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One-year follow-up evaluation of approved Subolesin anti-tick vaccine in Uganda. 乌干达批准的亚伯莱素抗蜱疫苗的一年随访评价。
IF 3.5 Pub Date : 2025-01-12 Epub Date: 2024-11-29 DOI: 10.1016/j.vaccine.2024.126562
Paul D Kasaija, Fredrick Kabi, Jimmy Semakula, Ivan Kyakuwa, Marinela Contreras, Gabriela de la Fuente, Justus Rutaisire, Swidiq Mugerwa, Christian Gortázar, José de la Fuente

After approval of the Subolesin-based anti-tick vaccine in Uganda, we completed a one-year follow-up evaluation study. The results showed significantly 2.1-5.0-fold higher anti-SUB IgG antibody titers in vaccinated cattle in Mbarara and Maruzi with vaccine effectiveness higher than 95 %. In Mbarara, total number of ticks were 0.8-fold lower in vaccinated cattle with a negative correlation tendency between anti-SUB antibody titers and tick counts. The CCHFV-seropositive cattle significantly decreased in 40 % in SUB-vaccinated animals with a significant positive correlation between CCHFV-seropositive cattle and the total number of ticks per animal and a negative correlation tendency between anti-SUB antibody titers and CCHFV-seropositive cattle. A boosting vaccine dose yearly after primary vaccination with three doses is sufficient to maintain protective antibody titers against ticks and tick-borne diseases affecting human and animal health. These results are relevant for implementation of anti-tick Subolesin-based vaccines in Uganda and other countries in Sub-Saharan Africa.

在乌干达批准基于素的抗蜱疫苗后,我们完成了一项为期一年的随访评估研究。结果表明,在姆巴拉拉和马鲁齐地区接种疫苗的牛抗sub - IgG抗体滴度显著提高2.1-5.0倍,疫苗效力高于95%。在姆巴拉拉,接种疫苗的牛的蜱虫总数降低了0.8倍,抗sub抗体滴度与蜱虫数量呈负相关趋势。cchfv血清阳性的牛在亚疫苗接种的牛中显著降低了40%,且cchfv血清阳性的牛与每只蜱总数呈显著正相关,而抗亚抗体滴度与cchfv血清阳性的牛呈负相关。初次接种三剂疫苗后,每年增加一剂加强疫苗,足以维持对影响人类和动物健康的蜱虫和蜱传疾病的保护性抗体滴度。这些结果与在乌干达和撒哈拉以南非洲其他国家实施抗蜱虫素疫苗有关。
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引用次数: 0
COVID-19 vaccine responses are influenced by distinct risk factors in naive and SARS-CoV-2 experienced hemodialysis recipients. 初诊和经历过SARS-CoV-2的血液透析患者的COVID-19疫苗应答受到不同危险因素的影响。
IF 3.5 Pub Date : 2025-01-12 Epub Date: 2024-11-29 DOI: 10.1016/j.vaccine.2024.126544
Nicolas Gemander, Delphine Kemlin, Stéphanie Depickère, Natasha S Kelkar, Shilpee Sharma, Pieter Pannus, Alexandra Waegemans, Véronique Olislagers, Daphnée Georges, Emilie Dhondt, Margarida Braga, Leo Heyndrickx, Johan Michiels, Anaïs Thiriard, Anne Lemy, Thomas Baudoux, Marylène Vandevenne, Maria E Goossens, André Matagne, Isabelle Desombere, Kevin K Ariën, Margaret E Ackerman, Alain Le Moine, Arnaud Marchant

Background: Clinical risk factors of deficient immune responses to COVID-19 mRNA vaccination in SARS-CoV-2 naive hemodialysis recipients (HDR) have already been identified. Clinical factors influencing hybrid immunity induced by SARS-CoV-2 infection and vaccination in HDR have not been reported.

Methods: A comprehensive analysis of antibody (Ab) and T cell responses to two doses of BNT162b2 mRNA vaccination was performed in 103 HDR, including 75 SARS-CoV-2 naive and 28 experienced patients, and in 106 healthy controls (HC) not undergoing HD, including 40 SARS-CoV-2 naive and 66 experienced subjects. Clinical risk factors associated with lower humoral and cellular immunity were analyzed in SARS-CoV-2 naive and experienced HDR by univariate and multivariate analyses.

Results: Naive HDR had lower neutralizing and non-neutralizing antibody responses to vaccination than naive HC; lower vaccine responses were correlated with previous transplantation, immunosuppressive treatment, corticosteroid treatment, hypoalbuminemia, older age, hypertension, and negative response to hepatitis B vaccination. In contrast, vaccine responses of SARS-CoV-2 experienced HDR were similar to those of HC and were correlated with time between infection and vaccination and with previous transplantation, but not with the other risk factors associated with lower vaccine responses in naive HDR.

Conclusion: COVID-19 vaccine responses are influenced by distinct risk factors in SARS-CoV-2 naive and experienced HDR. These observations have important implications for the understanding of vaccine-induced immunity and for the management of this vulnerable patient population.

背景:已经确定了SARS-CoV-2初始血液透析受者(HDR)对COVID-19 mRNA疫苗接种免疫反应缺陷的临床危险因素。影响HDR地区SARS-CoV-2感染和疫苗接种诱导的混合免疫的临床因素尚未见报道。方法:对103例HDR(包括75例SARS-CoV-2初发者和28例经验者)和106例未经历SARS-CoV-2的健康对照(包括40例SARS-CoV-2初发者和66例经验者)进行两剂BNT162b2 mRNA疫苗接种后的抗体(Ab)和T细胞反应进行综合分析。通过单因素和多因素分析,分析了SARS-CoV-2初发和已经历HDR患者体液和细胞免疫降低的相关临床危险因素。结果:初发期HDR对疫苗的中和和非中和抗体反应低于初发期HC;较低的疫苗应答与既往移植、免疫抑制治疗、皮质类固醇治疗、低白蛋白血症、年龄较大、高血压和乙型肝炎疫苗接种阴性反应相关。相比之下,经历过HDR的SARS-CoV-2的疫苗反应与HC相似,并且与感染和接种疫苗之间的时间以及以前的移植相关,但与与初次HDR疫苗反应较低相关的其他危险因素无关。结论:SARS-CoV-2初发和已经历HDR患者的COVID-19疫苗应答受不同危险因素影响。这些观察结果对理解疫苗诱导的免疫和对这一脆弱患者群体的管理具有重要意义。
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引用次数: 0
Investigating parental perceptions of respiratory syncytial virus (RSV) and attitudes to RSV vaccine in Jiangsu, China: Insights from a cross-section study. 调查江苏省父母对呼吸道合胞病毒(RSV)的认知和对RSV疫苗的态度:来自横断面研究的见解
IF 3.5 Pub Date : 2025-01-12 Epub Date: 2024-11-29 DOI: 10.1016/j.vaccine.2024.126570
Qiang Wang, Liuqing Yang, Lan Li, Shixin Xiu, Min Yang, Xuwen Wang, Yuan Shen, Weibing Wang, Leesa Lin

Introduction: Our study aimed to assess parents' perceptions of respiratory syncytial virus (RSV) and their attitudes towards the RSV vaccine in China.

Method: The cross-section study was performed between August 21 and November 15, 2023, in Jiangsu province, eastern China. We collected socio-demographics, awareness, knowledge, perceptions of susceptibility and severity of RSV, and attitudes towards RSV vaccine using online survey questionnaire from parents of child aged ≤14 years old. The chi-square test and logistic regression model to explore the associated factors.

Results: A total of 2135 participants were included. About 26.0 % indicated that they had never heard of RSV (556/2135) and were unaware that infants and young children are at a high risk of contracting RSV (557/2135). The proportion of parents with a child under 1 year of age who were unaware of RSV was notably higher than that of parents with children in other age groups. 42.9 % of parents (916/2135) showed low level of perceived susceptibility of contacting RSV infection for their child. 70.6 % of parents (1508/2135) expressed their willingness to vaccinate their child against RSV. The most common reason for refusing the RSV vaccine was "Concern about vaccine's safety or side effects." 60.8 % of participants (1299/2135) considered a price of the RSV vaccine below 200 CNY (28 USD) as acceptable.

Conclusion: The parents, particularly those with younger children, exhibited limited awareness and knowledge regarding RSV infection. Our study also showed the potential role of vaccine price as a barrier to the future use of RSV vaccine in China.

前言:本研究旨在了解中国家长对呼吸道合胞病毒(RSV)的认知及对RSV疫苗的态度。方法:横断面研究于2023年8月21日至11月15日在中国东部江苏省进行。我们通过在线调查问卷收集了年龄≤14岁儿童父母的社会人口统计学、意识、知识、对RSV易感性和严重程度的看法,以及对RSV疫苗的态度。采用卡方检验和logistic回归模型探讨相关因素。结果:共纳入受试者2135人。约26.0%的人表示他们从未听说过RSV(556/2135),并且不知道婴幼儿是感染RSV的高危人群(557/2135)。有1岁以下儿童的家长不知道呼吸道合胞病毒感染的比例明显高于有其他年龄组儿童的家长。42.9%的家长(916/2135)对孩子接触性呼吸道合胞病毒感染的易感程度较低。70.6%的家长(1508/2135)表示愿意为孩子接种RSV疫苗。拒绝接种RSV疫苗最常见的原因是“担心疫苗的安全性或副作用”。60.8%的参与者(1299/2135)认为RSV疫苗的价格低于200元人民币(28美元)是可以接受的。结论:患儿家长,尤其是幼儿家长,对呼吸道合胞病毒感染的认识和知识有限。我们的研究还显示,疫苗价格可能成为未来RSV疫苗在中国使用的障碍。
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引用次数: 0
Establishing the African region monitoring vaccine effectiveness (AFRO-MoVE) network for respiratory pathogens. 建立非洲地区呼吸道病原体疫苗有效性监测网络(AFRO-MoVE)。
Pub Date : 2024-12-31 DOI: 10.1016/j.vaccine.2024.126616
C E Gurry, J M Mwenda, A Nardone, S Cohuet, A Worwui, M Valenciano, H C Lewis, C S Wiysonge, R Katsande, R Mukaro, F Braka, A S Gueye, T Balde, I Bergeri, B Impouma

Population-level vaccination with newly developed vaccines to respond to the COVID-19 pandemic created a need to monitor vaccine effectiveness (VE) in the context of emerging SARS-CoV-2 variants and changing epidemiology. WHO and partners launched the African Region Monitoring Vaccine Effectiveness (AFRO-MoVE) Network in March 2021 to assess the performance of COVID-19 vaccines in real-world conditions in Africa. The Network aimed to facilitate and support comparable COVID-19 vaccine effectiveness studies in the African region, to provide a platform of scientific expertise and infrastructure, encourage the use of robust similar study designs to enable pooling to produce regional VE estimates and to build a sustainable network of hospitals, institutions, and experts to evaluate vaccines against pandemic and endemic respiratory pathogens. In the two years since its inception, the network has coordinated VE studies in the region and provided technical guidance and generic protocols employing robust methodologies. It brought together over 200 experts, representing 22 African countries and 55 organisations, and strengthened capacities by hosting ten webinars and six technical workshops. Of the 55 partners organisations, 25 based in 13 countries collaborated on implementing VE studies in the region. AFRO-MoVE supported study implementation in two phases, first targeting COVID-19 vaccination priority groups, then the general population. The network provides technical and financial support to nine studies, including three cohort studies in health workers and adults with comorbidities, and six test-negative design studies evaluating VE against symptomatic and severe disease. A data platform was established for pooled regional estimates. The AFRO-MoVE Network can form a sustainable platform to provide data for evidence informed decisions and timely VE monitoring for existing and new vaccines against respiratory pathogens and other diseases in the African region. Further development and consolidation of the network's activities can enable rapid response to future epidemics and pandemics.

为应对COVID-19大流行,在新出现的SARS-CoV-2变体和不断变化的流行病学背景下,使用新开发的疫苗进行人群水平疫苗接种产生了监测疫苗有效性(VE)的需求。世卫组织及其合作伙伴于2021年3月启动了非洲区域疫苗有效性监测网络,以评估COVID-19疫苗在非洲现实条件下的表现。该网络旨在促进和支持在非洲区域开展类似的COVID-19疫苗有效性研究,提供一个科学专业知识和基础设施平台,鼓励使用强有力的类似研究设计,以便汇集起来产生区域免疫系统评估,并建立一个由医院、机构和专家组成的可持续网络,以评估针对大流行和地方性呼吸道病原体的疫苗。自成立以来的两年中,该网络协调了该区域的VE研究,并采用可靠的方法提供了技术指导和通用协议。它汇集了代表22个非洲国家和55个组织的200多名专家,并通过举办10次网络研讨会和6次技术讲习班加强了能力。在55个伙伴组织中,13个国家的25个合作组织在本区域实施了企业教育研究。AFRO-MoVE支持的研究分两个阶段实施,首先针对COVID-19疫苗接种重点群体,然后针对普通人群。该网络为9项研究提供技术和财政支持,其中包括3项针对卫生工作者和患有合并症的成人的队列研究,以及6项检测阴性设计研究,评估VE对有症状和严重疾病的影响。建立了汇总区域估计的数据平台。AFRO-MoVE网络可以形成一个可持续的平台,为在有证据的情况下作出决定和及时监测非洲区域针对呼吸道病原体和其他疾病的现有疫苗和新疫苗提供数据。进一步发展和巩固该网络的活动可以对未来的流行病和大流行病作出快速反应。
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引用次数: 0
FTIR monitoring of the 13-valent pneumococcal conjugate vaccine for lung cancer patients: Changes in amides vibrations correlated with biochemical assays. 用于肺癌患者的 13 价肺炎球菌结合疫苗的傅立叶变换红外光谱监测:与生化检测相关的酰胺振动变化。
IF 3.5 Pub Date : 2024-12-02 Epub Date: 2024-10-19 DOI: 10.1016/j.vaccine.2024.126459
Jolanta Smok-Kalwat, Stanisław Góźdź, Paweł Macek, Piotr Wasiński, Maryna Khalavka, Przemyslaw Raczkiewicz, Andrzej Stepulak, Joanna Depciuch

Lung cancer is one of the most lethal cancers. Unfortunately, respiratory tract infections are very common in lung cancer patients, delaying appropriate anticancer therapy. To increase therapy efficiency, in this study we examined the effect of 13-Valent Pneumococcal Conjugate Vaccine on the immune response in lung cancer patients, which indirectly affects the success of anticancer therapy. The study was done using biochemical tests and Fourier Transform InfraRed (FTIR) spectroscopy. For this purpose, serum from lung cancer patients aged 52 ± 9 years (III and IV clinical stage; 79 %; n = 103) before and seven as well as 30 days after vaccination was collected. Obtained results showed increasing concentrations of immunoglobulin IgG and IgG2 groups in patients after vaccination in comparison with group before vaccination. This result was confirmed by FTIR spectroscopy, where higher absorbances of amides vibrations were observed after vaccination. Interestingly, lack of differences in the amides absorbances between patients 7 and 30 days after vaccination were noticed. FTIR spectra also showed changes in the ratio between amide I and amide III as well as between amide II and amide III in the groups of patients after vaccination. From deconvolution of made I range (1600 cm-1-1700 cm-1) decrease of the ratio between α-helix and β-sheet around 0.05 was noticed in serum collected from patients after vaccination in comparison with patients before vaccination. Using Principal Component Analysis (PCA) analysis of FTIR data it was observed that serum collected from all three analyzed groups of samples was possible to differentiate. The highest accuracy in differentiation group of samples before and 7 days after vaccination was visible in amide I, while before and 30 days after vaccination using amide II. Correlation between immunoglobulin IgG and IgG2 concentrations obtained by biochemical assays and FTIR were noticed only in the group of serum collected 30 days after vaccination, which suggested that FTIR spectroscopy reflects biochemical data.

肺癌是最致命的癌症之一。不幸的是,呼吸道感染在肺癌患者中非常常见,从而延误了适当的抗癌治疗。为了提高治疗效率,我们在本研究中探讨了 13 价肺炎球菌结合疫苗对肺癌患者免疫反应的影响,因为免疫反应会间接影响抗癌治疗的成功与否。研究采用了生化测试和傅立叶变换红外光谱(FTIR)技术。为此,研究人员收集了 52 ± 9 岁肺癌患者(临床分期为 III 和 IV 期;79%;n = 103)在接种疫苗前、接种疫苗后 7 天和 30 天的血清。结果显示,与接种疫苗前相比,接种疫苗后患者体内免疫球蛋白 IgG 和 IgG2 组的浓度有所增加。傅立叶变换红外光谱证实了这一结果,接种疫苗后酰胺振动的吸光度更高。有趣的是,接种疫苗 7 天和 30 天后,患者的酰胺吸光度没有差异。傅立叶变换红外光谱还显示,接种疫苗后各组患者的酰胺 I 和酰胺 III 之间以及酰胺 II 和酰胺 III 之间的比例发生了变化。与接种疫苗前相比,接种疫苗后患者的血清中α-螺旋体和β-片状体之间的比例下降了约0.05。通过对傅立叶变换红外光谱数据进行主成分分析 (PCA) 发现,从所有三组分析样本中采集的血清都可以进行区分。在接种疫苗前和接种疫苗后 7 天的样本组中,酰胺 I 的分辨准确率最高,而在接种疫苗前和接种疫苗后 30 天的样本组中,酰胺 II 的分辨准确率最高。只有在接种疫苗 30 天后采集的血清组中,生化测定和傅立叶变换红外光谱法获得的免疫球蛋白 IgG 和 IgG2 浓度之间才存在相关性,这表明傅立叶变换红外光谱法反映了生化数据。
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引用次数: 0
Pseudomonas aeruginosa elongation factor-Tu (EF-Tu) is an immunogenic protective protein antigen. 铜绿假单胞菌延伸因子-Tu(EF-Tu)是一种免疫原性保护蛋白抗原。
IF 3.5 Pub Date : 2024-12-02 Epub Date: 2024-10-30 DOI: 10.1016/j.vaccine.2024.126476
Dina A Moustafa, Emma Lou, Morgan E Schafer-Kestenman, Margalida Mateu-Borrás, Antonio Doménech-Sanchez, Sebastián Albertí, Joanna B Goldberg

Pseudomonas aeruginosa is a Gram-negative, opportunistic pathogen that infects immunocompromised individuals, especially in the hospital setting. This bacterium is an important pathogen in people with weakened immune systems, injuries, and other underlying physiologic dysfunctions. P. aeruginosa is responsible for up to 20 % of all hospital-acquired pneumonias. It is one of the major causes of nosocomial infections and has been noted to be one of the most common bacteria co-infecting patients with COVID-19 or causing super-infections following COVID-19 infections. Despite improvements in antimicrobial therapy and hospital care, P. aeruginosa bacteremia and pneumonia remain fatal in about 30 % of cases. P. aeruginosa is also the leading cause of chronic life-threatening lung infections in cystic fibrosis patients. This bacterium is naturally antibiotic resistant, and infections are notoriously difficult to treat once established, with no vaccine available. We have previously shown that elongation factor-Tu (EF-Tu), a protein best known for its role in protein synthesis, is surface exposed on P. aeruginosa. As this protein is highly expressed, evolutionally conserved, and essential, we hypothesized it would make a good vaccine target. In this study, we found that P. aeruginosa EF-Tu is immunogenic in people, and that mice can develop an immune response following immunization with recombinant P. aeruginosa EF-Tu. Furthermore, immunized mice were protected from subsequent P. aeruginosa pneumonia and transfer of this vaccine antisera to naïve mice resulted in decreased colonization. Altogether these findings support the consideration of EF-Tu as a new vaccine candidate against P. aeruginosa.

铜绿假单胞菌是一种革兰氏阴性机会性病原体,可感染免疫力低下的人,尤其是在医院环境中。这种细菌是免疫力低下、受伤和其他潜在生理机能障碍患者的重要病原体。在所有医院获得性肺炎中,铜绿假单胞菌的感染率高达 20%。它是引起院内感染的主要病因之一,也是合并感染 COVID-19 或在 COVID-19 感染后引起超级感染的最常见细菌之一。尽管抗菌治疗和医院护理有所改善,但仍有约 30% 的铜绿假单胞菌菌血症和肺炎病例是致命的。铜绿假单胞菌也是导致囊性纤维化患者发生危及生命的慢性肺部感染的主要原因。这种细菌天生具有抗生素耐药性,一旦感染就很难治疗,也没有疫苗可用。我们之前已经证明,铜绿假单胞菌表面暴露有伸长因子-Tu(EF-Tu),这是一种因其在蛋白质合成中的作用而最为人熟知的蛋白质。由于这种蛋白质表达量高,在进化过程中保持不变,而且是必不可少的,因此我们推测它将成为一个很好的疫苗靶标。在这项研究中,我们发现铜绿假单胞菌 EF-Tu 在人体内具有免疫原性,小鼠免疫重组铜绿假单胞菌 EF-Tu 后可产生免疫反应。此外,免疫后的小鼠在随后的铜绿假单胞菌肺炎中受到保护,将这种疫苗抗血清转移到天真小鼠身上可减少定植。总之,这些研究结果支持将 EF-Tu 作为一种新的铜绿假单胞菌候选疫苗。
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引用次数: 0
"But then that's another barrier": A qualitative study of parent and provider perspectives on rural versus urban disparities in adolescent vaccination. "但这又是一个障碍":从家长和医疗服务提供者的角度对青少年疫苗接种中的农村与城市差异进行定性研究。
IF 3.5 Pub Date : 2024-12-02 Epub Date: 2024-10-21 DOI: 10.1016/j.vaccine.2024.126456
Sarah E Brewer, Jessica R Cataldi, Cathryn Perreira, Andrea Nederveld, Michael P Fisher, Anna Furniss, Charnetta Williams, Sean T O'Leary, Amanda F Dempsey

Purpose: Vaccination rates are significantly lower among adolescents living in rural areas compared to those living in urban areas. The objective of this study was to understand the factors contributing to disparities in vaccination between adolescents in rural compared to urban areas.

Methods: Semi-structured qualitative interviews were conducted with parents and providers in 16 rural and 4 urban counties of Colorado. Interview questions followed the socioecological model of health and addressed personal, interpersonal, community, and environment/structural barriers and facilitators that impact adolescent vaccination rates. Qualitative content analysis with a directed content analysis approach was used. Urban and rural interviews were compared to identify barriers unique to rural communities.

Findings: Reported barriers included lack of vaccine access at primary care, lack of routine preventive care utilization, the need to take off time from work and school, and misinformation about vaccines. Barriers that were unique to rural communities included structural barriers such as lack of evening and weekend appointments, providers not stocking vaccines, short provider tenures, and costs; logistical barriers such as the need for multiple visits to multiple locations and distance and travel time; and beliefs and behaviors such as an overreliance on sports physicals (in lieu of preventive visits) and natural lifestyle cultures.

Conclusions: There are unique challenges to adolescent vaccination in rural areas that contribute to fewer adolescents receiving their recommended vaccines. Addressing structural barriers may address this disparity.

目的:与城市青少年相比,农村青少年的疫苗接种率明显偏低。本研究的目的是了解造成农村地区与城市地区青少年疫苗接种率差异的因素:对科罗拉多州 16 个农村县和 4 个城市县的家长和医疗服务提供者进行了半结构化定性访谈。访谈问题遵循健康的社会生态模式,涉及影响青少年疫苗接种率的个人、人际、社区和环境/结构障碍和促进因素。采用定向内容分析法进行定性内容分析。对城市和农村的访谈进行了比较,以确定农村社区特有的障碍:所报告的障碍包括基层医疗机构缺乏疫苗接种渠道、缺乏常规预防性医疗服务、需要请假工作和上学以及关于疫苗的错误信息。农村社区特有的障碍包括结构性障碍,如缺乏晚间和周末预约、医疗服务提供者没有疫苗储备、医疗服务提供者任期较短以及费用;后勤障碍,如需要在多个地点多次就诊以及距离和旅行时间;以及信仰和行为,如过度依赖运动体检(代替预防性就诊)和自然生活方式文化:结论:农村地区的青少年接种疫苗面临着独特的挑战,导致接受推荐疫苗接种的青少年人数较少。解决结构性障碍可能会消除这种差异。
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引用次数: 0
Virtual reality for routine immunisations in needle phobic children with and without developmental disabilities: A pilot study. 虚拟现实技术用于患有或不患有发育障碍的打针恐惧症儿童的常规免疫接种:试点研究。
IF 3.5 Pub Date : 2024-12-02 Epub Date: 2024-11-01 DOI: 10.1016/j.vaccine.2024.126481
Allya Makhijani, Narelle Jenkins, Jessica Kaufman, Monsurul Hoq, Sabine Priestley, Sonja Elia, Ian McKenzie, Andrew Davidson, Paul Leong, Teresa Lazzaro, Sarah McNab, Margie Danchin

Virtual reality for routine immunisations in needle phobic children with and without developmental disabilities: a pilot study.

Background: Virtual Reality (VR) headsets can improve needle procedure success and experiences for children, but they have not been evaluated to support immunisation in children with anxiety and behavioural challenges. This study assessed the feasibility and acceptability of VR for immunisation in children with needle phobia, including children with and without developmental disabilities.

Methods: A mixed method pilot study was conducted at the Royal Children's Hospital, Melbourne. Children with needle phobia aged 4-14 years scheduled for immunisation with distraction and conscious sedation were eligible. VR was offered to children with needle anxiety and/or developmental disabilities before and during immunisation in addition to standard care. Children and caregivers completed electronic surveys pre- and post-immunisation, followed by qualitative interviews post-immunisation. Clinicians completed post-immunisation surveys. Primary outcomes were feasibility and acceptability of VR according to children, caregivers and clinicians.

Results: Between May and December 2022, we screened 54 children and included 30; 15 with and 15 without developmental disability. Preparation to use VR took less than five minutes for most children (24/30; 80 %). Twenty nine (96 %) used VR immediately before immunisation, and 17 (57 %) continued using it during immunisation (7 with developmental disability, 10 without). Twenty seven (90 %) children were immunised successfully, with a small reduction in required sedation. Of those who used VR during immunisation, 16/17 (94 %) reported a more positive overall experience. Of those who only used VR before immunisation, 3/13 (23 %) still reported benefit. VR was therefore described as beneficial for 19/30 (63 %) participants (9 with developmental disability, 10 without). Caregivers reported willingness to use VR in future immunisation encounters for 23/30 (77 %) children (11 with developmental disability, 12 without).

Discussion: This pilot study suggests VR was feasible and acceptable for many children with needle phobia, both with and without developmental disability. These findings will inform a randomised controlled trial to assess effectiveness.

虚拟现实技术用于患有或不患有发育障碍的打针恐惧症儿童的常规免疫接种:一项试点研究:背景:虚拟现实(VR)头戴式设备可以提高针刺过程的成功率并改善儿童的体验,但尚未对其是否适用于焦虑和行为障碍儿童的免疫接种进行评估。本研究评估了虚拟现实技术在针头恐惧症儿童(包括有和没有发育障碍的儿童)免疫接种中的可行性和可接受性:方法:在墨尔本皇家儿童医院开展了一项混合方法试点研究。患有打针恐惧症的 4-14 岁儿童均符合条件,他们计划在分散注意力和有意识镇静的情况下接受免疫接种。在免疫接种前和免疫接种过程中,除标准护理外,还为患有打针焦虑症和/或发育障碍的儿童提供 VR。儿童和护理人员在免疫接种前和免疫接种后完成电子调查,然后在免疫接种后进行定性访谈。临床医生完成免疫接种后调查。主要结果是儿童、护理人员和临床医生对 VR 的可行性和可接受性的评价:2022 年 5 月至 12 月间,我们对 54 名儿童进行了筛查,并纳入了 30 名儿童;其中 15 名有发育障碍,15 名无发育障碍。大多数儿童(24/30;80%)使用虚拟现实的准备时间不超过五分钟。29 名儿童(96%)在免疫接种前立即使用了 VR,17 名儿童(57%)在免疫接种期间继续使用 VR(7 名发育障碍儿童,10 名非发育障碍儿童)。27 名(90%)儿童成功接种了疫苗,所需的镇静剂也略有减少。在免疫接种过程中使用虚拟现实技术的儿童中,16/17(94%)表示总体体验更加积极。在那些只在免疫接种前使用过虚拟现实技术的儿童中,3/13(23%)的儿童表示仍能从中受益。因此,19/30(63 %)的参与者(9 人有发育障碍,10 人没有发育障碍)认为虚拟现实技术对他们有益。23/30 (77 %) 名儿童(11 名发育障碍儿童,12 名非发育障碍儿童)的护理人员表示愿意在今后的免疫接种中使用 VR:讨论:这项试点研究表明,对于许多患有针刺恐惧症的儿童(包括有发育障碍和无发育障碍的儿童)来说,VR 是可行的,也是可以接受的。这些发现将为随机对照试验的有效性评估提供参考。
{"title":"Virtual reality for routine immunisations in needle phobic children with and without developmental disabilities: A pilot study.","authors":"Allya Makhijani, Narelle Jenkins, Jessica Kaufman, Monsurul Hoq, Sabine Priestley, Sonja Elia, Ian McKenzie, Andrew Davidson, Paul Leong, Teresa Lazzaro, Sarah McNab, Margie Danchin","doi":"10.1016/j.vaccine.2024.126481","DOIUrl":"10.1016/j.vaccine.2024.126481","url":null,"abstract":"<p><p>Virtual reality for routine immunisations in needle phobic children with and without developmental disabilities: a pilot study.</p><p><strong>Background: </strong>Virtual Reality (VR) headsets can improve needle procedure success and experiences for children, but they have not been evaluated to support immunisation in children with anxiety and behavioural challenges. This study assessed the feasibility and acceptability of VR for immunisation in children with needle phobia, including children with and without developmental disabilities.</p><p><strong>Methods: </strong>A mixed method pilot study was conducted at the Royal Children's Hospital, Melbourne. Children with needle phobia aged 4-14 years scheduled for immunisation with distraction and conscious sedation were eligible. VR was offered to children with needle anxiety and/or developmental disabilities before and during immunisation in addition to standard care. Children and caregivers completed electronic surveys pre- and post-immunisation, followed by qualitative interviews post-immunisation. Clinicians completed post-immunisation surveys. Primary outcomes were feasibility and acceptability of VR according to children, caregivers and clinicians.</p><p><strong>Results: </strong>Between May and December 2022, we screened 54 children and included 30; 15 with and 15 without developmental disability. Preparation to use VR took less than five minutes for most children (24/30; 80 %). Twenty nine (96 %) used VR immediately before immunisation, and 17 (57 %) continued using it during immunisation (7 with developmental disability, 10 without). Twenty seven (90 %) children were immunised successfully, with a small reduction in required sedation. Of those who used VR during immunisation, 16/17 (94 %) reported a more positive overall experience. Of those who only used VR before immunisation, 3/13 (23 %) still reported benefit. VR was therefore described as beneficial for 19/30 (63 %) participants (9 with developmental disability, 10 without). Caregivers reported willingness to use VR in future immunisation encounters for 23/30 (77 %) children (11 with developmental disability, 12 without).</p><p><strong>Discussion: </strong>This pilot study suggests VR was feasible and acceptable for many children with needle phobia, both with and without developmental disability. These findings will inform a randomised controlled trial to assess effectiveness.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126481"},"PeriodicalIF":3.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142565369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study. 在一项三期临床研究中,基于改良安卡拉疫苗载体的多价 RSV 疫苗显示出对老年人 RSV 引起的疾病具有适度的保护作用。
IF 3.5 Pub Date : 2024-12-02 Epub Date: 2024-10-25 DOI: 10.1016/j.vaccine.2024.126427
Elke Jordan, Victoria Jenkins, Günter Silbernagl, Maria Paulina Velasco Chávez, Darja Schmidt, Frauke Schnorfeil, Stephanie Schultz, Liddy Chen, Fernanda Salgado, Jeanne-Marie Jacquet, Tobias Welte, Laurence De Moerlooze

Respiratory syncytial virus (RSV) causes a significant disease burden in older adults. The live recombinant vaccine based on a nonreplicating modified vaccinia Ankara (MVA-BN) poxvirus, MVA-BN-RSV, encoding for multiple proteins of RSV subtypes A and B, was assessed for efficacy against respiratory disease caused by RSV. Adults aged ≥60 years, with or without underlying chronic conditions, were enrolled and randomized in a 1:1 ratio to receive a single dose of vaccine or placebo and were followed for disease caused by RSV infection during the 2022-2023 season. The 2 primary endpoints were RSV-associated lower respiratory tract disease (LRTD) with ≥3 and ≥ 2 symptoms; acute respiratory disease (ARD) was a key secondary endpoint. The humoral RSV-specific immune response was assessed at baseline and 14 days post-vaccination. Safety was evaluated by collection of solicited adverse events (AEs) and unsolicited AEs for 7 and 28 days post-vaccination respectively, and SAEs for the entire study period. In total, 18,348 participants were included in the final efficacy and safety analyses. Vaccine efficacy was 42.9 % (95 % CI: -16.1; 71.9) against RSV-associated LRTD with ≥3 symptoms, 59.0 % (95 % CI: 34.7; 74.3) against LRTD with ≥2 symptoms, and 48.8 % (95 % CI: 25.8; 64.7) against ARD. The primary objective was not met for LRTD with ≥3 symptoms since the lower bound of the 95 % CI was below 20 %, the prespecified success criterion. The vaccine-elicited immune response showed mean fold-increases of 1.7 for RSV A and B neutralizing antibodies and 2.9 and 4.3 for RSV-specific IgG and IgA, respectively. The vaccine displayed mild to moderate reactogenicity, and no safety concerns were identified. MVA-BN-RSV induced suboptimal protection against RSV-associated LRTD, likely due to suboptimal neutralizing antibody response. The vaccine had an acceptable safety profile and confirmed immunogenicity, overall showing promise for MVA-BN-vectored constructs targeting other diseases. Trial Registration:Clinicaltrials.gov Identifier NCT05238025 (Registered February 14, 2022).

呼吸道合胞病毒(RSV)给老年人带来了沉重的疾病负担。我们评估了基于非复制改良安卡拉疫苗(MVA-BN)痘病毒的重组活疫苗 MVA-BN-RSV(编码 RSV A 和 B 亚型的多种蛋白)对 RSV 引起的呼吸道疾病的疗效。年龄≥60岁、患有或不患有基础慢性疾病的成人被纳入研究,并按1:1的比例随机分配接受单剂量疫苗或安慰剂,并在2022-2023年期间对RSV感染引起的疾病进行随访。两个主要终点是RSV相关的下呼吸道疾病(LRTD),症状≥3和≥2;急性呼吸道疾病(ARD)是关键的次要终点。体液 RSV 特异性免疫反应在基线和接种后 14 天进行评估。安全性通过收集接种后 7 天和 28 天的主动不良事件 (AE) 和非主动不良事件以及整个研究期间的 SAE 进行评估。共有 18348 名参与者参与了最终的有效性和安全性分析。疫苗对≥3 种症状的 RSV 相关 LRTD 的有效率为 42.9% (95 % CI: -16.1; 71.9),对≥2 种症状的 LRTD 的有效率为 59.0% (95 % CI: 34.7; 74.3),对 ARD 的有效率为 48.8% (95 % CI: 25.8; 64.7)。由于 95 % CI 的下限低于 20%,即预设的成功标准,因此症状≥3 的 LRTD 未达到主要目标。疫苗诱导的免疫反应显示,RSV A 型和 B 型中和抗体的平均增加倍数分别为 1.7 倍,RSV 特异性 IgG 和 IgA 的平均增加倍数分别为 2.9 倍和 4.3 倍。疫苗的致反应性为轻度至中度,未发现安全性问题。MVA-BN-RSV 对 RSV 相关 LRTD 的保护效果不理想,这可能是由于中和抗体反应不理想造成的。该疫苗的安全性可接受,免疫原性也得到了证实,总体上显示了针对其他疾病的 MVA-BN 病毒构建物的前景。试验注册:Clinicaltrials.gov Identifier NCT05238025(2022年2月14日注册)。
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引用次数: 0
Safety of mRNA COVID-19 vaccines among persons 15- years and above in Ghana: A cohort event monitoring study. 加纳 15 岁及以上人群接种 mRNA COVID-19 疫苗的安全性:队列事件监测研究。
IF 3.5 Pub Date : 2024-12-02 Epub Date: 2024-10-23 DOI: 10.1016/j.vaccine.2024.126460
Delese Mimi Darko, Seth Kwaku Seaneke, Eric Karikari-Boateng, Edwin Nkansah, Kwame Amponsa-Achiano, Naziru Tanko Mohamed, Harriet Affran Bonful, Richard Osei Buabeng, Adela Ashie, Abena Asamoa-Amoakohene, Jeremiah Ewudzie-Sampson, Alexander Mwinteru Derizie, Adjabui D Neimatu, Agongo A Wilfred, Comfort Ogar, Aida Hagos, George Tsey Sabblah

Introduction: The development of COVID-19 vaccines during the pandemic occurred with an unprecedented speed, requiring extraordinary post-approval safety monitoring to facilitate ongoing evaluation of their benefit-risk profile. In Ghana, the Food and Drugs Authority granted emergency use authorization to six of these vaccines including the two mRNA COVID-19 vaccines, namely, Pfizer-BioNTech and Moderna COVID-19 vaccines. The objective of the study was to estimate the incidence of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) in persons vaccinated with mRNA COVID-19 vaccines, and to identify factors associated with the development of AEFIs.

Methods: We conducted a prospective cohort event monitoring study in seven selected static vaccination center in six of Ghana's 16 regions. The choice of regions was based on their geographical locations and the incidence rate of COVID-19 at the time of the study. The study was conducted with people aged 15 years and older who were vaccinated with mRNA COVID-19 vaccines, including pregnant women. Study participants were recruited starting in November 2021, with the last participant followed up in August 2022. Persons vaccinated were followed up on days 1, 7, and 28 post-dose 1 and up to 91 days after dose 2. AEFIs were described with the most specific, or lowest-level, term using the Medical Dictionary for Regulatory Activities (MedDRA) version 26.1. Frequencies of AEFIs after each vaccine dose and vaccination center were determined. Cox-proportional hazard regression was used to assess the independent risk factors associated with the incidence of AEFI among the participants.

Results: Overall, 4678 persons who received Pfizer-BioNTech or Moderna COVID-19 vaccines from the seven vaccination centers were enrolled in the study. The mean age of participants was 32.9 years (SD ± 14.4). A total of 17.4 % (95 % CI: 16.3 % to 18.5 %) of participants experienced AEFI, with a higher incidence among Moderna COVID-19 vaccine recipients (20.4 %) compared to Pfizer-BioNTech COVID-19 vaccine recipients (14.0 %). The top five common AEFIs included injection site pain, headache, dizziness, fatigue, and fever. No serious AEFIs were reported during the study. Factors such as vaccination center and history of chronic medical conditions influenced the risk of experiencing an AEFI. Cox-proportional hazard regression revealed a 37 % lower risk of AEFI with the Pfizer-BioNTech COVID-19 vaccine compared to the Moderna COVID-19 vaccine.

Conclusion: The study on mRNA COVID-19 vaccines in Ghana showed that the vaccines are tolerated well with no significant safety concerns. Reports of systemic and local events were consistent with those reported in the summary of product characteristics of the two vaccines. The study's outcome showed that there were no safety issues with mRNA COVID-19 vaccines in Ghana.

简介:COVID-19 疫苗在大流行期间以前所未有的速度得到开发,这就要求在批准后进行非常规的安全监测,以促进对其效益-风险状况的持续评估。在加纳,食品药品管理局批准了其中六种疫苗的紧急使用许可,包括两种 mRNA COVID-19 疫苗,即辉瑞生物技术公司生产的 COVID-19 疫苗和 Moderna COVID-19 疫苗。该研究的目的是估计接种 mRNA COVID-19 疫苗的人群中免疫接种后不良事件(AEFIs)和特别关注不良事件(AESIs)的发生率,并确定与 AEFIs 发生相关的因素:我们在加纳 16 个地区中的 6 个地区选定的 7 个固定疫苗接种中心开展了一项前瞻性队列事件监测研究。选择这些地区的依据是它们的地理位置和研究时 COVID-19 的发病率。研究对象为接种过 mRNA COVID-19 疫苗的 15 岁及以上人群,包括孕妇。研究参与者从 2021 年 11 月开始招募,最后一名参与者的随访时间为 2022 年 8 月。在接种第一剂疫苗后的第 1 天、第 7 天和第 28 天,以及接种第二剂疫苗后的第 91 天,对接种者进行了随访。AEFI使用《监管活动医学词典》(MedDRA)26.1版中最具体或最低级的术语进行描述。确定每个疫苗剂量和接种中心后的 AEFI 频率。采用 Cox 比例危险回归法评估与参与者 AEFI 发生率相关的独立风险因素:共有4678人在7个疫苗接种中心接种了辉瑞生物技术公司或Moderna COVID-19疫苗。参与者的平均年龄为 32.9 岁(SD ± 14.4)。共有 17.4 %(95 % CI:16.3 % 至 18.5 %)的参与者发生过 AEFI,其中 Moderna COVID-19 疫苗接种者的发生率(20.4 %)高于辉瑞生物 COVID-19 疫苗接种者(14.0 %)。最常见的五种 AEFI 包括注射部位疼痛、头痛、头晕、疲劳和发烧。研究期间未报告严重的 AEFI。疫苗接种中心和慢性病史等因素会影响发生 AEFI 的风险。Cox比例危险回归显示,与Moderna COVID-19疫苗相比,Pfizer-BioNTech COVID-19疫苗的AEFI风险低37%:在加纳进行的 mRNA COVID-19 疫苗研究表明,疫苗的耐受性良好,没有明显的安全性问题。关于全身和局部事件的报告与两种疫苗的产品特性摘要中的报告一致。研究结果表明,mRNA COVID-19 疫苗在加纳不存在安全性问题。在各国计划将 COVID-19 疫苗常规化的过程中,这项研究的结果可作为重要的宣传工具来解决疫苗犹豫不决的问题。此外,在未来的大流行病期间,主动监测研究还可作为药物警戒系统薄弱的中低收入国家 (LMIC) 开展此类研究的范例。
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引用次数: 0
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Vaccine
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