Hib vaccine conjugate(LG Chem Ltd.)(Hib vaccine conjugate(LG Chem Ltd.)) - 在研适应症：嗜血杆菌感染_专利_临床

概要

基本信息

药物类型

治疗性疫苗、结合疫苗

别名

Euhib、Hib vaccine conjugate

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

嗜血杆菌感染

非在研适应症-

原研机构

LG Chem Ltd.

在研机构

LG Chem Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

韩国 (2010-08-10),

嗜血杆菌感染

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Hib vaccine conjugate(LG Chem Ltd.) 相关的临床试验

NCT01251133 / Completed临床3期

A Phase III Study to Assess Immunogenicity and Safety of 4th LBVH0101 Vaccination Compared With 4th Hiberix™ Vaccination in Healthy Toddlers Who Completed Primary Vaccination in LG-VHCL002 Study

This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same vaccination with primary one in healthy toddlers who completed the primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study.

开始日期2008-07-01

申办/合作机构

LG Life Sciences Ltd.

NCT01019772 / Completed临床3期

A Multicentre, Comparative, Two-arm, Parallel-group, Double-blind, Randomized Phase III Study to Assess Immunogenicity and Safety of LBVH0101 (Haemophilus Influenzae Type b Tetanus Toxoid Conjugate Vaccine) Compared With Hiberix™ Vaccine in Healthy Infants at Two, Four and Six Months of Age

The purpose of this study is to evaluate and compare the immunogenicity and safety of LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™ at vaccination in healthy infants at their 2, 4, and 6 months of age.

开始日期2007-07-01

申办/合作机构

LG Life Sciences Ltd.

100 项与 Hib vaccine conjugate(LG Chem Ltd.) 相关的临床结果

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100 项与 Hib vaccine conjugate(LG Chem Ltd.) 相关的转化医学

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100 项与 Hib vaccine conjugate(LG Chem Ltd.) 相关的专利（医药）

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37

项与 Hib vaccine conjugate(LG Chem Ltd.) 相关的文献（医药）

2023-12-04·West African journal of medicine

SEROPROTECTION RATE OF HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE AND ASSOCIATED CLINICAL OUTCOMES AMONG NIGERIAN CHILDREN AGED 6 TO 23 MONTHS.

作者: Ebisike, Kelechi Joseph ; Shwe, David Danjuma ; Ehizibolo, David Odion ; Yilgwan, Christopher Sabo ; Ozhe, Sunday Ikukpla'si ; Isaac, Johnson Ajeh ; Ocheke, Isaac Ejembi ; Luka, Pam Dachung

IntroductionHaemophilus influenzae type b (Hib) causes invasive infections almost exclusively in under- fives with those aged 6-23 months being the most vulnerable. In Nigeria, it is estimated to cause nearly 400,000 annual infections and another 30,000 under-five mortality attributable to pneumonia and meningitis alone. The Hib Conjugate Vaccine (HCV) is in widespread use to combat these devastating infections. Data on its impact in Nigeria is grossly scanty. This study evaluated the seroprotection rates (SPR) of HCV and associated clinical outcomes among children aged 6-23 months in Obi L.G.A. of Nasarawa State, Nigeria.MethodsA cross-sectional study of 267 children aged 6-23 months who had completed three doses of HCV. They were enrolled via a two-staged household-level cluster sampling. Relevant sociodemographic and clinical data were obtained using structured questionnaires and serum samples collected were analysed serologically for antipolyribosylribitol phosphate (anti-PRP) antibodies using ELISA.ResultsThe overall SPRs against invasive Hib disease and Hib nasopharyngeal colonization were 74.2% and 26.2%, respectively. The overall geometric mean titre (GMT) of anti-PRP was 1.85 µg/mL (95%CI: 1.60-2.14) and across age groups, GMTs were >1 µg/mL-the threshold for long-term protection against invasive Hib disease. Rates/duration of healthcare admissions and average episodes of probable Hib disease syndromes were lower in seroprotected but not statistically different from non-seroprotected children.ConclusionThe demonstrated anti-PRP titres and Seroprotection Rates infer a very good HCV efficacy in Nigerian children. The lack of significant difference in clinical outcomes may be attributable to nonspecificity.

2022-01-01·Vaccine3区 · 医学

Reactivity characterization of bromoacetyl derivatized polyribosylribitol polysaccharide in Haemophilus influenzae type b for PedvaxHIB® by NMR spectroscopy

3区 · 医学

Article

作者: Rustandi, Richard R ; Xu, Qiuwei

PedvaxHIB® is a highly purified capsular polysaccharide (polyribosylribitol phosphate or PRP) of Haemophilus influenzae type b (Hib) that is covalently linked to an outer membrane protein complex (OMPC) of Neisseria meningitidis pediatric vaccine. This Hib protein conjugate vaccine is very effective in protecting infants from invasive gram-negative bacterium Hib. Before conjugation of PRP to OMPC, PRP is first derivatized with butadiamine and bromoacetyl group which reacts with thiolated OMPC. This report describes an NMR method to analyze the reactivity of bromoacetyl group in derivatized PRP (BrAc-derivatized PRP) toward small molecule thiol group, 2-mercapto imidazole (MI) which is used as a surrogate for thiolated OMPC. Reaction with MI helped identify observable amide protons in BrAc-derivatized PRP according to presence or absence of bromine. Furthermore, the new method can be used to monitor the percent of bromoacetylation during manufacturing and potentially a stability indicating assay for loss of bromine in BrAc-derivatized PRP.

2021-06-16·Clinical Microbiology Reviews1区 · 医学

Invasive Haemophilus influenzae Infections after 3 Decades of Hib Protein Conjugate Vaccine Use

1区 · 医学

Review

作者: Mackenzie, G. A. ; Grimwood, K. ; Cripps, A. W. ; Slack, M. P. E. ; Ulanova, M.

100 项与 Hib vaccine conjugate(LG Chem Ltd.) 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

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适应症	国家/地区	公司	日期
嗜血杆菌感染	韩国	LG Chem Ltd.	2010-08-10

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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


NCT01019772 \| NCT01251133 (Pubmed \| Vaccine)	临床3期	-	185	LBVH0101	鹽蓋積築遞膚壓齋醖積(築襯壓憲餘餘齋衊艱範) = 壓憲觸淵蓋範積淵製齋鏇膚鬱觸鑰選顧網願憲 (齋積艱構廠襯壓製觸淵 ) 更多	-	2012-02-27
				LBVH0101 (Hiberix)	鹽蓋積築遞膚壓齋醖積(築襯壓憲餘餘齋衊艱範) = 構範製範蓋衊襯壓顧憲鏇膚鬱觸鑰選顧網願憲 (齋積艱構廠襯壓製觸淵 ) 更多