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Mumps virus neurovirulence assessment-impact of viral doses, animal sex and age on results dispersion 腮腺炎病毒神经病毒性评估--病毒剂量、动物性别和年龄对结果散布的影响。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-09 DOI: 10.1016/j.vaccine.2024.126487
Maja Lang Balija, Maja Jagušić, Dubravko Forčić, Jelena Ivančić-Jelečki, Tanja Košutić Gulija
Mumps epidemics highlight the necessity for new live mumps vaccines. For vaccine candidate neurosafety assessment, the most commonly used test is the rat-based neurovirulence test (RNVT). Its main experimental and ethical deficiency is the results dispersion which requires large number of animals to obtain statistically relevant results.
To additionally characterize the RNVT the impact of two experimental animal characteristics, age for inoculation and sex, as well as range of infectious viral doses were analysed. Results obtained from two neurovirulent mumps viruses, SHdeopti-MRV2 and 9218/Zg98, demonstrated no corelation between animal sex and RNVT results (p = 0.9638 and p = 0.3337). Analysis of animal inoculation age found that hydrocephalus formation is impaired in neonatal rats older than 3 days. The inoculation period could be extended from first to the second postanatal day without the impact on RNVT results (p = 0.5865).
RNVT results demonstrated robustness to infectious doses in a range from 100 to 1000 PFU, but using the non-standard infectious doses,10 PFU or 100 CCID50, poses a risk of underestimating the neurovirulence potential of the MuV. However, none of the analysed parameters influenced the high dispersion of results.
In conclusion, although our finding will facilitate the implementation of the RNVT, the dispersion of the results indicates the need for a better mumps neurovirulence test that would align more closely with the 3R principles.
流行性腮腺炎疫情凸显了新型流行性腮腺炎活疫苗的必要性。在候选疫苗的神经安全性评估中,最常用的试验是大鼠神经毒力试验(RNVT)。它在实验和伦理方面的主要缺陷是结果分散,需要大量动物才能获得统计相关的结果。为了进一步说明 RNVT 的特点,我们分析了两种实验动物特征(接种年龄和性别)以及传染性病毒剂量范围的影响。两种神经病毒性腮腺炎病毒(SHdeopti-MRV2 和 9218/Zg98)的结果表明,动物性别与 RNVT 结果之间没有核心关系(p = 0.9638 和 p = 0.3337)。对动物接种年龄的分析发现,3 天以上的新生大鼠脑积水的形成会受到影响。接种期可以从出生后第一天延长到第二天,但不会影响 RNVT 结果(p = 0.5865)。RNVT 结果表明,感染剂量在 100 到 1000 PFU 的范围内都是稳健的,但使用非标准感染剂量(10 PFU 或 100 CCID50)有可能低估 MuV 的神经感染潜力。然而,没有一个分析参数会影响结果的高度分散性。总之,尽管我们的发现将有助于 RNVT 的实施,但结果的分散性表明需要一种更好的流行性腮腺炎神经毒力检测方法,使其更符合 3R 原则。
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引用次数: 0
Relative effectiveness of homologous NVX-CoV2373 and BNT162b2 COVID-19 vaccinations in South Korea 韩国同源 NVX-CoV2373 和 BNT162b2 COVID-19 疫苗接种的相对效果。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-09 DOI: 10.1016/j.vaccine.2024.126503
Eunseon Gwak , Seung-Ah Choe , Erdenetuya Bolormaa , Young June Choe , Chengbin Wang , Jonathan Fix , Muruga Vadivale , Matthew D. Rousculp
To estimate the relative effectiveness of NVX-CoV2373 versus BNT162b2 (Pfizer–BioNTech) in preventing SARS-CoV-2 infection and severe COVID-19 disease during the Omicron variant dominance in South Korea, we conducted a retrospective cohort-study among ≥12-year-olds using the K-COV-N database, which links COVID-19 vaccine registry data with health insurance claims data. The Cox proportional-hazards model and inverse probability of treatment weighting were employed to calculate adjusted hazard ratios (aHRs). Among homologous primary-series NVX-CoV2373 versus BNT162b2 recipients at Day 180 post-vaccination, the aHR was 0.90 (95% CI: 0.87–0.93) for all laboratory-confirmed and 0.65 (95% CI: 0.48–0.88) for severe infections. Among homologous 1st-booster recipients, it was 1.15 (95% CI: 1.01–1.30) for all laboratory-confirmed and 0.39 (95% CI: 0.20–0.75) for severe infections. At 180-days post-immunization, we observed homologous, NVX-CoV2373 primary-series added and 1st booster offered comparable protection against SARS-CoV-2 infection versus BNT162b2.
为了估算 NVX-CoV2373 与 BNT162b2(辉瑞生物技术公司)在韩国 Omicron 变异优势期预防 SARS-CoV-2 感染和严重 COVID-19 疾病的相对有效性,我们利用 K-COV-N 数据库对年龄≥12 岁的儿童进行了回顾性队列研究,该数据库将 COVID-19 疫苗登记数据与医疗保险索赔数据联系在一起。研究采用了 Cox 比例危险模型和逆概率治疗加权法来计算调整后的危险比(aHRs)。在接种后第 180 天,同源初免系列 NVX-CoV2373 与 BNT162b2 接种者中,所有实验室确诊感染的 aHR 为 0.90(95% CI:0.87-0.93),严重感染的 aHR 为 0.65(95% CI:0.48-0.88)。在同源第 1 次加强免疫者中,所有实验室确诊的感染率为 1.15(95% CI:1.01-1.30),严重感染率为 0.39(95% CI:0.20-0.75)。在免疫后 180 天,我们观察到同源、添加 NVX-CoV2373 主系列和第一加强剂与 BNT162b2 相比,对 SARS-CoV-2 感染的保护效果相当。
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引用次数: 0
Vaccination strategies to protect chickens from fowl adenovirus (FAdV)-induced diseases: A comprehensive review 保护鸡免受鸡腺病毒 (FAdV) 引起的疾病影响的疫苗接种策略:全面综述。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-09 DOI: 10.1016/j.vaccine.2024.126496
Carlotta De Luca, Michael Hess
In recent years, fowl adenovirus (FAdV)-induced diseases became a global problem with considerable impact on chicken health and welfare. This has prompted numerous studies to focus on experimental immunization strategies using whole virus formulations (live or killed vaccines), some of them modified as recombinantly constructed vector vaccines. In addition, FAdV capsid proteins were frequently reported as immunizing antigens (subunit vaccines), with fiber proteins being amongst the most successful candidates. To date, there is no standardized protocol to assess vaccine efficacy in experimental FAdV protection studies, with the consequence that the experimental settings present several degrees of variations even when sharing similar premises. Differences in formulation preparations, route of inoculation, antigen dose, vaccination scheme, choice of challenge strain, or type and age of the birds are capable to greatly influence the magnitude of the immune response and the consequent protective efficacy, altogether addressing remaining challenges. Beyond the antigen composition of a vaccine, the epidemiology of FAdVs with the potential of vertical transmission of virus and/or antibodies from breeders to progenies has a substantial impact on protection strategies. The goal of this review is to outline a broad overview of the findings made thus far regarding immunization strategies against diseases associated to FAdV infections, considering the literature published since the appearance of hepatitis-hydropericardium syndrome (HHS) in the late Eighties, in order to emphasize the current knowledge on FAdV vaccines and highlight fields of future research and intervention.
近年来,鸡腺病毒(FAdV)引起的疾病已成为一个全球性问题,对鸡的健康和福利造成了相当大的影响。这促使许多研究开始关注使用全病毒制剂(活疫苗或杀毒疫苗)的试验性免疫策略,其中一些是经过改良的重组载体疫苗。此外,FAdV 的囊膜蛋白经常被报道为免疫抗原(亚单位疫苗),其中纤维蛋白是最成功的候选抗原之一。迄今为止,在 FAdV 保护实验研究中还没有评估疫苗疗效的标准化方案,因此,即使在相似的前提下,实验设置也会出现不同程度的差异。制剂配制、接种途径、抗原剂量、接种方案、挑战株的选择或禽类的类型和年龄等方面的差异都会极大地影响免疫反应的程度和由此产生的保护效力,从而彻底解决剩余的难题。除了疫苗的抗原成分外,FAdV 的流行病学以及病毒和/或抗体从种鸡向后代垂直传播的可能性对保护策略也有重大影响。本综述旨在概述自八十年代末出现肝炎-心包积水综合征(HHS)以来,有关针对 FAdV 感染相关疾病的免疫策略的研究成果,以强调当前有关 FAdV 疫苗的知识,并突出未来研究和干预的领域。
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引用次数: 0
Concurrent use of the foot-and-mouth disease and other vaccines in livestock 在牲畜中同时使用口蹄疫疫苗和其他疫苗。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-09 DOI: 10.1016/j.vaccine.2024.126504
Pelin Tuncer Göktuna , Can Çokçalışkan
Foot-and-mouth disease (FMD), a viral infection affecting cloven-hoofed animals, persists as an endemic challenge worldwide, causing significant economic losses. Vaccination is a pivotal strategy for disease control, especially in endemic regions where it may be the sole option. In FMD-free countries, “vaccination to cull” strategies are increasingly considered to prevent disease spread. Concurrently, the coexistence of FMD with other animal diseases in endemic regions raises the prospect of simultaneous or combined administration of multiple vaccines for cost, labor, and animal welfare benefits. We conducted a narrative review to investigate the positive or negative effects of concurrent FMD vaccination with other viral and bacterial vaccines. For this purpose, the literature is organized chronologically. Duplicate sources were eliminated, and older sources without sufficient data were excluded. Studies only those targeting the specific species were included. This comprehensive review synthesizes findings from over 50 years of research, offering insights applicable in the ongoing fight against endemic diseases and inspiring innovative approaches.
口蹄疫(FMD)是一种影响蹄类动物的病毒性传染病,一直是世界范围内的地方性难题,造成了巨大的经济损失。疫苗接种是疾病控制的关键策略,特别是在流行地区,疫苗接种可能是唯一的选择。在没有口蹄疫的国家,人们越来越多地考虑采用 "接种疫苗后扑杀 "的策略来防止疾病传播。同时,在口蹄疫流行地区,口蹄疫与其他动物疾病同时存在,这为同时或联合接种多种疫苗带来了成本、劳动力和动物福利方面的好处。我们对口蹄疫疫苗与其他病毒和细菌疫苗同时接种的积极或消极影响进行了综述。为此,我们按时间顺序对文献进行了整理。剔除了重复的资料来源,也排除了没有足够数据的旧资料来源。仅纳入了针对特定物种的研究。这篇全面的综述综合了 50 多年来的研究成果,提供了适用于当前防治地方病的见解,并启发了创新方法。
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引用次数: 0
The association between service experience in vaccination centers and expectation confirmation as a driver of future vaccination intentions: Results from a survey among users of a Swiss mass COVID-19 vaccination center 疫苗接种中心的服务体验与作为未来疫苗接种意愿驱动因素的期望确认之间的关联:对瑞士大规模 COVID-19 疫苗接种中心用户的调查结果。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-08 DOI: 10.1016/j.vaccine.2024.126509
Franziska Mattes , Julia Dratva , Sarah Schmelzer , Aylin Wagner , Florian Liberatore

Background

During the COVID-19 pandemic, vaccination centers were established to achieve widespread immunization of the public within a short time. This may, however, have come at the cost of customer experience. This study analyzes factors related to the special characteristics of service experiences in COVID-19 vaccination centers and their impact on expectation confirmation as a driver of future vaccination intentions.

Methods

Our analysis is based on data from an online survey among clients of a vaccination center in Switzerland receiving a second dose of COVID-19 vaccines between May and September 2021 (n = 3192). Using a structural equation model, we analyzed the impact of perceived competence, informed consent, safety beliefs, privacy perceptions, and warmth on service experience and expectation confirmation.

Results

Perceived competence (path coefficient [p.c.] 0.199 95 % confidence interval [CI] 1.123–0.288), safety beliefs (p.c. 0.124, 95 % CI 0.070–0.178), privacy perceptions (p.c. 0.226, 95 % CI 0.162–0.299), and warmth (p.c. 0.286, 95 % CI 0.180–0.381) have a direct positive effect on service experience, which in turn has a positive effect on expectation confirmation (p.c. 0.313, 95 % CI 0.246–0.380). The quality of the informed consent discussion (p.c. 0.071, 95 % CI −0.001–0.145) between vaccinating health professional and customer had no effect on service experience. The effect size (f2) of warmth (f2 0.089, 95 % CI 0.180–0.381), and privacy perceptions (f2 0.060, 95 % CI 0.162–0.299) on service experience was higher than that for perceived competence (f2 0.041, 95 % CI 0.123–0.288) and safety beliefs (f2 0.020, 95 % CI 0.0.07–0.178).

Conclusions

The service experience in vaccination centers is related to expectation confirmation, which can enhance the likelihood of future revaccination. When planning vaccination center operations, attention should be paid to providing a comfortable and service-friendly environment for clients.
背景:在 COVID-19 大流行期间,建立了疫苗接种中心,以便在短时间内为公众广泛接种疫苗。然而,这可能是以客户体验为代价的。本研究分析了与 COVID-19 疫苗接种中心服务体验的特殊性有关的因素及其对作为未来疫苗接种意愿驱动因素的期望确认的影响:我们的分析基于一项在线调查数据,调查对象是 2021 年 5 月至 9 月期间在瑞士一家接种中心接种第二剂 COVID-19 疫苗的客户(n = 3192)。通过结构方程模型,我们分析了感知能力、知情同意、安全信念、隐私感和温馨度对服务体验和期望确认的影响:结果:感知能力(路径系数 [p.c.] 0.199 95 % 置信区间 [CI] 1.123-0.288)、安全信念(p.c. 0.124, 95 % CI 0.070-0.178)、隐私感知(p.c. 0.226, 95 % CI 0.162-0.299)和温暖感知(p.c. 0.226, 95 % CI 0.162-0.299)对服务体验和期望确认的影响。299)和温暖感(p.c. 0.286,95 % CI 0.180-0.381)对服务体验有直接的积极影响,而服务体验又对期望确认(p.c. 0.313,95 % CI 0.246-0.380)有积极影响。接种保健专业人员与顾客之间的知情同意讨论质量(p.c. 0.071,95 % CI -0.001-0.145)对服务体验没有影响。温暖感(f2 0.089,95 % CI 0.180-0.381)和隐私感(f2 0.060,95 % CI 0.162-0.299)对服务体验的影响大小(f2)高于能力感(f2 0.041,95 % CI 0.123-0.288)和安全信念(f2 0.020,95 % CI 0.0.07-0.178):结论:疫苗接种中心的服务体验与期望确认有关,而期望确认可提高未来再次接种的可能性。在规划疫苗接种中心的运营时,应注意为客户提供舒适的服务环境。
{"title":"The association between service experience in vaccination centers and expectation confirmation as a driver of future vaccination intentions: Results from a survey among users of a Swiss mass COVID-19 vaccination center","authors":"Franziska Mattes ,&nbsp;Julia Dratva ,&nbsp;Sarah Schmelzer ,&nbsp;Aylin Wagner ,&nbsp;Florian Liberatore","doi":"10.1016/j.vaccine.2024.126509","DOIUrl":"10.1016/j.vaccine.2024.126509","url":null,"abstract":"<div><h3>Background</h3><div>During the COVID-19 pandemic, vaccination centers were established to achieve widespread immunization of the public within a short time. This may, however, have come at the cost of customer experience. This study analyzes factors related to the special characteristics of service experiences in COVID-19 vaccination centers and their impact on expectation confirmation as a driver of future vaccination intentions.</div></div><div><h3>Methods</h3><div>Our analysis is based on data from an online survey among clients of a vaccination center in Switzerland receiving a second dose of COVID-19 vaccines between May and September 2021 (<em>n</em> = 3192). Using a structural equation model, we analyzed the impact of perceived competence, informed consent, safety beliefs, privacy perceptions, and warmth on service experience and expectation confirmation.</div></div><div><h3>Results</h3><div>Perceived competence (path coefficient [p.c.] 0.199 95 % confidence interval [CI] 1.123–0.288), safety beliefs (p.c. 0.124, 95 % CI 0.070–0.178), privacy perceptions (p.c. 0.226, 95 % CI 0.162–0.299), and warmth (p.c. 0.286, 95 % CI 0.180–0.381) have a direct positive effect on service experience, which in turn has a positive effect on expectation confirmation (p.c. 0.313, 95 % CI 0.246–0.380). The quality of the informed consent discussion (p.c. 0.071, 95 % CI −0.001–0.145) between vaccinating health professional and customer had no effect on service experience. The effect size (f2) of warmth (f2 0.089, 95 % CI 0.180–0.381), and privacy perceptions (f2 0.060, 95 % CI 0.162–0.299) on service experience was higher than that for perceived competence (f2 0.041, 95 % CI 0.123–0.288) and safety beliefs (f2 0.020, 95 % CI 0.0.07–0.178).</div></div><div><h3>Conclusions</h3><div>The service experience in vaccination centers is related to expectation confirmation, which can enhance the likelihood of future revaccination. When planning vaccination center operations, attention should be paid to providing a comfortable and service-friendly environment for clients.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126509"},"PeriodicalIF":4.5,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142635270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pertussis vaccination coverage in women at two months postpartum and associated factors in France, National Perinatal Survey 2021 法国产后两个月妇女百日咳疫苗接种率及相关因素,2021 年全国围产期调查。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-08 DOI: 10.1016/j.vaccine.2024.126502
Lisa Dilange , Fatima Ait El Belghiti , Virginie Demiguel , Olivia Anselem , Nolwenn Regnault , Camille Le Ray , Isabelle Parent Du-Châtelet , Sophie Vaux , ENP-2021 Study Group and ENP-DROM 2021 Study Group

Background

Pertussis vaccination in young mothers aims to protect neonates through cocooning. We estimated pertussis vaccination coverage (VC) in women at two months postpartum in France in 2021, and the proportion of women who got vaccinated in the first two months postpartum; associated determinants were studied.

Methods

We used data from the 2021 National Perinatal Surveys conducted in metropolitan France (ENP 2021) and French overseas territories (ENP-DROM 2021). Multivariate poisson regressions were employed to study the following determinants: age, educational level, monthly household income, socio-professional situation, birth country, parity, health professional who monitored pregnancy, influenza vaccination during pregnancy, region of residence, prenatal care consultations, having health insurance, having a partner, and having a chronic pathology. Results were weighted.

Results

The study sample comprised 7999 women. Estimated pertussis VC at two months postpartum was 66.8 % (95 %CI [65.5–68.0]).
VC was significantly lower in i) unemployed women (vs. executives/managers, intermediate and higher intellectual professionals), ii) those on low income (vs. high), and iii) those with two or more children (vs. primiparous). It was significantly higher in i) women born in France, ii) those vaccinated against influenza during pregnancy, iii) those who received pre-natal care from a private midwife, and iv) those with more prenatal consultations.
The proportion of women vaccinated against pertussis in the two-month postpartum period (33.4 % [31.7–35.9]) was significantly lower in i) women on low incomes, ii) unemployed women, iii) women with health insurance, and iv) multiparous women. It was significantly higher in those vaccinated against influenza during pregnancy.

Discussion - Conclusion

Pertussis VC in women at two months postpartum in 2021 was insufficient and was marked by social and territorial inequalities in health. Vaccination for pregnant women has been recommended in France since 2022. A study monitoring the impact of this new recommendation is essential.
背景:为年轻母亲接种百日咳疫苗旨在通过破茧保护新生儿。我们估算了2021年法国产后两个月妇女的百日咳疫苗接种覆盖率(VC),以及产后头两个月接种疫苗的妇女比例;并对相关决定因素进行了研究:我们使用了在法国本土(ENP 2021)和法国海外领地(ENP-DROM 2021)进行的 2021 年全国围产期调查的数据。采用多变量泊松回归研究了以下决定因素:年龄、教育水平、家庭月收入、社会职业状况、出生国家、奇偶数、监测妊娠的卫生专业人员、孕期流感疫苗接种、居住地区、产前护理咨询、有医疗保险、有伴侣和有慢性病。结果已加权:研究样本包括 7999 名妇女。产后两个月的百日咳 VC 估计值为 66.8%(95 %CI [65.5-68.0])。i) 失业妇女(与行政/经理、中级和高级知识专业人员相比)、ii) 低收入妇女(与高收入妇女相比)和 iii) 有两个或两个以上孩子的妇女(与初产妇相比)的 VC 明显较低。i) 在法国出生的妇女,ii) 在怀孕期间接种过流感疫苗的妇女,iii) 接受过私人助产士产前护理的妇女,iv) 接受过更多产前咨询的妇女,接种流感疫苗的比例明显更高。产后两个月内接种百日咳疫苗的妇女比例(33.4% [31.7-35.9])在以下人群中明显较低:i) 低收入妇女;ii) 失业妇女;iii) 有医疗保险的妇女;iv) 多胞胎妇女。在怀孕期间接种过流感疫苗的妇女中,这一比例明显更高:2021 年,产后两个月的妇女百日咳疫苗接种率不足,且存在社会和地区健康不平等现象。法国建议自 2022 年起为孕妇接种疫苗。对这一新建议的影响进行监测研究至关重要。
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引用次数: 0
Trained immunity-based vaccines: A vision from the one health initiative 训练有素的免疫疫苗:一个健康倡议的愿景。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-08 DOI: 10.1016/j.vaccine.2024.126505
Miriam Angulo , Carlos Angulo
Trained immunity-based vaccines (TIbV or TRIMbV) represent a novel approach to combating infectious diseases. The innate immune system in animals, including humans, exhibits “memory-like” functions. Remarkably, the immunological mechanisms —both epigenetic and metabolic—) underlying this memory enables immune cells to develop defensive and protective outcomes against unspecific pathogenic infections. Under this context, the One Health initiative promotes integrative efforts to combat zoonotic (and anthropozoonotic) diseases, which is critical because 3 of 4 animal infections are transmitted to humans. Therefore, TIbV constitutes a potential affordable approach to control zoonotic pathologies, especially under pandemic scenarios. This review describes the state-of-the-art TIbV and their hurdles, opportunities, and prospects for the One Health initiative to prevent, control, and treat infectious diseases.
基于训练免疫的疫苗(TIbV 或 TRIMbV)是抗击传染病的一种新方法。动物(包括人类)的先天免疫系统具有 "记忆 "功能。值得注意的是,这种记忆所依据的免疫机制(包括表观遗传学和新陈代谢)使免疫细胞能够对非特异性病原体感染产生防御和保护作用。在此背景下,"同一健康 "倡议提倡综合防治人畜共患病(和人畜共患病),这一点至关重要,因为 4 种动物感染中有 3 种会传染给人类。因此,TIbV 是控制人畜共患病的一种潜在且经济实惠的方法,尤其是在大流行的情况下。本综述介绍了最先进的 TIbV 及其在预防、控制和治疗传染病的 "同一健康 "计划中面临的障碍、机遇和前景。
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引用次数: 0
Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose 一项随机试验显示,五价脑膜炎球菌 MenABCWY 疫苗所激发的 hSBA 滴度在初次接种后可持续长达 4 年,并显示了加强剂量的安全性和免疫原性。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-08 DOI: 10.1016/j.vaccine.2024.126469
James Peterson , Daniel Drazan , Beth Moughan , Jason D. Maguire , Lefteris Zolotas , Roger Maansson , Robert O'Neill , Paula Peyrani , Luis Jodar , William C. Gruber , Annaliesa S. Anderson , Johannes Beeslaar

Background

Vaccination against 5 prominent meningococcal serogroups (A/B/C/W/Y) is necessary for broad disease protection. We report immunopersistence through 4 years after a 2-dose (6-month interval) pentavalent MenABCWY primary vaccine series and safety and immunogenicity of a booster administered 4 years after primary vaccination.

Methods

This randomized, active-controlled, observer-blinded study was conducted in the United States and Europe. In stage 1, healthy MenACWY vaccine-naive or -experienced 10- to 25-year-olds were randomized 1:2 to receive MenABCWY and placebo or MenB-fHbp and MenACWY-CRM. Eligible participants were randomly selected to participate in stage 2, which was an open-label immunopersistence and booster extension. Immunogenicity was assessed through serum bactericidal antibody using human complement (hSBA) assays with serogroups A/C/W/Y (MenA/C/W/Y) and 4 primary serogroup B (MenB) test strains. Immunogenicity endpoints included hSBA seroprotection rates through 48 months after primary vaccination and 1 month after the booster. Safety endpoints included booster reactogenicity events and adverse events (AEs).

Results

Of 1379 eligible participants, 353 entered stage 2; 242 completed the 48-month blood draw after primary vaccination and 240 completed the booster vaccination phase. MenA/C/W/Y seroprotection rates remained high for 4 years following a 2-dose MenABCWY primary series (MenACWY-naive, 62.0 %–100.0 %; MenACWY-experienced, 98.7 %–100.0 %) and trended higher than those after a single MenACWY-CRM dose (MenACWY-naive, 38.1 %–95.2 %; MenACWY-experienced, 89.7 %–100.0 %). Corresponding seroprotection rates against MenB remained stable and generally higher than baseline (MenABCWY, 18.2 %–36.6 %; MenB-fHbp, 16.2 %–31.9 % across strains). Following a booster, seroprotection rates against all 5 serogroups were ≥ 93.8 % across groups. Most booster dose reactogenicity events were mild or moderate in severity, and AEs were infrequent.

Conclusions

Immune responses remained high for MenA/C/W/Y and above baseline for MenB through 4 years after the MenABCWY primary series, with robust responses for all 5 serogroups observed following a booster. The MenABCWY booster had an acceptable safety and tolerability profile consistent with the primary series. NCT03135834.
背景:接种针对 5 个主要脑膜炎球菌血清群(A/B/C/W/Y)的疫苗是提供广泛疾病保护的必要条件。我们报告了接种 2 剂(间隔 6 个月)五价 MenABCWY 初次接种系列疫苗 4 年后的免疫持久性,以及初次接种 4 年后加强接种的安全性和免疫原性:这项随机、主动对照、观察者盲法研究在美国和欧洲进行。在第一阶段,10 至 25 岁未接种或接种过 MenACWY 疫苗的健康人按 1:2 的比例随机接受 MenABCWY 和安慰剂或 MenB-fHbp 和 MenACWY-CRM。符合条件的参与者被随机选中参加第二阶段,这是一个开放标签的免疫持续期和加强期。免疫原性通过血清A/C/W/Y(MenA/C/W/Y)血清群和4种主要B血清群(MenB)试验菌株的人补体(hSBA)血清杀菌抗体测定进行评估。免疫原性终点包括初次接种后 48 个月和加强接种后 1 个月的 hSBA 血清保护率。安全性终点包括强化免疫反应性事件和不良事件(AEs):在 1379 名符合条件的参与者中,353 人进入了第二阶段;242 人完成了初次接种后 48 个月的抽血,240 人完成了加强接种阶段。在接种两剂 MenABCWY 初次系列疫苗后的 4 年中,MenA/C/W/Y 血清保护率一直很高(MenACWY-未接种者,62.0%-100.0%;MenACWY-有接种经验者,98.7%-100.0%),并有高于接种单剂 MenACWY-CRM 后的血清保护率的趋势(MenACWY-未接种者,38.1%-95.2%;MenACWY-有接种经验者,89.7%-100.0%)。相应的 MenB 血清保护率保持稳定,普遍高于基线(MenABCWY,18.2%-36.6%;各菌株 MenB-fHbp,16.2%-31.9%)。加强剂量后,各组对所有 5 个血清群的血清保护率均≥ 93.8%。大多数加强剂量引起的反应性事件的严重程度为轻度或中度,AEs并不常见:结论:MenA/C/W/Y 的免疫反应仍然很高,MenB 的免疫反应在 MenABCWY 初级系列之后的 4 年中一直高于基线,所有 5 个血清群在加强剂量后都观察到了很强的反应。MenABCWY强化剂的安全性和耐受性与初治系列一致,可以接受。NCT03135834。
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引用次数: 0
Proteomic signatures of vaccine-induced and breakthrough infection-induced host responses to SARS-CoV-2 疫苗诱导和突破性感染诱导宿主对 SARS-CoV-2 反应的蛋白质组特征。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-08 DOI: 10.1016/j.vaccine.2024.126484
Erin Williams , Felipe Echeverri Tribin , Juan Manuel Carreño , Florian Krammer , Michael Hoffer , Suresh Pallikkuth , Savita Pahwa
The severity of SARS-CoV-2 illness is influenced by factors including age, sex, pre-existing health conditions, and individual immune responses. However, the mechanisms conferring immunity following antigenic challenge have not been fully elucidated. There are currently no studies evaluating longitudinal proteomic changes in individuals following vaccination and breakthrough, limiting our understanding of the underlying mechanisms driving conferred immunity. In this work, we evaluated the differential protein expression in individuals with (CoV-P) or without (CoV-N) prior SARS-CoV-2 infection following primary vaccination and after breakthrough infection (CoV-BT). Overall, we found that individuals receiving primary vaccination relied on innate immune mechanisms, including complement and coagulation cascades, and natural killer cell-mediated cytotoxicity, while conversely, breakthrough infection immune mechanisms relied on T cell-mediated immunity. These mechanistic differences may help explain heterogeneity associated with vaccine-induced and breakthrough infection-related outcomes.
SARS-CoV-2 疾病的严重程度受年龄、性别、原有健康状况和个体免疫反应等因素的影响。然而,抗原挑战后产生免疫力的机制尚未完全阐明。目前还没有研究评估接种疫苗和突破后个体蛋白质组的纵向变化,这限制了我们对赋予免疫力的基本机制的了解。在这项工作中,我们评估了在接种初级疫苗和突破性感染(CoV-BT)后,先前感染过(CoV-P)或未感染过(CoV-N)SARS-CoV-2 的个体蛋白质表达的差异。总体而言,我们发现接种初级疫苗的个体依赖于先天性免疫机制,包括补体和凝血级联以及自然杀伤细胞介导的细胞毒性,而相反,突破性感染的免疫机制依赖于 T 细胞介导的免疫。这些机制上的差异可能有助于解释疫苗诱导和突破性感染相关结果的异质性。
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引用次数: 0
Economic burden of children hospitalized with respiratory syncytial virus infection in Spain, 2016–2019 2016-2019 年西班牙呼吸道合胞病毒感染住院儿童的经济负担。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-07 DOI: 10.1016/j.vaccine.2024.126512
M. Haeberer , A. López-Ibáñez de Aldecoa , S. Seabroke , J.L. Ramirez Agudelo , L. Mora , L. Sarabia , E. Meroc , Z. Aponte-Torres , R. Sato , A.W. Law
This retrospective observational study aimed to quantify the costs associated with hospitalized respiratory syncytial virus (RSV) in children <18 years admitted to the Spanish National Healthcare System between 2016 and 2019 and contrast them with the costs of unspecified bronchiolitis/bronchitis/pneumonia (UBP) and influenza. The mean cost per hospitalization episode was reported by age group, risk category and prematurity. Total annual hospitalization costs were calculated from population incidence rates and the mean cost per episode. A total of 41,934 children were hospitalized with RSV, 70,160 with UBP and 8525 with influenza during 2016–2019. The highest incidence of hospitalization for RSV, UBP, and influenza occurred among infants <6 months. The mean cost per episode was highest for RSV cases aged <6 months with at least one risk factor (€4760 high vs €2827 low risk), while the mean cost ranged from €3704–4352 for high-risk and €2687–3475 for low-risk children of other ages, and from €4300–44,594 for preterm infants. In the 0–5 months age group, the mean cost per episode for UBP was €4189 and €2666 for high and low risk, and for influenza it was €3134 and €2081, respectively; while the mean cost of co-infected RSV-influenza cases was €4809 and €2887, respectively. The mean total annual estimated cost for RSV for children aged 0–17 years was €39.3 M based only on reported cases, rising to €53.8 M if we correct for under-diagnosis and all RSV-attributable cases are considered. In contrast, the mean total annual cost for influenza was €5.9 M. Compared to influenza, RSV has a substantially higher economic burden; nevertheless, the Spanish immunization schedule recommends influenza vaccine between 6 and 59 months of age and RSV monoclonal antibody only for those aged <6 months. RSV immunization is still to be implemented in older children, considering that 37 % of RSV hospitalized patients were aged ≥6 months.
这项回顾性观察研究旨在量化与儿童呼吸道合胞病毒(RSV)住院治疗相关的费用。
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引用次数: 0
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Vaccine
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