Recombinant Zoster Vaccine (Shingrix) and GLP-1 Receptor Agonist for the Preservation of Beta-Cell Function in Adults With Recent-Onset Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial.

Type 1 diabetes (T1D) is a chronic autoimmune disease characterized by progressive destruction of pancreatic beta cells mediated by autoreactive T lymphocytes, resulting in absolute insulin deficiency. Preservation of residual beta-cell function at the time of diagnosis is a critical therapeutic window, as even marginal endogenous insulin secretion - reflected by detectable C-peptide levels - is associated with improved glycemic control, reduced hypoglycemia burden, and decreased long-term vascular complication rates.
This study evaluates the hypothesis that combinatorial immunomodulation - using the AS01B adjuvant system within the Recombinant Zoster Vaccine (RZV; Shingrix, GSK) alongside metabolic and cytoprotective support via a GLP-1 receptor agonist (semaglutide) - can synergistically preserve residual beta-cell function in adults within 100 days of T1D diagnosis. The AS01B adjuvant system activates innate immune pathways that promote regulatory T-cell (Treg) expansion and shift the immunological milieu toward tolerance, while GLP-1 receptor agonism provides direct beta-cell cytoprotection, reduces glucotoxicity, and may suppress autoimmune cytokine signaling.
SHIELD-T1D is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial enrolling 240 adults (18-50 years) diagnosed with T1D within 100 days, with confirmed residual beta-cell function (stimulated C-peptide ≥0.2 nmol/L). Participants are randomized 1:1:1:1 to one of four arms: (1) Shingrix alone, (2) Semaglutide alone, (3) Shingrix + Semaglutide combination, or (4) dual placebo. The primary endpoint is change in 2-hour stimulated C-peptide AUC during a Mixed Meal Tolerance Test (MMTT) from baseline to 12 months.
This phase II randomized, double-blind, placebo-controlled multicenter trial will evaluate the efficacy and safety of the recombinant zoster vaccine (Shingrix) and a glucagon-like peptide-1 (GLP-1) receptor agonist, alone and in combination, for preservation of residual beta-cell function in adults with recent-onset type 1 diabetes. The working hypothesis is that combining AS01 adjuvant-mediated immunomodulation with the metabolic and cytoprotective actions of a GLP-1 receptor agonist will provide dual protection for pancreatic beta cells, slowing autoimmune destruction and improving functional insulin secretion compared with placebo.

开始日期2027-01-01

申办/合作机构-

CTIS2025-521547-20-00

/ Active, not recruiting临床4期IIT

Herpes zoster after recombinant herpes zoster vaccination - Immediate post-RHZ-vaccination evolution of CMI, HMI and lymphocyte count and typing.

开始日期2026-06-01

申办/合作机构

Centre Hospitalier Universitaire de Liege

NCT07485283

/ Recruiting临床4期IIT

A Pragmatic Randomized Trial to Evaluate the Effect of Recombinant Herpes Zoster Vaccine on Major Adverse Cardiovascular Events and Dementia in Adults Aged 65 Years or Above

DAN-ZOSTER is a nationwide randomized study investigating whether vaccination against herpes zoster (shingles) can reduce the risk of cardiovascular disease and dementia in older adults. Herpes zoster is caused by reactivation of the varicella-zoster virus and becomes more common with increasing age. Some observational studies have suggested that vaccination against herpes zoster may also lower the risk of heart attacks, strokes, and dementia, but this has not been confirmed in randomized clinical trials.
In this study, approximately 162,000 adults aged 65 years or older living in Denmark will be randomly assigned to either receive the recombinant herpes zoster vaccine (Shingrix®) or receive no vaccine. Participants in the vaccine group will receive two doses given 2-6 months apart.
Participants will be identified and invited using Danish national registries and digital mail systems. Information about health outcomes will be collected through nationwide health registries during follow-up.
The main outcomes of the study are major cardiovascular events (heart attack, stroke, or cardiovascular death) and new diagnoses of dementia. The goal of the study is to determine whether herpes zoster vaccination can help prevent these conditions in older adults.

开始日期2026-04-28

申办/合作机构

Herlev and Gentofte Hospital

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2026-12-31·Human Vaccines & Immunotherapeutics

Predictors of initiation and completion of Shingrix vaccination in immunocompetent adults newly eligible for vaccination from 2018–2024

Article

作者: Masters, Nina B. ; Do, Duy ; Farrar, Karen Gilbert ; Cartwright, Brianna M. G.

The Shingrix vaccine has been recommended for immunocompetent adults aged ≥50 y since October 2017. It is important to assess recent trends and predictors of Shingrix vaccination among those newly eligible to evaluate acceptability, desirability, and uptake of the vaccine. In this retrospective cohort study, we used electronic health record data with linked medical and pharmacy claims data from Truveta. Immunocompetent adults turning 50 between 2018 and 2024 with at least 1 y of continuous enrollment after their 50th birthday were included. We estimated the cumulative incidence of vaccination by eligibility year and assessed series completion at 6 and 12 m. Multivariable logistic regression identified predictors of initiation and series completion. Among 153,899 adults (57.0% female; 62.2% White), 9.9% received ≥1 Shingrix dose within 1 y of eligibility. One-year uptake increased from 2.6% (2018 cohort) to 14.0% (2024 cohort). Three-year uptake reached 27.5% among those eligible in 2022. Among initiators within the first year of eligibility, 62.6% completed the series within 6 m and 74.5% within 12 m. Influenza vaccination during a person's 50th y was the strongest non time-based predictor of Shingrix vaccination (odds ratio 1.96, 95% CI 1.88-2.03). Women and Asian adults had higher odds of initiation, whereas Black or African American adults, Medicaid/CHIP enrollees, rural residents, and those with cardiovascular disease had lower odds. Shingrix uptake among newly eligible adults has increased rapidly since 2018. Persistent sociodemographic disparities highlight the need for targeted strategies to improve equitable vaccine uptake.

2026-12-31·Human Vaccines & Immunotherapeutics

Herpes zoster hospitalization burden in Spain during the initial period of recombinant zoster vaccine implementation

Article

作者: Blanc, Jose-Maria ; Gil-de-Miguel, Ángel ; Jimeno-Sanz, Isabel ; Hernández-Barrera, Valentín

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.

2026-12-31·Human Vaccines & Immunotherapeutics

TLR9 and STING agonists adjuvanted varicella-zoster virus glycoprotein E induced a potent and durable nasal vaccine response

Article

作者: Su, Yu-Wen ; Su, Yu-Siang ; Tien, Chih-Feng ; Yu, Guann-Yi ; Tseng, Jen-Chih ; Chuang, Tsung-Hsien ; Chen, Linyi ; Imana, Zaida Nur ; Yang, Jing-Xing ; Liu, Yi-Ling ; Lin, Po-Yen ; Tsai, Wan-Ting ; Huang, Ming-Hsi ; Chen, Jen-Kun

Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV), primarily affecting middle-aged and older individuals and often accompanied by severe pain and other complications. Vaccination is an effective preventive measure against this disease. In the present study, we evaluated the adjuvant activity of Toll-like receptor (TLR)9 and TLR7 agonists in combination with stimulator of interferon genes (STING) agonists for a VZV-glycoprotein E (gE)-based vaccine. Among the tested combinations, the CpG-2722 (TLR9 agonist) and 2'3'-c-di-AM(PS)2 (STING agonist) pairing exhibited potent immunostimulatory activity in immune cells and superior adjuvant activity for VZV-gE vaccines in a mouse models. Shingrix, a licensed herpes zoster vaccine, is administered intramuscularly. The CpG-2722/2'3'-c-di-AM(PS)2 combination adjuvanted VZV vaccine, administered intramuscularly, effectively induced higher gE-specific IgG responses than that induced by the Shingrix and imiquimod/2'3'-c-di-AM(PS)2 adjuvant vaccine. Notably, intranasal administration of the CpG-2722/2'3'-c-di-AM(PS)2 adjuvanted VZV vaccine to mice elicited a robust antigen-specific IgA response, which was barely detectable in intramuscularly administered vaccines. Two doses of the intranasal immunization, administered at a two-week interval, provided long-lasting protection, as antigen-specific IgG levels remained elevated for months without booster immunization. Further investigation into the functional mechanism revealed that CpG-2722 combined with 2'3'-c-di-AM(PS)2 induced a strong antigen-dependent T helper 1 (Th1) cytokine response, consistent with the antigen-independent cytokine-inducing properties of this adjuvant combination. This study demonstrates that the TLR9 and STING agonists formulated adjuvant induces a potent and long-lasting immune response, highlighting its potential as a promising adjuvant candidate for nasal VZV vaccines.

653

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2026-06-25

·虹树下

医药日报6.25：NMPA四款FIC·GSK千亿收购

今日导读 🏛️ NMPA历史性时刻：6月22日一日批准4款全球首发创新药——双抗ADC、实体瘤CAR-T、狂犬病双抗、抗菌肽 💰 超级并购：GSK 106亿美元收购Nuvalent（精准肿瘤学）；礼来收购4E Therapeutics加码非阿片止痛 🤖 AI制药加速：赛诺菲×Owkin构建AI生物制药智能体；BMS部署Claude覆盖3万员工；字节拆分AI制药估值10亿美元 🔬 临床与审批：Ionis olezarsen获FDA批准（严重高甘油三酯血症）；武田zasocitinib头对头3期优效 🤖 AI 创新应用 🤝 战略合作赛诺菲×Owkin：五年期K Pro合作构建AI生物制药智能体 6月5日，赛诺菲与AI生物科技公司Owkin宣布多年合作，基于Owkin的K Pro AI科学家平台构建端到端AI生物制药智能体（biopharma agents），覆盖从早期靶点发现到临床试验决策的全流程。双方合作始于2021年9000万欧元肿瘤AI合作，此次扩展至免疫学等领域。赛诺菲旨在实现"生物人工智能超级智能"愿景，加速自动化药物研发最复杂环节。 🏢 企业级部署BMS携手Anthropic：Claude AI覆盖3万员工，打造药企"共享智能平台" 5月20日，百时美施贵宝（BMS）与Anthropic签署战略协议，将Claude AI部署为覆盖研发、临床开发、生产、商业化及企业职能的"共享智能平台"，赋能超3万名员工。部署聚焦三大方向：加速药物发现与开发、优化临床运营、提升商业决策。这是大型药企首次将前沿大模型作为企业级基础设施全面铺开，标志着AI从"实验工具"走向"核心生产力"。 🔥 独立融资字节跳动拆分AI制药业务：估值约10亿美元，首轮融资近2亿 6月中旬，字节跳动AI制药业务线正式启动拆分独立融资，核心团队、算法平台及在研管线整体注入新主体，落地上海。新公司估值约10亿美元，首轮融资近2亿美元，字节仍控股。同期，阿里健康发布战略级医学AI产品"氢离子"；京东健康AI医生"大为"用户突破50万；百度百图生科递交港交所上市申请；腾讯公开AI设计GLP-1减肥药专利——互联网巨头全面涌入AI制药赛道。 📊 行业趋势2026上半年Big Pharma AI交易井喷：从单点合作走向基础设施级部署 2026上半年，大型药企AI合作密集爆发：礼来与Chai Discovery、Noetik、Insilico Medicine（最高27.5亿美元）合作；辉瑞与Boltz合作抗体/小分子设计；武田与Iambic合作超17亿美元；Gilead扩展与Tempus AI合作。分析显示AI可将药物研发周期缩短40-50%，提升I期成功率。趋势核心：药企不再满足于"找分子"，而是在构建覆盖发现-临床-商业化的AI基础设施。🇺🇸 FDA 审批动态 ✅ 刚刚获批FDA批准Ionis TRYNGOLZA(olezarsen)：首个降低严重高甘油三酯血症胰腺炎风险药物 6月24日，FDA批准Ionis Pharmaceuticals的TRYNGOLZA（olezarsen）上市，作为饮食辅助疗法用于降低严重高甘油三酯血症（sHTG）患者的甘油三酯水平及急性胰腺炎风险。这是首个且唯一被批准同时降低甘油三酯和胰腺炎风险的疗法。Olezarsen为反义寡核苷酸（ASO）药物，此前已获优先审评。此次批准距PDUFA日（6/30）提前一周，凸显FDA审评效率。 📅 即将裁决6月底FDA冲刺周：Arcutis ZORYVE、Viridian veligrotug等多款待批 6月最后一周FDA将密集裁决：Arcutis ZORYVE乳膏0.3%（PDUFA 6/29）——拓展至2-5岁儿童斑块型银屑病，将成为该年龄段首个外用PDE4抑制剂；Viridian veligrotug（PDUFA 6/30）——甲状腺眼病BLA，THRIVE试验显著改善突眼；Lantheus LNTH-2501（6/29）——Ga-68 edotreotide PET显像剂。此前Ensitrelvir（口服新冠暴露后预防）和Cytisinicline（20年首个戒烟新药）已于6月16日和20日过PDUFA日。 GSK启动106亿美元收购Nuvalent要约：精准肿瘤学管线补强 6月24日，GSK正式启动对Nuvalent的106亿美元现金要约收购（$124/股，溢价40%），这是GSK十年来最大并购。Nuvalent核心资产zidesamtinib（ROS1抑制剂，PDUFA 9/18）和neladalkib（ALK抑制剂，PDUFA 11/27）均已获FDA突破性疗法认定，峰值销售潜力30-40亿美元。GSK新任CEO Luke Miels借此发力肿瘤赛道，应对Shingrix专利悬崖压力。💰 行业并购与交易 💊 非阿片止痛礼来收购4E Therapeutics：加码非阿片类慢性疼痛管线 6月16日，礼来宣布收购奥斯汀神经科学公司4E Therapeutics，聚焦下一代非阿片类慢性疼痛疗法。美国超5000万人受慢性疼痛困扰，阿片类诉讼压力催生巨大市场机遇。这是礼来近期M&A spree的延续——2026年至今已接连收购Curevo、LimmaTech等公司约38亿美元，礼来过去十年收购的biotech数量超过任何制药巨头。 🧠 精神神经大冢7亿美元完成收购Transcend Therapeutics，布局下一代精神神经治疗 6月12日，大冢制药（Otsuka）完成对Transcend Therapeutics的收购，首付7亿美元+最高5.25亿美元里程碑。Transcend的核心技术使用AI精准识别药物候选的适用患者群体，解决III期试验因患者队列错配而失败的老大难问题。大冢借此扩展下一代精神疾病治疗方案，呼应行业从"关系驱动"向"精准驱动"转型的趋势。 2026生物制药M&A破1060亿美元：专利悬崖倒逼Big Pharma"买管线" 截至6月，2026年生物制药M&A总额已达1060亿美元（201笔交易），全年有望创历史新高。近一个月内31笔交易合计超26亿美元，其中AI/计算平台类占16笔。核心驱动力：专利悬崖迫近、公开市场回暖、Big Pharma管线补充需求。叠加GSK 106亿美元收购Nuvalent、艾伯维109亿美元收购Apogee，超级并购节奏未见放缓。🔬 临床研究进展 🧬 头对头3期武田zasocitinib头对头3期优效：银屑病口服治疗标杆或将易主 6月11日，武田公布zasocitinib（TYK2抑制剂）对比deucravacitinib的头对头III期研究结果，在斑块型银屑病关键终点上实现统计学优效。Zasocitinib为每日一次口服药，此前已展现快速持久的皮损清除能力。该结果有望重新定义口服银屑病治疗标准，对BMS的deucravacitinib（Sotyktu）构成直接竞争威胁。 🦠 抗真菌F2G/盐野义olorofim全球3期OASIS研究阳性：全新机制抗真菌药问世 6月18日，F2G与盐野义宣布口服olorofim对比AmBisome序贯标准疗法治疗侵袭性曲霉病的全球III期OASIS研究取得积极顶线结果。Olorofim属于全新orotomide类抗真菌药，靶向嘧啶生物合成途径，与现有三唑类/棘白菌素类无交叉耐药。数据将递交FDA（F2G）和EMA（盐野义），有望成为20年来首个新机制口服抗真菌药。 Definium DT120抑郁症3期成功：速效微剂量LSD衍生物呼之欲出 6月22日，Definium Therapeutics公布DT120（lysergide ODT 100µg口崩片）治疗重度抑郁症的EMERGE 3期试验达主要终点，股价当日飙升近50%。该药为微剂量LSD衍生物，具有起效快的差异化优势，若获批将成为抑郁症治疗的重要新选择，挑战传统SSRI类药物的统治地位。🏛️ 国内监管与政策 🏆 历史性突破NMPA一日批准4款全球首发创新药：中国创新药进入"全球首发"收获期 6月22日，NMPA连发五条公告，一日内密集批准4款全球首款中国原创1类创新药：①伦康依隆妥单抗（百利天恒BL-B01D1）——全球首款EGFR/HER3双抗ADC，用于复发/转移性鼻咽癌，III期cORR 54.6% vs 27.0%，海外权益已授权BMS（84亿美元）；②舒瑞基奥仑赛（科济药业CT041）——全球首款实体瘤CAR-T，靶向CLDN18.2治疗晚期胃癌，mPFS翻倍（3.25 vs 1.77个月）；③斯乐韦米单抗（智翔金泰）——全球首款狂犬病双特异性抗体，用于暴露后被动免疫；④培来加南喷雾剂（普莱医药）——全球首款加南类抗菌肽，用于烧烫伤创面感染。互联网巨头全面涌入AI制药：字节、百度、阿里、腾讯、京东各出奇招 6月以来，中国互联网巨头AI制药布局集中浮出水面：字节跳动拆分AI制药业务（估值10亿美元）；百度百图生科秘密递交港交所上市申请；阿里健康发布战略级医学AI产品"氢离子"；京东健康AI医生"大为"用户突破50万；腾讯公开AI设计GLP-1减肥药专利。行业判断：中国AI制药正从"跟跑"转向"部分领域领跑"，成为全球合作中的关键一极。 2026医保目录调整申报已完成，创新药准入持续提速国家医保局5月31日发布《2026年药品目录调整工作方案》，首次将商业健康保险创新药品目录纳入联动调整。6月1日-10日已完成网上申报。同步，第十二批国家药品集采已明确年内开展。政策趋向：鼓励真创新、淘汰伪创新，医保准入向创新药倾斜与集采常态化双轨并行。🧬 生物技术与研究前沿 🧪 AI设计疫苗全球首个AI设计通用冠状病毒疫苗通过I期人体试验 6月5日，剑桥大学及衍生企业DIOSynVax在《感染杂志》发表全球首个完全由AI设计的泛沙贝科冠状病毒疫苗pEVAC-PS的I期临床试验结果：疫苗安全、耐受性良好，并能产生针对多种冠状病毒的免疫反应。该疫苗由AI计算平台设计靶点抗原，标志着AI从药物发现扩展至疫苗设计领域，为下一代广谱疫苗开发开辟新路径。 Intellia体内CRISPR疗法滚动上市申请进行中，有望2027年上市 Intellia Therapeutics的CRISPR基因编辑疗法在关键临床试验中取得成功，已向FDA启动滚动式递交上市申请（rolling BLA）。若获批计划2027年上市，这将是继CASGEVY后又一走向市场的CRISPR疗法。结合此前荷兰团队开发的能精准辨别肿瘤DNA的CRISPR变体、以及佛罗里达大学DNA引导CRISPR系统，基因编辑技术正进入快速迭代和临床转化期。⚡ 今日速览 🏛️ NMPA：一日批准4款全球首发——双抗ADC、实体瘤CAR-T、狂犬病双抗、抗菌肽 ✅ FDA：Ionis olezarsen获批（严重高甘油三酯血症） 💰 并购：GSK 106亿美元收购Nuvalent（精准肿瘤学） 💊 并购：礼来收购4E Therapeutics（非阿片止痛）；大冢7亿美元收购Transcend 🤖 AI：赛诺菲×Owkin AI智能体；BMS部署Claude覆盖3万人；字节拆分AI制药 🔬 临床：武田zasocitinib头对头3期优效；F2G olorofim抗真菌3期阳性 🧬 前沿：AI设计通用冠状病毒疫苗通过I期人体试验 📢 声明以上内容整理自公开信息，仅供参考，不构成投资建议。数据来源包括FDA官网、NMPA官网、Nature、BioSpace、FierceBiotech、RTTNews、药时代、腾讯新闻、新浪财经、InforCapital、LevelFields等。如有疏漏，欢迎指正。

2026-06-24

·PRNewswire

New Study Suggests Shingles Vaccination May Be Associated with Reduced Dementia Risk in Older Adults

Research published in Annals of Internal Medicine uses PointClickCare Life Sciences' EHR data linked with Medicare claims to analyze outcomes in more than 500,000 individuals TORONTO, June 24, 2026 /PRNewswire/ -- New research published in Annals of Internal Medicine suggests that shingles vaccination may be associated with a reduced risk of dementia among older adults entering skilled nursing facilities. The study, led by researchers from Brown University School of Public Health and University of Delaware, evaluated outcomes in more than 500,000 adults aged 66 and older. Using Medicare claims linked with deidentified electronic health record (EHR) data from PointClickCare Life Sciences, the researchers conducted a target trial emulation to examine the relationship between the recombinant zoster vaccine (RZV) and the risk of developing dementia. "Older adults admitted to skilled nursing facilities represent a particularly vulnerable population, with elevated risk for both shingles and dementia," said Jeff Wessinger, vice president & GM of Life Sciences at PointClickCare. "However, this group is often underrepresented in traditional clinical research, making it difficult to generate evidence tailored to their care needs. We are proud that our longitudinal EHR data collected from the majority of long-term care (LTC) facilities in the U.S. can contribute to studies that will change outcomes for aging and vulnerable populations." The results showed that individuals who received at least one dose of the shingles vaccine within 12 months of entering a skilled nursing facility experienced a 24% relative reduction in dementia risk over four years, compared with those who were not vaccinated. "One of the strengths of this research was the ability to use linked Medicare and PointClickCare Life Sciences' EHR data to study older adults entering skilled nursing facilities," said Kaley Hayes, PharmD, PhD, assistant professor at Brown University School of Public Health and lead author of the study. "That combination gave us a real-world view of vaccination history, clinical characteristics, and outcomes in a population that is often underrepresented in traditional research." The study leveraged detailed, longitudinal clinical data captured within skilled nursing facilities, including resident demographics, assessments, medication administration records, and vaccination history. These data were linked with Medicare administrative claims to provide a comprehensive view of patient care before, during, and after facility admission. While the findings demonstrate a meaningful association between shingles vaccination and reduced dementia risk, the authors emphasize that further research, including randomized trials, will be needed to establish a causal relationship. The study also highlights persistently low uptake of shingles vaccination among older adults in skilled nursing settings. The research underscores the increasing role of real-world data in advancing evidence generation for aging populations. By enabling large-scale analyses in clinically complex populations, linked EHR and claims data can help researchers explore outcomes that are difficult to study in traditional trial settings. To learn more about our data, visit the website here. About the Study The study, Dementia Risk After Recombinant Herpes Zoster Vaccination in Older Adults With a Recent Skilled Nursing Facility Stay, is published in Annals of Internal Medicine. It used a target trial emulation design to estimate the association between RZV vaccination and incident dementia, drawing on linked Medicare claims and nursing home EHR data from PointClickCare. View the study abstract: View the patient summary: About PointClickCare Life Sciences PointClickCare Life Sciences partners with researchers and pharmaceutical organizations to accelerate the development, delivery, and evaluation of therapies for aging and vulnerable populations. Leveraging the most comprehensive real-world deidentified datasets derived from its widely adopted electronic health record (EHR) platform in long-term and post-acute care, PointClickCare Life Sciences provides deep, longitudinal insights into patient journeys, treatment patterns, and outcomes. This continuously updated, research-grade data captured as part of routine care enables life sciences organizations to inform clinical research, optimize commercialization strategies, and improve access to therapies for populations often underrepresented in traditional datasets. Media Contact Andie Morataya [email protected] SOURCE PointClickCare 21% more press release views with Request a Demo

疫苗临床结果

2026-06-24

·BioBAY

全球首个！艾博生物带状疱疹mRNA疫苗三期临床启动

近日，据药物临床试验登记与信息公示平台公示，BioBAY园内企业艾博生物（Abogen Biosciences）自主研发的冻干带状疱疹mRNA疫苗（代号：ABO1108）已正式登记启动III期临床试验。这是全球范围内首个进入III期临床研究阶段的带状疱疹mRNA疫苗，标志着中国在mRNA疫苗技术路线上又一次走在世界前列。艾博生物成立于2019年，是国内最早布局信使核糖核酸药物研发的生物技术公司之一。公司由英博博士创立，拥有业界领先且具有自主知识产权的mRNA和纳米脂球（LNP）递送技术平台，是国内为数不多具备完整价值链能力的mRNA药物研发企业，覆盖从mRNA设计、制剂开发到大规模生产的各个环节。成立至今，艾博生物已建立了覆盖传染病防治和肿瘤免疫等多领域的丰富产品管线，其技术平台的核心组件——可电离脂质，是目前国内唯一经大规模III期临床验证且拥有自主知识产权的LNP组分，已获得中美澳及欧洲多个主要国家的专利授权。 ABO1108的临床推进速度可谓迅猛。2025年3月28日，其新药临床试验申请获得国家药监局临床默示许可；同年5月15日，I期临床试验在广西融水正式启动，成为国内首批进入临床研究的冻干带状疱疹mRNA疫苗之一。I期研究共纳入180名40岁及以上健康成年人，旨在评估其耐受性、反应原性和安全性。同年11月，II期临床试验紧随其后启动，首次公示于2025年11月10日，目标入组300人，主要终点为接种后30天内的免疫原性，包括抗gE抗体几何平均浓度和VZV特异性T细胞反应等指标。今年3月至4月间，ABO1108的III期临床志愿者招募工作正式铺开，研究已获国家药监局和各省疾控中心伦理委员会批准。此次III期临床计划入组18000例受试者，由广西壮族自治区疾病预防控制中心黄腾主任主持，在广西、浙江、河北、山东四省疾控中心同步开展。接种方式与现有重组带状疱疹疫苗类似，共接种2剂，间隔60天。带状疱疹是由水痘-带状疱疹病毒再激活引起的感染性皮肤病，常见于40岁以上人群及慢性病患者，典型症状为成簇水疱伴剧烈神经痛。带状疱疹后神经痛可持续数月至数十年，严重影响患者生活质量。据《中国带状疱疹诊疗专家共识（2023版）》数据，我国50岁以上人群带状疱疹年发病率为3.94-5.8/1000人年，50岁后发病率每10年翻一番。全球范围内，GSK的Shingrix疫苗2025年销售额突破35.58亿英镑（约合47.05亿美元），连续5年稳居全球疫苗销售额前三，足见该市场的巨大潜力。 ABO1108采用的冻干剂型是其区别于其他mRNA疫苗的核心技术亮点之一。传统mRNA疫苗因对冷链运输条件要求极高（通常需-20℃至-70℃储存），在物流配送和基层推广方面面临较大挑战。ABO1108通过冻干技术将疫苗稳定性大幅提升，可在2-8℃常规冷藏条件下稳定保存，显著降低了运输和储存成本，提高了疫苗的可及性，尤其适合在偏远地区和基层医疗单位推广使用。 ABO1108作为目前全球已公开披露临床进展的带状疱疹mRNA疫苗中唯一进入III期临床的产品，研发进度处于全球领跑地位，中国mRNA疫苗技术的自主研发能力再次得到有力验证，BioBAY作为国内生物医药产业高地，将持续见证并协助推动这一进程，为全球带状疱疹预防提供全新“中国方案”。 ▌网络资料整理撰稿：赵家帅责编：于嘉敏审核：任旭推荐阅读《科技日报》头版关注园区同心医疗：一颗“中国心”的科技密码博瑞医药BGM0504注射液减重适应症新药上市申请获国家药品监督管理局受理全球首创！再鼎医药呫诺美林曲司氯铵胶囊（凯捷乐®）上市，惠及国内精神分裂症患者

100 项与重组带状疱疹 (GlaxoSmithKline) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	重组带状疱疹 (GlaxoSmithKline)	J07BK03	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
疱疹后神经痛	欧盟	GlaxoSmithKline Biologicals SA	2018-03-21
疱疹后神经痛	冰岛	GlaxoSmithKline Biologicals SA	2018-03-21
疱疹后神经痛	列支敦士登	GlaxoSmithKline Biologicals SA	2018-03-21
疱疹后神经痛	挪威	GlaxoSmithKline Biologicals SA	2018-03-21
带状疱疹	加拿大	GlaxoSmithKline, Inc.	2017-10-13

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ECCO2026	N/A	炎症性肠病	420	Recombinant zoster vaccine (RZV) Shingrix (Inflammatory bowel disease)	蓋鏇淵積廠廠醖憲窪網(鑰選顧獵簾獵選醖遞遞) = 糧醖襯築築廠製蓋壓廠網憲簾餘襯壓淵觸構構 (膚膚餘觸積壓積窪範願 ) 更多	积极	2026-02-18
ASH2025	N/A	副蛋白血症	89	Recombinant adjuvanted zoster vaccine	築壓蓋鏇齋鏇顧獵網蓋(簾糧製廠獵簾網艱顧廠) = Adverse events due to vaccination included fever (n=32, 36.0%), pain (n=31, 34.8%) and redness (n=28, 31.5%) at the injection site while 4 (4.5%) patients reported none. 鏇窪簾蓋襯構襯鹽憲獵 (蓋鹹夢獵鹽繭壓遞壓醖 ) 更多	积极	2025-12-06
EULAR2025	N/A	肌肉骨骼系统疾病	150	Recombinant zoster vaccine (RZV)	艱憲醖簾蓋築顧壓選簾(餘網鏇鹹鬱醖鏇廠鑰艱) = By then, pain at the site of injection in 97 (32.7%) patients was the most frequent AE, followed by fever (42 (14.1%)), fatigue (28 (9.4%)), musculoskeletal pain (24 (8.1%)), swelling at the injection side (19 (6.4%)) and redness at the injection side (19 (6.4%)). Infections (14 (4.7%)), worsening of the disease (11 (3.7%) or other AEs (n=23 (7.7%) were reported until M3. 糧憲顧積夢觸願構窪獵 (獵廠鏇網鑰糧遞醖簾鏇 ) 更多	积极	2025-06-11
NCT06001606 (EULAR2025)	临床3期	系统性红斑狼疮	60	HZ/su vaccine	遞選鹽築襯顧簾餘積遞(遞淵壓艱淵鑰餘鹽鹹築) = 廠蓋觸衊窪顧蓋構網鬱窪獵醖鏇憲範遞鬱積製 (積顧鏇廠網壓網夢衊願, 460.0 ~ 1775.8)	积极	2025-06-11
NCT04176939 (ERA2025)	临床3期	带状疱疹	68	Recombinant zoster vaccine (RZV) (renal transplant)	壓淵範簾鏇製鹹襯蓋餘(獵窪範艱製齋積鹹膚製) = 積積衊糧鹹顧鑰壓窪觸觸衊衊膚簾襯範夢襯獵 (衊鏇糧齋範壓衊衊鏇鹽 ) 更多	积极	2025-06-04
NCT02723773 (ZOE-LTFU, Literature \| NEWS) 人工标引	临床3期	带状疱疹	7,273	Herpes Zoster Vaccine GSK1437173A	範構齋襯鹽網築糧窪淵(遞衊艱觸網淵鹽窪鏇願) = 糧廠餘膚鬱餘願獵憲餘糧膚鹽選夢顧簾構衊糧 (餘夢範餘憲鹹鬱築夢衊, 73.7 ~ 84.6) 更多	积极	2025-05-12
NCT04091451 (CTgov)	临床3期	带状疱疹	1,430	Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) (HZ/su Group)	衊範蓋鹽遞簾憲構憲願 = 膚繭廠壓範鏇鹽夢壓衊願範構壓鬱簾鑰範鹹膚 (範網蓋遞築願鹹蓋襯糧, 窪顧窪糧艱選製觸觸鹹 ~ 鹹積膚糧顧製衊製顧齋) 更多	-	2025-03-30
NCT04091451 (CTgov)	临床3期	带状疱疹	1,430	Placebo (Placebo Group)	衊範蓋鹽遞簾憲構憲願 = 獵獵觸淵餘壓遞構壓糧願範構壓鬱簾鑰範鹹膚 (範網蓋遞築願鹹蓋襯糧, 觸齋艱積夢鹽糧鹽衊製 ~ 構醖鹽鬱選窪築壓膚壓) 更多	-	2025-03-30
NCT05219253 (Pubmed \| Vaccine)	临床3期	带状疱疹辅助	-	Adjuvanted Recombinant Zoster Vaccine (RZV)	艱繭齋觸衊窪蓋鹹窪齋(鑰壓窪鏇繭餘淵糧糧淵) = 壓顧鏇鏇製鏇襯築繭蓋顧觸齋廠蓋遞衊糧淵窪 (構築齋餘繭廠齋網糧廠, 78.4 ~ 91.3)	积极	2025-03-01
NCT03591770 (CTgov)	临床4期	溃疡性结肠炎	15	SHINGRIX (UC Patients on Tofacitinib Monotherapy)	範夢鑰網鹽膚夢鏇繭顧 = 顧觸鏇選簾獵範繭顧壓顧壓選簾製簾積壓願餘 (繭壓膚衊願膚衊襯夢觸, 襯壓壓遞簾餘醖網遞蓋 ~ 觸簾窪淵糧構構膚觸廠) 更多	-	2025-02-21
NCT03591770 (CTgov)	临床4期	溃疡性结肠炎	15	SHINGRIX (UC Patients on Anti-TNF Monotherapy)	範夢鑰網鹽膚夢鏇繭顧 = 繭鬱築願網網遞餘膚憲顧壓選簾製簾積壓願餘 (繭壓膚衊願膚衊襯夢觸, 蓋構選淵膚壓鬱艱淵衊 ~ 膚壓積範築齋鹽衊糧鬱) 更多	-	2025-02-21
NCT05007041 (Pubmed \| JAMA Netw Open)	临床3期	带状疱疹 \| 流感病毒感染	267	Adjuvanted Recombinant Zoster Vaccine (RZV) and Adjuvanted Inactivated Influenza Vaccine (aIIV4)	壓獵餘遞襯餘選襯構構(淵鹹願繭鬱獵鬱糧網憲) = 襯鹹簾窪鏇鹽築膚壓顧構衊蓋壓繭壓遞觸遞鬱 (壓遞簾糧憲鏇選膚遞糧 )	积极	2024-10-24
NCT05007041 (Pubmed \| JAMA Netw Open)	临床3期	带状疱疹 \| 流感病毒感染	267	Adjuvanted Recombinant Zoster Vaccine (RZV) and Quadrivalent High-Dose Inactivated Influenza Vaccine (HD-IIV4)	壓獵餘遞襯餘選襯構構(淵鹹願繭鬱獵鬱糧網憲) = 觸膚鑰選壓鹽築齋簾淵構衊蓋壓繭壓遞觸遞鬱 (壓遞簾糧憲鏇選膚遞糧 )	积极	2024-10-24