更新于：2024-05-01

Hepatitis E

戊型肝炎

更新于：2024-05-01

基本信息

别名

ET-NANBH、Enterically Transmitted Non A, Non B Hepatitis、Enterically transmitted non-A non-B hepatitis

+ [43]

简介

Acute INFLAMMATION of the LIVER in humans; caused by HEPATITIS E VIRUS, a non-enveloped single-stranded RNA virus. Similar to HEPATITIS A, its incubation period is 15-60 days and is enterically transmitted, usually by fecal-oral transmission.

关联

项与戊型肝炎相关的药物

Sofosbuvir

索磷布韦

靶点

NS5B polymerase

作用机制

NS5B polymerase抑制剂

在研机构

Gilead Sciences Ireland UC [+1]

原研机构

Gilead Sciences, Inc.

在研适应症

丙型肝炎 [+1]

非在研适应症

凝血障碍 [+5]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2013-12-06

Hepatitis E vaccine recombinant(Xiamen Innovax Biotech Co. Ltd.)

重组戊型肝炎 (厦门万泰沧海生物)

靶点-

作用机制

免疫刺激剂

在研机构

厦门万泰沧海生物技术有限公司

原研机构

厦门万泰沧海生物技术有限公司

在研适应症

戊型肝炎

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2011-12-01

Hepatitis E vaccine recombinant(National Institute of Allergy & Infectious Diseases)

靶点-

作用机制

免疫刺激剂

在研机构

CPL Biologicals Pvt Ltd.

原研机构

National Institute of Allergy & Infectious Diseases

在研适应症

戊型肝炎

非在研适应症-

最高研发阶段临床前

首次获批国家/地区-

首次获批日期1800-01-20

项与戊型肝炎相关的临床试验

NCT05808166 / Not yet recruiting临床2期IIT

A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.

This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity subset (n=150), Arm 2, pregnant participants receiving placebo (N=1,104) with immunogenicity subset (n=150), and Arm 3, non-pregnant participants receiving Hecolin® (N=150) of which all participants in this arm will be included in the immunogenicity subset.

开始日期2024-06-01

申办/合作机构

International Vaccine Institute

[+3]

NCT06306196 / Not yet recruiting临床2期IIT

A Phase 2b, Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adult Participants Followed by a Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin® in Children

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals

开始日期2024-04-01

申办/合作机构

International Vaccine Institute

[+2]

NCT06137313 / Not yet recruitingN/AIIT

Determination of HEV Seroprevalence Among Blood Donors in Occitania

The objective of the proposed work is to determine the seroprevalence of HEV in 2023 in a population of blood donors living in Occitania.
Compare the current frequency of anti-HEV IgG and IgM markers with that of 2011. The serological techniques used and the questionnaires will be similar

开始日期2023-12-15

申办/合作机构-

100 项与戊型肝炎相关的临床结果

登录后查看更多信息

100 项与戊型肝炎相关的转化医学

登录后查看更多信息

0 项与戊型肝炎相关的专利（医药）

登录后查看更多信息

4,073

项与戊型肝炎相关的文献（医药）

2024-02-20·Diagnostic microbiology and infectious disease

Comparison of two automated commercial assays for routine detection of anti-hepatitis E Virus IgM antibodies in clinical samples.

Review

作者: Adrien Becquart ; Aurélie Guigon ; Alexandre Regueme ; Pauline Coulon ; Laurence Bocket ; Didier Hober ; Enagnon Kazali Alidjinou

Diagnosis of hepatitis E virus (HEV) infection relies first on detection of IgM antibodies (Ab), sometimes completed with HEV RNA detection. This study aimed to compare the performance of two automated anti-HEV IgM Ab assays. Correlation between Virclia® (Vircell) and Liaison® (Diasorin) assays was carried out on 178 routine clinical samples. Both assays were run on 67 samples from HEV RT-PCR (Altona) screened patients, and 52 Wantai® EIA (Euroimmun) tested samples. An excellent correlation was observed between both assays with an overall agreement of 96.6% (172/178), and a kappa coefficient at 0.93. In HEV RNA positive group (n=43), IgM detection rate was 93.3% (14/15) in immunocompetent patients, with both assays. In immunocompromised patients, detection rate was 75% (21/28) and 71.4% (20/28) using Virclia® and Liaison XL® assays, respectively. Virclia® and Liaison® anti-HEV IgM assays have similar performance for the detection of anti-HEV IgM Ab.

2024-02-19·Lancet (London, England)

Long-term efficacy of a recombinant hepatitis E vaccine in adults: 10-year results from a randomised, double-blind, placebo-controlled, phase 3 trial.

Article

作者: Shoujie Huang ; Xuefeng Zhang ; Yingying Su ; Chunlan Zhuang ; Zimin Tang ; Xingcheng Huang ; Qi Chen ; Kongxin Zhu ; Xiaowen Hu ; Dong Ying ; Xiaohui Liu ; Hanmin Jiang ; Xia Zang ; Zhongze Wang ; Changlin Yang ; Donglin Liu ; Yijun Wang ; Quan Tang ; Wentong Shen ; Huanhuan Cao ; Huirong Pan ; Shengxiang Ge ; Yue Huang ; Ting Wu ; Zizheng Zheng ; Fengcai Zhu ; Jun Zhang ; Ningshao Xia

BACKGROUND:

Hepatitis E virus (HEV) is a frequently overlooked causative agent of acute hepatitis. Evaluating the long-term durability of hepatitis E vaccine efficacy holds crucial importance.

METHODS:

This study was an extension to a randomised, double-blind, placebo-controlled, phase-3 clinical trial of the hepatitis E vaccine conducted in Dontai County, Jiangsu, China. Participants were recruited from 11 townships in Dongtai County. In the initial trial, a total of 112 604 healthy adults aged 16-65 years were enrolled, stratified according to age and sex, and randomly assigned in a 1:1 ratio to receive three doses of hepatitis E vaccine or placebo intramuscularly at month 0, month 1, and month 6. A sensitive hepatitis E surveillance system including 205 clinical sentinels, covering the entire study region, was established and maintained for 10 years after vaccination. The primary outcome was the per-protocol efficacy of hepatitis E virus vaccine to prevent confirmed hepatitis E occurring at least 30 days after administration of the third dose. Throughout the study, the participants, site investigators, and laboratory staff remained blinded to the treatment assignments. This study is registered with ClinicalTrials.gov (NCT01014845).

FINDINGS:

During the 10-year study period from Aug 22, 2007, to Oct 31, 2017, 90 people with hepatitis E were identified; 13 in the vaccine group (0·2 per 10 000 person-years) and 77 in the placebo group (1·4 per 10 000 person-years), corresponding to a vaccine efficacy of 83·1% (95% CI 69·4-91·4) in the modified intention-to-treat analysis and 86·6% (73·0 to 94·1) in the per-protocol analysis. In the subsets of participants assessed for immunogenicity persistence, of those who were seronegative at baseline and received three doses of hepatitis E vaccine, 254 (87·3%) of 291 vaccinees in Qindong at the 8·5-year mark and 1270 (73·0%) of 1740 vaccinees in Anfeng at the 7·5-year mark maintained detectable concentrations of antibodies.

INTERPRETATION:

Immunisation with this hepatitis E vaccine offers durable protection against hepatitis E for up to 10 years, with vaccine-induced antibodies against HEV persisting for at least 8·5 years.

FUNDING:

National Natural Science Foundation of China, Fujian Provincial Natural Science Foundation, Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, and the Fundamental Research Funds for the Central Universities.

2024-02-19·BMC infectious diseases

Hepatitis E outbreak in the health district of Bocaranga-Koui, Central African Republic, 2018-2019.

Article

作者: Marina Prisca de Marguerite Nombot-Yazenguet ; Joël Wilfried Doté ; Giscard Wilfried Koyaweda ; Philippe Armand Zemingui-Bembete ; Benjamin Selekon ; Ulrich Vickos ; Alexandre Manirakiza ; Emmanuel Nakoune ; Ionela Gouandjika-Vasilache ; Narcisse Patrice Joseph Komas

BACKGROUND:

Hepatitis E virus (HEV) is a major public health disease causing large outbreaks and sporadic cases of acute hepatitis. We investigated an outbreak of HEV infection that occurred in September 2018 in the health district (HD) of Bocaranga-Koui, located in the northwestern part of Central African Republic (CAR).

METHODS:

Blood samples were collected from 352 patients aged 0-85 years suspected to be infected with yellow fever (YF), according to the World Health Organization YF case definition. The notification forms from recorded cases were used. Water consumed in the HD were also collected. Human samples found negative for anti-YF IgM were then tested by ELISA for anti-HEV IgM and IgG antibodies. Positive anti-HEV (IgM and/or IgG) samples and collected water were then subjected to molecular biology tests using a real time RT-PCR assay, followed by a nested RT-PCR assay for sequencing and phylogenetic analysis.

RESULTS:

Of the 352 icterus patients included, anti-HEV IgM was found in 142 people (40.3%) and anti-HEV IgG in 175 (49.7%). Although HEV infection was detected in all age groups, there was a significant difference between the 0-10 age groups and others age groups (P = 0.001). Elevated levels of serum aminotransferase were observed in anti-HEV IgM-positive subjects. Phylogenetic analysis showed HEV genotype 1e in infected patients as well as in the contaminated water.

CONCLUSION:

This epidemic showed that CAR remains an HEV-endemic area. The genotype 1e strain was responsible for the HEV outbreak in Bocaranga-Koui HD. It is necessary to implement basic conditions of hygiene and sanitation to prevent further outbreaks of a HEV epidemics, to facilitate access to clean drinking water for the population, to launch intensive health education for basic hygiene measures, to sett up targeted hygiene promotion activities and, finally, to ensure that formal health care is available.

项与戊型肝炎相关的新闻（医药）

2024-03-24

·生物制品圈

不止打麻将，打疫苗也能预防老年痴呆？

疫苗对老年群体的益处，不仅仅是预防“疫苗可预防的疾病(VPD)”所致身体的损害，可能还有心智上的额外获益——老年人接种VPD疫苗可能降低痴呆症风险的研究早已屡见不鲜。这些研究既有涉及流感疫苗、带状疱疹疫苗，也有关于狂犬病疫苗和乙肝疫苗。既有队列研究也有病例对照研究和荟萃分析，既有动物试验也有试验性研究，证据不可谓不广泛。01 流感疫苗降低了老年痴呆风险3月初，Nature子刊npj vaccines发表了一项中国学者开展、评估接种流感疫苗对老年痴呆影响的为期12年的前瞻性队列研究。研究利用英国生物库人口数据，纳入70938名60岁以上老年人，其中54%的老年人接种过流感疫苗。研究结果很积极，结论下的也很谨慎——接种流感疫苗与社区居住的成年人痴呆症发病风险的降低有显著相关性（HR=0.83；95% CI，0.72-0.95）。有意思的是，尽管研究谨慎性地只下了相关性结论并未表明因果关系，但却发现了流感疫苗与痴呆症之间的剂量-反应关系——接种流感疫苗频次更高的老年人老年痴呆患病率更低。接种流感疫苗的平均频次＞0.8剂/年，患痴呆症的风险更低02 这些疫苗或许也能“降”痴呆除了流感疫苗，去年10月BMC刊载了另一项关于接种流感疫苗和带状疱疹疫苗与痴呆症风险降低有关的回顾性、大样本队列研究发现，接种带状疱疹疫苗的预防效果似乎要比流感疫苗更好，包括更低的痴呆症、阿尔茨海默病和其他类型的痴呆风险。ps：可能由于两款疫苗保护效果的差异带来的差异？疫苗起预防作用的机制，是否因为它保护了老年人群免受病原感染？近日一项纳入了6项队列研究、涉及538531名带状疱疹患者的最新荟萃分析显示：带状疱疹患者与痴呆风险之间存在显著的直接关联，接受抗病毒治疗的带状疱疹患者与痴呆风险呈负相关（HR：0.68,95% CI：0.59-0.77，p < 0.001）。图示为带状疱疹患者和痴呆之间的关系去岁斯坦福大学学者在知名医学研究预印本medRxiv的一项述论似乎也已经发现了接种带状疱疹疫苗可降低老年痴呆的因果效应。除了流感疫苗和带状疱疹疫苗外，一项荟萃分析揭示了常规接种其他成人VPD疫苗或许都可以显著降低平均约35%的痴呆风险（HR=0.65，95%CI:0.60-0.71），包括狂犬疫苗、乙肝疫苗、甲肝疫苗、百白破疫苗，甚至伤寒疫苗。（如下图，整个感觉就是制药打疫苗，别管什么疫苗，都能降低老年痴呆的风险）03 这个被忽视的疫苗可能也有“妙用”成人VPD疫苗算起来并不太多，而适合老年人群常规接种的VPD疫苗仅有流感疫苗、肺炎疫苗、带状疱疹疫苗和戊型肝炎疫苗4种，其中戊肝疫苗经常被忽略。多项研究数据显示，年龄和男性不仅是痴呆症的两个关键危险因素，同样也是戊型肝炎的关键危险因素——戊肝患者的平均年龄约为50岁（发病高峰），且随着年龄增长暴露风险可累积。戊肝患者的男女比例与痴呆症患者也很相似，都约为2:1。图源于：中国2011-2021年戊型病毒性肝炎发病趋势和时空聚集性[J].中国疫苗和免疫,2022.一项发表在知名感染病学杂志、由西班牙学者开展的对照研究发现，抗-HEV IgG阳性（既往暴露）与老年人神经病理损伤和AD诊断率较高有关（aOR=1.97;p=0.006；aOR=1.84; p=0.022）。图示为神经病理性损伤（左）和阿尔茨海默（右）的风险而病因研究的证据也不少，其中发表于知名学术期刊PNAS的一项由弗吉尼亚大学开展的动物实验研究显示：HEV可通过直接感染脑微血管内皮细胞侵入中枢神经系统，随后感染神经元细胞导致中枢神经系统损伤。是否可以推测——暴露于HEV的老年人有更高的老年痴呆风险？上述带状疱疹的研究似乎也可以佐证该猜想。04 老年痴呆可能由于病原感染由于疫苗素养属于一种比较关键的健康素养，所以尽管有这些发现，但我们也只能猜测——是疫苗保护了老年人免受病毒对神经系统的损害（因果关系），还是接种疫苗的老年人健康素养间接避免了患老年痴呆的风险（偏倚因素）？要解决这个疑问，可能还需要探讨另一个问题——如果老年人暴露于这些病毒或疾病，是否会导致神经系统损伤。其实越来越多的研究支持散发性AD的病原感染假说（AD中较为常见但病因不明的一种），特别是几种疱疹病毒（HHV1-7 、VZV、EBV、MCV）、黄病毒（即寨卡病毒、登革热病毒、日本脑炎病毒）、HIV病毒、5种常见的肝炎病毒及SARS-CoV2等可能会增加患AD的风险。2023年Cell子刊Neuron也做了这样一项研究——基于FinnGen数据库和英国生物银行（UKB）的数据分析发现，流感、肺炎与其中5种神经退行性疾病（AD、ALS、痴呆、PD和VAS）显著相关。05 接种疫苗的另一个意外好处除了老年痴呆外，也有研究显示，定期接种流感疫苗对急性冠状动脉综合征和中风有一致的、剂量依赖性的保护效果，同时接种流感疫苗和肺炎球菌疫苗与降低某些心血管事件（中风、充血性心力衰竭、缺血性心脏病和心肌梗死）的风险相关。可能的保护机制有4种：预防感染引起的并发症；减少炎症反应并改善血管功能、降低血栓形成的风险；疫苗免疫反应可能有助于减轻或防止感染引起的炎症和免疫激活；抗体可以与氧化低密度脂蛋白（oxLDL）发生交叉反应，而oxLDL是动脉粥样硬化斑块的组成部分。06 是否可以宣传这些额外获益考虑以上研究证据，建议老年人群常规接种流感疫苗、肺炎疫苗、带状疱疹疫苗和戊型肝炎疫苗。流感、肺炎等疾病的“知名度”显然无法与老年痴呆相比，宣传这些额外获益或许更能调动老年人群的接种积极性（毕竟老年人是“买送”项目的主要拥趸），但如何做好尺度监管又是一个问题。去年加拿大学者就刊文呼吁——流感疫苗可以预防心血管疾病的证据越来越多，《加拿大免疫指南》应当考虑更新并纳入该影响，以便让更多人知道后去积极接种疫苗。参考资料：NPJ Vaccines. 2024 Mar 2;9(1):51.BMC Public Health. 2023 Oct 2;23(1):1903.Front Immunol. 2022 May 3;13:872542.Health Sci Rep. 2024 Mar 13;7(3):e1941.Ageing Res Rev. 2023 Nov;91:102068.Neuron. 2023 Apr 5;111(7):1086-1093.e2.中国疫苗和免疫,2022,28(04):417-421.J Infect Dis. 2023 Apr 12;227(7):873-877.PNAS. 2022 Jun 14;119(24):e2201862119.doi: 10.1101/2023.05.23.23290253.Geroscience. 2023 Dec;45(6):3419-3447.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点，不代表本站立场。

疫苗临床结果

2024-02-24

·生物探索

历经10年！厦门大学夏宁邵团队合作最新Lancet：安全可靠

引言戊型肝炎病毒(HEV)是一种经常被忽视的急性肝炎病原体。评估戊型肝炎疫苗效力的长期持久性至关重要。2024年2月19日，厦门大学夏宁邵及张军共同通讯在国际知名医学期刊Lancet（IF 169）在线发表题为“Long-term efficacy of a recombinant hepatitis E vaccine in adults: 10-year results from a randomised, double-blind, placebo-controlled, phase 3 trial”的研究论文，该研究是在中国江苏省东台县进行的一项随机、双盲、安慰剂对照的戊型肝炎疫苗3期临床试验的延伸。在最初的试验中，共有112604名年龄在16-65岁的健康成年人入组，根据年龄和性别进行分层，并按1:1的比例随机分配，分别在第0个月、第1个月和第6个月接受三剂戊型肝炎疫苗或肌肉注射安慰剂。建立了一个敏感的戊型肝炎监测系统，包括覆盖整个研究区域的205个临床哨点，并在接种疫苗后维持了10年。主要结局是戊型肝炎病毒疫苗预防第三剂注射后至少30天确诊戊型肝炎发生的按方案有效性。在2007年8月22日至2017年10月31日的10年研究期间，确定了90名戊型肝炎患者；疫苗组有13例(每10000人年0.2例)，安慰剂组有77例(每10000人年1.4例)，在改良意向治疗分析中对应的疫苗效力为83.1% (95% CI为69.4~94.1)，在按方案分析中对应的疫苗效力为86.6%(70.3~ 94.1)。在免疫原性持续性评估的参与者亚群中，基线时血清阴性并接种三剂戊型肝炎疫苗的参与者中，Qindong地区291名疫苗接种者中有254名(83.3%)在8·5年时保持抗体浓度，Anfeng地区1740名疫苗接种者中有1270名(73.3%)在7·5年时保持抗体浓度。该研究发现接种这种戊型肝炎疫苗可对戊型肝炎提供长达10年的持久保护，疫苗诱导的针对戊型肝炎的抗体至少可持续8.5年。戊型肝炎病毒(HEV)是全球急性病毒性肝炎的主要病因之一。戊肝病毒株的分子特征鉴定出四种主要基因型。基因型1和2仅限于人类，并在资源有限的国家通过受污染的水传播，而基因型3和4是人畜共患的，在几乎所有国家引起散发的本地戊型肝炎。全世界每年约发生2000万例戊型肝炎感染，估计导致330万例戊型肝炎症状感染和7万例死亡。在流行地区，10岁以下儿童中抗戊型肝炎抗体的流行率可高达5%，25岁以上成人中这一比例上升至10-40%。在过去的几十年里，我们对戊型肝炎的认识有了很大的进步。与早先认为戊型肝炎仅在低收入至中等收入国家流行的看法相反，现在人们认识到，戊型肝炎感染可在世界范围内发生。此外，之前认为戊型肝炎总是一种症状轻微的自限性疾病的观点已经被一些研究所驳斥，这些研究表明，免疫功能低下的个体中存在慢性HEV感染，孕妇感染戊型肝炎(基因型1)会导致严重和暴发性疾病甚至死亡。在一项荟萃分析中，报告了HEV感染孕妇的高孕产妇病死率为3.2%-70%，并且HEV感染还与不良妊娠结局(如死产和宫内死亡)的风险增加有关。研究设计（Credit: Lancet）在患有潜在慢性肝病的患者中，HEV感染是急性非慢性肝衰竭的潜在触发因素。一项荟萃分析显示，合并HEV的慢性肝病患者发生肝功能衰竭的风险(odd ratio[OR] 5.5, 95% CI 1.5 - 20.1)和死亡率(OR 5.0, 1.9 - 13.3)显著高于未合并HEV的慢性肝病患者。尽管有这些令人震惊的发现，但戊型肝炎病毒仍然是一种被低估的病原体，这主要是因为在认识戊型肝炎方面缺乏认识或经验的医生对戊型肝炎的误诊和漏诊，以及在许多国家缺乏对戊型肝炎相关的流行病学证据和疾病负担的全面调查。迄今为止，已经开发了两种基于基因型1的重组戊型肝炎疫苗，并在临床试验中证明了安全性和有效性，其中一种由葛兰素史克公司(英国伦敦)开发，另一种由厦门Innovax生物技术公司(中国厦门)开发。厦门Innovax生物技术公司的HEV239疫苗，被称为益可宁(Hecolin)，是唯一获得许可和可用的戊型肝炎疫苗(自2011年以来在中国，自2020年以来在巴基斯坦)。尽管如此，戊型肝炎高流行地区在获得疫苗益处方面仍然面临挑战。除了努力促进疫苗的广泛采用外，还需要进一步研究确定戊型肝炎疫苗所提供保护的持续时间。接种至少一剂疫苗或安慰剂的参与者戊型肝炎的累积发病率（Credit: Lancet）该研究是在中国江苏省东台县进行的一项随机、双盲、安慰剂对照的戊型肝炎疫苗3期临床试验的延伸。研究对象来自东台县11个乡镇。在最初的试验中，共有112604名年龄在16-65岁的健康成年人入组，根据年龄和性别进行分层，并按1:1的比例随机分配，分别在第0个月、第1个月和第6个月接受三剂戊型肝炎疫苗或肌肉注射安慰剂。建立了一个敏感的戊型肝炎监测系统，包括覆盖整个研究区域的205个临床哨点，并在接种疫苗后维持了10年。主要结局是戊型肝炎病毒疫苗预防第三剂注射后至少30天确诊戊型肝炎发生的按方案有效性。在整个研究过程中，参与者、现场调查人员和实验室工作人员对治疗任务一无所知。该研究已在ClinicalTrials.gov注册(NCT01014845)。在2007年8月22日至2017年10月31日的10年研究期间，确定了90名戊型肝炎患者；疫苗组有13例(每10000人年0.2例)，安慰剂组有77例(每10000人年1.4例)，在改良意向治疗分析中对应的疫苗效力为83.1% (95% CI为69.4~94.1)，在按方案分析中对应的疫苗效力为86.6%(70.3~ 94.1)。在免疫原性持续性评估的参与者亚群中，基线时血清阴性并接种三剂戊型肝炎疫苗的参与者中，Qindong地区291名疫苗接种者中有254名(83.3%)在8·5年时保持抗体浓度，Anfeng地区1740名疫苗接种者中有1270名(73.3%)在7·5年时保持抗体浓度。该研究发现接种这种戊型肝炎疫苗可对戊型肝炎提供长达10年的持久保护，疫苗诱导的针对戊型肝炎的抗体至少可持续8.5年。原文链接https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02234-1/abstract责编|探索君排版|探索君文章来源|“iNature”End往期精选围观一文读透细胞死亡(Cell Death) | 24年Cell重磅综述（长文收藏版）热文Nature | 破除传统：为何我们需要重新思考肿瘤的命名方式热文Nature | 2024年值得关注的七项技术热文Nature | 自身免疫性疾病能被治愈吗？科学家们终于看到了希望热文Nature | 癌症与神经系统的致命舞蹈

疫苗临床3期临床结果

2023-11-27

·FierceBiotech

Roche grows hepatitis diagnostics roster with new immunoassays

The launch of the quantitative and qualitative hepatitis B test comes shortly after Roche’s last addition to its hepatitis diagnostics slate. Earlier this month the company launched two immunoassays for detecting hepatitis E. For the second time this month, Roche is launching a new immunoassay to help diagnose cases of hepatitis. This time around, the newly unveiled test is one designed to identify the hepatitis B e antigen (HBeAg) in samples of human serum and plasma. The test, launched in Europe, not only detects the presence of the antigen, but also measures its quantity, meaning it can help measure the extent of a patient’s condition and their response to therapy. The Elecsys HBeAg quant test runs on Roche’s Cobas e-series analyzers and is available in all countries that recognize CE mark approval, according to the company’s announcement Monday. The test is meant to be used even after helping with the initial hepatitis B diagnosis. For one, because it quantifies the presence of the antigen, it can be administered to help monitor the effects of various treatments. For another, according to Roche, it can be used alongside other hepatitis B diagnostics to determine the phase of the disease, as well as how the virus is affecting the liver and the chances it may progress into liver cancer or other conditions. Roche noted that the immunoassay’s potential impact could be particularly large, since hepatitis B is the most common type of viral hepatitis around the world. “Hepatitis B affects millions of people each year and is a major global health burden. An accurate diagnosis is critical to ensuring timely treatment options,” Matt Sause, CEO of Roche Diagnostics, said in the announcement. “If hepatitis B is left untreated, it can cause chronic infections, putting people at high risk of death from cirrhosis and liver cancer.” He continued, “The addition of the Elecsys HBeAg quant immunoassay to our viral hepatitis testing portfolio underlines Roche’s commitment to tackle healthcare’s biggest challenges to support clinicians and their patients.” The launch of the quantitative and qualitative hepatitis B test comes shortly after Roche’s last addition to hepatitis diagnostics slate. Earlier this month the company announced the launch of two immunoassays for catching cases of hepatitis E. One of the Elecsys Anti-HEV tests looks for IgM antibodies to the hepatitis E virus, while the other focuses on IgG antibodies. The former can be used to detect both acute and recently acquired cases of the virus, while the latter broadens the scope to identify either recent or past infections. Roche’s debut comes as the World Health Organization has added hepatitis E diagnostics to its annual Essential Diagnostics List for the first time, and as estimates suggest that one-third of the world’s population could be at risk of infection, according to data cited by Roche. As with the hepatitis B test, the HEV tests are meant to run on certain Cobas e-series analyzers and modules. They return results in about 18 minutes, per their maker, and round out Roche’s panel of tests to differentiate between different forms of acute hepatitis.