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Heterologous Prime-Boost with ChAdOx1-VZV Establishes Dual-Layer Immunogenicity Conferring Protective Potential Against Herpes Zoster. ChAdOx1-VZV异种启动-增强建立双层免疫原性,赋予对带状疱疹的保护潜力
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-05 DOI: 10.3390/vaccines13121226
Jiayu Zhao, Juan Shao, Xiuwen Sui, Menghan Wei, Xinjian Ma, Zhijun Xu, Tao Zhu

Background/Objectives: Varicella-zoster virus (VZV) causes herpes zoster (HZ/shingles), particularly in older adults with weakened cell-mediated immunity (CMI), which is essential for controlling VZV reactivation and reducing HZ severity. Currently vaccines, like recombinant subunit or live-attenuated vaccine, showed shortcomings in eliciting CD8+ T-cell responses. Addressing this, we utilized the novel replication-defective chimpanzee adenovirus vector ChAdOx1 to construct the ChAdOx1-VZV (CVE) vaccine, using full-length glycoprotein E (gE) as antigen. This study evaluated the immunogenicity of a heterologous intramuscular (IM) prime/intranasal (IN) boost regimen with the aim of developing a novel VZV vaccine candidate. Methods: BALB/c mice were immunized with CVE using homologous or heterologous prime-boost regimens via IM or IN. And cynomolgus macaques were immunized intramuscularly with three doses of CVE. Cellular responses were assessed by intracellular cytokine staining (ICS) and IFN-γ ELISpot using splenocytes and PBMCs. Humoral responses were evaluated by serum gE-IgG ELISA and bone-marrow LLPC ELISpot. Memory subsets and tissue-resident T cells were analyzed by flow cytometry. Results: Heterologous IM prime/IN boost CVE regimen markedly enhanced both cellular and humoral responses, especially CD8+ T-cell responses. The induced LLPC and memory T cell responses indicate the potential for long-term protection against herpes zoster. In cynomolgus macaques, CVE induced robust serum gE-specific IgG responses and strong IFN-γ secreting T-cell activity, supporting the immunogenicity of CVE in a genetically distinct primate model and enhancing its clinical translational potential. Conclusions: CVE induces potent cellular and humoral immunogenicity, with IM prime/IN boost vaccination. Cross species immunogenicity observed in nonhuman primates further strengthens the translational relevance of this platform. These findings support CVE as a promising herpes zoster vaccine candidate and provide a rationale for continued evaluation in human-relevant systems.

背景/目的:水痘带状疱疹病毒(VZV)引起带状疱疹(HZ/带状疱疹),特别是在细胞介导免疫(CMI)减弱的老年人中,这对于控制VZV再激活和降低HZ严重程度至关重要。目前的疫苗,如重组亚单位或减毒活疫苗,在引发CD8+ t细胞反应方面存在缺陷。为了解决这一问题,我们利用新的复制缺陷黑猩猩腺病毒载体ChAdOx1,以全长糖蛋白E (gE)为抗原,构建了ChAdOx1- vzv (CVE)疫苗。本研究评估了异种肌内注射(IM) /鼻内注射(IN)增强方案的免疫原性,目的是开发一种新的VZV候选疫苗。方法:采用同种或异源CVE经IM或IN免疫BALB/c小鼠。用三剂CVE对食蟹猕猴进行肌肉免疫。采用细胞内细胞因子染色(ICS)和IFN-γ ELISpot检测脾细胞和pbmc细胞的细胞反应。采用血清gE-IgG ELISA和骨髓LLPC ELISpot检测体液应答。流式细胞术分析记忆亚群和组织驻留T细胞。结果:异源IM /IN增强CVE方案显著提高细胞和体液反应,特别是CD8+ t细胞反应。诱导的LLPC和记忆T细胞反应表明对带状疱疹具有长期保护作用的潜力。在食蟹猕猴中,CVE诱导了强大的血清ge特异性IgG反应和强大的IFN-γ分泌t细胞活性,支持了CVE在遗传上独特的灵长类动物模型中的免疫原性,并增强了其临床转化潜力。结论:CVE可诱导有效的细胞和体液免疫原性,IM prime/IN增强疫苗接种。在非人灵长类动物中观察到的跨物种免疫原性进一步加强了该平台的翻译相关性。这些发现支持CVE作为一种有希望的带状疱疹候选疫苗,并为在人类相关系统中继续进行评估提供了依据。
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引用次数: 0
Effectiveness and Safety of Recombinant Zoster Vaccine in Rheumatic Diseases: Real-World Evidence from a Single-Centre Italian Cohort. 重组带状疱疹疫苗在风湿病中的有效性和安全性:来自意大利单中心队列的真实世界证据。
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-05 DOI: 10.3390/vaccines13121227
Silvia Valentini, Jurgen Sota, Irene Fineschi, Edoardo Conticini, Estrella Garcia-Gonzalez, Emilio D'Ignazio, Marco Bardelli, Stefano Gentileschi, Marta Fabbroni, Francesca Bellisai, Paolo Falsetti, Enrico Selvi, Luca Cantarini, Bruno Frediani, Caterina Baldi

Background: Patients with rheumatic diseases (RMDs) are at increased risk of herpes zoster (HZ), particularly when receiving immunosuppressive treatment. While recombinant zoster vaccine (RZV) has shown high effectiveness in the general population, evidence in rheumatologic patients remain limited due to their exclusion from pivotal trials.

Objectives: To evaluate the effectiveness of RZV and to collect additional safety data in a heterogeneous cohort of rheumatologic patients, compared with a control cohort from the general population.

Methods: We conducted a retrospective study including 179 adults who received two intramuscular doses of RZV between January 2021 and June 2025. The cohort included 114 patients with RMDs and 65 individuals from the general population. Effectiveness was defined as the ability to prevent HZ reactivation while safety concerns were recorded as any adverse event temporally associated with the vaccination.

Results: We observed a statistically significant reduction in terms of VZV relapses following vaccination (p < 0.001). Among patients diagnosed with RMDs, only one case of HZ recurrence was observed 14 weeks after vaccination, with no significant difference compared to general care patients. One patient experienced a disease flare requiring glucocorticosteroids. RZV demonstrated a favourable safety profile, with minor adverse events (fever, injection-site reactions, headache and myalgia) reported in 17.5% of patients after the first dose and 21.5% after the second. No significant association was observed between adverse events and advanced immunosuppressive therapy.

Conclusions: RZV displayed an effective and reassuring safety profile in a heterogeneous cohort of patients affected by RMDs, irrespective of the diagnosis and the ongoing therapy. This supports the broader use of RZV as a safe and valuable preventive strategy in patients with RMDs.

背景:风湿性疾病(RMDs)患者发生带状疱疹(HZ)的风险增加,特别是在接受免疫抑制治疗时。虽然重组带状疱疹疫苗(RZV)在普通人群中显示出很高的有效性,但在风湿病患者中的证据仍然有限,因为他们被排除在关键试验之外。目的:与来自普通人群的对照队列相比,评估RZV在风湿病患者异质队列中的有效性并收集额外的安全性数据。方法:我们进行了一项回顾性研究,包括179名成年人,他们在2021年1月至2025年6月期间接受了两次肌肉注射RZV。该队列包括114名rmd患者和65名普通人群。有效性被定义为防止HZ再次激活的能力,而安全性被记录为与疫苗接种相关的任何暂时不良事件。结果:我们观察到接种疫苗后VZV复发的统计学显著降低(p < 0.001)。在诊断为RMDs的患者中,接种疫苗14周后仅观察到一例HZ复发,与一般护理患者相比无显著差异。一名患者出现疾病发作,需要使用糖皮质激素。RZV显示出良好的安全性,第一次注射后17.5%的患者报告了轻微的不良事件(发烧、注射部位反应、头痛和肌痛),第二次注射后21.5%的患者报告了轻微的不良事件。未观察到不良事件与高级免疫抑制治疗之间的显著关联。结论:RZV在受rmd影响的异质队列患者中显示出有效和令人放心的安全性,无论诊断和正在进行的治疗如何。这支持在rmd患者中更广泛地使用RZV作为一种安全而有价值的预防策略。
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引用次数: 0
A Review of the Effects of Ipsilateral or Contralateral Vaccine Boosting on the Adaptive Immune Response. 同侧或对侧疫苗增强对适应性免疫反应的影响
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-04 DOI: 10.3390/vaccines13121225
Amal Naji, Hana M El Sahly, Jennifer A Whitaker

Vaccines have been pivotal in reducing the incidence and severity of infectious diseases, improving population health, and lowering mortality rates globally. While substantial progress has been made in optimizing vaccine formulations, adjuvants, and schedules, comparatively less attention has been given to how the site of vaccination may influence immunologic outcomes. This review examines the impact of the administration of prime and booster vaccine doses in the same (ipsilateral) versus the opposite arms (contralateral) on vaccine immunogenicity. We review animal model and human studies evaluating the impact of ipsilateral versus contralateral COVID-19 and non-COVID-19 vaccine boosting on immunologic outcomes with a focus on the germinal center response, antibody production, and T cell activation. While some studies suggest that ipsilateral administration may enhance the quality of germinal center B cell responses and antibody magnitude, data across different studies have been inconsistent. Relatively few studies have compared ipsilateral versus contralateral boosting, and differences in study design and outcomes have limited the ability to draw conclusions as to whether one is superior to the other. This review highlights a noteworthy and underexplored area in vaccinology and the need for future research to clarify whether ipsilateral/contralateral boosting strategies matter. To answer this question, high-quality, randomized controlled trials evaluating different types of vaccines that consider immunologic mechanisms, capture key time points and appropriate specimens, and evaluate early and long-term immunogenicity endpoints are required.

疫苗在减少传染病的发病率和严重程度、改善人口健康和降低全球死亡率方面发挥了关键作用。虽然在优化疫苗配方、佐剂和时间表方面取得了实质性进展,但相对而言,对接种地点如何影响免疫结果的关注较少。本综述探讨了在同侧(同侧)和对侧(对侧)接种初级和加强疫苗剂量对疫苗免疫原性的影响。我们回顾了动物模型和人类研究,评估了同侧与对侧COVID-19和非COVID-19疫苗增强对免疫结果的影响,重点是生发中心反应、抗体产生和T细胞活化。虽然一些研究表明,同侧给药可以提高生发中心B细胞反应的质量和抗体强度,但不同研究的数据不一致。相对较少的研究比较了同侧和对侧增强,研究设计和结果的差异限制了得出结论的能力,即一个是否优于另一个。这篇综述强调了疫苗学中一个值得注意但未被充分探索的领域,以及未来研究澄清同侧/对侧加强策略是否重要的必要性。为了回答这个问题,需要进行高质量的随机对照试验,评估不同类型的疫苗,考虑免疫机制,捕获关键时间点和适当的标本,并评估早期和长期免疫原性终点。
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引用次数: 0
Anti-Idiotypic Antibodies in Immune Regulation and Disease: Therapeutic Promise for Next-Generation Vaccines. 抗独特型抗体在免疫调节和疾病中的应用:下一代疫苗的治疗前景。
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-03 DOI: 10.3390/vaccines13121224
Anna M Timofeeva, Sergey E Sedykh, Georgy A Nevinsky

Background: Antibodies have the unique ability to recognize antigens and to be recognized as antigens by other antibodies, creating a balanced network that regulates the humoral part of the immune system. An antibody that uniquely identifies another antibody of a given specificity as its antigen is referred to as an anti-idiotypic antibody. Methods: A descriptive literature review was conducted using the PubMed database, including publications up to 2025. Results: This review examines the formation mechanisms of anti-idiotypic antibodies, their functional attributes, and their importance in diverse pathologies. A key focus is their capacity to neutralize pathogenic autoantibodies, offering a novel strategy for treating autoimmune diseases. Conversely, the generation of anti-Id Abs against therapeutic monoclonal antibodies (anti-drug antibodies) represents a significant challenge for biologic therapy, a complication addressed in a dedicated section on detection methods. Furthermore, consideration is given to the application of anti-Id Abs as innovative tools for vaccine design, particularly in oncology. By mimicking tumor-associated antigens, anti-Id Abs can induce a potent, targeted immune response against cancer with minimal side effects, presenting an alternative to conventional chemotherapy and radiation. Conclusions: Anti-Id Abs hold significant therapeutic promise. Their ability to selectively suppress pathogenic autoantibodies allows for precise immune intervention without broad immunosuppression. Additionally, their utility extends to vaccine development for various diseases. Further research into anti-Id Abs will deepen our understanding of immune regulation and open new avenues for targeted therapies.

背景:抗体具有识别抗原和被其他抗体识别为抗原的独特能力,从而形成一个平衡的网络,调节免疫系统的体液部分。一种能够唯一地识别具有特定特异性的另一种抗体作为其抗原的抗体被称为抗独特型抗体。方法:使用PubMed数据库进行描述性文献综述,包括截至2025年的出版物。结果:本文综述了抗独特型抗体的形成机制、功能属性及其在不同病理中的重要性。一个关键的焦点是它们能够中和病原性自身抗体,为治疗自身免疫性疾病提供一种新的策略。相反,针对治疗性单克隆抗体(抗药物抗体)的抗id抗体的产生对生物治疗来说是一个重大挑战,在检测方法的专门章节中讨论了这一并发症。此外,考虑到抗抗体作为疫苗设计的创新工具的应用,特别是在肿瘤学方面。通过模仿肿瘤相关抗原,抗- id抗体可以诱导一种有效的靶向免疫反应,以最小的副作用对抗癌症,是传统化疗和放疗的替代方案。结论:抗- id抗体具有显著的治疗前景。它们选择性抑制致病性自身抗体的能力允许在没有广泛免疫抑制的情况下进行精确的免疫干预。此外,它们的用途还扩展到各种疾病的疫苗开发。对抗id抗体的进一步研究将加深我们对免疫调节的理解,并为靶向治疗开辟新的途径。
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引用次数: 0
Assessing COVID-19 Infection and Severe Disease Risk in Cancer Patients and Survivors: The Role of Vaccination Status, Circulating Variants, and Comorbidities-A Population-Based Study in Northern Italy. 评估癌症患者和幸存者的COVID-19感染和严重疾病风险:疫苗接种状况、流行变体和合并症的作用——意大利北部一项基于人群的研究
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-03 DOI: 10.3390/vaccines13121223
Massimo Vicentini, Pamela Mancuso, Francesco Venturelli, Sergio Mezzadri, Eufemia Bisaccia, Alessandro Zerbini, Lucia Mangone, Paolo Giorgi Rossi, On Behalf Of The Reggio Emilia Covid-Working Group

Background: Cancer patients are particularly vulnerable to severe outcomes from COVID-19 due to immune suppression, treatment effects, and comorbidities. This population-based study aimed to assess how vaccination, circulating variants, and comorbidities influenced infections and severe disease risks in cancer patients compared with the general population. Methods: The study included 538,516 residents of Reggio Emilia Province, Italy, alive on 20 February 2020, followed until 30 September 2022. Cancer diagnoses (1996-2021) were obtained from the Reggio Emilia Cancer Registry and linked with COVID-19 surveillance, vaccination, hospitalization, and mortality data. Vaccination and prior infection were modelled as time-dependent variables. Hazard ratios for infection (HRs) and odds ratios for severe disease in those infected (ORs) were estimated using Cox and logistic regression models adjusting for sex, age, and comorbidities. Results: Among the 33,307 residents who had cancer, 9135 SARS-CoV-2 infections were recorded. Infection risk was similar to the general population before Omicron (HR 1.00; 95%CI 0.96-1.05) and slightly higher during Omicron (HR 1.08; 95%CI 1.05-1.11). Cancer patients showed higher probability of severe disease once infected (OR 1.33 pre-Omicron; 1.67 Omicron), with the greatest excess in recent diagnoses. Vaccination substantially reduced infections and severe outcomes in both groups in the pre-Omicron period; while only hybrid immunity reached high protection from Omicron infection. Conclusions: Vaccinations were effective in the populations with and without cancer; hybrid immunity conferred the strongest protection. However, because cancer patients, especially those recently diagnosed, retain a higher baseline risk of severe disease, vaccination yields even greater individual and public health benefits.

背景:由于免疫抑制、治疗效果和合并症,癌症患者特别容易受到COVID-19的严重后果。这项基于人群的研究旨在评估与普通人群相比,疫苗接种、流行变异和合并症如何影响癌症患者的感染和严重疾病风险。方法:该研究包括意大利雷焦艾米利亚省的538,516名居民,他们于2020年2月20日存活,随访至2022年9月30日。癌症诊断(1996-2021年)从雷焦艾米利亚癌症登记处获得,并与COVID-19监测、疫苗接种、住院和死亡率数据相关联。疫苗接种和既往感染被建模为时间相关变量。使用Cox和逻辑回归模型对性别、年龄和合并症进行校正,估计感染的风险比(hr)和感染者严重疾病的优势比(ORs)。结果:在33,307名癌症患者中,记录了9135例SARS-CoV-2感染。Omicron前感染风险与一般人群相似(HR 1.00; 95%CI 0.96 ~ 1.05),而Omicron后感染风险略高(HR 1.08; 95%CI 1.05 ~ 1.11)。癌症患者一旦感染后出现严重疾病的概率更高(OR 1.33前Omicron; OR 1.67 Omicron),在最近的诊断中出现的概率最大。在欧米克隆前时期,接种疫苗大大减少了两组的感染和严重后果;而只有杂交免疫对欧米克隆感染有很高的保护作用。结论:疫苗接种对癌症患者和非癌症患者均有效;杂交免疫提供了最强的保护。然而,由于癌症患者,特别是最近确诊的癌症患者,患严重疾病的基线风险较高,因此接种疫苗可产生更大的个人和公共卫生效益。
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引用次数: 0
Engineering Anti-Tumor Immunity: An Immunological Framework for mRNA Cancer Vaccines. 工程抗肿瘤免疫:mRNA肿瘤疫苗的免疫学框架。
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-03 DOI: 10.3390/vaccines13121222
Olivia Roy, Karen S Anderson

The landscape of cancer immunotherapy has been redefined by mRNA vaccines as rapid clinically viable strategies that help induce potent, tumor-specific immune responses. This review highlights the current advances in mRNA engineering and antigen design to establish an integrated immunological framework for cancer vaccine development. Achieving durable clinical benefit requires more than antigen expression. Effective vaccines need precise epitope selection, optimized delivery systems, and rigorous immune monitoring. The field is shifting from merely inducing immune responses to focusing more on the biochemistry and molecular design principles that combine magnitude, polyfunctionality, and longevity to overcome tumor-induced immune suppression. We examine an integrated immunological framework for mRNA cancer vaccine development, examining how rational molecular engineering of vaccine components, from nucleoside modifications and codon optimization to untranslated regions and linker sequences, shapes immunogenicity and therapeutic efficacy. Future directions will depend on balancing combinatorial strategies combining vaccination with immune checkpoint inhibitors and adoptive cell therapies.

mRNA疫苗作为一种快速临床可行的策略,有助于诱导有效的肿瘤特异性免疫反应,重新定义了癌症免疫治疗的前景。本文综述了mRNA工程和抗原设计的最新进展,以建立癌症疫苗开发的综合免疫学框架。获得持久的临床效益需要的不仅仅是抗原表达。有效的疫苗需要精确的表位选择、优化的递送系统和严格的免疫监测。该领域正在从仅仅诱导免疫反应转向更多地关注生物化学和分子设计原理,这些原理结合了大小、多功能性和寿命来克服肿瘤诱导的免疫抑制。我们研究了mRNA癌症疫苗开发的综合免疫学框架,研究了疫苗成分的合理分子工程,从核苷修饰和密码子优化到非翻译区和连接子序列,如何塑造免疫原性和治疗效果。未来的方向将取决于平衡组合策略结合疫苗接种与免疫检查点抑制剂和过继细胞疗法。
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引用次数: 0
Humoral Response in Cattle Vaccinated with the Heterologous Sheeppox Virus Vaccine for Protection Against Lumpy Skin Disease: A Field Study. 牛接种异源羊痘病毒疫苗预防肿块性皮肤病的体液反应:实地研究。
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-03 DOI: 10.3390/vaccines13121221
Anna M Lyapina, Natalya V Kichemazova, Maxim S Lavrukhin, Yuri V Saltykov, Sergey S Zaytsev, Olga S Larionova, Valentina A Feodorova

Background/objectives: Lumpy skin disease (LSD) is a notifiable disease due to a marked potency for rapid spread and a significant negative economic impact on agriculture worldwide. As such, vaccination is considered the most effective way to control the disease in endemic countries, and the serological response to homologous LSDV-based vaccines is widely investigated. However, less is known about the seroconversion and duration of the immune response that is elicited by live attenuated heterologous vaccines based on the Sheeppox virus (SPPV) used for LSD prevention. This study aimed to investigate the humoral immune response in cattle immunized with a heterologous SPPV-based vaccine in the field.

Methods: Commercial ELISA, based on P32 protein, as well as immunoblotting, were used to assess the antibody response in 6-month-old, 17-month-old, and older animals before and after the first immunization and revaccination.

Results: Only a secondary immune response was detected when using commercial ELISA in revaccinated animals in each of the groups (83.3% and 30%, respectively). A comparative bioinformatic analysis proved a marked polymorphism of P32, derived from LSDV/SPPV/GTPV, which potentially resulted in negative responses in the ELISA. However, immunoblotting revealed a 100% seroconversion in vaccinated animals after the first vaccination and revaccination. Notably, specific antibodies were found in the sera of 80% of 6-month-old calves before the first vaccination, which had probably been passively transferred from their mothers, who were multiply vaccinated with SPPV-based vaccines.

Conclusions: Several immunodominant antigens were able to induce a humoral immune response in cattle to the SPPV-based vaccine after passive and active immunization, serving as promising markers for a humoral immune response to heterologous vaccines.

背景/目的:肿块性皮肤病(LSD)是一种必须报告的疾病,因为它具有明显的快速传播潜力,并对全世界的农业产生重大的负面经济影响。因此,在流行国家,疫苗接种被认为是控制疾病的最有效方法,并且对基于lsdv的同源疫苗的血清学反应进行了广泛调查。然而,对用于预防LSD的基于羊痘病毒(SPPV)的减毒异源活疫苗所引发的血清转化和免疫反应的持续时间知之甚少。本研究旨在研究牛外源sppv疫苗在野外免疫后的体液免疫反应。方法:采用基于P32蛋白的商业ELISA和免疫印迹法,对6月龄、17月龄和年龄较大的动物首次免疫和再接种前后的抗体反应进行评估。结果:在每组再次接种的动物中,使用商用ELISA只检测到二次免疫应答(分别为83.3%和30%)。比较生物信息学分析证实,LSDV/SPPV/GTPV衍生的P32基因存在明显的多态性,这可能导致ELISA检测结果为阴性。然而,免疫印迹显示,接种过疫苗的动物在第一次接种和再次接种后血清转化为100%。值得注意的是,在第一次接种前,在80%的6个月大的小牛的血清中发现了特异性抗体,这些抗体可能是被动地从它们的母亲那里转移过来的,它们的母亲多次接种了sppv疫苗。结论:几种免疫优势抗原在被动和主动免疫后能够诱导牛对sppv疫苗产生体液免疫应答,这是对异源疫苗产生体液免疫应答的有希望的标记物。
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引用次数: 0
Impact of a Universal Nirsevimab Prevention Program Against Respiratory Syncytial Virus Bronchiolitis in Infants in Sicily (Italy) During the 2024-2025 Epidemic Season: A Retrospective Cohort Study. 2024-2025年流行季节西西里岛(意大利)婴儿普遍使用尼西维单抗预防呼吸道合胞病毒细支气管炎的影响:一项回顾性队列研究
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-02 DOI: 10.3390/vaccines13121219
Claudio Costantino, Emanuele Amodio, Rosario Asciutto, Costanza Affranchi, Franco Belbruno, Nicole Bonaccorso, Sonia Cilia, Fabio Massimo Contarino, Vincenzo Di Gaetano, Francesco Di Gregorio, Angelo Foresta, Roberto Furnari, Flavio Genna, Dario Genovese, Gabriele Giorgianni, Carmelo Massimo Maida, Sara Palmeri, Giovanna Parrino, Alessandra Piazza, Sebastiano Pollina Addario, Giovanni Tinervia, Fabio Tramuto, Francesco Vitale

Objectives: The introduction of universal prophylaxis with Nirsevimab represents a major innovation in preventing respiratory syncytial virus (RSV) infections in newborns. In Sicily, Nirsevimab administration began on 1 November 2024, for all newborns under one year and at-risk infants during the 2024-2025 season. This study assessed the real-world impact of this strategy in reducing RSV-related hospitalizations. Methods: This retrospective cohort study examined newborns residing in Sicily from 2015 to May 2025, evaluating hospitalization incidence rates attributable to RSV during the first year of life. RSV hospitalizations were identified using ICD-9 codes (079.6, 466.11, 480.1) in any diagnostic position. Incidence rates in the 2024-2025 season (intervention period) were compared with preceding seasons. Results: During the study period, 4431 RSV hospitalization cases occurred (19.84 cases per 1000 person-years), peaking in 2023-2024 (53.47 cases per 1000 person-years). A statistically significant 40% reduction in RSV hospitalizations was observed during the 2024-2025 season (October-April) compared with the preceding season, with a relative reduction ranging between 33.4% and 54.8% across sensitivity models. Conclusions: These results confirm the significant impact of the universal prophylaxis program in real-world practice, consistent with other European programs. These findings support universal RSV prevention strategies and provide insights for optimizing regional and national health policies.

目的:在新生儿呼吸道合胞病毒(RSV)感染预防方面,采用尼塞维单抗进行普遍预防是一项重大创新。在西西里岛,2024年11月1日开始对2024-2025年期间一岁以下的所有新生儿和高危婴儿使用Nirsevimab。本研究评估了该策略在减少rsv相关住院方面的实际影响。方法:本回顾性队列研究调查了2015年至2025年5月居住在西西里岛的新生儿,评估出生后第一年因呼吸道合胞病毒住院的发生率。使用ICD-9代码(079.6,466.11,480.1)在任何诊断位置确定RSV住院病例。将2024-2025年季节(干预期)的发病率与前几个季节进行比较。结果:研究期间共发生4431例RSV住院病例(19.84例/ 1000人-年),2023-2024年达到高峰(53.47例/ 1000人-年)。与前一个季节相比,在2024-2025年季节(10月至4月)观察到RSV住院率在统计学上显著降低40%,各敏感性模型的相对降低幅度在33.4%至54.8%之间。结论:这些结果证实了普遍预防项目在实际实践中的显著影响,与其他欧洲项目一致。这些发现支持普遍的RSV预防策略,并为优化区域和国家卫生政策提供见解。
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引用次数: 0
Interactive, Narrative-Based Digital Health Interventions for Vaccine Communication: Scoping Review. 交互式,基于叙述的数字健康干预疫苗传播:范围审查。
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-02 DOI: 10.3390/vaccines13121220
Ahmed Haji Said, Fiona Syed, Isabelle Ma, Rida Akbar, Nidhi Ramprasad, Erin E Reardon, Robert A Bednarczyk, Kate Winskell, Lavanya Vasudevan

Background: Interactive, narrative-based digital health interventions may positively influence vaccination-related attitudes, intentions, and uptake. However, evidence on their implementation and evaluation for vaccine communication has not yet been comprehensively synthesized. Our research questions (RQs) were to describe the use of interactive, narrative-based digital health interventions for vaccine communication (RQ1), their impact on individuals' vaccine intention or uptake (RQ2), and factors associated with their implementation (RQ3). Methods: A scoping review was conducted using Arksey and O'Malley's 5-stage framework and the PRISMA-ScR guidelines. We searched PubMed, Embase, Scopus, Web of Science, CINAHL, and PsycINFO from inception to 18 April 2023. To be included in the review, studies had to include empirical findings from primary data collection, address vaccine communication, use narrative communication that enabled audience engagement (i.e., interactivity), and deliver the narrative through a digital health device or modality. Results: The search identified 6834 records, with 25 studies meeting the inclusion criteria. For RQ1, the interventions most often focused on HPV vaccination (12 studies). Communication objectives included addressing vaccine hesitancy and increasing vaccination confidence or knowledge. Intervention delivery formats included multi-device compatibility (utilizing more than one device type, 7 studies) and incorporated interactive features, such as gamification and push notifications. Invented narratives were the most frequent narrative approach (8 studies). For RQ2, vaccination outcomes were reported in nearly half the studies (12 studies), with vaccination intention assessed in 8 studies and both vaccination intention and uptake assessed in 4 studies. For RQ3, implementation factors were reported in nearly half the studies (12 studies), with the most frequently reported outcome being acceptability (6 studies). Conclusions: Evidence supporting interactive, narrative-based digital health interventions for vaccine communication can be strengthened by diversifying narrative strategies, expanding the range of interactivity modalities tested, and focusing on a broader range of vaccines. Further research is needed to assess the effectiveness of these interventions, particularly of vaccine uptake. The insights from this scoping review may inform the development of novel future interventions for vaccine communication. The generalizability of these findings may be limited by the small number of studies in some categories and the preponderance of studies from high-income settings.

背景:交互式、基于叙述的数字卫生干预措施可能对疫苗接种相关的态度、意图和吸收产生积极影响。然而,关于疫苗传播的实施和评价的证据尚未得到全面综合。我们的研究问题(rq)是描述在疫苗沟通(RQ1)中使用交互式、基于叙述的数字健康干预措施,它们对个人疫苗意向或摄取(RQ2)的影响,以及与实施(RQ3)相关的因素。方法:采用Arksey和O'Malley的5阶段框架和PRISMA-ScR指南进行范围审查。我们检索了PubMed, Embase, Scopus, Web of Science, CINAHL和PsycINFO从成立到2023年4月18日。要纳入审查,研究必须包括来自主要数据收集的实证结果,解决疫苗传播问题,使用能够使受众参与(即互动性)的叙事传播,并通过数字卫生设备或模式传递叙事。结果:检索到6834条记录,其中25项研究符合纳入标准。对于RQ1,干预措施通常集中于HPV疫苗接种(12项研究)。沟通目标包括解决疫苗犹豫问题和增加疫苗接种信心或知识。干预交付格式包括多设备兼容性(使用多种设备类型,7项研究),并结合互动功能,如游戏化和推送通知。虚构叙事是最常见的叙事方法(8项研究)。对于RQ2,近一半的研究(12项研究)报告了疫苗接种结果,8项研究评估了疫苗接种意图,4项研究评估了疫苗接种意图和摄取。对于RQ3,近一半的研究(12项研究)报告了实施因素,最常见的报告结果是可接受性(6项研究)。结论:可以通过多样化叙述策略、扩大所测试的互动模式的范围以及侧重于更广泛的疫苗,来加强支持用于疫苗传播的交互式、基于叙述的数字卫生干预的证据。需要进一步的研究来评估这些干预措施的有效性,特别是疫苗接种的有效性。这一范围审查的见解可能为未来疫苗传播的新型干预措施的发展提供信息。这些发现的普遍性可能受到某些类别的研究数量较少和高收入环境的研究优势的限制。
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引用次数: 0
Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV. RSVpreF疫苗在HIV感染孕妇中的安全性、耐受性和免疫原性
IF 5.2 3区 医学 Q1 IMMUNOLOGY Pub Date : 2025-12-01 DOI: 10.3390/vaccines13121218
Landon Myer, Emily Wasserman, Saiqa Tabasum, Emma Shittu, Yanping Liu, Lisa Jose, Elizea Horne, Robert S Moraba, Agatha Wilhase, Heather J Zar, Nazreen Hussen, Mokgadi S Mogashoa, Mookho Malahleha, Shabir A Madhi, Uzma N Sarwar, Hasra Snaggs, Rahsan Erdem, David Radley, Elena V Kalinina, Barbara A Pahud, Maria Maddalena Lino, Olympia Evdoxia Anastasiou, Kena A Swanson, Annaliesa S Anderson, Alejandra Gurtman, Iona Munjal

Background/Objectives: HIV-exposed uninfected (HEU) infants experience increased severe respiratory syncytial virus lower respiratory tract illness (RSV-LRTI) rates compared with HIV-unexposed infants. Maternal bivalent RSVpreF vaccination can prevent infant RSV-LRTI but data from HEU infants are lacking. Methods: This phase 3 randomized, double-blinded trial assessed RSVpreF safety and immunogenicity in pregnant participants from South Africa living with HIV and their infants. Maternal participants with stable HIV disease taking antiretroviral therapy received RSVpreF or placebo (24-36 weeks' gestation). Primary safety endpoints included reactogenicity through 7 days after vaccination (maternal participants), adverse events (AEs) through 1 month after vaccination (maternal participants) or birth (infants), and serious AEs (SAEs) throughout the study (maternal participants) or through 6 months after birth (infants). Immune responses were evaluated by 50% RSV-A and RSV-B neutralizing titers prevaccination and at delivery (maternal participants) or birth (infants). Results: Overall, 343 maternal participants received RSVpreF (n = 172) or placebo (n = 171). Most reactogenicity events were mild/moderate. AEs and SAEs were generally reported at similar frequencies in maternal RSVpreF and placebo groups including percentages of hypertensive disorders of pregnancy. There were no safety concerns in infants; percentages of reported AEs and SAEs were generally similar between RSVpreF and placebo groups and no difference in preterm birth. RSVpreF elicited high maternal neutralizing RSV-A and RSV-B immune responses, with efficient RSV antibody transplacental transfer to infants demonstrated by levels greater than the placebo group at birth (geometric mean ratios (GMRs) of RSVpreF to placebo were 7.8 for RSV-A and 6.8 for RSV-B) and by comparison with a cohort of HIV-unexposed infants from the pivotal phase 3 efficacy trial (GMRs of HEU to HIV-unexposed infants were 0.86 for RSV-A and 0.72 for RSV-B). Conclusions: These results support maternal RSVpreF vaccination among those living with stable HIV for preventing RSV-LRTI in HEU infants. (NCT06325657).

背景/目的:与未接触hiv的婴儿相比,hiv暴露的未感染(HEU)婴儿出现严重呼吸道合胞病毒下呼吸道疾病(RSV-LRTI)的比例增加。母亲二价rsv - pref疫苗接种可以预防婴儿RSV-LRTI,但缺乏HEU婴儿的数据。方法:这项3期随机双盲试验评估了RSVpreF在南非感染艾滋病毒的孕妇及其婴儿中的安全性和免疫原性。在妊娠24-36周时,接受抗逆转录病毒治疗的HIV病情稳定的母亲参与者接受RSVpreF或安慰剂治疗。主要安全终点包括疫苗接种后7天(母亲参与者)的反应原性,疫苗接种后1个月(母亲参与者)或出生后(婴儿)的不良事件(ae),以及整个研究期间(母亲参与者)或出生后6个月(婴儿)的严重ae (sae)。免疫应答通过50% RSV-A和RSV-B中和滴度进行评估,预防接种和分娩时(母亲参与者)或分娩时(婴儿)。结果:总体而言,343名母亲参与者接受了RSVpreF (n = 172)或安慰剂(n = 171)。大多数反应性事件为轻度/中度。在母体RSVpreF组和安慰剂组中,包括妊娠期高血压疾病的百分比,ae和SAEs的报告频率一般相似。婴儿没有安全问题;在RSVpreF组和安慰剂组之间,报告的ae和sae的百分比大致相似,在早产方面没有差异。RSVpreF引起了高的母体中和RSV- a和RSV- b免疫应答,与出生时安慰剂组相比,婴儿的RSV抗体经胎盘转移效率更高(RSV- a和RSV- b的RSVpreF与安慰剂的几何平均比(GMRs)为7.8,RSV- b为6.8),并且与关键3期疗效试验中未暴露的婴儿队列进行比较(HEU与未暴露的婴儿的GMRs为0.86,RSV- b为0.72)。结论:这些结果支持在携带稳定HIV病毒的孕妇中接种RSVpreF疫苗,以预防HEU婴儿的RSV-LRTI。(NCT06325657)。
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引用次数: 0
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Vaccines
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