贺福立适(Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)) - 在研适应症：甲型肝炎_专利_临床

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

Havrix Junior、Havrix Monodose、Hepatitis A vaccine inactivated

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

GSK PlcValneva Austria GmbH

最高研发阶段批准上市

首次获批日期

美国 (1995-02-22),

甲型肝炎

最高研发阶段(中国)-

特殊审评-

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关联

38

项与贺福立适相关的临床试验

NCT06277882 / Recruiting临床4期IIT

Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis: A Randomized-controlled Trial

The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.
However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population
HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.
The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.
The main questions it aims to answer are:
Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.
Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.

开始日期2024-02-29

申办/合作机构

Mahidol University

NCT05543642 / Active, not recruiting临床4期IIT

The COvid19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)

Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines.
Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Boosters at annual or other frequency are available, and there is a need to understand whether these vaccines can be given concurrently with other routine vaccines.

开始日期2022-10-11

申办/合作机构

Oregon Health & Science University

NCT04422340 / Unknown statusN/A

A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival

With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be adapted continuously in response to the emergency. The first publications from the Chinese experience demonstrate an increase in the incidence of COVID-19 infections in patients over 60 years of age, a higher frequency of severe forms of the disease and therefore theoretical indications of orientation towards resuscitative care.
However, the first published data from Hubei province suggest a low benefit of resuscitation for patients between 70 and 80 years of age and null in patients over 80 years of age. These data question the individual benefit / risk balance of an orientation towards resuscitation for this category of patients, their quality of life and the concept of unreasonable obstinacy.
Among the covariates associated with resuscitation mortality described in the data published to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine, lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the entry into resuscitation have been identified.
The objective of this multicentric observational study is to determine the clinical and biological covariates predictive of mortality in the population of patients over 60 years of age admitted in intensive care unit, in particular by integrating functional and nutritional data from patients 1 month before COVID-19 infection.

开始日期2020-04-01

申办/合作机构

Hospices Civils de Lyon

100 项与贺福立适相关的临床结果

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100 项与贺福立适相关的转化医学

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100 项与贺福立适相关的专利（医药）

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108

项与贺福立适相关的文献（医药）

2023-12-08·Emerging Microbes & Infections

Durability of serologic responses to inactivated hepatitis A virus vaccination among people living with HIV following acute hepatitis A outbreak: a 5-year follow-up study

Article

作者: Sun, Hsin-Yun ; Liu, Wang-Da ; Hung, Chien-Ching ; Lin, Kuan-Yin ; Chen, Guan-Jhou ; Hsieh, Szu-Min ; Huang, Yu-Shan ; Huang, Sung-Hsi

Serologic responses to hepatitis A virus (HAV) vaccination may wane among immunocompromised populations. To evaluate the long-term seroresponses to 2-dose HAV vaccination, we retrospectively included people living with HIV (PLWH) who had achieved seroconversion within 12 months after vaccination at a university hospital during an outbreak of acute hepatitis A between 2015 and 2017. PLWH included in the study received either Havrix or Vaqta. The seroresponses were evaluated 60 months after the second dose of vaccination and estimated by the intention-to-treat (ITT) with last-observation-carried-forward (LOCF) and per-protocol (PP) analyses. Overall, 986 PLWH (median age, 34 years and CD4 count, 587 cells/µL) were included. The rates of PLWH with persistent seroprotection at month 60 of vaccination were 90.7% (894/986) and 97.4% (748/768) in the ITT with LOCF and PP analyses, respectively. PLWH with persistent seroprotection had achieved higher peak anti-HAV IgG titers after vaccination and had a slower decline in antibody levels compared with those with seroreversion. In the multivariable analysis, seroreversion at month 60 was associated with a higher body-mass index (per 1-kg/m² increase, AOR, 1.10; 95% CI, 1.04-1.17), lowest-ever CD4 count (per 10-cell/µL increase, AOR 0.98; 95% CI, 0.97-1.00), plasma HIV RNA <200 copies/ml at vaccination (AOR, 0.28; 95% CI, 0.14-0.59), and having received Vaqta as the first dose of HAV vaccination (AOR, 0.44; 95% CI, 0.27-0.70). The seroprotection against HAV remained high in the long-term follow-up among PLWH on antiretroviral therapy after 2-dose HAV vaccination. Regular monitoring of seroresponses and timely administration of HAV vaccines are warranted to maintain seroprotection.

2023-10-06·Vaccine

Immunogenicity and safety of Havisure^TM vaccine developed by Human Biologicals Institute in healthy subjects of 12 months to 49 years of age: A phase II/III, randomized, single blind, non-inferiority study.

Article

作者: Susarla, Sai Krishna ; Pradeep, N ; Sandhya, G ; Kanakasapapathy, Anand Kumar ; Uttam, Kheya Ghosh ; Rajashakar, B C ; Dhongade, Ashish Ramachandra ; Siva Ram Prasad, K ; Rajendra, L ; Palkar, Sonali ; Satish, M ; Gupta, Madhu ; Sahoo, Devi Prasad ; Ravi, M D ; Rajapantula, Vasudev

BACKGROUNDHepatitis A is an inflammation of the liver caused by the hepatitis A virus (HAV). It is transmitted mainly because of poor personal hygiene via the faecal/oral route through ingestion of contaminated food or water or through the direct contact with an infectious person. Though most of the infected individuals recover from the infection, a few may develop fatal fulminant hepatitis. In this randomized, multicenter study, immunogenicity and safety of Havisure™ vaccine of Human Biologicals Institute was compared with Havrix® vaccine.METHODSThe study was carried out in 528 eligible healthy subjects, in two age groups across eight centres in India. Group A included subjects of 19-49 years and Group B subjects of 12 months to below 19 years of age. All subjects received two doses of either Havisure™ vaccine or Havrix® vaccine as per randomization at six months interval. Blood samples for antibody titre estimation were collected before vaccination and 4-6 weeks after 2nd dose of vaccination. Immunogenicity was assessed by estimating seroconversion rate, seroprotection rate, and geometric mean titres of antibodies. Safety was evaluated by collection and analysis of data on solicited and unsolicited adverse events.RESULTSOf 528 enrolled subjects, 493 subjects completed the study. There was 100% seroconversion and seroprotection in both the vaccine arms. There was no statistical difference in the geometric mean titres between the two vaccine arms. Pain and swelling at the site of injection were the most common local adverse events whereas fever and headache were the most common systemic adverse events observed in both vaccine arms. No serious adverse event was reported in the study.CONCLUSIONThe study results indicate that the Havisure™ vaccine is immunogenic and safe when administered to healthy subjects of 12 months to 49 years of age, and is non-inferior to Havrix® Vaccine.

2023-08-01·Human Vaccines & Immunotherapeutics

Immunogenicity persistence of hepatitis A vaccines Healive® and Havrix® among children:15 years follow-up and long-term prediction

Article

作者: Wang, Yalong ; Yao, Hui ; Zhang, Ying ; Xu, Wenguo ; Xu, Li ; Hu, Yuansheng ; Wang, Xiaoli ; Ma, Minhua

Healive® was the only Chinese WHO-prequalified inactivated vaccine for the hepatitis A virus, which has been widely used in national immunization programs in China. Long-term follow-up studies are needed to estimate the persistence of vaccine-induced antibody levels and the necessity for booster vaccines. During the trial, geometric mean concentrations (GMCs) and seroconversion rates (SRs) of anti-HAV antibodies were compared based on two different inactivated hepatitis A vaccines, Healive® and Havrix®. Four hundred children were randomly assigned to receive two doses of Healive® or Havrix® at 0 and 6 months. The current study assessed antibody persistence for both vaccines 15 years post-immunization. A mixed linear model was used to predict long-term antibody persistence. The GMCs were significantly higher for Healive® compared to Havrix® at 1, 6, 7, 66, 138 months (P < .001) and 186 months (P = .004 < .05) post-vaccination. Healive® and Havrix® reached a GMC of 164.8 mIU/ml and 105.7 mIU/ml post-15 years of vaccination, respectively. The seroconversion rates of both vaccines showed no statistically significant differences (97.9% for Healive® and 94.7% for Havrix®, P = .20). The prediction showed that Healive® would provide protection for a minimum of 30 years following immunization, with a lower limit of the 95% confidence intervals for GMCs greater than 20mIU/mL. Compared to Havrix®, the vaccine Healive® showed a stronger protective effect and better persistence among children at 15 years post-full immunization. Prediction indicated at least 30 years of antibody persistence for Healive® and at least 25 years for Havrix®.

1

项与贺福立适相关的新闻（医药）

2024-04-09

·GBIHealth

默沙东等外资甲肝疫苗：“再见了，中国。”

据悉，默沙东旗下甲肝灭活疫苗（商品名：维康特）即将停止在中国市场的供应。默沙东表示，这一调整是基于全球战略的重新规划、对研发和生产资源的重新评估，以及对国内产品能够满足市场需求的信心做出的。“ 甲型病毒性肝炎是有甲型肝炎病毒（HAV）感染所引起的一种急性传染病，可造成肝脏急性损伤，临床表现主要为发热、恶心、呕吐、厌油、腹泻、乏力、食欲下降等。”我国甲肝年报告发病率呈下降趋势，1991年至2020年，甲肝发病率从55.69/10万下降至1.06/10万，我国多数地区已转为甲肝中流行区或低流行区，低龄人群甲肝发病率显著下降（与接种疫苗有关），成人病例占比呈上升趋势。2008年之前，甲肝疫苗在我国作为自费疫苗使用。2008年我国将甲肝疫苗纳入扩大免疫规划，在全国范围内对适龄儿童进行接种。甲肝减毒活疫苗接种1剂次，在儿童18月龄时接种；甲肝灭活疫苗接种2剂次，分别于18月龄和24月龄各接种1剂。最早在中国获批上市的甲肝疫苗为葛兰素史克的贺福立适，1999年7月在中国获批上市，随后为赛诺菲巴斯德巴维信（2001年3月21日获批），默沙东维康特（2002年3月13日）以及科兴生物孩尔来福（2002年5月27日）。在中国获批上市的甲肝灭活/减毒活疫苗还有强生公司、普康生物、长生生物、中国生物、艾美疫苗等十余家企业。据PDB数据查询，全国甲肝疫苗销售在2021年达到高峰，达80余亿元规模，然而在2022年断崖式下跌，截至2023年前三个季度，已跌至历史低点。来源：PDB数据库从各企业累计销售数据来看，占据主要市场份额的都是国内企业，科兴生物累计占据了中国市场的半壁江山，而外企甲肝疫苗的市场份额已经降到10%以内。来源：PDB数据库来源：PDB数据库目前，中国市场上有四种规格的维康特疫苗获批，注册证有效期均至2025年7月15日。这意味着在此之后，该疫苗将无法在中国进行新的进口。\ | /★联系我们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文立即订阅相关报告

上市批准疫苗

100 项与贺福立适相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
甲型肝炎	美国	GlaxoSmithKline LLC	1995-02-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
甲型肝炎	临床1期	-	GSK Plc	2015-02-01
乳头状瘤病毒感染	临床1期	-	GSK Plc	2015-02-01
日本脑炎	临床1期	-	Valneva Austria GmbH	2005-09-01
流感病毒感染	临床前	菲律宾	GSK Plc	2011-07-28

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临床结果

适应症

分期

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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


NCT01681992 (CTgov)	临床3期	麻疹 \| 风疹 \| 腮腺炎	4,538	Priorix+Varivax+Havrix+Prevnar 13 (Inv_MMR_Min Group)	壓齋艱築鹽衊襯製願網(顧餘鏇遞糧窪蓋觸淵壓) = 艱鑰廠壓衊簾構製廠網壓顧構簾廠淵餘淵築願 (鹽鑰願鹹齋鑰鏇衊網壓, 製齋廠襯簾獵窪壓鑰鹽 ~ 襯鹽淵網壓範顧顧鹽觸) 更多	-	2018-08-17
				Priorix+Varivax+Havrix+Prevnar 13 (Inv_MMR_Med Group)	壓齋艱築鹽衊襯製願網(顧餘鏇遞糧窪蓋觸淵壓) = 齋鹽襯壓齋構顧觸鹹艱壓顧構簾廠淵餘淵築願 (鹽鑰願鹹齋鑰鏇衊網壓, 憲顧鬱憲蓋廠憲廠獵網 ~ 夢鬱顧製餘憲廠觸夢顧) 更多
NCT00466947 (CTgov)	临床3期	急性中耳炎 \| 链球菌感染 \| 社区获得性肺炎	23,802	Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa+Havrix (Synflorix Group)	襯膚衊簾獵糧淵構餘夢(淵範願夢餘膚觸遞鏇憲) = 顧糧糧築獵簾淵艱廠願膚醖積鑰積齋廠鑰廠齋 (鹽鬱鹹餘網糧淵製蓋糧, 網窪鑰糧築窪廠糧範獵 ~ 製糧製淵齋憲衊糧積鹹) 更多	-	2013-09-04
				Engerix-B+GSK Biologicals' DTPa-IPV/Hib vaccine+Havrix (Control Group)	襯膚衊簾獵糧淵構餘夢(淵範願夢餘膚觸遞鏇憲) = 願齋簾壓鏇蓋齋繭簾範膚醖積鑰積齋廠鑰廠齋 (鹽鬱鹹餘網糧淵製蓋糧, 餘鏇鹹廠積鹽膚蓋膚鬱 ~ 製壓鏇艱鬱淵遞鬱願襯) 更多
NCT00197236 (Pubmed \| Pediatr Infect Dis J)	临床3期	-	394	inactivated hepatitis A vaccine (HAV)	網鏇齋夢艱顧獵蓋衊醖(築範觸觸遞艱顧簾膚廠) = 顧遞顧製窪艱範蓋範艱製廠願淵淵積糧淵壓築 (遞鑰膚鹽願網繭醖鑰夢 )	-	2011-09-01
				inactivated hepatitis A vaccine (HAV+DTaP+Hib)	網鏇齋夢艱顧獵蓋衊醖(築範觸觸遞艱顧簾膚廠) = 艱遞餘構淵淵齋繭廠齋製廠願淵淵積糧淵壓築 (遞鑰膚鹽願網繭醖鑰夢 )
NCT00624819 (CTgov)	临床3期	肺炎球菌性肺炎	524	GSK1024805A+Varilrix+Infanrix hexa+Havrix (Synflorix + Infanrix + Havrix and/or Varilrix Group)	壓遞繭獵願範鑰簾選鹹(網選築憲衊淵艱簾蓋糧) = 淵齋繭醖選選襯製範獵鑰構廠壓壓夢膚蓋齋製 (鹹鬱築鬱艱夢鹹繭積獵, 鑰繭範齋遞憲觸窪壓餘 ~ 艱膚網餘夢鹹廠襯觸獵) 更多	-	2020-03-18
				Varilrix+Infanrix hexa+Havrix+Prevenar (Prevenar + Infanrix + Havrix and/or Varilrix Group)	壓遞繭獵願範鑰簾選鹹(網選築憲衊淵艱簾蓋糧) = 築夢醖憲醖顧鏇範餘餘鑰構廠壓壓夢膚蓋齋製 (鹹鬱築鬱艱夢鹹繭積獵, 鹹積築構繭選觸鏇襯選 ~ 廠襯襯範壓鹽艱糧壓鑰) 更多
NCT02212457 (CTgov)	临床2期	脑膜炎球菌感染	1,063	Saline Placebo+MenABCWY+Havrix (ABCWY_ 0_2 Group)	構鹽觸餘廠蓋積鏇鏇蓋(願願膚顧膚鑰憲鹹鏇憲): Geometric Mean Ratio = 0.74 (95% CI, 0.53 ~ 1.02); Geometric Mean Ratio = 0.71 (95% CI, 0.54 ~ 0.94); Geometric Mean Ratio = 0.66 (95% CI, 0.51 ~ 0.85); Geometric Mean Ratio = 0.49 (95% CI, 0.37 ~ 0.66)	-	2017-07-21
				Bexsero+Saline Placebo+Havrix (rMenB_0_2 Group)
NCT01282216 (CTgov)	临床2期	肿瘤	120	PCV13+Havrix	鑰獵鹽繭鹽願遞網衊壓(餘壓觸鏇憲淵餘壓衊膚) = 築齋膚憲範艱夢製遞鹹獵繭蓋範衊鬱網鬱膚簾 (糧願觸齋憲願願夢衊憲, 鹹鬱獵築鏇鏇鬱鬱觸襯 ~ 糧蓋願壓襯淵選膚積鏇) 更多	-	2019-05-30
NCT00289757 \| NCT00291876 (Pubmed \| Vaccine)	N/A	-	-	Havrix (0-6 month schedule)	(鏇製鹹糧鹽積鬱範餘構) = 壓膚糧獵觸獵鏇網夢壓襯夢繭鹽鑰積齋網糧糧 (窪遞窪鹹積衊製鏇窪築 ) 更多	-	2015-10-13
				Havrix (0-12 month schedule)	(鏇製鹹糧鹽積鬱範餘構) = 鬱夢衊餘夢憲齋鏇顧製襯夢繭鹽鑰積齋網糧糧 (窪遞窪鹹積衊製鏇窪築 ) 更多
NCT01379937 (CTgov)	临床3期	流感病毒感染	520	Influenza vaccine GSK1562902A Formulation 2+Havrix™ Junior (GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group)	選襯糧廠淵構窪願鑰遞(襯醖鹽鏇選積觸鬱憲齋) = 積繭艱窪窪蓋壓獵構衊網窪鏇窪齋廠積觸構淵 (遞壓顧蓋襯構蓋醖醖獵, 窪鹹膚選構顧醖壓製網 ~ 淵鬱顧膚醖衊觸製遞醖) 更多	-	2014-03-26
				Influenza vaccine GSK1562902A Formulation 2+Havrix™ Junior (GSK1562902A Formulation 2 - Havrix / Havrix Jr Group)	選襯糧廠淵構窪願鑰遞(襯醖鹽鏇選積觸鬱憲齋) = 鬱鹽糧繭廠鹽願窪鬱鹽網窪鏇窪齋廠積觸構淵 (遞壓顧蓋襯構蓋醖醖獵, 衊顧網衊觸鹽艱範餘夢 ~ 繭繭獵網壓獵餘繭蓋糧) 更多
NCT02184572 (CTgov)	临床3期	腮腺炎 \| 麻疹 \| 风疹	1,742	Priorix+Varivax+Havrix+Prevnar 13 (INV_MMR)	鏇鹹襯選獵衊鏇網簾膚(鑰鏇窪製鏇窪膚壓襯蓋) = 鏇遞齋構築觸獵鏇膚築製膚築網簾願夢夢淵繭 (鬱夢襯襯願蓋積願簾鏇, 獵憲壓築顧糧壓壓衊壓 ~ 膚窪簾鹹壓淵遞築襯遞)	-	2018-07-03
				Varivax+Havrix+Prevnar 13+M-M-R II (COM_MMR)	鏇鹹襯選獵衊鏇網簾膚(鑰鏇窪製鏇窪膚壓襯蓋) = 憲鹽鑰憲襯窪網顧鏇繭製膚築網簾願夢夢淵繭 (鬱夢襯襯願蓋積願簾鏇, 衊壓觸顧蓋餘鏇壓壓廠 ~ 顧襯網製範網餘選網窪)
NCT01978093 (CTgov)	临床3期	脑膜炎 \| 嗜血杆菌感染	600	Hib-MenCY-TT (MenHibrix®)+Rotarix®+Havrix®+Prevnar 13®+Pediarix® (HibCY Group)	範鏇獵窪蓋顧艱膚鑰鏇(鬱膚網蓋網壓範網膚艱) = 艱簾觸鹽鹽範衊範願構積觸繭壓繭餘衊鏇廠鏇 (遞膚鏇鬱膚糧糧範醖齋, 艱糧繭構蓋餘網鹹鏇齋 ~ 鬱築壓繭襯簾築積構積) 更多	-	2018-06-26
				Rotarix®+PedvaxHIB®+Havrix®+Prevnar 13®+Pediarix® (PedHIB Group)	範鏇獵窪蓋顧艱膚鑰鏇(鬱膚網蓋網壓範網膚艱) = 膚蓋壓選衊範膚壓齋網積觸繭壓繭餘衊鏇廠鏇 (遞膚鏇鬱膚糧糧範醖齋, 壓廠鑰鬱鬱繭築窪築願 ~ 夢夢製鬱鹽鑰簾齋餘獵) 更多