The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

开始日期2020-07-28

申办/合作机构

University of Colorado Denver

[+1]

NCT04016714

/ Completed临床3期

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2)

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.
The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.

开始日期2019-08-28

申办/合作机构

Merck Sharp & Dohme Corp.

NCT03192319

/ CompletedN/AIIT

Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation

The purpose of this study is to determine the optimal timing of zoster vaccination to induce both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with history of hematopoietic stem cell transplantation(HSCT).

开始日期2017-07-01

申办/合作机构

Seoul National University Hospital

100 项与 Zoster vaccine live(Merck Sharp & Dohme Corp.) 相关的临床结果

登录后查看更多信息

100 项与 Zoster vaccine live(Merck Sharp & Dohme Corp.) 相关的转化医学

登录后查看更多信息

100 项与 Zoster vaccine live(Merck Sharp & Dohme Corp.) 相关的专利（医药）

登录后查看更多信息

329

项与 Zoster vaccine live(Merck Sharp & Dohme Corp.) 相关的文献（医药）

2025-02-25·JOURNAL OF VIROLOGY

Insights into pathologic mechanisms occurring during serious adverse events following live zoster vaccination

Review

作者: Grose, Charles ; Kennedy, Peter G. E.

ABSTRACT:

An effective live zoster vaccine has been widely used around the world. Although no deaths occurred in the original large clinical trial, we analyzed 10 serious adverse events, including six deaths that have subsequently occurred in four countries. The goal is to define the viral pathogenesis of these unexpected adverse events secondary to a viremia with dissemination of the vaccine virus. We also propose a new hypothesis for acute retinal necrosis that occurs post-immunization.

2025-02-01·BMJ Open

Association of herpes zoster vaccination and cardiovascular risk in patients with diabetes: long-term insights from a retrospective cohort study

Article

作者: Yang, Yi-Sun ; Wang, Yu-Hsun ; Huang, Chien-Ning ; Wang, Chi-Chih ; Kornelius, Edy ; Lo, Shih-Chang

Objectives:

Herpes zoster (HZ) infection is associated with a higher risk of major adverse cardiovascular events (MACE), including stroke and coronary artery disease (CAD). Patients with diabetes are at an increased risk of MACE, highlighting the importance of studying this population to assess the potential protective effects of HZ vaccination. This study aims to investigate the risk of MACE after HZ vaccination in patients with diabetes.

Design:

Retrospective cohort study.

Setting:

Community-based population in the USA.

Participants:

Using the TriNetX database, the study included 4.9 million patients with diabetes from 2006 to 2022. It established two cohorts: 68 178 patients in the HZ vaccination (comprising any HZ vaccine, Shingrix or Zostavax) and 4 835 246 patients in the no HZ vaccination group. After excluding patients with a history of MACE, immune disease and complications of HZ prior to the index date, the study cohort was reduced to 45 960 patients. Propensity score matching, accounting for age, sex, race, socio-economic status and disease comorbidities, was conducted to minimise study bias.

Interventions:

HZ vaccination.

Outcome measures:

MACE outcomes are defined as the first occurrence of CAD or stroke. Comparative risk analysis was conducted using HRs.

Results:

Post matching, the mean patient age was 63.5 years, with 49.2% females. The incidence rate of MACE was lower among vaccinated patients compared with unvaccinated individuals, with an HR of 0.76 (0.72–0.79). For secondary endpoints, the HRs were 0.73 (0.69–0.78) for CAD, 0.79 (0.74–0.84) for stroke and 0.54 (0.52–0.57) for all-cause mortality. These protective effects remained consistent across different age groups, sexes and diabetes types, supporting the potential benefit of HZ vaccination in reducing cardiovascular risk.

Conclusions:

HZ vaccination is associated with a lower risk of MACE in patients with diabetes. Further prospective studies are critically needed to confirm this finding.

2025-01-01·Infectious Diseases and Therapy

Modelled Public Health Impact of Introducing Adjuvanted Recombinant Zoster Vaccine into the UK National Immunisation Programme

Article

作者: Curran, Desmond ; Giannelos, Nikolaos ; Vekria, Yasmeeta ; Marijam, Alen ; Hunjan, Manjit

INTRODUCTION:

In 2023, recombinant zoster vaccine (RZV) replaced zoster vaccine live (ZVL) vaccine in the UK National Immunisation Programme (NIP) for prevention of herpes zoster (HZ). The vaccination age was reduced from 70 to 65 years, with a subsequent planned reduction to 60 years. This modelling study aimed to evaluate the public health impact (PHI) of RZV vaccination in the 70 years of age (YOA) population and in younger individuals 65 and 60 YOA.

METHODS:

PHI was evaluated from a National Health Service perspective, as cases of HZ, post-herpetic neuralgia (PHN), non-PHN complications and deaths, hospitalisations, and general practitioner (GP) visits avoided using a multicohort Markov model. Three scenarios (RZV vs. no vaccination, ZVL vs. no vaccination, and RZV vs. ZVL) were explored for each age group using population estimates from the UK Office for National Statistics, i.e. 70 YOA (n = 649,822), 65 YOA (n = 760,578) and 60 YOA (n = 849,501).

RESULTS:

Modelled outcomes in 70 YOA individuals estimated that RZV vaccination would avoid 32,894 cases of HZ and 5915 cases of PHN compared with no vaccination and 26,954 HZ and 3218 PHN cases compared with ZVL. Compared with no vaccination, 2264 fewer hospitalisations and 158,549 fewer GP visits were predicted with RZV vaccination. Hospitalisations were predicted to be reduced by 1996 and GP visits by 130,821 for RZV versus ZVL vaccination. In individuals 65 YOA, it was estimated that RZV vaccination would avoid 50,128 HZ cases, 8623 PHN cases, 222,646 GP visits, and 2671 hospitalisations versus no vaccination. In the 60 YOA group, RZV vaccination was predicted to avoid 57,182 HZ cases, 9327 PHN cases, 234,330 GP visits, and 2547 hospitalisations versus no vaccination.

CONCLUSION:

The recent introduction of RZV into the NIP could substantially reduce HZ disease burden and healthcare resource use in the UK. A graphical abstract is available with this article.

项与 Zoster vaccine live(Merck Sharp & Dohme Corp.) 相关的新闻（医药）

2025-04-22

·药时代

近160亿：生物医药行业3月融资规模再破记录

今年3月，美国及欧洲的生物医药行业共发生18起融资事件，融资规模达21.8亿美元（约158.96亿人民币），其中值得关注的有：AI制药领域大额融资集中爆发：3月，位居融资额前两位均是AI制药公司，其中，诺奖得主创立的Isomorphic Labs更是单轮完成创纪录的6亿美元融资；前沿技术路线与新靶点受到关注：3月，HDAC6抑制剂公司Augustine 、mGluR5负变构调节剂公司Tempero Bio、KnotBody药物公司Maxion Therapeutics等前沿技术公司均获得大额融资。1、Isomorphic Labs：诺奖得主创办的AI药企3月31日，Isomorphic Labs宣布在第一轮外部融资中筹集了6亿美元。本轮融资由Thrive Capital领投，GV、Alphabet提供后续资金。此次领投的Thrive Capital是如今全球最为炙手可热的风险投资机构之一，以“在少数初创企业押下巨额赌注”的风格著称，曾投出过OpenAI、Instagram、Stripe、Spotify等一众明星项目。Isomorphic Labs成立于2021年，创始人兼CEO为2024年诺贝尔化学奖得主Demis Hassabis。公司致力于利用人工智能技术重新定义药物发现和开发流程，其核心技术包括AlphaFold等革命性AI模型。此前木头姐的《Big Ideas 2025》报告中，将Isomorphic Labs列为AI药物研发领域的少数关键公司。AlphaFold是一种能够预测蛋白质三维结构的AI模型，将预测误差从传统方法的10Å级别压缩至原子尺度（1.6Å）。基于AlphaFold的技术基础，Isomorphic Labs开发了PhoenixAI平台，该平台通过图神经网络（GNN）与扩散模型（Diffusion Model）的融合架构，能够模拟药物分子与蛋白质口袋的原子级相互作用，显著缩短了先导化合物优化周期。2024年5月，Isomorphic Labs与谷歌DeepMind共同开发的AlphaFold 3模型发布，能够准确预测所有生命分子的结构和相互作用，能够显著降低新药研发成本，并提高临床成功率。据摩根士丹利预测，该技术若完全落地，可将新药研发成本从当前平均26亿美元压缩至1.7亿美元，同时将临床成功率从9.6%提升至34%。公司优异的技术，斩获了多家大药企的合作，合作金额高达30亿美元：2024年1月7日，Isomorphic Labs宣布与礼来达成战略研究合作，合作开发针对多个靶点的小分子疗法，公司将获得4500万美元的预付现金，以及潜在高达17亿美元的里程碑付款和净销售额高达两位数的分成；2024年1月7日，Isomorphic Labs宣布与诺华达成战略研究合作，合作开发针对三个未公开靶点的小分子疗法。公司获得3750万美元的预付款，以及潜在高达12亿美元的里程碑付款和从中单到低两位数的净销售额的分成；除了这些合作伙伴关系外，Isomorphic 还在推进多个治疗领域和药物模式的设计项目，包括肿瘤、自身免疫疾病等。公司计划今年年底前将一些人工智能设计的药物投入临床试验。公司的科学顾问委员会包括2020年诺贝尔化学奖获得者、CRISPR先驱 Jennifer Doudna，2021年诺贝尔化学奖获得者David MacMillan，2001年诺贝尔生理学或医学奖得 Paul Nurse，以及阿斯利康前执行副总裁Mene Pangalos等知名人士。近年来，AI制药是资本市场追逐的热点，包括Retro Biosciences（10亿美元A轮）、Xaira Therapeutics（10亿美元初始资金）、EvolutionaryScale（1.42 亿美元种子轮）在内的多家AI制药企业近期获得或正在筹集巨额早期融资。2、Lila Sciences：Flagship Pioneering孵化的AI药物公司3月10日，Lila Sciences宣布完成2亿美元的种子轮融资。本轮融资投资人包括Flagship Pioneering、General Catalyst、March capital、ARK Venture Fund、Altitude Life Science Ventures、Blue Horizon Advisors、State of Michigan Retirement System、Modi Ventures和阿布扎比投资局（ADIA）等知名机构。Lila Science于2023年诞生在Flagship内部实验室。当时，Flagship孵化了两家早期AI公司：一家专注于新材料，另一家专注于生物学，后来两家公司的发展目标趋于一致，招募相同的人才，因此在内部合并。Lila Science致力于在开发一款人工智能程序，该程序经过已发表的实验数据以及科学过程推理的训练。仅仅两年时间，公司平台已在多个领域表现出超越人类和现有人工智能基准的性能，例如：生成优于市售疗法的最佳基因药物结构、发现和验证数百种适用于广泛治疗靶点的新型抗体、肽和结合剂、设计用于工业规模碳捕获的新材料等。在商业模式上，Lila并未像其他AI制药公司那样自己直接下场研发新药，而是与Flagship孵化药企、外部生物技术公司合作，承担 “科研助推器”的角色，加快同行药物研发速度。团队方面，Lila Science集聚了业内众多知名专家：哈佛大学著名遗传学家 George Church担任首席科学家、OpenAI前高管Kenneth Stanley担任高级副总裁、Flagship的普通合伙人Geoffrey von Maltzahn 担任首席执行官。3、Callio Therapeutics：Frazier Life Sciences孵化的ADC药物公司3月3日，Callio Therapeutics宣布完成1.87亿美元的A轮融资。本轮融资由Frazier Life Sciences领投，Jeito Capital、Novo Holdings A/S、Omega Funds、ClavystBio、Platanus、Norwest、Pureos Bioventures、SEEDS Capital和EDBI等知名机构跟投。Callio Therapeutics是一家由Frazier Life Sciences孵化设立的ADC药物公司，致力于开发下一代多载荷ADC。公司的ADC采用差异化的有效载荷和接头技术，能够将多载荷靶向递送至肿瘤细胞，从而最大限度地提高治疗效果。Callio Therapeutics的管线与技术来自Hummingbird Bioscience的授权。公司获得了后者双plyload技术平台、以及两个ADC管线的独家授权。其中一个较快的管线为靶向Her2双payload ADC，第二个管线尚未披露靶点。而Hummingbird则获得Callio的股权，以及两个授权管线的未来里程碑付款。Hummingbird的ADC技术来自著名的ADC技术平台公司Synaffix：2023年1月，Hummingbird以1.5亿美元总额获得了Synaffix三大平台技术GlycoConnect™、HydraSpace™、ToxSYN™的授权。公司的首个项目是靶向HER2的双有效载荷ADC：HMBD-802。根据公司在2024年AACR大会上的介绍，HMBD-802的两个payload分别为拓扑异构酶Ⅰ抑制剂和ATR抑制剂，用以克服单一Topo1i ADC的耐药性。公司联合创始人兼CEOPiers Ingram此前曾是Hummingbird Bioscience的联合创始人，亦曾在此前在赛诺菲等医药企业从事了15年的研发咨询、商业战略和学术工作。首席医疗官Naomi曾担任ProfoundBio（普方生物）的首席医疗官（被Genmab以18亿美元收购），在此之前，她曾担任Silverback Therapeutics的首席医疗官、Acerta Pharma的临床开发和医疗事务副总裁、Seattle Genetics的临床开发副总裁等职务。4、Latigo Biotherapeutics：Vertex镇痛药的潜在挑战者3月17日，Latigo Biotherapeutics宣布完成1.5亿美元的B轮融资，本轮融资由Blue Owl Capital管理的基金领投，卡塔尔投资局、Deep Track Capital、Access Biotechnology、Cormorant Asset Management、赛诺菲风险投资公司、Rock Springs Capital、UPMC Enterprises、Kern Capital、Westlake Village BioPartners、Foresite Capital、5AM Ventures和Alexandria Venture Investments等机构跟投。Latigo Biotherapeutics由生物医药投资机构Westlake Village BioPartners于2020年孵化设立，是一家专注于开发非阿片类止痛药的生物技术公司。目前，公司有四款在研药物，其中最为主要的是LTG-001。这是一款口服选择性Nav1.8抑制剂，目前正在进行临床二期试验，旨在治疗急性和慢性疼痛，预计今年下半年发布数据。NaV 1.8抑制剂为近几年走进医药行业视野的全新机制镇痛药，具有起效快、疗效显著、安全性优于标准护理且不影响中枢神经系统等潜在优势。今年1月底，Vertex Pharmaceuticals旗下药物Journavx成功获批，成为首个获得FDA批准针对 NaV1.8 的止痛药物。虽说Journavx面临着一定程度的商业挑战，疼痛缓解市场一直被廉价的阿片类药物“霸占”，但分析师们还是相当看好药物前景，预测它能够跻身十亿美元药物。Latigo的LTG-001有可能成为有望成为“best-in-class”药物。除了LTG-001，公司还有一系列Nav1.8抑制剂，正处于发现阶段。Westlake运营合伙人Desmond Padhi博士为公司首席执行官。在加入Westlake之前，Padhi博士在安进（Amgen）工作了20年，曾担任药代动力学、药物代谢和临床药理学副总裁一职。在一级市场，2024年2月，Latigo Biotheraputics宣布完成1.35亿美元的A轮融资，本轮融资由Westlake Village BioPartners领投，5AM Ventures和Foresite Capital，Corner Ventures参与跟投。公司的孵化机构Westlake Village BioPartners成立于2018年，致力于与有望为患者带来变革性疗法的企业家共同培育、发展生命科学公司。Westlake的联合创始人Sean Harper博士于2002年进入安进研发部门，并于2012年成为研发执行副总裁，期间领导安进心血管疾病、肿瘤学、神经科学和肾脏疾病领域药物的新品获批。5、Curevo Vaccine：带状疱疹疫苗Shingrix的挑战者3月17日，Curevo Vaccine宣布完成1.1亿美元的B轮融资。本轮融资由Medicxi领投，OrbiMed、HBM Healthcare Investments、赛诺菲风险投资公司、RA Capital Management、Janus Henderson investors、Adjuvant Capital和GC Biopharma等机构跟投。Curevo Vaccine创立于2018年，是一家专注于生产新一代带状疱疹疫苗的药企。公司唯一的管线CRV-101是一款佐剂亚单位疫苗，用于预防老年人带状疱疹。CRV-101被专门设计为在使用少量佐剂的同时产生最佳免疫应答，目的是获得与目前批准的带状疱疹疫苗相似的疗效，但副作用较少。目前，已经上市的带状疱疹疫苗有默沙东的减毒活疫苗Zostavax、以及葛兰素史克的基因重组亚单位疫苗Shingrix。其中，Shingrix凭借90%的有效率，占据市场主导地位。2024年1月7日，公司宣布CRV-101疫苗在对随机、对照、观察者盲法各组的临床二期试验达到了主要终点。CRV-101有效性为100%，而Shingrix为97.9%。此外，CRV-101较Shingrix相比表现出更低的局部或全身不良反应发生率。为了将Shingrix彻底比下去，公司还在进行多达640人的扩展试验，旨在确定临床三期的剂量选择。管理层方面，公司董事会主席Moncef Slaoui博士曾在葛兰素史克工作了近30年，期间为许多新疫苗的开发做出了贡献，包括Shingrix®（带状疱疹）、Cervarix®（HPV诱导的宫颈癌疫苗）、Mosquirix®（疟疾）、Rotarix®）（轮状病毒肠胃炎）和Synflorix®。另外一位董事Tal Zaks 博士在Moderna担任首席医疗官超过六年，期间还负责监督COVID-19的mRNA疫苗Spikevax的开发。在一级市场，公司曾完成两轮融资：2022 年2月，Curevo Vaccine宣布完成6000万美元A轮融资。本轮融资由RA Capital牵头，Aduvant Capital、Janus Henderson investors、EN Investment和创始投资者GC Pharma跟投；2022年11月，Curevo Vaccine宣布完成2600万美元A+轮融资，投资人包括Janus Henderson、RA Capital 、Adverant Capital和GC Biopharma。6、Character Biosciences：博士伦支持的眼科新药公司3月25日，Character Biosciences宣布完成1亿美元的C轮融资。本轮融资由aMoon和Luma Group共同领投，博士伦、Jefferson Life Sciences、Innovation Endeavors、Catalio Capital、S32和KdT Ventures等机构跟投。Character Biosciences成立于2019年，致力于采用资金效率更高的观察性研究来构建患者数据库并开拓多基因疾病的精准医疗解决方案。通过与全美150多家眼科中心合作，公司构建了一个涵盖6500多名患者的基因-临床-影像数据库，实现了AMD的遗传亚型重分类，并以此发现关键致病机制和靶点，结合AI与多组学方法，有望提升复杂眼病精准治疗的成功率。目前，公司有四个在研管线，其中最为重要的有：CTX114：一款补体抑制剂，旨在减缓晚期干性AMD的地图样萎缩的进展。药物设计用于抑制补体系统激活，保护视网膜细胞表面免受免疫攻击；CTX203：一款脂质调节剂，适应症为高风险中期AMD。该药为人工设计的ApoA1类似肽，针对ABCA1脂质转运通道，具有“延缓进展”而非“逆转疾病”的作用方向，定位于尚无药物覆盖的中早期AMD人群（尚未发展至地形萎缩）。CTX203与CTX114预计将于今年进入临床试验阶段。该公司还利用其人工智能驱动的基于基因组学的平台，将其产品线扩展到其他眼科疾病。对外合作方面，2024年1月，公司宣布与博士伦签署协议，共同开发针对AMD的治疗方法，并可能将双方的合作扩展至其他眼科疾病领域。公司创始人兼CEO Cheng Zhang先生拥有丰富的跨行业经验，曾在多家知名公司担任重要职务。在瑞银（UBS）、Oliver Wyman和辉瑞等公司任职期间，他积累了宝贵的战略规划和创新管理经验，参与并推动了多项战略计划的实施。7、Augustine Therapeutics：礼来支持的HDAC6抑制剂药企3月24日，Augustine Therapeutics宣布完成8480万美元的A轮融资。本轮融资由Novo Holdings和Jeito Capital共同领投，Asabys Partners、礼来、AdBio Partners、V-Bio Ventures、PMV、VIB、Gemma Frisius Fund、Charcot Marie Tooth（CMT）研究基金会、Newton Biocapital等机构跟投。Augustine Therapeutics成立于2019年，由比利时弗拉芒生物技术研究所（VIB）与鲁汶大学（KU Leuven）的联合孵化，致力于解决目前缺乏有效治疗方案的重大医疗需求，包括腓骨肌萎缩征等影响周围神经的遗传性疾病，以及其他神经肌肉、神经退行性和心脏代谢性疾病。公司的科学基础源于VIB-KU鲁汶脑与疾病研究中心的Ludo Van Den Bosch教授在胞浆组蛋白脱乙酰酶6（HDAC6）抑制方面的突破性研究，他认为HDAC6抑制剂是治疗CMT和其他神经疾病的有前景的方法。HDAC6是一种II类组蛋白脱酰酶。HDAC6是一种众所周知的分子靶点，对神经系统疾病有很强的生物学基础，对心脏代谢疾病有很高的治疗潜力。2023年，诺华以8000万美元获得了韩国公司Chong Kun Dang Pharmaceutical的1期阶段的HDAC6抑制剂CKD-510。目前，Augustine Therapeutics正在开发HDAC6的同类最佳的小分子抑制剂，适应症为Charcot-Marie Tooth（CMT）。CMT是最常见的外周神经系统遗传性疾病，影响全球约300万人。一级市场，Augustine最初由V-Bio Ventures、AdBio Partners、VIB、PMV和Gemma Frisius Fund组成并提供种子资金，并于2024年6月完成1850万美元的A轮融资，投资人包括Asabys Partners、礼来、Charcot Marie Tooth研究基金会等机构。8、Arbor Biotechnologies：张峰的又一家基因编辑公司3月18日，Arbor Biotechnologies宣布完成7390万美元的C轮融资。本轮融资由ARCH Venture Partners和TCGX领投，QIA、abrdn、Partners Investment、Revolution Partners、Kerna Ventures、Ally Bridge、Arrowmark、Deep Track、Piper Heartland Healthcare、Surveyor、淡马锡、T.Rowe Price Associates和Vertex制药等机构跟投。Arbor Biotechnologies成立于2016年，是一家基因编辑酶开发公司。Arbor联合创始人包括张锋教授、David Walt、David Scott、Winston Yan等业内知名人士。Arbor主要是通过机器学习与人工智能技术来开发新的基因编辑器，截至目前，公司已拥有17种基因编辑器，覆盖90%以上的基因组。还发现了超60多种核酸酶家族和70多种CRISPR转座酶，数量是已发表文献中的6倍和30倍。Arbor的基因编辑器主要包括两大类：CRISPR核酸酶编辑器、CRISPR转座酶编辑器。其中CRISPR核酸酶包括DNA核酸酶（Cas12h，Cas12i）和RNA核酸酶（Cas13d，Cas12g，III-E型）等。2024年5月，Arbor还收购了张锋旗下另一家基因编辑公司Serendipity Biosciences，获得了DNA核酸内切酶基因编辑器Fanzor、基因编辑器IsrB等技术。目前，公司有在研管线8款，最为重要的是ABO-101。ABO-101是一种针对原发性高草酸尿症（PH）的体内基因编辑疗法，于2024年12月获得了FDA的IND批准，目前正在PH1中进行临床I/II期试验，预计2029年初步完成。此前，在2024 ASGCT年会上，Arbor公布了BO-101的临床前数据。在非人灵长类动物（NHP）中，BO-101对HAO1基因实现了有效的体内编辑，多次给药具有良好的耐受性。此外，公司还在推进其首个同类项目的IND/CTA备案，包括一个罕见肝病的RT（逆转录酶）编辑项目和一个针对肌萎缩侧索硬化症（ALS）的项目。对外合作方面，Vertex是公司的长期合作伙伴，于2018年首次达成合作，并于2021年和2023年两次扩大合作协议，尤其是2021年的扩展合作金额高达12亿美元。此外，Arbor分别在2022年和2024年Allogene与博雅辑因达成了授权合作。在一级市场，公司曾完成两轮融资：2017年5月，Arbor宣布完成560万美元A轮融资后走出隐匿模式；2021年11月，Arbor宣布完成2.15亿美元的B轮融资。本轮融资由淡马锡、汇桥资本和TCG Crossover领投，Arrowmark、Deep Track、Great Point Ventures、Illumina Ventures、Janus Henderson investors、Logos Capital、Ono Venture、Piper Heartland Healthcare、Ridgeback Capital、Section 32、Surveyor Capital、T.Rowe Price Associates、Tao等机构跟投。图片来源：123RF版权声明/免责声明本文为授权转载文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩!

引进/卖出

2025-04-02

·drugs

Shingles Vaccine Protects Against Dementia

TUESDAY, April 2, 2025 -- The shingles vaccine can do more than protect seniors from painful, blistering rashes. It also appears to protect older folks from dementia , researchers say. Seniors who got the shingles vaccine when it became available in the U.K. were 20% less likely to develop dementia than those who did not take the jab, according to research published April 2 in the journal Nature . “It was a really striking finding,” senior researcher Dr. Pascal Geldsetzer , an assistant professor of medicine at Stanford University, said in a news release. “This huge protective signal was there, any which way you looked at the data.” These findings came about due to a “natural experiment” that resulted from the way the shingles vaccine was handed out in Wales after it became available in 2013, Geldsetzer said. Shingles is caused by the same virus that causes chicken pox, varicella-zoster . The virus stays dormant in the nerve cells of people who get chicken pox as children, and then re-emerges as folks’ immune systems weaken due to old age or illness. The vaccine works by boosting seniors’ immune response against varicella-zoster, preventing the dormant virus from emerging and causing shingles. However, researchers wondered if the shingles vaccine might protect the brain as well. Recent evidence has indicated that certain viral infections might increase a person’s risk of dementia . To test this theory, researchers looked to Wales. There, on Sept. 1, 2013, public health officials began offering the vaccine to anyone 79 years of age. People could only get the vaccine once they’d turned 79, and only for that year. Once folks turned 80, they were out of luck, including anyone who’d already turned 80 by the start of the vaccine program. The rules were designed to ration a limited supply of vaccine, but they also created a natural randomized trial that could test the vaccine’s effects on people, researchers said. By comparing people who turned 80 just before September 2013 with those who turned 80 just after, researchers could isolate the vaccine’s effects. “We know that if you take a thousand people at random born in one week and a thousand people at random born a week later, there shouldn’t be anything different about them on average. They are similar to each other apart from this tiny difference in age,” Geldsetzer said. “What makes the study so powerful is that it’s essentially like a randomized trial with a control group — those a little bit too old to be eligible for the vaccine — and an intervention group — those just young enough to be eligible,” he added. Researchers tracked health outcomes over the next seven years for people who got the vaccine versus those who didn’t. As expected, shingles cases were 37% lower in people who’d received the vaccine, researchers found. But by 2020, vaccine recipients also were 20% less likely to develop dementia, results show. This finding held even after researchers considered other potential factors that might influence dementia risk like level of education or chronic illnesses such as diabetes , heart disease or cancer. “The signal in our data was so strong, so clear and so persistent,” Geldsetzer said. Results also showed that the protection against dementia was much more pronounced in women than in men. This could be because women on average respond better to vaccination than men, researchers said. Also, shingles is more common in women than in men, so the vaccine’s protection might matter more for them. This research team has since replicated the Wales findings using health records from England, Australia, New Zealand and Canada. “We just keep seeing this strong protective signal for dementia in dataset after dataset,” Geldsetzer said. It’s not clear, however, why the vaccine would protect against dementia at all, researchers said. It might protect the brain by boosting the immune system overall, or by specifically preventing varicella-zoster from having some yet-unknown affect on brain health, researchers speculated. It’s also not known whether the newest version of the vaccine, which is the only one available in the U.S., would confer the same protection, researchers noted. The first vaccine, Zostavax , contained a live but weakened version of the varicella-zoster virus to which the immune system responded. It’s now been replaced by Shingrix, a genetically engineered version of the vaccine that contains only certain proteins from the virus. Shingrix is more effective against varicella-zoster – 97% versus 51% in clinical trials – but might have a different impact on dementia risk than its predecessor, researchers said. Geldsetzer hopes these new findings will inspire others to look into Shingrix’s effectiveness against dementia. “At least investing a subset of our resources into investigating these pathways could lead to breakthroughs in terms of treatment and prevention,” he concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

疫苗临床结果

2025-03-25

·生物制品圈

【突发】GSK 疫苗意外发现抗痴呆潜力！现实世界实验引爆学界震动

导语：在阿尔茨海默病治疗遭遇瓶颈的当下，一款已上市的带状疱疹疫苗正引发科学界的新期待。英国制药巨头葛兰素史克（GSK）宣布与英国痴呆研究所（UK DRI）合作，利用 NHS 接种政策调整形成的 “自然实验”，研究其明星疫苗 Shingrix 是否能降低痴呆症风险。这场看似偶然的研究，或将重塑全球疫苗与神经退行性疾病治疗的产业格局。一、“自然随机化” 实验：源于政策调整的科学机遇 2023 年 9 月，英国 NHS 调整带状疱疹疫苗接种资格，仅允许 65 岁及以上人群接种 Shingrix，而 66 岁人群需等到 70 岁。这一政策变化意外创造了两组自然对照：140 万 65-66 岁人群中，65 岁组可接种，66 岁组无法接种。GSK 与 UK DRI 抓住这一机遇，启动名为 EPI-ZOSTER-110 的研究，旨在通过真实世界数据验证 Shingrix 的潜在抗痴呆作用。 “这种自然随机化实验在医学研究中可遇不可求。” 伦敦大学学院流行病学专家 David Smith 评价道，“它为我们提供了近乎完美的观察条件。”二、疫苗与痴呆症：从偶然发现到科学假说 Shingrix 的抗痴呆潜力源于早期回顾性研究的意外发现。2024 年《新英格兰医学杂志》发表论文指出，接种 Shingrix 的老年人群痴呆症发病率较未接种者降低 37%。尽管该研究为观察性，无法证明因果关系，但其结果引发行业震动。可能的作用机制：抗病毒免疫激活：带状疱疹病毒（VZV）与单纯疱疹病毒（HSV）被认为与阿尔茨海默病淀粉样斑块形成相关，疫苗可能通过抑制病毒再激活降低神经炎症。免疫调节效应：疫苗激发的 Th1 型免疫反应可能改善大脑清除淀粉样蛋白的能力。三、GSK 的战略考量：疫苗业务的 “第二曲线” 此次研究正值 GSK 疫苗业务面临挑战： Shingrix 增长乏力：2024 年销售额 10.6 亿美元，勉强维持 “重磅药物” 地位（需年销 10 亿美元以上），低于 2023 年的 12 亿美元。管线竞争加剧：默沙东的 Zostavax（减毒活疫苗）通过降价抢占市场，而辉瑞的 RSV 疫苗已获批，分食成人疫苗市场。 “GSK 急需为 Shingrix 找到新适应症。” 投行 Jefferies 分析师指出，“若抗痴呆效果获证实，该疫苗的市场潜力将从 30 亿美元跃升至 200 亿美元。”四、行业影响：从药物研发到公共卫生政策 GSK 的探索引发连锁反应：学术研究加速：全球启动 12 项类似研究，包括美国 CDC 的百万级队列分析。政策讨论升温：英国卫生部已将 Shingrix 接种年龄降至 60 岁，部分欧洲国家考虑将其纳入痴呆症预防指南。技术融合趋势：GSK 与丹麦 Muna Therapeutics 合作，利用大脑转录组学数据开发阿尔茨海默病药物，显示其从疫苗向神经科学领域的战略延伸。五、挑战与争议：观察性研究的 “可信度危机” 尽管前景诱人，研究仍面临多重质疑：因果关系存疑：观察性研究易受混杂因素影响，如接种者可能更注重健康，导致结果偏差。生物学证据不足：目前缺乏直接证据证明 VZV 与痴呆症的因果关系，动物实验中疫苗的神经保护效果尚不明确。商业利益冲突：GSK 既是研究发起方又是疫苗制造商，其独立性遭部分学者质疑。六、专家观点：改写历史的机会与风险 “这是疫苗学与神经科学的一次跨界碰撞。” 阿尔茨海默病协会首席科学家 Maria Carrillo 表示，“若成功，将开启疾病预防的新纪元。但若数据不支持，可能引发公众对疫苗的信任危机。” 行业分析师指出，GSK 需在 2026 年前完成研究，以赶上全球痴呆症治疗市场的爆发期。据预测，2030 年该市场规模将突破 1500 亿美元，而预防手段的价值可能数倍于治疗药物。七、结语当一款疫苗被赋予对抗痴呆症的使命，它承载的已不仅是商业利益，更是人类对衰老与疾病的终极抗争。GSK 的这场 “现实世界实验”，或将成为医学史上最具争议的转折点 —— 而答案，正藏在英国 NHS 的百万份接种记录中。参考来源：https://www.biospace.com/drug-development/gsk-builds-on-real-world-experiment-to-study-shingrixs-impact-on-dementia 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗

100 项与 Zoster vaccine live(Merck Sharp & Dohme Corp.) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	Zoster vaccine live(Merck Sharp & Dohme Corp.)	J07BK02	DB10318

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
带状疱疹	欧盟	Merck Sharp & Dohme BV	2006-05-19
带状疱疹	冰岛	Merck Sharp & Dohme BV	2006-05-19
带状疱疹	列支敦士登	Merck Sharp & Dohme BV	2006-05-19
带状疱疹	挪威	Merck Sharp & Dohme BV	2006-05-19
疱疹后神经痛	欧盟	Merck Sharp & Dohme BV	2006-05-19
疱疹后神经痛	冰岛	Merck Sharp & Dohme BV	2006-05-19
疱疹后神经痛	列支敦士登	Merck Sharp & Dohme BV	2006-05-19
疱疹后神经痛	挪威	Merck Sharp & Dohme BV	2006-05-19

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
水痘带状疱疹病毒感染	临床3期	-	Merck Sharp & Dohme Corp.	2007-03-01
流感病毒感染	临床3期	-	Merck Sharp & Dohme LLC	2005-09-01
水痘	临床3期	-	Merck Sharp & Dohme Corp.	2005-08-01
HIV感染	临床2期	美国	Merck Sharp & Dohme Corp.	2009-04-29

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04169009 (CTgov)	临床4期	带状疱疹	105	Zostavax (ZVL)+Zostavax (ZVL >5 Years Previously (Cohort 1))	鏇鏇願鏇鹽夢夢膚遞鹹(齋壓壓築齋壓餘鏇齋膚) = 齋膚選蓋廠襯窪襯遞簾淵願窪鏇蓋壓艱壓糧壓 (夢構齋鏇獵艱窪鏇憲齋, NA) 更多	-	2024-10-15
				ZVL (ZVL 6-12 Months Previously (Cohort 3))	鏇鏇願鏇鹽夢夢膚遞鹹(齋壓壓築齋壓餘鏇齋膚) = 網膚糧繭憲網鏇選淵憲淵願窪鏇蓋壓艱壓糧壓 (夢構齋鏇獵艱窪鏇憲齋, NA) 更多
NCT02624375 (CTgov)	临床4期	带状疱疹	10	Zostavax	鑰鏇齋餘膚淵壓窪衊齋(遞積廠夢鏇願範憲觸範) = 廠衊築構獵艱鬱餘鹹齋鹹願積糧顧醖獵憲蓋鑰 (夢蓋鏇網獵齋製積醖鏇, 壓鏇範網選鏇齋淵鏇網 ~ 願範膚構壓艱築製鏇齋) 更多	-	2019-12-05
NCT02704572 (Pubmed \| Infect Chemother)	N/A	带状疱疹	60	Live Zoster Vaccine (6-12 months group)	鏇淵糧膚鬱廠鹽遞築鏇(夢糧積構願觸夢構範鹽) = 窪積構艱艱顧製鏇艱糧鬱繭鑰夢築齋衊選艱鑰 (範夢鏇蓋願顧糧餘廠糧 )	-	2018-12-01
				Live Zoster Vaccine (1-5 years group)	鏇淵糧膚鬱廠鹽遞築鏇(夢糧積構願觸夢構範鹽) = 憲範範鹽蓋窪鹹構遞遞鬱繭鑰夢築齋衊選艱鑰 (範夢鏇蓋願顧糧餘廠糧 )
NCT00561080 (V211-043, CTgov)	临床3期	带状疱疹	759	Zostavax (Group 2: Zostavax - Day 0 and Month 1)	鏇襯鹽鏇觸襯築襯範顧(鏇醖艱艱衊觸鏇獵夢選) = 鬱淵觸鑰獵範顧鹽觸構獵鏇簾築願簾糧鬱蓋繭 (構觸顧醖積願壓網遞餘, 網鏇獵遞襯蓋製鹽艱獵 ~ 窪範範醖壓遞選艱窪齋) 更多	-	2017-12-22
				Zostavax (Group 3: Zostavax - Day 0 and Month 3)	鏇襯鹽鏇觸襯築襯範顧(鏇醖艱艱衊觸鏇獵夢選) = 構襯鏇製淵製齋餘廠構獵鏇簾築願簾糧鬱蓋繭 (構觸顧醖積願壓網遞餘, 鑰範積構膚壓觸壓築製 ~ 觸壓淵淵鹹夢餘膚壓糧) 更多
NCT01391546 (V211-045, CTgov)	临床3期	带状疱疹	354	ZOSTAVAX (ZOSTAVAX Intramuscular (IM) Route)	簾鬱鑰蓋鏇衊窪餘廠選(繭觸製鬱糧窪構齋鑰鬱) = 遞顧顧顧構壓選鹹繭遞窪遞衊觸餘鑰膚壓網餘 (構蓋選鹽憲鹽築鏇壓範, 願鹹壓遞鹹壓製獵醖鑰 ~ 範齋蓋衊構壓廠壓觸範) 更多	-	2017-11-20
				ZOSTAVAX (ZOSTAVAX Subcutaneous (SC) Route)	簾鬱鑰蓋鏇衊窪餘廠選(繭觸製鬱糧窪構齋鑰鬱) = 鹹襯鏇鬱蓋窪製膚齋衊窪遞衊觸餘鑰膚壓網餘 (構蓋選鹽憲鹽築鏇壓範, 鹹鏇獵網廠鹽築範艱範 ~ 網鹽網淵遞顧淵願壓膚) 更多
NCT02958345 (CTgov)	临床4期	纤维化 \| 带状疱疹	28	Zostavax (Zostavax)	鹽衊網襯選憲構艱範構(齋獵艱膚餘簾淵觸艱餘) = 願構獵獵構遞憲願範繭鑰糧顧襯鹹積壓範襯願 (鏇鑰鏇衊觸鹹壓遞齋構, 顧構艱衊製觸鏇願窪遞 ~ 鏇選鬱積憲築膚製艱廠) 更多	-	2017-07-19
				Placebo (Placebo)	鹽衊網襯選憲構艱範構(齋獵艱膚餘簾淵觸艱餘) = 鏇憲範醖憲築繭築顧鏇鑰糧顧襯鹹積壓範襯願 (鏇鑰鏇衊觸鹹壓遞齋構, 選窪鬱淵製選鏇鑰醖獵 ~ 鑰醖齋築繭艱鑰淵製鹹) 更多
NCT02519855 (V211-062, CTgov)	临床3期	带状疱疹 \| 流感病毒感染	882	Placebo to ZOSTAVAX™+ZOSTAVAX™ (Concomitant Vaccination)	願選築鏇鏇鹽鹽衊簾鹽(蓋遞獵築餘淵鑰網鹹鹹) = 鏇鬱鹹簾廠襯選積憲淵簾構醖網鏇築鏇鬱衊淵 (繭願觸窪襯範襯憲簾獵, 願醖遞範範願衊鏇鏇衊 ~ 廠齋遞願醖齋鑰網繭齋) 更多	-	2017-02-14
				Placebo to ZOSTAVAX™+ZOSTAVAX™ (Nonconcomitant Vaccination)	願選築鏇鏇鹽鹽衊簾鹽(蓋遞獵築餘淵鑰網鹹鹹) = 衊糧築網鏇蓋簾衊鏇襯簾構醖網鏇築鏇鬱衊淵 (繭願觸窪襯範襯憲簾獵, 糧淵獵鏇餘獵膚構餘範 ~ 糧衊構鏇繭鏇壓衊積製) 更多
ARVO2015	N/A	眼带状疱疹	341	Herpes Zoster Vaccination (Zostavax)	夢糧衊鹽醖鹹觸鹹淵選(廠醖築遞願醖繭鏇鬱醖) = 鹽淵鬱衊膚鬱艱繭鑰襯製糧鑰觸廠鹹願襯餘糧 (艱餘憲夢糧構夢繭繭鹹 )	-	2015-06-01
				Herpes Zoster Vaccination (Non-vaccinated group)	鑰鹹築製選窪鏇醖艱觸(糧構憲積範鏇艱夢襯製) = 餘齋憲遞顧衊網齋膚蓋艱齋窪餘製網壓鬱觸窪 (艱壓積餘鏇鏇齋夢鬱鏇 ) 更多
NCT01527370 (V211-025, CTgov)	临床3期	带状疱疹	250	Zoster Vaccine Live	夢範鏇觸構鬱鹽範襯廠(壓餘齋網廠衊艱夢觸選) = 鬱艱夢繭鑰積壓糧繭製齋鑰鹹選窪遞遞鬱網蓋 (艱願鹹顧醖夢願衊網艱, 醖築鏇願繭廠餘衊構窪 ~ 壓積製廠製簾窪糧鹹糧) 更多	-	2013-12-30
NCT01556451 (V211-034, CTgov)	临床4期	带状疱疹	180	Zoster Vaccine Live	夢夢願壓選鹹壓廠網選(襯簾襯醖鑰選膚糧鹹廠) = 獵鹹壓鹹遞憲醖窪簾醖願窪襯廠遞淵構艱膚壓 (襯積膚鏇遞簾選夢衊蓋, 廠鹹膚衊壓壓繭蓋夢繭 ~ 網壓憲膚膚醖積範鹽範) 更多	-	2013-09-23