加9.5%(发生率=1.095,95%CI:1.078-1.111;P≤0.0001)。与阿片类药物使用率较高相关的其他重要协变量包括年龄(与2-12相比,13岁及以上)和非阿片类止痛药数量的增加。非研究SCD相关药物,和SCD相关并发症。结论:在12个月的研究期间,大多数SCD患者至少发生了一次VOC事件,并服用了阿片类药物。我们发现,每个VOC事件都与阿片类药物的使用增加9.5%有关。SCD指南推荐阿片类药物用于治疗VOC相关疼痛。付款人和提供者应该意识到这一人群中阿片类药物的使用,考虑采取适当的VOC预防措施,并为SCD患者提供适当的疼痛管理。
    Background/Objectives: Among sickle cell disease (SCD) patients, vaso-occlusive crises (VOCs) are recurrent and unpredictable attacks of acute pain. These pain crises are often treated with analgesics, including opioids, which have been associated with misuse and overdose. The aim of this study was to examine the association between VOC events and opioid use and assess the association between opioid prescriptions and health care resource utilization among SCD patients. Methods: This was a retrospective cohort study using Texas Medicaid medical and prescription claims between September 2011 and August 2016. The index date was the first SCD diagnosis. Patients (2-63 years) with at least one inpatient or two outpatient SCD diagnoses, who were continuously enrolled during 12 months postindex, were included in the study. The primary outcome was number of opioid prescriptions, while the independent variable was number of VOC events. Covariates included age, gender, nonopioid medication use, nonstudy SCD-related medication (penicillin and folic acid) use, evidence of blood transfusions, number of SCD-related complications, number of SCD-related comorbid conditions, and Charlson Comorbidity Index score. Negative binomial regression analysis was used to address study objectives. Results: Of 3368 included patients, 1978 (58.7%) had at least one opioid prescription with a mean of 4.2 (SD=7.2). Overall, 2071 (61.5%) had at least one VOC event with an average of 2.9 (SD=4.4). The results from the negative binomial regression showed that for every increase in VOC events, the number of opioid prescriptions increased by 9.5% (Incidence rate ratio=1.095, 95% CI: 1.078-1.111; P ≤ 0.0001). Other significant covariates associated with higher opioid use included age (13 and older compared to 2-12) and increase in the number of nonopioid pain medications, nonstudy SCD-related medications, and SCD-related complications. Conclusions: The majority of SCD patients had at least one VOC event and were prescribed opioids during the 12-month study period. We found that each VOC event was associated with a 9.5% increase in the use of opioids. SCD guidelines recommend opioids for the treatment of VOC-related pain. Payers and providers should be aware of opioid use in this population, consider appropriate VOC prevention measures, and provide SCD patients with access to appropriate pain management.
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  • 文章类型: Journal Article
    生物质燃烧排放的增加趋势显着影响了北美的空气质量。在受烟雾影响的时期,城市地区臭氧(O3)的混合比提高是通过输送烟雾中产生的O3或通过将热解挥发性有机化合物(PVOCs)与城市氮氧化物(NOx=NONO2)混合来实现的。这里,我们分析了一组详细的化学测量,包括一氧化碳(CO),NOx,和特定的挥发性有机化合物(VOC),为了评估从相对局部和远程火灾中输送的烟雾对博尔德现场测得的O3的影响,科罗拉多,2020年夏季相对于无烟期,CO,背景O3,OH反应性,在局部和长期烟雾期间,总挥发性有机化合物都增加了,但NOx混合比保持大致恒定。这些观察结果与PVOCs(主要由含氧化合物组成)的传输一致,但与烟气中NOx的传输以及市区逆风烟气中产生的O3的影响一致。盒模型计算表明,在所有三个时期中,当地的O3产量都处于对NOx敏感的状态。因此,在所有三个时期,这种本地产生的O3都相似,并且对PVOCs的增加相对不敏感。然而,计算的NOx敏感性表明,PVOCs在过渡和NOx饱和(VOC敏感)状态下显着增加了O3的产量。这些结果表明,(1)烟雾传输过程中产生的O3是NOx敏感城市地区O3增加的主要驱动因素,(2)烟雾可能导致NOx饱和(VOC敏感)城市地区的局部O3产量增加。有必要在受烟雾影响的城市地区进行更详细的VOC和NOx测量,以广泛量化野火烟雾对城市O3的影响并制定有效的缓解策略。
    Increasing trends in biomass burning emissions significantly impact air quality in North America. Enhanced mixing ratios of ozone (O3) in urban areas during smoke-impacted periods occur through transport of O3 produced within the smoke or through mixing of pyrogenic volatile organic compounds (PVOCs) with urban nitrogen oxides (NOx = NO + NO2) to enhance local O3 production. Here, we analyze a set of detailed chemical measurements, including carbon monoxide (CO), NOx, and speciated volatile organic compounds (VOCs), to evaluate the effects of smoke transported from relatively local and long-range fires on O3 measured at a site in Boulder, Colorado, during summer 2020. Relative to the smoke-free period, CO, background O3, OH reactivity, and total VOCs increased during both the local and long-range smoke periods, but NOx mixing ratios remained approximately constant. These observations are consistent with transport of PVOCs (comprised primarily of oxygenates) but not NOx with the smoke and with the influence of O3 produced within the smoke upwind of the urban area. Box-model calculations show that local O3 production during all three periods was in the NOx-sensitive regime. Consequently, this locally produced O3 was similar in all three periods and was relatively insensitive to the increase in PVOCs. However, calculated NOx sensitivities show that PVOCs substantially increase O3 production in the transition and NOx-saturated (VOC-sensitive) regimes. These results suggest that (1) O3 produced during smoke transport is the main driver for O3 increases in NOx-sensitive urban areas and (2) smoke may cause an additional increase in local O3 production in NOx-saturated (VOC-sensitive) urban areas. Additional detailed VOC and NOx measurements in smoke impacted urban areas are necessary to broadly quantify the effects of wildfire smoke on urban O3 and develop effective mitigation strategies.
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  • 文章类型: Journal Article
    UNASSIGNED:已经在各种设置中研究了使用场非对称波形离子迁移谱(FAIMS)和相关方法从体液中检测挥发性有机化合物(VOC)。初步结果表明,可以检测前列腺,结直肠,尿样中的卵巢癌和胰腺癌。在这项研究中,我们的主要目的是通过使用内镜逆行胰胆管造影术(ERCP)期间获得的胆汁样本,将胰腺癌与胰腺炎和胰腺良性肿瘤区分开来.其次,我们旨在区分所有胰腺区域恶性肿瘤和所有其他类型的良性胆道梗阻。
    UNASSIGNED:在坦佩雷大学医院进行ERCP治疗期间,94名患者成功吸出胆汁样本。在ERCP后,对医院和患者记录进行了至少两年的前瞻性随访。使用Lonestar化学分析器(Owlstone,英国)使用ATLAS采样系统和分流箱。对来自分析的诊断和相应数据进行匹配,并分为两个子类别进行比较。使用线性判别分析进行统计分析,支持向量机,和5倍交叉验证。
    未经证实:胰腺癌(n=8)与良性胰腺病变(n=9)的敏感性为100%,特异性为77.8%,正确率为88%。所有胰腺区域癌症(n=19)均与所有其他类型的胆道梗阻良性原因(n=75)区分开,相应值为21.1%,94.7%,和80.7%。样本量太小,无法尝试将胰腺癌与相邻癌症区分开来。
    未经证实:使用FAIMS分析胆汁中的VOCs在检测胰腺癌和胰腺区域的其他癌症方面显示出很有希望的能力。
    UNASSIGNED: Detection of volatile organic compounds (VOCs) from bodily fluids with field asymmetric waveform ion mobility spectrometry (FAIMS) and related methods has been studied in various settings. Preliminary results suggest that it is possible to detect prostate, colorectal, ovarian and pancreatic cancer from urine samples. In this study, our primary aim was to differentiate pancreatic cancer from pancreatitis and benign tumours of the pancreas by using bile samples obtained during endoscopic retrograde cholangiopancreatography (ERCP). Secondarily, we aimed to differentiate all pancreatic region malignancies from all other kinds of benign causes of biliary obstruction.
    UNASSIGNED: A bile sample was successfully aspirated from 94 patients during ERCP in Tampere University Hospital. Hospital and patient records were prospectively followed up for at least two years after ERCP. Bile samples were analysed using a Lonestar chemical analyser (Owlstone, UK) using an ATLAS sampling system and a split-flow box. Diagnoses and corresponding data from the analyses were matched and divided into two subcategories for comparison. Statistical analysis was performed using linear discriminant analysis, support vector machines, and 5-fold cross-validation.
    UNASSIGNED: Pancreatic cancers (n=8) were differentiated from benign pancreatic lesions (n=9) with a sensitivity of 100%, specificity of 77.8%, and correct rate of 88%. All pancreatic region cancers (n=19) were differentiated from all other kinds of benign causes of biliary obstruction (n=75) with corresponding values of 21.1%, 94.7%, and 80.7%. The sample size was too small to try to differentiate pancreatic cancers from adjacent cancers.
    UNASSIGNED: Analysing bile VOCs using FAIMS shows promising capability in detecting pancreatic cancer and other cancers in the pancreatic area.
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  • 文章类型: Journal Article
    制备了具有中心四苯基甲烷和外围3,5-二-(叔丁酰基氨基)苯甲酰基哌嗪部分的两个树枝状聚合物的合理产率。这些树枝状聚合物在固态下具有空隙空间,因此它们吸附客体分子。他们的BET值各不相同,取决于外围部分和气体分子之间的H键相互作用,构成空隙空间的树枝状框架是柔性的。在极性气体分子如CO2的存在下,BET显著增加并且是N2下BET的约4-8倍。一种树枝状聚合物吸附氰基苯的水平为436mg/g,which,对于作者最好的知识,几乎相当于文献中的最高报道值。
    Reasonable yields of two dendrimers with central tetraphenylmethane and peripheral 3,5-di-(tert-butanoylamino)benzoylpiperazine moieties are prepared. These dendrimers have a void space in the solid state so they adsorb guest molecules. Their BET values vary, depending on the H-bond interaction between the peripheral moiety and the gas molecules, and the dendritic framework that fabricates the void space is flexible. In the presence of polar gas molecules such as CO2, the BET increases significantly and is about 4-8 times the BET under N2. One dendrimer adsorbs cyanobenzene to a level of 436 mg/g, which, to the authors\' best knowledge, is almost equivalent to the highest reported value in the literature.
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  • 文章类型: Journal Article
    背景:在正在进行的COVID-19大流行中,高龄是SARS-CoV-2感染严重临床病程的危险因素。因此,老年人可能特别受益于强效疫苗的加强剂量,研究应侧重于最佳疫苗接种时间表.除了每个人的病史,免疫衰老值得在这一人群中进一步研究。这项研究调查了疫苗诱导的免疫反应超过1年。
    方法:EU-COVAT-1-AGED是一个随机对照,适应性,多中心II期方案评估年龄≥75岁(n=600)已接种SARS-CoV-2疫苗的个体的不同加强策略。初始方案预见到第三次疫苗接种(第一次加强)作为研究干预。本试验的修改后的B部分预计mRNA-1273(Spikevax®)与BNT162b2(Comirnaty®)作为第4次疫苗接种剂量(第2次加强),用于比较评估其针对SARS-CoV-2野生型和变体的免疫原性和安全性。试验的主要终点是评估通过针对野生型病毒的定量酶联免疫吸附测定(抗RBD-ELISA)测量的疫苗接种后14天抗体滴度增加2倍的速率。次要终点包括在14天至12个月时针对野生型以及针对关注变体(VOC)的中和抗体滴度(病毒中和测定)的变化。通过qPCR测量的T细胞应答将在作为探索性终点的14天在亚组中进行。正在收集生物样本以针对潜在的未来VOC中和抗体滴度。此外,体液免疫反应之间的潜在相关性,将评估T细胞应答和中和能力。一旦观察到所有患者的主要终点(第4次疫苗接种后14天),将触发主要终点分析。
    结论:EU-COVAT-1-AGED试验B部分比较了mRNA-1273(Spikevax®)和BNT162b2(Comirnaty®)作为第4种SARS-CoV-2疫苗剂量在≥75岁的成年人中的免疫原性和安全性。这项试验的结果有可能优化针对这一高危人群的COVID-19疫苗接种策略。
    背景:ClinicalTrials.govNCT05160766。2021年12月16日注册
    方法:V06_0:2022年7月27日。
    BACKGROUND: In the ongoing COVID-19 pandemic, advanced age is a risk factor for a severe clinical course of SARS-CoV-2 infection. Thus, older people may benefit in particular from booster doses with potent vaccines and research should focus on optimal vaccination schedules. In addition to each individual\'s medical history, immunosenescence warrants further research in this population. This study investigates vaccine-induced immune response over 1 year.
    METHODS: EU-COVAT-1-AGED is a randomised controlled, adaptive, multicentre phase II protocol evaluating different booster strategies in individuals aged ≥75 years (n=600) already vaccinated against SARS-CoV-2. The initial protocol foresaw a 3rd vaccination (1st booster) as study intervention. The present modified Part B of this trial foresees testing of mRNA-1273 (Spikevax®) vs. BNT162b2 (Comirnaty®) as 4th vaccination dose (2nd booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants. The primary endpoint of the trial is to assess the rate of 2-fold antibody titre increase 14 days after vaccination measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wild-type virus. Secondary endpoints include the changes in neutralising antibody titres (Virus Neutralisation Assay) against wild-type as well as against Variants of Concern (VOC) at 14 days and up to 12 months. T cell response measured by qPCR will be performed in subgroups at 14 days as exploratory endpoint. Biobanking samples are being collected for neutralising antibody titres against potential future VOC. Furthermore, potential correlates between humoral immune response, T cell response and neutralising capacity will be assessed. The primary endpoint analysis will be triggered as soon as for all patients the primary endpoint (14 days after the 4th vaccination dose) has been observed.
    CONCLUSIONS: The EU-COVAT-1-AGED trial Part B compares immunogenicity and safety of mRNA-1273 (Spikevax®) and BNT162b2 (Comirnaty®) as 4th SARS-CoV-2 vaccine dose in adults ≥75 years of age. The findings of this trial have the potential to optimise the COVID-19 vaccination strategy for this at-risk population.
    BACKGROUND: ClinicalTrials.gov NCT05160766 . Registered on 16 December 2021.
    METHODS: V06_0: 27 July 2022.
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