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Opportunities and challenges of immuno-oncology: A bibliometric analysis from 2014 to 2023. 免疫肿瘤学的机遇与挑战:2014年至2023年的文献计量分析。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-01-30 DOI: 10.1080/21645515.2024.2440203
Siqi Zhang, Lina Miao, Xiaoxia Tian, Bingxu Yang, Baoping Luo

The emergence of immuno-oncology (IO) has led to revolutionary changes in the field of cancer treatment. Despite notable advancements in this field, a thorough exploration of its full depth and extent has yet to be performed. This study provides a comprehensive overview of publications pertaining to IO. Publications on IO from 2014 to 2023 were retrieved by searching the Web of Science Core Collection database (WoSCC). VOSviewer software and Citespace software were used for the visualized analysis. A total of 1,874 articles have been published in the IO domain. The number of publications and citations has been increasing annually. This study also examines the primary research directions within the field of IO. In conclusion, this study offers a comprehensive overview of the opportunities and challenges associated with IO, illuminating the current status of research and indicating potential future trajectories in this rapidly progressing field. This study provides a comprehensive survey of the current research status and hot spots within the field of IO. It will assist researchers in comprehending the current research emphasis and development trends in this field and offers guidance for future research directions.

免疫肿瘤学(IO)的出现导致了癌症治疗领域的革命性变化。尽管这一领域取得了显著进展,但尚未对其全部深度和范围进行彻底的探索。本研究提供了有关IO的出版物的全面概述。通过Web of Science Core Collection数据库(WoSCC)检索2014 ~ 2023年关于IO的出版物。采用VOSviewer软件和Citespace软件进行可视化分析。IO领域共发表了1874篇文章。出版物和引用的数量每年都在增加。本研究还探讨了IO领域的主要研究方向。总之,本研究提供了与IO相关的机遇和挑战的全面概述,阐明了研究的现状,并指出了这一快速发展领域的潜在未来轨迹。本研究对IO领域的研究现状和研究热点进行了全面的综述。它将帮助研究者了解当前该领域的研究重点和发展趋势,并为未来的研究方向提供指导。
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引用次数: 0
An mRNA vaccine candidate encoding cholera toxin subunit B and conserved antigens of influenza viruses confers cross-protection against influenza a viruses in adult and aged mice. 一种编码霍乱毒素亚基B和流感病毒保守抗原的mRNA候选疫苗在成年和老年小鼠中对甲型流感病毒具有交叉保护作用。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-16 DOI: 10.1080/21645515.2025.2453304
Liang Xu, Zhihao Yu, Yifan Xu, Qin Wang, Guiqin Wang, Benchi Li, Qian Weng, Yongxiang Yi, Junwei Li

Currently, vaccination with influenza vaccines is still an effective strategy to prevent infection by seasonal influenza virus. However, seasonal influenza vaccines frequently fail to induce effective immune protection against rapidly changing seasonal influenza viruses and emerging zoonotic influenza viruses. In addition, seasonal influenza vaccines may not confer potent protection in elderly and immunocompromised individuals. There is an urgent need to develop potent broad-spectrum influenza vaccines to address this problem. Herein, we designed an mRNA-based broad-spectrum influenza vaccine candidate encoding cholera toxin subunit B and conserved antigens of influenza viruses. In both adult and aged mice, this universal influenza mRNA vaccine candidate stimulated robust T-cell and humoral immune responses and conferred effective protection against broad-spectrum influenza viruses in both adult and aged mice.

目前,接种流感疫苗仍是预防季节性流感病毒感染的有效策略。然而,季节性流感疫苗往往不能对迅速变化的季节性流感病毒和新出现的人畜共患流感病毒产生有效的免疫保护。此外,季节性流感疫苗可能不能对老年人和免疫功能低下的个体提供有效保护。迫切需要开发强效的广谱流感疫苗来解决这一问题。在此,我们设计了一种基于mrna的广谱流感候选疫苗,该疫苗编码霍乱毒素亚基B和流感病毒的保守抗原。在成年和老年小鼠中,这种通用流感mRNA候选疫苗刺激了强大的t细胞和体液免疫反应,并在成年和老年小鼠中有效地保护了广谱流感病毒。
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引用次数: 0
A 10-year knowledge mapping of T cells in rheumatoid arthritis: A bibliometric analysis. 类风湿关节炎中T细胞的十年知识图谱:文献计量学分析。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-17 DOI: 10.1080/21645515.2025.2450855
Yanfang Gao, Yang Liu, Huiqin Hao

Rheumatoid arthritis (RA) is a chronic inflammatory joint disease of autoimmune origin. T cells play crucial roles in the initiation and progression of RA. Although bibliometric methods have been widely used to synthesize knowledge trajectories across different biomedical fields, it has hardly been used to underscore the knowledge trends in relation to T cell and RA. This study used bibliometric methods to delineate the evolution of research on T cells and RA. Data were sourced from the Web of Science™ Core Collection and were scientometrically analyzed using CiteSpace and VOSviewer. From 2014 to 2023, 7037 papers on T cells and RA were retrieved. The number of annual publications is stable between 600 and 800, and the citation frequency continues to rise. The United States, China, the United Kingdom and Japan were the most productive countries. Karolinska Institute, and Harvard Medical School were the institutions that published the most research papers. Wei W, Cho ML, and Park SH were the most prolific authors. Mclnnes IB and Smolen JS were the most frequently cited authors. The journals with the most articles are Frontiers in Immunology, Arthritis Research & Therapy, and Arthritis & Rheumatology. Current research hotspots include pathogenic factors and targeted biological therapy, immune mechanisms, inflammatory mechanisms, and bone destruction mechanisms. The current research frontiers in this field are gut microbiota, identification, fibroblast-like synoviocytes, biologic therapy, mesenchymal stem cells, and risk. This work provides new insights into the scientific research and clinical application of T cells to develop therapeutic targets for RA.

类风湿性关节炎(RA)是一种慢性炎症性关节疾病的自身免疫性起源。T细胞在RA的发生和发展中起着至关重要的作用。虽然文献计量学方法已被广泛用于综合不同生物医学领域的知识轨迹,但它很少被用于强调与T细胞和RA相关的知识趋势。本研究使用文献计量学方法来描述T细胞和RA研究的演变。数据来源于Web of Science™Core Collection,使用CiteSpace和VOSviewer进行科学计量学分析。2014 - 2023年共检索到T细胞与RA相关论文7037篇。年发表数稳定在600 ~ 800篇之间,被引频次持续上升。美国、中国、英国和日本是生产率最高的国家。卡罗林斯卡学院和哈佛医学院是发表研究论文最多的机构。魏伟、赵茂林、朴诗是最多产的作者。Mclnnes IB和Smolen JS是最常被引用的作者。文章最多的期刊是免疫学前沿、关节炎研究与治疗、关节炎与风湿病学。目前的研究热点包括致病因素及靶向生物治疗、免疫机制、炎症机制、骨破坏机制等。目前该领域的研究前沿是肠道微生物群、鉴定、成纤维细胞样滑膜细胞、生物治疗、间充质干细胞和风险。这项工作为T细胞开发RA治疗靶点的科学研究和临床应用提供了新的见解。
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引用次数: 0
A narrative review on the effectiveness of PPSV23 vaccination in adults in China. 中国成人PPSV23疫苗接种效果的述评
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-03-18 DOI: 10.1080/21645515.2024.2440955
Weiyan Zhang, Peng Bai, Weijun Hu

Pneumococcal Polysaccharide Vaccine (PPSV23) is available for free in some Chinese cities for elderly patients and those with comorbidities. However, there is a lack of studies summarizing its preventive effect specifically in Chinese adults. This review aims to discuss the epidemiology of pneumococcal disease, coverage and effectiveness of PPSV23 vaccination, elderly individuals and patients with comorbidities, coadministration of PPSV23 vaccine with other vaccines, and future directions for its use in China. It was found that the PPSV23 vaccination rate among the elderly ranged from 1.2% to 42.1% depending on location, with an effectiveness of 9.34%(95%CI: 2.05%, 16.62%) to 57.7%(95%CI: 20.7%, 77.5%). There is a need to raise awareness of pneumococcal disease and its prevention, especially in China. To better manage pneumococcal disease in China, developing new vaccines for common serotypes and continuously monitoring serotype distribution associated with the disease is also needed.

肺炎球菌多糖疫苗(PPSV23)在中国一些城市免费提供给老年患者和有合并症的患者。然而,目前还缺乏专门总结其在中国成人中的预防作用的研究。本综述旨在探讨肺炎球菌疾病的流行病学、PPSV23疫苗接种的覆盖率和有效性、老年人和合并症患者、PPSV23疫苗与其他疫苗的联合使用以及未来在中国的应用方向。结果发现,老年人PPSV23疫苗接种率根据地区的不同在1.2% ~ 42.1%之间,有效率为9.34%(95%CI: 2.05%, 16.62%) ~ 57.7%(95%CI: 20.7%, 77.5%)。有必要提高对肺炎球菌病及其预防的认识,特别是在中国。为了更好地管理中国的肺炎球菌疾病,还需要开发针对常见血清型的新疫苗,并持续监测与该疾病相关的血清型分布。
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引用次数: 0
Streptococcus pneumoniae serotype distribution in low- and middle-income countries of South Asia: Do we need to revisit the pneumococcal vaccine strategy? 南亚低收入和中等收入国家肺炎链球菌血清型分布:我们是否需要重新审视肺炎球菌疫苗战略?
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-25 DOI: 10.1080/21645515.2025.2461844
Priya Dhawale, Sanket Shah, Kaushal Sharma, Deepa Sikriwal, Varnik Kumar, Arnabjyoti Bhagawati, Sakshi Dhar, Pratiksha Shetty, Syed Ahmed

S. pneumoniae serotypes responsible for pneumococcal disease differ with respect to disease severity, invasiveness, antimicrobial susceptibility, geographies, immunization history, age groups, and with time. Although PCVs have blunted the pneumococcal disease burden, they are plagued with numerous challenges, especially the emergence of NVTs. In this review, we show that there are diverse serotypes, especially NVTs, responsible for causing pneumococcal diseases in LMICs of South Asia across different studies conducted between 2012 and 2024. We propose that pharmaceutical/biotech companies should tailor/customize the PCVs as per the region-specific serotype prevalence based on surveillance data. Furthermore, protein-based vaccines, or WCVs, have been explored and can serve as viable alternatives to address the limitations associated with PCVs. However, robust studies are warranted in different geographies to demonstrate its efficacy and safety in clinical trials as well as the real-world effectiveness of these promising candidates.

导致肺炎球菌疾病的肺炎链球菌血清型在疾病严重程度、侵袭性、抗菌素敏感性、地理位置、免疫接种史、年龄组和时间方面存在差异。尽管pcv减轻了肺炎球菌疾病负担,但它们面临着许多挑战,特别是nvt的出现。在这篇综述中,我们发现在2012年至2024年间进行的不同研究中,存在不同的血清型,特别是nvt,导致南亚低收入国家的肺炎球菌疾病。我们建议制药/生物技术公司应根据监测数据根据地区特定血清型患病率量身定制pcv。此外,已经探索了基于蛋白质的疫苗(wcv),可以作为解决与pcv相关的局限性的可行替代方案。然而,需要在不同地区进行强有力的研究,以证明其在临床试验中的有效性和安全性,以及这些有希望的候选药物的实际有效性。
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引用次数: 0
Meningococcal vaccination disparities in the United States (2010-2021): Findings from the National Immunization Survey-Teen and a commercial insurance database. 美国脑膜炎球菌疫苗接种差异(2010-2021):来自国家免疫调查-青少年和商业保险数据库的发现
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-03-19 DOI: 10.1080/21645515.2025.2479338
Oscar Herrera-Restrepo, Marta Kwiatkowska, Samuel Huse, Nelson Ndegwa, Zeki Kocaata, Michael L Ganz

In the United States, while meningococcal vaccines are available and recommended for adolescents and young adults, coverage remains low and disparities persist. We evaluated meningococcal serogroups A, C, W, Y (MenACWY) and B (MenB) vaccine uptake, completion, and compliance using a cross-sectional analysis of National Immunization Survey-Teen (NIS-Teen) data (2015-2021) and a cohort analysis of commercial claims data (2010-2021). Regression models were used to identify factors associated with vaccine uptake. Included in the NIS-Teen MenACWY and MenB analyses were 138,952 and 177,077 patients, respectively. Included in the claims MenACWY and MenB analyses were 953,905 and 818,424 patients, respectively. In 2021, MenACWY uptake was 86.4% (95% confidence interval [CI]: 83.6-88.8%) among ≤13-year-olds (NIS-Teen) and 63.2% (62.8-63.5%) among 11-12-year-olds (claims). MenB was 33.7% (30.5-37.1%) among ≤17-year-olds (NIS-Teen), 41.6% (41.2-42.0%) among 16-18-year-olds (claims), and 15.0% (14.7-15.4%) among 19-23-year-olds (claims). The states with the lowest and highest MenB uptake by ≤17-year-olds in 2021 (NIS-Teen) were Minnesota (10.1% [3.9-23.6%]) and North Dakota (69.9% [52.1-83.2%]). Factors associated with MenACWY uptake included living in a state with a vaccine mandate, Black or Hispanic race (versus White), and well-child visit attendance. Factors associated with MenB uptake included having Medicaid (versus private insurance) and Hispanic race (versus White). The findings suggest that meningococcal vaccination coverage disparities persist across vaccines, age, geography, and race and ethnicity. Higher MenACWY (versus MenB) coverage suggests the benefit of routine recommendations. Annual well-child visits and simplified vaccination schedules could reduce vaccination access barriers.

在美国,虽然可以获得脑膜炎球菌疫苗,并建议青少年和年轻人接种,但覆盖率仍然很低,差距仍然存在。我们通过全国免疫调查-青少年(NIS-Teen)数据(2015-2021)的横断面分析和商业索赔数据(2010-2021)的队列分析,评估了脑膜炎球菌血清群A、C、W、Y (MenACWY)和B (MenB)疫苗的摄取、完成和依从性。回归模型用于确定与疫苗摄取相关的因素。NIS-Teen MenACWY和MenB分析分别包括138,952例和177,077例患者。MenACWY和MenB分析分别包括953,905例和818,424例患者。2021年,≤13岁儿童(NIS-Teen)的MenACWY摄取率为86.4%(95%可信区间[CI]: 83.6-88.8%), 11-12岁儿童(claims)的MenACWY摄取率为63.2%(62.8-63.5%)。MenB在≤17岁人群(NIS-Teen)中占33.7%(30.5-37.1%),16-18岁人群(索赔)中占41.6%(41.2-42.0%),19-23岁人群(索赔)中占15.0%(14.7-15.4%)。2021年(NIS-Teen)≤17岁儿童MenB感染率最低和最高的州是明尼苏达州(10.1%[3.9-23.6%])和北达科他州(69.9%[52.1-83.2%])。与MenACWY摄入相关的因素包括生活在强制接种疫苗的州,黑人或西班牙裔(相对于白人),以及儿童出诊率。与MenB摄取相关的因素包括医疗补助(与私人保险相比)和西班牙裔种族(与白人相比)。研究结果表明,脑膜炎球菌疫苗接种覆盖率的差异在疫苗、年龄、地理、种族和民族之间持续存在。较高的MenACWY(相对于MenB)覆盖率表明常规推荐的好处。每年对儿童进行健康检查和简化疫苗接种时间表可以减少疫苗接种障碍。
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引用次数: 0
Patient preferences toward herpes zoster vaccination among individuals aged 50 years or older in South Korea: Findings from a discrete choice experiment. 韩国50岁以上患者对带状疱疹疫苗接种的偏好:离散选择实验的结果。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-03-10 DOI: 10.1080/21645515.2025.2469419
Sumitra Shantakumar, Eun Ju Choo, Raunak Parikh, Taeyeon Kwon, Hyungwoo Kim, Lawrence Vandervoort, Vince Grillo, Jacob Lee

In South Korea, the increasing incidence of herpes zoster (HZ) and aging population warrant consideration of HZ vaccination for older adults. There is a need to understand the HZ vaccine-related preferences of adults aged ≥50 years and adult children (working or financially independent adults contributing to healthcare decision-making for their parents aged ≥50 years). A discrete choice experiment was conducted to elicit HZ vaccine preferences of the HZ-naïve general public aged ≥50 years (n = 500), current/former HZ patients aged ≥50 years (n = 150), and adult children (n = 150). An online questionnaire was administered through March-May 2023; for each preference-elicitation question, respondents selected between three hypothetical HZ vaccine profiles, characterized by five attributes with varying levels, or "no vaccine". Respondents generally accepted an increased number of doses (from one to two) for a longer protection duration (from ≥4 to ≥7 or ≥10 years). By mean relative importance (RI), protection duration (RI: 37.1%; 95% confidence interval [CI]: 36.0%, 38.1%), lifetime HZ risk reduction (27.3%; 95% CI: 26.3%, 28.4%) and short-term side effects (14.9%; 95% CI: 14.1%, 15.6%) had the strongest impact on respondents' HZ vaccine decision-making. Adult children viewed short-term side effects with significantly greater RI than the general public and current/former HZ patients (19.1%, 13.5%, 15.2%, respectively, p < .001). Respondents with selected comorbidities placed higher RI than those without comorbidities on protection duration (39.3% versus 34.2%, p < .001) and lower RI on prevention of HZ-related complications (8.7% versus 10.4%, p = .007). Findings may guide health policy design/refinement and physician-patient conversations on HZ vaccination/vaccines.

在韩国,带状疱疹(HZ)发病率的增加和人口老龄化值得考虑老年人接种HZ疫苗。有必要了解年龄≥50岁的成年人和成年子女(为年龄≥50岁的父母提供医疗保健决策的工作或经济独立的成年人)的HZ疫苗相关偏好。通过离散选择实验,得出HZ-naïve年龄≥50岁的普通公众(n = 500)、年龄≥50岁的当前/曾经的HZ患者(n = 150)和成年儿童(n = 150)对HZ疫苗的偏好。一份在线调查问卷于2023年3月至5月进行;对于每个偏好诱导问题,受访者在三种假设的HZ疫苗概况中进行选择,其特征是五个不同水平的属性,或“无疫苗”。应答者普遍接受增加剂量(从一次到两次)以延长保护时间(从≥4年到≥7年或≥10年)。根据平均相对重要性(RI),保护时间(RI: 37.1%;95%可信区间[CI]: 36.0%, 38.1%),终生HZ风险降低(27.3%;95% CI: 26.3%, 28.4%)和短期副作用(14.9%;95% CI: 14.1%, 15.6%)对应答者的HZ疫苗决策影响最大。成年儿童的短期副作用显著高于普通大众和目前/以前的HZ患者(分别为19.1%,13.5%,15.2%,p p p = .007)。研究结果可以指导卫生政策的设计/完善和关于HZ疫苗接种/疫苗的医患对话。
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引用次数: 0
Global research trends of immunosenescence and immunotherapy: A bibliometric study. 免疫衰老和免疫治疗的全球研究趋势:文献计量学研究。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-24 DOI: 10.1080/21645515.2025.2469403
Wendi Li, Lin Xiao, Haiyang Li, Wei Cui

Immunosenescence refers to the gradual decline in immune system function with age, increasing susceptibility to infections and cancer in the elderly. The advent of novel immunotherapies has revolutionized the field of cancer treatment. However, the majority of patients exhibit poor re-sponses to immunotherapy, with immunosenescence likely playing a significant role. In recent years, significant progress has been made in understanding the interplay between immunosenescence and immunotherapy. Our research aims to explore the prospects and development trends in the field of immunosenescence and immunotherapy using a bibliometric analysis. Relevant articles were collected from the Web of Science Core Collection (WoSCC) (retrieved on July 20, 2024). Primary bibliometric characteristics were analyzed using the R package "Biblio-metrix," and keyword co-occurrence analysis and visualization were conducted using VOSviewer. A total of 213 English-language original research and review articles spanning 35 years were re-trieved for bibliometric analysis. There was a surge in publications in this field starting in 2017. The United States and China contributed the most articles. Frontiers in Immunology was the most productive journal, while the University of California System was the highest contributing institution. Besse Benjamin from France emerged as the most influential researcher in this field. Popular keywords included "nivolumab," "T cells," "dendritic cells," and "regulatory T cells." The "immunosenescence-associated secretory phenotype" has become a new hotspot, with immune checkpoint inhibitors remaining a central theme in this domain. The field of immunosenescence and immunotherapy is entering a phase of rapid development and will continue to hold significant value in future research.

免疫衰老是指随着年龄的增长,免疫系统功能逐渐下降,老年人对感染和癌症的易感性增加。新型免疫疗法的出现使癌症治疗领域发生了革命性的变化。然而,大多数患者对免疫治疗反应不佳,免疫衰老可能起着重要作用。近年来,在了解免疫衰老与免疫治疗之间的相互作用方面取得了重大进展。我们的研究旨在通过文献计量学分析来探讨免疫衰老和免疫治疗领域的前景和发展趋势。相关文章来源于Web of Science Core Collection (wscc)(检索日期:2024年7月20日)。使用R软件包“Biblio-metrix”分析主要文献计量学特征,使用VOSviewer进行关键词共现分析和可视化。共检索了35年来的213篇英语原创研究和评论文章进行文献计量分析。从2017年开始,这一领域的出版物激增。美国和中国贡献的文章最多。《免疫学前沿》是产出最高的期刊,而加州大学系统是贡献最高的机构。法国的贝塞·本雅明是这一领域最具影响力的研究者。热门关键词包括“纳武单抗”、“T细胞”、“树突状细胞”和“调节性T细胞”。“免疫衰老相关的分泌表型”已成为一个新的热点,免疫检查点抑制剂仍然是这一领域的中心主题。免疫衰老和免疫治疗领域正处于快速发展的阶段,在未来的研究中将继续具有重要的价值。
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引用次数: 0
Safety, tolerability, and immunogenicity of pentavalent meningococcal MenABCWY vaccine in healthy infants: A phase 2b randomized clinical trial. 五价脑膜炎球菌menabcy疫苗在健康婴儿中的安全性、耐受性和免疫原性:一项2b期随机临床试验
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-24 DOI: 10.1080/21645515.2025.2463194
Federico Martinon-Torres, Erik Lamberth, Silvina Natalini Martinez, Ignacio Salamanca de la Cueva, Lefteris Zolotas, Islamiat Oladipupo, Jason D Maguire, James Trammel, Robert O'Neill, Paul A Liberator, Paula Peyrani, Luis Jodar, William C Gruber, Annaliesa S Anderson, Johannes Beeslaar

Invasive meningococcal disease is an uncommon but serious disease predominantly affecting children. This phase 2b study evaluated MenABCWY in 6-month-old infants followed by MenB-fHbp and MenABCWY in 2-month-old infants, the latter being the target age and intervention. Participants were randomized to MenABCWY, 60 µg or 120 µg MenB-fHbp+MenACWY-TT, or 4CMenB+MenACWY-TT, administered as 2 primary and 1 booster dose. The primary safety objective was to describe the safety profile of MenABCWY in participants enrolled at 2 months. Primary immunogenicity objectives were the percentage of participants achieving seroprotective serum bactericidal antibody using human complement titers. Overall, 314 and 12 participants were randomized to sentinel cohort and open-label expanded-enrollment stages, respectively. Based on 2 reports of fever requiring invasive investigations and accompanied by cerebrospinal fluid pleocytosis and 1 report arising from a previous study, the Sponsor terminated the study. Local reactions and systemic events after primary vaccination were generally mild to moderate, and tended to be higher with MenABCWY versus 4CMenB+MenACWY-TT. Immunogenicity data suggest that 1 month after vaccination 2, MenABCWY responses for MenA/C/W/Y were robust and comparable with 4CMenB+MenACWY-TT in 2-month-old participants. Immune responses for MenB test strains were higher with MenABCWY versus 4CMenB+MenACWY-TT and generally similar with 60 µg and 120 µg MenB-fHbp+MenACWY-TT or MenABCWY. Based on the limited results, the consistency of MenB immune responses with 60 µg and 120 µg MenB-fHbp suggests doses < 60 µg could be investigated to assess whether a more acceptable safety profile in conjunction with beneficial immune responses is possible in 2-month-old infants.

侵袭性脑膜炎球菌病是一种罕见但严重的疾病,主要影响儿童。这项2b期研究评估了6个月婴儿的MenABCWY,随后是MenB-fHbp和2个月婴儿的MenABCWY,后者是目标年龄和干预措施。参与者被随机分配到menabcy, 60µg或120µg MenB-fHbp+MenACWY-TT,或4CMenB+MenACWY-TT,作为2个主要剂量和1个加强剂量给药。主要的安全性目标是描述menabcvy在2个月时的安全性。主要免疫原性目标是使用人补体滴度获得血清保护性血清杀菌抗体的参与者百分比。总体而言,314名和12名参与者分别被随机分配到哨点队列和开放标签扩大入组阶段。基于2例需要侵入性检查并伴有脑脊液多胞症的发热报告和1例来自先前研究的报告,发起人终止了研究。初次接种后的局部反应和全身事件一般为轻度至中度,与4CMenB+MenACWY-TT相比,MenABCWY的局部反应和全身事件往往更高。免疫原性数据表明,接种1个月后,menabcy对MenA/C/W/Y的应答是稳健的,并且在2个月大的参与者中与4CMenB+MenACWY-TT相当。MenABCWY对MenB试验菌株的免疫应答高于4CMenB+MenACWY-TT,与60µg和120µg MenB- fhbp +MenACWY-TT或MenABCWY基本相似。基于有限的结果,60µg和120µg MenB- fhbp的MenB免疫反应一致性提示剂量
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引用次数: 0
Efficacy, immunogenicity, and safety of heterologous boosting with a novel chimera Chinese mRNA (RQ3013) SARS-CoV-2 vaccine: A randomized, double-blind, active-controlled trial. 新型嵌合体中国mRNA (RQ3013) SARS-CoV-2疫苗异体增强的有效性、免疫原性和安全性:一项随机、双盲、主动对照试验
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-05-16 DOI: 10.1080/21645515.2025.2502250
Xiao-Qiang Liu, Yang-Yang Qi, Tao Huang, Li-Li Huang, Ming-Xuan Zhao, Zhong-Fang Wang, Jun Dai, Yan-Xia Wang, Jing-Jing Chen, Xiao-Yun Yang, Hui-Lan Fan, Xue-Mei Yan, Jian-Chang He, Yan-Xiang Zou, Zhi-Wei Jiang, Zhi-Fei Zhan, Si-Wen Tao, De-Fang Dai, Feng Shi, Qiong-Na Zhang, Xiu-Liang Yang, Xiao-Zhong Li, Wei Li, Jing Lu, Jiang-Bing Zheng, Zhi-Hua Zhang, Gao-Xiang Chen, Hong Su, Wei-Min Gao, Lorenz von Seidlein, Xuan-Yi Wang, Lin Yuan, Jin-Zhong Lin

A randomized, double-blind, controlled phase 3 trial was conducted during a COVID-19 outbreak after the initial, stringent zero-Covid policy was relaxed in three provinces. Eligible adults aged ≥18 years who had received three doses of inactivated COVID-19 vaccines 6 months earlier were randomly assigned in a 1:1 ratio to receive either one intramuscular injection of RQ3013 or ZF2001 vaccine. The primary end point was protection against PCR-confirmed symptomatic SARS-CoV-2 infection with onset at least 7 days after the booster. A total of 3,167 and 3,169 eligible participants received one dose of RQ3013 or ZF2001 vaccine, respectively. COVID-19 illness was confirmed in 91 participants in the ZF2001 group (11.8 per 100 person years; 95% confidence interval [CI]: 9.6-14.6) and in 45 participants in the RQ3013 group (5.7 per 100 person-years; 95% CI: 4.3-7.7) during a 4-month follow-up, resulting in a relative efficacy of 51.7% (95% CI, 30.9-66.2%) (p < .001) in an intention-to-treat analysis. The RQ3013 vaccine was also found to be significantly more immunogenic against omicron BA.5 compared to the ZF2001 vaccine. Moderate, transient adverse reaction after vaccination occurred more frequently in the RQ3013 group than in the ZF2001 group. Serious adverse events (SAEs) were rare and occurred almost equally in two groups. All SAEs were not related to the vaccination. These findings suggest that a chimeric mRNA vaccine design involving multiple antigenic epitopes provides broader protection across subvariants and variants of SARS-CoV-2 than the subunit vaccine ZF2001.

一项随机、双盲、对照的3期试验是在三个省份最初放松严格的零冠政策后进行的。6个月前接种过三剂COVID-19灭活疫苗的年龄≥18岁的符合条件的成年人按1:1的比例随机分配,接受一次肌肉注射RQ3013或ZF2001疫苗。主要终点是预防pcr证实的症状性SARS-CoV-2感染,这种感染在增强疫苗接种后至少7天出现。共有3167名和3169名符合条件的参与者分别接种了一剂RQ3013或ZF2001疫苗。ZF2001组有91名参与者确诊COVID-19疾病(每100人年11.8例;95%可信区间[CI]: 9.6-14.6)和RQ3013组45名参与者(5.7 / 100人-年;95% CI: 4.3-7.7),相对有效率为51.7% (95% CI: 30.9-66.2%)
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引用次数: 0
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Human Vaccines & Immunotherapeutics
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