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Phase 1 dose-escalation trial evaluating a group 2 influenza hemagglutinin stabilized stem nanoparticle vaccine 评估第 2 组流感血凝素稳定干纳米颗粒疫苗的第 1 阶段剂量递增试验
IF 9.2 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-17 DOI: 10.1038/s41541-024-00959-0
Joseph P. Casazza, Amelia R. Hofstetter, Pamela J. M. Costner, LaSonji A. Holman, Cynthia S. Hendel, Alicia T. Widge, Richard L. Wu, William R. Whalen, Jennifer Cunningham, Anita Arthur, Xiaolin Wang, Abidemi Ola, Jamie Saunders, Floreliz Mendoza, Laura Novik, Maria C. Burgos Florez, Ana M. Ortega-Villa, Preeti J. Apte, Larisa Strom, Lu Wang, Marjaan Imam, Manjula Basappa, Mursal Naisan, Mike Castro, Jessica F. Trost, Sandeep R. Narpala, Hillary A. Vanderven, Galina V. Yamshchikov, Nina M. Berkowitz, Ingelise J. Gordon, Sarah H. Plummer, Diane L. Wycuff, Sandra Vazquez, Rebecca A. Gillespie, Adrian Creanga, William C. Adams, Kevin Carlton, Jason G. Gall, Adrian B. McDermott, Leonid A. Serebryannyy, Katherine V. Houser, Richard A. Koup, Barney S. Graham, Julie E. Ledgerwood, John R. Mascola, Theodore C. Pierson, Sarah F. Andrews, Masaru Kanekiyo, Lesia K. Dropulic

The relative conservation of the influenza hemagglutinin (HA) stem compared to that of the immunodominant HA head makes the HA stem an attractive target for broadly protective influenza vaccines. Here we report the first-in-human, dose-escalation, open-label trial (NCT04579250) evaluating an unadjuvanted group 2 stabilized stem ferritin nanoparticle vaccine based on the H10 A/Jiangxi-Donghu/346/2013 influenza HA, H10ssF, in healthy adults. Participants received a single 20 mcg dose (n = 3) or two 60 mcg doses 16 weeks apart (n = 22). Vaccination with H10ssF was safe and well tolerated with only mild systemic and local reactogenicity reported. No serious adverse events occurred. Vaccination significantly increased homologous H10 HA stem binding and neutralizing antibodies at 2 weeks after both first and second vaccinations, and these responses remained above baseline at 40 weeks. Heterologous H3 and H7 binding antibodies also significantly increased after each vaccination and remained elevated throughout the study. These data indicate that the group 2 HA stem nanoparticle vaccine is safe and induces stem-directed binding and neutralizing antibodies.

与免疫优势的HA头相比,流感血凝素(HA)茎的相对保护性使HA茎成为广泛保护性流感疫苗的一个有吸引力的靶点。在此,我们报告了首次人体剂量递增开放标签试验(NCT04579250),该试验在健康成人中评估了基于 H10 A/Jiangxi-Donghu/346/2013 流感 HA 的无佐剂第 2 组稳定茎铁蛋白纳米粒子疫苗 H10ssF。参与者接种一次 20 毫微克剂量(3 人)或两次 60 毫微克剂量(22 人),每次间隔 16 周。接种 H10ssF 疫苗安全且耐受性良好,仅有轻微的全身和局部反应性报告。未发生严重不良事件。在第一次和第二次接种后 2 周,接种疫苗可明显增加同源 H10 HA 干结合抗体和中和抗体,这些反应在 40 周时仍高于基线。异源 H3 和 H7 结合抗体也在每次接种后显著增加,并在整个研究过程中保持升高。这些数据表明,第 2 组 HA 干细胞纳米颗粒疫苗是安全的,并能诱导干细胞定向结合抗体和中和抗体。
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引用次数: 0
CircRNA based multivalent neuraminidase vaccine induces broad protection against influenza viruses in mice 基于 CircRNA 的多价神经氨酸酶疫苗可诱导小鼠对流感病毒产生广泛的保护作用
IF 9.2 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-16 DOI: 10.1038/s41541-024-00963-4
Xinyu Yue, Cailing Zhong, Rui Cao, Sizhe Liu, Zhiran Qin, Lin Liu, Yanmei Zhai, Wanyu Luo, Yikai Lian, Mengjie Zhang, Hongjie Lu, Yuanyuan Wang, Mengxin Xu, Shuning Liu, Kexin Lv, Yuzhu Sun, Xingchen Zhu, Haoting Mai, Jing Liao, Jingyi Yang, Lei Deng, Yang Liu, Caijun Sun, Ke-Wei Zheng, Yuelong Shu, Yao-Qing Chen

Developing broad-spectrum influenza vaccines is crucial for influenza control and potential pandemic preparedness. Here, we reported a novel vaccine design utilizing circular RNA (circRNA) as a delivery platform for multi-subtype neuraminidases (NA) (influenza A N1, N2, and influenza B Victoria lineage NA) immunogens. Individual NA circRNA lipid nanoparticles (LNP) elicited robust NA-specific antibody responses with neuraminidase inhibition activity (NAI), preventing the virus from egressing and infecting neighboring cells. Additionally, the administration of circRNA LNP induced cellular immunity in mice. To achieve a universal influenza vaccine, we combined all three subtypes of NA circRNA-LNPs to generate a trivalent circRNA vaccine. The trivalent vaccine elicited a balanced antibody response against all three NA subtypes and a Th1-biased immune response in mice. Moreover, it protected mice against the lethal challenge of matched and mismatched H1N1, H3N2, and influenza B viruses, encompassing circulating and ancestral influenza virus strains. This study highlights the potential of delivering multiple NA antigens through circRNA-LNPs as a promising strategy for effectively developing a universal influenza vaccine against diverse influenza viruses.

开发广谱流感疫苗对于流感控制和潜在的大流行防备至关重要。在此,我们报告了一种新型疫苗设计,利用环状 RNA(circRNA)作为多亚型神经氨酸酶(NA)(甲型 N1、N2 和乙型 Victoria 系 NA 流感病毒)免疫原的递送平台。单个NA circRNA脂质纳米颗粒(LNP)可激发具有神经氨酸酶抑制活性(NAI)的强NA特异性抗体反应,阻止病毒外逸并感染邻近细胞。此外,给小鼠注射 circRNA LNP 还能诱导细胞免疫。为了获得通用流感疫苗,我们将所有三种亚型的 NA circRNA-LNPs 结合在一起,制成了三价 circRNA 疫苗。三价疫苗能引起小鼠对所有三种 NA 亚型的平衡抗体反应和 Th1 偏向的免疫反应。此外,它还能保护小鼠免受匹配和不匹配的 H1N1、H3N2 和 B 型流感病毒(包括流行的和祖先的流感病毒株)的致命挑战。这项研究凸显了通过 circRNA-LNPs 提供多种 NA 抗原的潜力,是有效开发针对不同流感病毒的通用流感疫苗的可行策略。
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引用次数: 0
Sequential immunization with chimeric hemagglutinin ΔNS1 attenuated influenza vaccines induces broad humoral and cellular immunity 用嵌合血凝素ΔNS1减毒流感疫苗接种可诱导广泛的体液免疫和细胞免疫
IF 9.2 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-16 DOI: 10.1038/s41541-024-00952-7
Raveen Rathnasinghe, Lauren A. Chang, Rebecca Pearl, Sonia Jangra, Amy Aspelund, Alaura Hoag, Soner Yildiz, Ignacio Mena, Weina Sun, Madhumathi Loganathan, Nicholas Alexander Crossland, Hans P. Gertje, Anna Elise Tseng, Sadaf Aslam, Randy A. Albrecht, Peter Palese, Florian Krammer, Michael Schotsaert, Thomas Muster, Adolfo García-Sastre

Influenza viruses pose a threat to public health as evidenced by severe morbidity and mortality in humans on a yearly basis. Given the constant changes in the viral glycoproteins owing to antigenic drift, seasonal influenza vaccines need to be updated periodically and effectiveness often drops due to mismatches between vaccine and circulating strains. In addition, seasonal influenza vaccines are not protective against antigenically shifted influenza viruses with pandemic potential. Here, we have developed a highly immunogenic vaccination regimen based on live-attenuated influenza vaccines (LAIVs) comprised of an attenuated virus backbone lacking non-structural protein 1 (ΔNS1), the primary host interferon antagonist of influenza viruses, with chimeric hemagglutinins (cHA) composed of exotic avian head domains with a highly conserved stalk domain, to redirect the humoral response towards the HA stalk. In this study, we showed that cHA-LAIV vaccines induce robust serum and mucosal responses against group 1 stalk and confer antibody-dependent cell cytotoxicity activity. Mice that intranasally received cH8/1-ΔNS1 followed by a cH11/1-ΔNS1 heterologous booster had robust humoral responses for influenza A virus group 1 HAs and were protected from seasonal H1N1 influenza virus and heterologous highly pathogenic avian H5N1 lethal challenges. When compared with mice immunized with the standard of care or cold-adapted cHA-LAIV, cHA-ΔNS1 immunized mice had robust antigen-specific CD8+ T-cell responses which also correlated with markedly reduced lung pathology post-challenge. These observations support the development of a trivalent universal influenza vaccine for the protection against group 1 and group 2 influenza A viruses and influenza B viruses.

流感病毒对公共健康构成威胁,人类每年的严重发病率和死亡率就证明了这一点。由于抗原漂移导致病毒糖蛋白不断变化,季节性流感疫苗需要定期更新,而由于疫苗与流行毒株不匹配,疫苗的有效性往往会下降。此外,季节性流感疫苗对具有大流行潜力的抗原变异流感病毒没有保护作用。在此,我们开发了一种基于减毒流感活疫苗(LAIVs)的高免疫原性疫苗接种方案,该方案由缺乏非结构蛋白1(ΔNS1)(流感病毒的主要宿主干扰素拮抗剂)的减毒病毒骨架和由外来禽类头部结构域与高度保守的柄结构域组成的嵌合血凝素(cHA)组成,以将体液反应重新定向到HA柄。在这项研究中,我们发现 cHA-LAIV 疫苗能诱导针对第 1 群病毒柄的强大血清和粘膜反应,并赋予抗体依赖性细胞毒性活性。小鼠经鼻内注射 cH8/1-ΔNS1 后,再注射 cH11/1-ΔNS1 异源加强剂,对甲型流感病毒 1 组 HAs 可产生强大的体液应答,并在季节性 H1N1 流感病毒和异源高致病性禽 H5N1 致命挑战中受到保护。与使用标准疗法或冷适配 cHA-LAIV 免疫的小鼠相比,cHA-ΔNS1 免疫小鼠具有强大的抗原特异性 CD8+ T 细胞反应,这也与挑战后肺部病理变化明显减少有关。这些观察结果支持了三价通用流感疫苗的开发,以预防第一和第二类甲型流感病毒和乙型流感病毒。
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引用次数: 0
Understanding the rationales and information environments for early, late, and nonadopters of the COVID-19 vaccine 了解 COVID-19 疫苗早期、后期和未采用者的理由和信息环境
IF 9.2 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-14 DOI: 10.1038/s41541-024-00962-5
Lisa Singh, Le Bao, Leticia Bode, Ceren Budak, Josh Pasek, Trivellore Raghunathan, Michael Traugott, Yanchen Wang, Nathan Wycoff

Anti-vaccine sentiment during the COVID-19 pandemic grew at an alarming rate, leaving much to understand about the relationship between people’s vaccination status and the information they were exposed to. This study investigated the relationship between vaccine behavior, decision rationales, and information exposure on social media over time. Using a cohort study that consisted of a nationally representative survey of American adults, three subpopulations (early adopters, late adopters, and nonadopters) were analyzed through a combination of statistical analysis, network analysis, and semi-supervised topic modeling. The main reasons Americans reported choosing to get vaccinated were safety and health. However, work requirements and travel were more important for late adopters than early adopters (95% CI on OR of [0.121, 0.453]). While late adopters’ and nonadopters’ primary reason for not getting vaccinated was it being too early, late adopters also mentioned safety issues more often and nonadopters mentioned government distrust (95% CI on OR of [0.125, 0.763]). Among those who shared Twitter/X accounts, early adopters and nonadopters followed a larger fraction of highly partisan political accounts compared to late adopters, and late adopters were exposed to more neutral and pro-vaccine messaging than nonadopters. Together, these findings suggest that the decision-making process and the information environments of these subpopulations have notable differences, and any online vaccination campaigns need to consider these differences when attempting to provide accurate vaccine information to all three subpopulations.

在 COVID-19 大流行期间,反疫苗情绪以惊人的速度增长,人们的疫苗接种状况与他们所接触到的信息之间的关系还有待进一步了解。本研究调查了疫苗接种行为、决策依据和在社交媒体上接触信息的时间之间的关系。该研究采用了一项具有全国代表性的美国成年人调查,通过统计分析、网络分析和半监督主题建模相结合的方法,对三个亚群(早期接种者、晚期接种者和非接种者)进行了分析。据报告,美国人选择接种疫苗的主要原因是安全和健康。然而,与早期采用者相比,工作要求和旅行对晚期采用者更为重要(OR 的 95% CI 为 [0.121, 0.453])。虽然晚接种者和未接种者不接种疫苗的主要原因是接种时间太早,但晚接种者也更常提到安全问题,而未接种者则提到对政府的不信任(OR 的 95% CI 为 [0.125, 0.763])。在分享 Twitter/X 账户的人群中,早期接种者和未接种者比晚期接种者关注了更多党派色彩浓厚的政治账户,而晚期接种者比未接种者接触了更多中立和支持疫苗的信息。这些发现共同表明,这些亚人群的决策过程和信息环境存在明显差异,任何在线疫苗接种活动在试图向所有三个亚人群提供准确的疫苗信息时都需要考虑这些差异。
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引用次数: 0
COVID-19 vaccine refusal is driven by deliberate ignorance and cognitive distortions 拒绝接种 COVID-19 疫苗的原因是故意的无知和认知扭曲
IF 9.2 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-14 DOI: 10.1038/s41541-024-00951-8
Kamil Fuławka, Ralph Hertwig, Thorsten Pachur

Vaccine hesitancy was a major challenge during the COVID-19 pandemic. A common but sometimes ineffective intervention to reduce vaccine hesitancy involves providing information on vaccine effectiveness, side effects, and related probabilities. Could biased processing of this information contribute to vaccine refusal? We examined the information inspection of 1200 U.S. participants with anti-vaccination, neutral, or pro-vaccination attitudes before they stated their willingness to accept eight different COVID-19 vaccines. All participants—particularly those who were anti-vaccination—frequently ignored some of the information. This deliberate ignorance, especially toward probabilities of extreme side effects, was a stronger predictor of vaccine refusal than typically investigated demographic variables. Computational modeling suggested that vaccine refusals among anti-vaccination participants were driven by ignoring even inspected information. In the neutral and pro-vaccination groups, vaccine refusal was driven by distorted processing of side effects and their probabilities. Our findings highlight the necessity for interventions tailored to individual information-processing tendencies.

在 COVID-19 大流行期间,疫苗犹豫不决是一项重大挑战。减少疫苗犹豫的一种常见但有时无效的干预措施是提供有关疫苗有效性、副作用和相关概率的信息。对这些信息的偏差处理是否会导致拒绝接种疫苗?我们对 1200 名持反对疫苗接种、中立或支持疫苗接种态度的美国参与者在表示愿意接种八种不同的 COVID-19 疫苗之前的信息检索进行了研究。所有参与者--尤其是那些反疫苗接种者--经常忽略一些信息。这种故意的无知,尤其是对极端副作用概率的无知,比通常调查的人口统计学变量更能预测拒绝接受疫苗的情况。计算模型表明,反疫苗接种者拒绝接种疫苗的原因是忽略了甚至是被忽略的信息。在中立和支持疫苗接种的群体中,拒绝接种疫苗的原因是对副作用及其概率的扭曲处理。我们的研究结果凸显了针对个人信息处理倾向进行干预的必要性。
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引用次数: 0
Risk benefit analysis to evaluate risk of thromboembolic events after mRNA COVID-19 vaccination and COVID-19 评估接种 mRNA COVID-19 疫苗和 COVID-19 后血栓栓塞事件风险的风险效益分析
IF 9.2 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-13 DOI: 10.1038/s41541-024-00960-7
Huong N. Q. Tran, Malcolm Risk, Girish B. Nair, Lili Zhao

We compared the risks and benefits of COVID-19 vaccines using a causal pathway analysis to weigh up possible risk factors of thromboembolic events post-vaccination. The self-controlled case series (SCCS) method examined the association between thromboembolic events and vaccination while a case-control study assessed the association between thromboembolic events and COVID-19, addressing under-reported infection data issues. The net vaccine effect was estimated using results from SCCS and case-control studies. We used electronic health record data from Corewell Health (16,640 subjects in SCCS and 106,143 in case-control). We found increased risks of thromboembolic events post-vaccination (incidence rate ratio: 1.19, 95% CI: [1.08, 1.31] after the first dose; 1.22, 95% CI: [1.11, 1.34] after the second dose). Vaccination attenuated infection-associated thromboembolic risks (odds ratio: 4.65, 95% CI: [4.18, 5.17] in unvaccinated vs 2.77, 95% CI: [2.40, 3.24] in vaccinated). After accounting for vaccine efficacy and protection against infection-associated thromboembolic events, vaccination decreases thromboembolic event risk, especially during high infection rate periods.

我们采用因果途径分析法比较了 COVID-19 疫苗的风险和益处,以权衡接种后血栓栓塞事件的可能风险因素。自控病例系列(SCCS)方法研究了血栓栓塞事件与疫苗接种之间的关联,而病例对照研究则评估了血栓栓塞事件与 COVID-19 之间的关联,解决了感染数据报告不足的问题。我们利用 SCCS 和病例对照研究的结果估算了疫苗的净效应。我们使用了 Corewell Health 的电子健康记录数据(16,640 名受试者参与了 SCCS 研究,106,143 名受试者参与了病例对照研究)。我们发现接种疫苗后发生血栓栓塞事件的风险增加(发病率比:第一剂后为 1.19,95% CI:[1.08, 1.31];第二剂后为 1.22,95% CI:[1.11, 1.34])。接种疫苗可降低与感染相关的血栓栓塞风险(几率比:未接种者为 4.65,95% CI:[4.18,5.17];接种者为 2.77,95% CI:[2.40,3.24])。考虑到疫苗功效和对感染相关血栓栓塞事件的保护作用,接种疫苗可降低血栓栓塞事件风险,尤其是在高感染率时期。
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引用次数: 0
WHO International Standards for antibodies to HPV6 HPV11 HPV31 HPV33 HPV45 HPV52 and HPV58 世界卫生组织 HPV6 HPV11 HPV31 HPV33 HPV45 HPV52 和 HPV58 抗体国际标准
IF 9.2 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-10 DOI: 10.1038/s41541-024-00949-2
Troy J. Kemp, Gitika Panicker, Carina Eklund, Jianhui Nie, Youchun Wang, Simon Beddows, Peter Rigsby, Weijin Huang, Joakim Dillner, Elizabeth R. Unger, Ligia A. Pinto, Dianna E. Wilkinson

Previously established World Health Organization (WHO) International Standards (IS) for anti-HPV16 and HPV18 antibodies are used to harmonize results across human papillomavirus (HPV) serology assays. Here, we present an international collaborative study to establish ISs for antibodies against HPV6 (NIBSC code 19/298), HPV11 (20/174), HPV31 (20/176), HPV33 (19/290), HPV45 (20/178), HPV52 (19/296) and HPV58 (19/300). The candidate standards were prepared using sera from naturally infected individuals. Each candidate was shown to be monospecific for reactivity against its indicated HPV type except for the HPV11 candidate, which was also reactive against other types. Expression of antibody levels relative to the relevant candidate IS reduced inter-laboratory variation allowing greater comparability between laboratories. Based on these results, the WHO Expert Committee on Biological Standardization established each of the 7 candidates as the 1st IS for antiserum to its indicated HPV type for use in the standardization of HPV pseudovirion-based neutralization and antibody-binding assays.

世界卫生组织(WHO)之前制定的抗HPV16和HPV18抗体国际标准(IS)用于统一人类乳头瘤病毒(HPV)血清学检测的结果。在此,我们介绍了一项国际合作研究,旨在建立抗 HPV6(NIBSC 代码 19/298)、HPV11(20/174)、HPV31(20/176)、HPV33(19/290)、HPV45(20/178)、HPV52(19/296)和 HPV58(19/300)抗体的国际标准。候选标准品是用自然感染者的血清制备的。除了 HPV11 候选标准品对其他类型的 HPV 也有反应外,每个候选标准品对其指定的 HPV 类型都有单特异性反应。相对于相关候选 IS 的抗体水平的表达减少了实验室之间的差异,从而提高了实验室之间的可比性。根据这些结果,世卫组织生物标准化专家委员会将这 7 种候选抗血清中的每一种都确定为其所针对的 HPV 类型的第一 IS,用于基于假病毒的 HPV 中和与抗体结合测定的标准化。
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引用次数: 0
Computationally designed Spike antigens induce neutralising responses against the breadth of SARS-COV-2 variants 计算设计的穗状抗原可诱导针对多种 SARS-COV-2 变体的中和反应
IF 9.2 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-09 DOI: 10.1038/s41541-024-00950-9
Sneha Vishwanath, George William Carnell, Martina Billmeier, Luis Ohlendorf, Patrick Neckermann, Benedikt Asbach, Charlotte George, Maria Suau Sans, Andrew Chan, Joey Olivier, Angalee Nadesalingam, Sebastian Einhauser, Nigel Temperton, Diego Cantoni, Joe Grove, Ingo Jordan, Volker Sandig, Paul Tonks, Johannes Geiger, Christian Dohmen, Verena Mummert, Anne Rosalind Samuel, Christian Plank, Rebecca Kinsley, Ralf Wagner, Jonathan Luke Heeney

Updates of SARS-CoV-2 vaccines are required to generate immunity in the population against constantly evolving SARS-CoV-2 variants of concerns (VOCs). Here we describe three novel in-silico designed spike-based antigens capable of inducing neutralising antibodies across a spectrum of SARS-CoV-2 VOCs. Three sets of antigens utilising pre-Delta (T2_32), and post-Gamma sequence data (T2_35 and T2_36) were designed. T2_32 elicited superior neutralising responses against VOCs compared to the Wuhan-1 spike antigen in DNA prime-boost immunisation regime in guinea pigs. Heterologous boosting with the attenuated poxvirus - Modified vaccinia Ankara expressing T2_32 induced broader neutralising immune responses in all primed animals. T2_32, T2_35 and T2_36 elicited broader neutralising capacity compared to the Omicron BA.1 spike antigen administered by mRNA immunisation in mice. These findings demonstrate the utility of structure-informed computationally derived modifications of spike-based antigens for inducing broad immune responses covering more than 2 years of evolved SARS-CoV-2 variants.

需要对 SARS-CoV-2 疫苗进行更新,以便在人群中产生针对不断演变的 SARS-CoV-2 变异株 (VOC) 的免疫力。在这里,我们描述了三种基于芯片设计的新型尖峰抗原,它们能够诱导一系列 SARS-CoV-2 VOCs 的中和抗体。我们设计了三组抗原,分别利用了前Delta(T2_32)和后Gamma序列数据(T2_35和T2_36)。在对豚鼠进行 DNA 原代强化免疫时,T2_32 对 VOC 的中和反应优于武汉-1 穗状抗原。用表达 T2_32 的减毒痘病毒--改良安卡拉疫苗--进行异源增强,可在所有接种动物中诱导出更广泛的中和免疫反应。与通过 mRNA 免疫接种小鼠的 Omicron BA.1 穗状抗原相比,T2_32、T2_35 和 T2_36 能够激发更广泛的中和能力。这些研究结果表明,基于计算得出的结构信息对尖峰抗原的修饰可诱导广泛的免疫反应,涵盖超过两年的 SARS-CoV-2 变异体。
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引用次数: 0
Applying causal inference and Bayesian statistics to understanding vaccine safety signals using a simulation study. 通过模拟研究应用因果推理和贝叶斯统计来理解疫苗安全信号。
IF 6.9 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-07 DOI: 10.1038/s41541-024-00955-4
Evelyn Tay, Michael Dymock, Laura Lopez, Catherine Glover, Yuanfei Anny Huang, K Shuvo Bakar, Thomas Snelling, Julie A Marsh, Yue Wu

Community perception of vaccine safety influences vaccine uptake. Our objective was to assess current vaccine safety monitoring by examining factors that may influence the availability of post-vaccination survey data, and thereby the specificity and sensitivity of existing signal detection methods. We used causal directed acyclic graphs (DAGs) and a Bayesian posterior predictive analysis (PPA) signal detection method to understand biological and behavioural factors which may influence signal detection. The DAGs informed the data simulated for scenarios in which these factors were varied. The influence of biological factors such as severity of adverse reactions and behavioural factors such as healthcare-seeking behaviour upon survey participation was found to drive signal detection. Where there was a low prevalence of moderate to severe reactions, false signals were detected when there was a strong influence of reaction severity on both survey participation and seeking medical attention. These findings provide implications for future vaccine safety monitoring.

社区对疫苗安全性的看法会影响疫苗的接种率。我们的目标是通过研究可能影响疫苗接种后调查数据可用性的因素,进而影响现有信号检测方法的特异性和灵敏度,来评估当前的疫苗安全性监测工作。我们使用因果有向无环图(DAG)和贝叶斯后验预测分析(PPA)信号检测方法来了解可能影响信号检测的生物和行为因素。DAG 为模拟这些因素变化的情景提供了数据信息。结果发现,不良反应严重程度等生物因素和医疗保健寻求行为等行为因素对参与调查的影响推动了信号检测。在中度至重度不良反应发生率较低的情况下,当不良反应严重程度对参与调查和就医都有很大影响时,就会检测到错误信号。这些发现为未来的疫苗安全监测提供了启示。
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引用次数: 0
Progress on the research and development of plague vaccines with a call to action. 鼠疫疫苗研发进展情况及行动呼吁。
IF 6.9 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-09-07 DOI: 10.1038/s41541-024-00958-1
E Diane Williamson, Paul B Kilgore, Emily K Hendrix, Blake H Neil, Jian Sha, Ashok K Chopra

There is a compelling demand for approved plague vaccines due to the endemicity of Yersinia pestis and its potential for pandemic spread. Whilst substantial progress has been made, we recommend that the global funding and health security systems should work urgently to translate some of the efficacious vaccines reviewed herein to expedite clinical development and to prevent future disastrous plague outbreaks, particularly caused by antimicrobial resistant Y. pestis strains.Content includes material subject to Crown Copyright © 2024.This is an open access article under the Open Government License ( http://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/ ).

由于鼠疫耶尔森氏菌的地方流行性及其大流行传播的潜力,我们迫切希望获得批准的鼠疫疫苗。虽然已经取得了实质性进展,但我们建议全球资金和健康安全系统应紧急行动起来,将本文中评述的一些有效疫苗转化为临床开发成果,以防止未来灾难性的鼠疫爆发,尤其是由具有抗药性的鼠疫耶尔森菌株引起的鼠疫爆发。内容包括受版权保护的材料© 2024。本文是根据开放政府许可( http://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/ ) 发布的开放存取文章。
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引用次数: 0
期刊
NPJ Vaccines
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