Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc)(Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc)) - 药物靶点：CMV gB_在研适应症：巨细胞病毒感染_专利_临床

概要

基本信息

药物类型

联合疫苗、预防性疫苗

别名

Cytomegalovirus glycoprotein vaccine、GSK Biologicals' recombinant CMV gB vaccine

+ [1]

靶点

CMV gB

作用机制

CMV gB拮抗剂(巨细胞病毒gB蛋白拮抗剂)

治疗领域

感染

在研适应症

巨细胞病毒感染

非在研适应症-

原研机构

GSK Plc

在研机构

GSK Plc

非在研机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc) 相关的临床试验

NCT05089630 / Active, not recruiting临床1/2期

A Phase 1/2, First-Time-in Human (FTiH), Randomized, Observer-blind, Placebo-controlled, Dose Escalation Study to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Cytomegalovirus (CMV) Vaccine Comprising Recombinant Protein and Adjuvant When Administered Intramuscularly in Healthy Adults

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the candidate CMV recombinant protein subunit (CMVsu) vaccine consisting of a combination of glycoproteins B (gB) and pentamer antigens adjuvanted, regardless of baseline CMV sero-status. This FTiH study will be conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine will be administered in a step-wise dose escalation manner, based upon safety adjudication.

开始日期2021-10-14

申办/合作机构

GSK Plc

NCT01357915 / CompletedN/A

A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults

The purpose of this study is to evaluate the persistence of the vaccine induced immune responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during the primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection in naturally infected subjects who participated in the screening visit of the primary study 108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value (seropositive reference group). In addition, this study will continue to assess the occurrence of CMV infections as well as the continued development and validation of read-outs in the CMV project.
The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting (NCT00435396).

开始日期2011-06-24

申办/合作机构

GSK Plc

NCT00435396 / Completed临床1期

A Phase I, Open-label, Vaccination Study to Evaluate the Safety and Immunogenicity of the GSK Biologicals Recombinant CMV gB Sub-unit Vaccine GSK1492903A in CMV-seronegative Healthy Male Adult Subjects

This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK adjuvant system. The vaccine will be administered to young male healthy subjects at 0, 1 and 6 months. The trial will assess the safety and immunogenicity of the candidate CMV vaccine. An additional secondary objective of this trial is to identify and validate a test which will be able to differentiate between previous CMV infection and CMV vaccination. Subjects will be followed for a total of 2 years.

开始日期2007-02-22

申办/合作机构

GSK Plc

100 项与 Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc) 相关的专利（医药）

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16

项与 Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc) 相关的文献（医药）

2023-03-01·Annals of medicine and surgery (2012)

Guillain-Barré syndrome following the second dose of COVID AstraZeneca vaccine in a 78-year-old male: a case report from Nepal.

作者: Kc, Sabin ; Karki, Shailendra ; Thapa, Pratima ; Acharya, Bimarsh ; Kc, Pooja

Guillain-Barré syndrome (GBS) is a rare acute idiopathic demyelinating polyneuropathy that causes bilateral, symmetrical, and progressive weakness of muscles. AstraZeneca vaccine is a genetically modified spike glycoprotein vaccine of an adenovirus vector. GBS following the second dose of the AstraZeneca vaccine dose is rare and not frequently noted.Case PresentationA 78-year-old male presented to the hospital with complaints of bilateral weakness of the lower limbs over 4 days following the second dose of the AstraZeneca vaccine. On examination, the power and tone of the limbs were diminished. The sensitivity pinprick test revealed low sensitivity in the right lower limb than in the left lower limb. Nerve conduction studies revealed acute inflammatory demyelinating polyneuropathy and the patient was diagnosed with GBS. After admission, the patient was successfully treated with intravenous immunoglobulins along with physiotherapy.Clinical DiscussionGBS can be diagnosed clinically with nerve conduction studies and Brighton's criteria. The robust causal relationships between COVID-19 infections, COVID-19 vaccination, and GBS are still unclear. The evaluation of the potential association and risk of GBS with vaccines warrants the need for precise post-vaccination surveillance measures and results.ConclusionOnly a few cases of GBS following the second dose of AstraZeneca are reported so far and there is a need for strong and accurate diagnosis of the disease and proper post-vaccination surveillance for the evaluation of risk associated with COVID vaccines.

2021-09-01·Biotechnology Journal3区 · 工程技术

High throughput chromatography and analytics can inform viral clearance capabilities during downstream process development for biologics

3区 · 工程技术

Article

作者: Arias, Gabriel F. ; Cibelli, Nicole L. ; O'Connell, Sarah E. ; Gowetski, Daniel B. ; Gulla, Krishana C. ; Schneiderman, Zachary J. ; Cetlin, David

AbstractHigh throughput process development (HTPD) using liquid handling robotics and RoboColumns is an established methodology in downstream process development to screen chromatography resins and optimize process designs to meet target product profiles. However, HTPD is not yet widely available for use in viral clearance capability of the resin due to a variety of constraints. In the present study, a BSL‐1‐compatible, non‐infectious MVM model, MVM‐VLP, was tested for viral clearance assessment with various resin and membrane chromatography operations in a HTPD mode. To detect the MVM‐VLP in the high throughput experiments, an electrochemiluminescence immunoassay (ECLIA) assay was developed with up to 5 logs of dynamic range. Storage time suitability of MVM‐VLP solutions in various buffer matrices, in the presence or absence of a glycoprotein vaccine candidate, were assessed. Then, MVM‐VLP and a test article monoclonal antibody (mAb) were used in a HTPD design that included commercially available ion exchange media chemistries, elucidating a wide variety of viral clearance ability at different operating conditions. The methodologies described herein have the potential to be a part of the process design stage in biologics manufacturing process development, which in turn can reduce risk associated with viral clearance validation studies.

2021-09-01·Vaccine3区 · 医学

A truncated glycoprotein G vaccine formulated with Advax-CpG adjuvant provides protection of mice against genital herpes simplex virus 2 infection

3区 · 医学

Article

作者: Liljeqvist, Jan-Åke ; Bergström, Tomas ; Honda-Okubo, Yoshikazu ; Petrovsky, Nikolai ; Bäckström, Malin ; Baldwin, Jeremy ; Görander, Staffan

Herpes simplex virus type 2 (HSV-2) is a common sexually transmitted disease that affects approximately 500 million individuals globally. There is currently no approved vaccine to prevent HSV-2 infection. EXCT4 is a truncated form of the mature glycoprotein G-2 (mgG-2) that unlike full mature form is secreted by expressing cells enabling it to be rapidly scaled up for production. The current study examined whether EXCT4 immunity in mice could be further enhanced through use of adjuvants. EXCT4 formulated with Advax-CpG adjuvant induced a strong Th1-type immune response characterized by interferon gamma (IFN-γ) and protected animals against a lethal genital challenge with HSV-2. This response was associated with reduced viral load in vaginal washes, spinal cord, and dorsal root ganglia. Together the results provide proof of concept that EXCT4 formulated with Advax-CpG adjuvant is a promising HSV-2 vaccine candidate warranting further investigation.

100 项与 Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc) 相关的药物交易

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研发状态

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
巨细胞病毒感染	临床2期	美国	GSK Plc	2021-10-14

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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


NCT01357915 (CTgov)	N/A	巨细胞病毒感染	47	Blood sampling+GSK149203A (GSK149203A S- Group)	糧選遞餘糧壓夢廠蓋憲(醖醖鏇範鬱鬱選遞網簾) = 構糧憲範選襯選廠範鬱醖簾鬱蓋廠餘觸憲夢鏇 (選範遞鏇餘鏇膚窪鹽鹹, 積餘壓蓋壓鏇淵鹽鏇鹹 ~ 鏇簾鏇鑰憲願獵鬱壓蓋) 更多	-	2017-10-06
				Blood sampling (GSK149203A S+ Group)	淵糧範顧壓觸簾襯餘膚(顧鑰觸遞廠築憲糧憲鏇) = 簾製糧積蓋餘鹹網蓋積願範夢構壓選獵鏇鏇鬱 (鏇蓋鑰築鏇遞膚簾鬱積, 網願遞膚鬱襯鬱鏇觸構 ~ 觸襯廠範壓製衊鬱襯積) 更多