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Immunogenicity and safety of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults ≥18 years of age in India: A phase 3 single-arm trial. 20价肺炎球菌结合疫苗在印度≥18岁未接种肺炎球菌疫苗的成人中的免疫原性和安全性:一项3期单臂试验
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-01-07 DOI: 10.1080/21645515.2025.2605847
Balachandra Giriappa, Nirmalkumar Choraria, Philip Ponce, Jelena Drozd, Xin Su, Lanyu Lei, Miranda Portka, Seema Pai, Annaliesa Anderson, Kara Bickham, Wendy Watson, Kathleen McElwee

Streptococcus pneumoniae is a leading cause of bacteremia, bacterial meningitis, and pneumonia. In India, there is an unmet need for an expanded valent pneumococcal conjugate vaccine (PCV) to protect older adults. This phase 3, single-arm study evaluated the safety and immunogenicity of 20-valent PCV (PCV20) in adults ≥18 y of age in India. Participants were enrolled into two age groups (18‒49 and ≥50 y old) and received a single dose of PCV20. Immunogenicity endpoints included geometric mean fold rises (GMFRs) in pneumococcal serotype-specific opsonophagocytic activity (OPA) titers from before to 1 month after vaccination. Safety endpoints included percentages of participants reporting local reactions and systemic events within 7 d after vaccination and adverse events (AEs) and serious AEs within 1 month after vaccination. All 400 participants (200 in each age group) received a single dose of PCV20. OPA geometric mean titers substantially increased from baseline to 1 month after PCV20 vaccination for all 20 serotypes. Overall, GMFRs ranged from 5.9 (serotype 14) to 49.8 (23F) for PCV13 serotypes and from 5.4 (11A) to 75.7 (12F) for the 7 additional PCV20 serotypes. Most local reactions and systemic events were mild or moderate in severity and transient. Overall, 2.3% of participants reported any AE through 1 month after vaccination. No related, immediate, severe, or serious AEs were reported. Consistent with previous trials, PCV20 elicited robust immune responses to all 20 serotypes following a single dose and was well tolerated with an acceptable safety profile in Indian adults ≥18 y of age. NCT05875727.

肺炎链球菌是引起菌血症、细菌性脑膜炎和肺炎的主要原因。在印度,对扩大价肺炎球菌结合疫苗(PCV)的需求未得到满足,以保护老年人。这项3期单臂研究评估了20价PCV (PCV20)在印度≥18岁成人中的安全性和免疫原性。参与者被分为两个年龄组(18-49岁和≥50岁),并接受单剂量PCV20。免疫原性终点包括肺炎球菌血清型特异性抗噬细胞活性(OPA)滴度从接种前到接种后1个月的几何平均倍数上升(GMFRs)。安全性终点包括接种疫苗后7天内报告局部反应和全身事件的参与者百分比,以及接种疫苗后1个月内报告的不良事件(ae)和严重ae的百分比。所有400名参与者(每个年龄组200人)接受了单剂PCV20。所有20种血清型的OPA几何平均滴度从基线到接种PCV20后1个月大幅增加。总体而言,PCV13血清型的GMFRs从5.9(14血清型)到49.8 (23F)不等,另外7种PCV20血清型的GMFRs从5.4 (11A)到75.7 (12F)不等。大多数局部反应和全身事件的严重程度为轻度或中度,是短暂的。总体而言,2.3%的参与者在接种疫苗后1个月内报告了任何AE。没有相关的、即时的、严重的或严重的ae报告。与先前的试验一致,PCV20在单次给药后对所有20种血清型均产生了强大的免疫应答,并且在18岁以上的印度成年人中具有良好的耐受性和可接受的安全性。NCT05875727。
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引用次数: 0
Dengue vaccination Knowledge, Attitudes, and Practices among healthcare providers in selected countries from Latin America and Asia Pacific. 拉丁美洲和亚太地区某些国家卫生保健提供者的登革热疫苗接种知识、态度和做法。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-01-26 DOI: 10.1080/21645515.2025.2593730
Eduardo López-Medina, Alberta Di Pasquale, Andrew Green

Healthcare professionals (HCPs) perform an essential role in facilitating dengue vaccine uptake, as they are trusted sources of vaccine information and their perspectives shape both patient acceptance and peer adoption. This study assessed HCPs' Knowledge, Attitudes, and Practices (KAP) regarding dengue vaccination, and identified factors influencing their likelihood to recommend the vaccine to patients ('recommendation') and to encourage colleagues to do the same ('advocacy'). A cross-sectional survey of 815 HCPs in Argentina, Brazil, Colombia, Indonesia, Malaysia, and Thailand was conducted. Globally, composite scores were lower for Knowledge (56%) than Attitudes (70%) and Practices (72%). In multivariate analysis, "Perceived ease of recommending dengue vaccines" (recommendation: regression coefficient 0.30, p < .001; advocacy: regression coefficient 0.23, p < .001) and "Urgency to protect against dengue" (recommendation: regression coefficient 0.37, p < .001; advocacy: regression coefficient 0.23, p < .001) were associated with both recommendation and advocacy. In contrast, "Awareness of severity and risk" (regression coefficient 0.24, p = .015) and "Confidence in available dengue vaccines" (regression coefficient 0.34, p < .001) were associated only with recommendation to patients. These findings highlight the need for targeted educational strategies and behavioral interventions to strengthen physician confidence, address barriers to recommending dengue vaccines, and support peer-to-peer advocacy. Such efforts are essential to improving vaccine uptake and maximizing the public health impact of dengue vaccination.

卫生保健专业人员(HCPs)在促进登革热疫苗的吸收方面发挥着至关重要的作用,因为他们是疫苗信息的可靠来源,他们的观点影响着患者的接受和同伴的采用。本研究评估了医护人员关于登革热疫苗接种的知识、态度和做法(KAP),并确定了影响他们向患者推荐疫苗(“推荐”)和鼓励同事也这样做(“倡导”)的可能性的因素。对阿根廷、巴西、哥伦比亚、印度尼西亚、马来西亚和泰国的815名hcp进行了横断面调查。在全球范围内,知识(56%)的综合得分低于态度(70%)和实践(72%)。在多变量分析中,“推荐登革热疫苗的容易程度”(建议:回归系数0.30,p p p p p =。015)和“对现有登革热疫苗的信心”(回归系数0.34,p
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引用次数: 0
A Capabilities, Opportunities, and Motivations behavioral analysis of healthcare professionals concerning dengue vaccination in selected countries from Latin America and Asia Pacific. 在拉丁美洲和亚太地区选定的国家对卫生保健专业人员进行登革热疫苗接种的能力、机会和动机行为分析。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-01-26 DOI: 10.1080/21645515.2025.2573533
Andrew Green, Alberta Di Pasquale, Eduardo Lopez-Medina

The success of dengue vaccination programs is heavily reliant on endorsement from healthcare professionals (HCPs). This survey of 815 HCPs from Argentina, Brazil, Colombia, Indonesia, Malaysia, and Thailand aimed to identify factors associated with HCPs' willingness to recommend dengue vaccination to patients. Survey responses were mapped to six subthemes within a Capabilities, Opportunities, and Motivations behavioral framework; composite scores were calculated and correlated with willingness to recommend the dengue vaccine. Psychological Capability, Reflective Motivation, and Automatic Motivation emerged as urgent priorities based on moderate correlation with willingness to recommend the vaccine (correlation coefficients 0.50, 0.56, and 0.45, respectively) and moderate scores (57‒58%). Physical Capability was categorized as a critical strength, while Physical and Social Opportunities were lesser priorities. Targeted interventions - including HCP education, risk communication, and peer-led advocacy - are likely to improve recommendation behaviors. Addressing both individual and external drivers is essential for enabling HCPs to recommend dengue vaccination effectively.

登革热疫苗接种规划的成功在很大程度上取决于卫生保健专业人员(HCPs)的认可。这项对来自阿根廷、巴西、哥伦比亚、印度尼西亚、马来西亚和泰国的815名医护人员的调查旨在确定与医护人员向患者推荐登革热疫苗接种意愿相关的因素。调查结果被映射到能力、机会和动机行为框架内的六个子主题;计算综合得分,并与推荐登革热疫苗的意愿相关。心理能力、反思动机和自动动机与推荐疫苗的意愿(相关系数分别为0.50、0.56和0.45)和中等分数(57-58%)之间存在中度相关性,因此成为当务之急。身体能力被归类为关键力量,而身体和社会机会则不那么重要。有针对性的干预措施——包括HCP教育、风险沟通和同行主导的倡导——可能会改善推荐行为。解决个人和外部驱动因素对于使卫生专业人员能够有效地推荐登革热疫苗接种至关重要。
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引用次数: 0
Statement of Retraction: Risk of all-cause and cardiac-related mortality after vaccination against COVID-19: A meta-analysis of self-controlled case series studies. 撤回声明:接种COVID-19疫苗后全因死亡率和心脏相关死亡率的风险:一项自控病例系列研究的荟萃分析。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-01-16 DOI: 10.1080/21645515.2025.2604465
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引用次数: 0
Herpes zoster hospitalization burden in Spain during the initial period of recombinant zoster vaccine implementation. 西班牙实施重组带状疱疹疫苗初期的带状疱疹住院负担。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-01-22 DOI: 10.1080/21645515.2026.2617717
Jose-Maria Blanc, Isabel Jimeno-Sanz, Valentín Hernández-Barrera, Ángel Gil-de-Miguel

Herpes zoster (HZ) is a vaccine-preventable disease with increasing incidence and hospitalization burden, particularly among older adults and immunocompromised individuals, who have an increased risk. In 2021, Spain introduced systematic vaccination with the recombinant zoster vaccine (RZV). We conducted a retrospective, descriptive study using hospital discharge data from the Spanish Minimum Basic DataSet (MBDS) for the years 2022-2023. Hospitalization rates (HR), mortality rates (MR), case fatality rates (CFR), length of stay, comorbidities, and costs were analyzed nationally and for the region of Madrid. A total of 16,277 HZ-related hospitalizations were recorded in Spain, with 80% occurring in individuals aged ≥65 y. The HR was 16.85 per 100,000 inhabitants, and the CFR was 7.44%. In Madrid, 3263 hospitalizations were recorded, with a higher HR (23.73 per 100,000) and CFR (6.41%) compared to the national average. Complicated HZ cases accounted for over 64% of hospitalizations nationally and 69% in Madrid. Total hospitalization costs were €98.1 million in Spain and €21.4 million in Madrid. This is the first study to assess HZ hospitalization burden in Spain and Madrid following the introduction of RZV. The findings highlight the substantial toll of HZ on older and immunocompromised populations. Future studies with longer follow-up are needed to assess vaccine impact.

带状疱疹(HZ)是一种疫苗可预防的疾病,发病率和住院负担不断增加,特别是在老年人和免疫功能低下的个体中,风险增加。2021年,西班牙引入了重组带状疱疹疫苗(RZV)的系统疫苗接种。我们使用西班牙最低基本数据集(MBDS)中2022-2023年的医院出院数据进行了回顾性描述性研究。分析了全国和马德里地区的住院率(HR)、死亡率(MR)、病死率(CFR)、住院时间、合并症和费用。西班牙共记录了16277例与hz相关的住院治疗,其中80%发生在年龄≥65岁的个体中。HR为16.85 / 10万居民,CFR为7.44%。在马德里,有3263人住院,死亡率(每10万人23.73人)和病死率(6.41%)高于全国平均水平。复杂的HZ病例占全国住院病例的64%以上,在马德里占69%。西班牙的住院总费用为9 810万欧元,马德里为2 140万欧元。这是西班牙和马德里引入RZV后评估HZ住院负担的第一项研究。研究结果强调了老年和免疫功能低下人群中HZ的大量死亡。未来需要更长的随访研究来评估疫苗的影响。
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引用次数: 0
Acceptance and the willingness to pay for human papilloma virus (HPV) vaccine: A systematic review. 接受和愿意支付人乳头瘤病毒(HPV)疫苗:系统评价。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-02-04 DOI: 10.1080/21645515.2025.2609345
Soheila Rajaie, Sara Emamgholipour, Samad Azari, Zeinab Karimi, Fereshte Karimi

Human papillomavirus (HPV) is a major global health concern due to its link to cervical and other cancers. Although HPV vaccination is highly effective, acceptance and willingness to pay (WTP) differ widely across populations. This review summarizes global evidence from 2015-2025. A systematic search of PubMed, Scopus, CENTRAL, Web of Science, and Google Scholar was conducted in 2025 following PRISMA guidelines. Studies reporting data on knowledge, acceptance, attitudes, and WTP across any population were included. Quality assessment used ISPOR checklists, and data were synthesized in Excel 2019. Thirty-five studies met inclusion criteria, with China and Nigeria contributing most. WTP ranged from 52.68% in lower-middle-income countries to 65.38% in low-income countries. Mean WTP was highest in upper-middle-income settings. Knowledge, positive attitudes, socioeconomic status, and trust increased WTP, while cost remained the primary barrier. Improving affordability, awareness, and policy support is essential to enhance global HPV.

人类乳头瘤病毒(HPV)是一个主要的全球健康问题,因为它与宫颈癌和其他癌症有关。尽管HPV疫苗接种非常有效,但不同人群的接受度和支付意愿差异很大。本综述总结了2015-2025年的全球证据。按照PRISMA的指导方针,于2025年对PubMed、Scopus、CENTRAL、Web of Science和b谷歌Scholar进行了系统检索。研究报告了任何人群的知识、接受度、态度和WTP数据。质量评估采用ISPOR清单,数据在Excel 2019中综合。35项研究符合纳入标准,其中中国和尼日利亚贡献最多。WTP从中低收入国家的52.68%到低收入国家的65.38%不等。平均WTP在中高收入环境中最高。知识、积极态度、社会经济地位和信任增加了WTP,而成本仍然是主要障碍。提高可负担性、认识和政策支持对于加强全球HPV至关重要。
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引用次数: 0
Human Papillomavirus vaccine knowledge and recommendation practice among primary care providers, Almaty, Kazakhstan - 2023. 初级保健提供者的人乳头瘤病毒疫苗知识和推荐实践,阿拉木图,哈萨克斯坦- 2023。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-02-02 DOI: 10.1080/21645515.2025.2610622
Feruza Ablimitova, Dilyara Nabirova, Saya Gazezova, Manar Smagul, Ainagul Kuatbaeva, Aizhan Yesmagambetova, Alexander J Millman, Roberta Horth

Kazakhstan planned to reintroduce the human papillomavirus (HPV) vaccine into the national vaccination calendar in 2024 for girls aged 12-14. A 2013 pilot attempt failed due to low acceptance. To inform implementation, we evaluated HPV vaccine knowledge and recommendation practices among primary healthcare workers (HCWs). In April-May 2023, we conducted a cross-sectional survey using convenience sampling among HCWs responsible for vaccination at 5 private and 29 of the largest public polyclinics in Almaty. Participants self-completed anonymous questionnaires. Knowledge scores >70% were considered adequate. We used logistic regression to assess factors associated with intention to recommend HPV vaccines, reporting adjusted odds ratios (OR) and 95% confidence intervals (CI). Among 832 participants, 68% were nurses, and 18% had >20 y experience. One-third (33%) had adequate HPV knowledge, 22% knew HPV has no cure, and 71% understood it is not airborne. One-fifth (20%) could dispel common HPV vaccine myths, 39% dispelled common childhood immunization myths, 61% correctly identified childhood vaccine contraindications, and 58% believed in childhood vaccines' safety and effectiveness. Overall, 28% would recommend the HPV vaccine to patients or their friends' children. Doctors were more likely to recommend than nurses (OR = 1.52, 95% CI = 1.06-2.18). Higher recommendation odds were also associated with ability to dispel childhood vaccines myths (OR = 1.47, 95% CI = 1.03-2.07), adequate HPV knowledge (OR = 1.63, 95% CI = 1.14-2.32), belief in vaccine safety (OR = 1.65, 95% CI = 1.12-2.47), and support for vaccinating HCWs (OR = 3.07, 95% CI = 2.11-4.54). HPV-related knowledge and recommendation intent among HCWs were low. Targeted training and communication may improve HPV vaccine uptake in Kazakhstan.

哈萨克斯坦计划在2024年将人乳头瘤病毒(HPV)疫苗重新纳入国家疫苗接种日程表,针对12-14岁的女孩。2013年的一次试点尝试因接受度低而失败。为了为实施提供信息,我们评估了初级卫生保健工作者(HCWs)的HPV疫苗知识和推荐做法。2023年4月至5月,我们对阿拉木图5家私立和29家最大的公立综合诊所负责疫苗接种的卫生保健员进行了一项抽样调查。参与者自行完成匿名问卷。知识得分为bb0 - 70%被认为是足够的。我们使用逻辑回归评估与推荐HPV疫苗意向相关的因素,报告调整优势比(OR)和95%置信区间(CI)。在832名参与者中,68%是护士,18%有20年的护理经验。三分之一(33%)的人对HPV有足够的了解,22%的人知道HPV无法治愈,71%的人知道HPV不会通过空气传播。五分之一(20%)的人能够消除常见的HPV疫苗误解,39%的人能够消除常见的儿童免疫误解,61%的人能够正确识别儿童疫苗禁忌症,58%的人相信儿童疫苗的安全性和有效性。总体而言,28%的人会向患者或其朋友的孩子推荐HPV疫苗。医生比护士更倾向于推荐(OR = 1.52, 95% CI = 1.06-2.18)。较高的推荐率还与消除儿童疫苗神话的能力(OR = 1.47, 95% CI = 1.03-2.07)、充分的HPV知识(OR = 1.63, 95% CI = 1.14-2.32)、对疫苗安全性的信念(OR = 1.65, 95% CI = 1.12-2.47)以及支持接种HCWs (OR = 3.07, 95% CI = 2.11-4.54)相关。卫生保健工作者对hpv相关知识的了解程度和推荐意愿较低。有针对性的培训和交流可以提高哈萨克斯坦人乳头瘤病毒疫苗的吸收率。
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引用次数: 0
Advancing the understanding of the immune escape in lung cancer immunotherapy: Global trends, collaborations, and future directions. 促进对肺癌免疫治疗中免疫逃逸的理解:全球趋势、合作和未来方向。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-02-09 DOI: 10.1080/21645515.2026.2628395
Dong Li, Jie Tian, Yingbo Zou

Immune escape mechanisms critically restrict the efficacy of immunotherapy in lung cancer (LC), with only 20%-30% of patients responding to checkpoint inhibitors. To systematically map global trends and identify emerging hotspots, this study analyzed 2813 publications related to immune escape in LC immunotherapy from 1995 to 2025 (data retrieved August 9, 2025; analysis of annual trends uses complete year data through 2024) sourced from the Web of Science Core Collection database. Bibliometric visualization was performed using VOSviewer (version 1.6.19), CiteSpace (version 6.2.R3), and the biblioshiny R package. The dataset encompassed 75 countries, 3421 institutions, and 18,023 researchers across 693 journals. Publication trends delineated three distinct phases: an initial phase (1995-2010), an acceleration phase (2011-2018), and a maturation phase (2019-2024). China dominates in publication volume (1,382 papers) and total citations (45,657), whereas the University of Texas MD Anderson Cancer Center emerged as the most influential institution (n = 87). The Frontiers in Immunology recorded the highest number of publications (n = 155), while Cancer Research received the most co-citations (6,149). Li Zhang ranks as the most prolific author with 19 publications and 1251 citations, while R.S. Herbst holds the highest number of co-citations (n = 628). Current research clusters focus primarily on "therapeutic strategies and treatment integration," "tumor microenvironment characterization and immune cell dynamics," and "translational biomarkers and precision immunotherapy." Future research emphasizes "spatial microenvironment architecture," "computational predictive modeling," "alternative cell death pathways," "precision biomarker development," "hypoxia-immune interactions," and "stemness-EMT immune interfaces." Overall, the field's exponential growth and geographic disparities provide a structural foundation for developing strategies to overcome immune escape mechanisms by integrating spatial microenvironment characterization with advanced computational modeling.

免疫逃逸机制严重限制了肺癌(LC)免疫治疗的疗效,只有20%-30%的患者对检查点抑制剂有反应。为了系统地绘制全球趋势并识别新兴热点,本研究分析了1995年至2025年期间LC免疫治疗中免疫逃逸相关的2813篇出版物(数据检索于2025年8月9日;年度趋势分析使用截至2024年的完整年度数据),这些出版物来自Web of Science Core Collection数据库。使用VOSviewer(版本1.6.19)、CiteSpace(版本6.2)进行文献计量可视化。R3)和biblioshiny R包。该数据集涵盖了75个国家、3421个机构和693种期刊的18023名研究人员。出版趋势描述了三个不同的阶段:初始阶段(1995-2010),加速阶段(2011-2018)和成熟阶段(2019-2024)。中国在论文发表量(1382篇)和总引用量(45657篇)上占据主导地位,而德克萨斯大学MD安德森癌症中心成为最具影响力的机构(n = 87)。《免疫学前沿》(Frontiers in Immunology)的发表次数最多(n = 155),而《癌症研究》(Cancer Research)的共被引次数最多(6149)。李章是最多产的作者,发表了19篇论文,被引用1251次,而R.S. Herbst的共被引次数最多(n = 628)。目前的研究主要集中在“治疗策略和治疗整合”、“肿瘤微环境表征和免疫细胞动力学”和“转化生物标志物和精确免疫治疗”。未来的研究重点是“空间微环境架构”、“计算预测建模”、“替代细胞死亡途径”、“精确生物标志物开发”、“缺氧-免疫相互作用”和“干细胞- emt免疫界面”。总体而言,该领域的指数增长和地理差异为通过将空间微环境表征与先进的计算建模相结合来制定克服免疫逃逸机制的策略提供了结构性基础。
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引用次数: 0
Waning immunity and the future of booster vaccination strategies in global vaccine programs post COVID-19. COVID-19后全球疫苗规划中免疫力下降和加强疫苗接种策略的未来
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-02-08 DOI: 10.1080/21645515.2026.2626088
Rhitam Biswas, Aditi Roy, Titirsha Kayal, Soumya Basu, Soumyadip Ghosh, Sudha Ramaiah, Anand Anbarasu

The problem of waning immunity is a major global concern of vaccine programs, with immunity against diseases such as COVID-19 (reduction in efficacy by ~25% in six months), pertussis (waning in 4-12 y), and influenza (annual updates needed) expected to decrease with time. While boosters reduce serious results in high-risk categories, these effects are short-term (4-6 months) and encourage global imbalances, where low-income areas lag in primary vaccination (<2%). Computational models have shown that primary vaccination in underserved regions prevents ~60% of hospitalizations worldwide, surpassing booster-focused measures (~47%). To maintain protection, variant-responsive boosters, rapid booster-design pipelines, universal vaccine platforms (including pan-coronavirus vaccines), and equity-based solutions (decentralized production) need to be integrated. Aligning with frameworks like the Immunization Agenda 2030 of the World Health Organization, plans should balance the expansion of high-risk groups while broadening primary access, providing infrastructure investment, and real-time surveillance to address evolving pathogens and systemic disparities.

免疫力下降的问题是全球疫苗项目关注的一个主要问题,对COVID-19(6个月内效力下降约25%)、百日咳(4-12年下降)和流感(需要每年更新)等疾病的免疫力预计会随着时间的推移而下降。虽然增强疫苗减少了高风险类别的严重后果,但这些影响是短期的(4-6个月),并助长了全球失衡,低收入地区在初级疫苗接种方面落后(
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引用次数: 0
Development and validation of a predictive model for high-risk immune-related adverse events in gastric cancer patients treated with ICIs. 开发和验证一种预测模型,用于胃肠道注射胰岛素治疗的胃癌患者高危免疫相关不良事件。
IF 3.5 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2026-12-01 Epub Date: 2026-01-22 DOI: 10.1080/21645515.2025.2610907
Li Ma, Junbo Wu, Yunyi Du, Min Liu, Wenqing Hu, Jun Zhao, Yong'ai Li

Immune checkpoint inhibitors (ICIs) may cause immune-related adverse events (irAEs), ranging from mild to life-threatening. High-risk irAEs can lead to treatment discontinuation and higher mortality, though ICI-treated patients' death rate is under 5%. Currently, no reliable biomarkers predict irAEs' occurrence or severity. This study investigates the link between accessible biomarkers and high-risk irAEs in gastric cancer patients on ICIs, as well as to develop and assess a predictive model for such events. Data were collected from patients with gastric cancer who received ICIs therapy between May 2020 and March 2025. The incidence and risk factors associated with irAEs were analyzed using the chi-square test or the Mann-Whitney U test. Univariate and multivariate logistic regression analyses were conducted to develop a predictive model. This model was validated through 10-fold cross-validation and assessed using the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), calibration curves, and decision curve analysis. A total of 184 gastric cancer patients receiving ICIs therapy were enrolled in this study. The incidence of irAEs of any grade was 21.2%, while the incidence of grade ≥3 irAEs was 12.5%. Multivariate logistic regression analysis identified NLR-1 (p < .001), NLR2-1 (p < .001), PLR-1 (p = .001), tumor thickness (p = .018), CV (p = .001), and intratumoral necrosis (p = .028) as independent predictors of grade ≥3 irAEs. The AUC of the developed model was 0.878, with a sensitivity of 78.26%, specificity of 80.12%, PPV of approximately 80.95%, and NPV of approximately 75.52%. The corrected C-index, derived from bootstrap resampling, was 0.849, and both calibration curves and decision curve analysis confirmed good calibration and clinical utility. These predictors may aid risk stratification and optimized patient management.

免疫检查点抑制剂(ICIs)可能导致免疫相关不良事件(irAEs),从轻微到危及生命。高风险的irae可导致治疗中断和更高的死亡率,尽管接受ici治疗的患者死亡率低于5%。目前,没有可靠的生物标志物预测irae的发生或严重程度。本研究探讨了可获得的生物标志物与接受ICIs治疗的胃癌患者高风险irae之间的联系,并开发和评估了此类事件的预测模型。数据收集自2020年5月至2025年3月期间接受ICIs治疗的胃癌患者。使用卡方检验或Mann-Whitney U检验分析与irae相关的发病率和危险因素。采用单因素和多因素logistic回归分析建立预测模型。通过10次交叉验证对该模型进行验证,并通过受试者工作特征曲线下面积(AUC)、敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)、校准曲线和决策曲线分析对该模型进行评估。本研究共纳入184例接受ICIs治疗的胃癌患者。任何级别的irAEs发生率为21.2%,而≥3级的irAEs发生率为12.5%。多因素logistic回归分析发现NLR-1 (p p p =。0.001),肿瘤厚度(p =。018), CV (p =。001)和瘤内坏死(p = 0.028)作为≥3级irae的独立预测因子。该模型的AUC为0.878,敏感性为78.26%,特异性为80.12%,PPV约为80.95%,NPV约为75.52%。校正后的自举重采样c指数为0.849,校正曲线和决策曲线分析均证实校正效果良好,具有临床应用价值。这些预测因素可能有助于风险分层和优化患者管理。
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Human Vaccines & Immunotherapeutics
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