Shigella sonnei vaccine (GlaxoSmithKline)(Shigella sonnei vaccine (GlaxoSmithKline))

概要

基本信息

药物类型

预防性疫苗

别名

1790GAHB vaccine、GVGH Shigella sonnei 1790GAHB vaccine

+ [1]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染消化系统疾病其他疾病

在研适应症-

非在研适应症

志贺氏菌感染

原研机构

Novartis AG

在研机构-

非在研机构

GSK Vaccines Institute for Global Health Srl

GSK Plc

权益机构-

最高研发阶段无进展临床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

5

项与 Shigella sonnei vaccine (GlaxoSmithKline) 相关的临床试验

PACTR202306741443913

/ Suspended临床1期IIT

Safety and feasibility of a Shigella sonnei 53G controlled human infection model in Kenyan adults: a dose finding and dose verification study

开始日期2023-10-01

申办/合作机构

University of Oxford

NCT03089879

/ Completed临床1期

A Phase 1, Open Label, Non-randomized, Single Center Study to Evaluate the Safety and Immunogenicity of 1 Booster Vaccination With (GVGH Shigella Sonnei 1790GAHB) Vaccine Administered Intramuscularly in Healthy Adults Previously Primed With Three Doses of the Same Vaccine in Study H03_01TP Compared to 1 Vaccination With (1790GAHB) Administered Intramuscularly Either to Subjects Who Received Placebo in the H03_01TP Study or naïve Subjects Who Were Not Part of H03_01TP Study

GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei.
A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with detectable versus undetectable antibody titres at baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic in completely naïve adults.
This study was then designed to further characterize the immunogenicity profile of the vaccine and to evaluate whether it was able to induce an immunological memory response.

开始日期2017-03-16

申办/合作机构

GSK Plc

NCT02676895

/ Completed临床2期

A Phase 2a, Observer Blind, Randomized, Controlled, Single Center Study To Evaluate The Safety, Reactogenicity And Immunogenicity Of 2 Doses Of The GVGH 1790GAHB Vaccine Against Shigella Sonnei, Administered Intramuscularly In Adult Subjects From A Country Endemic For Shigellosis

The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.

开始日期2016-08-08

申办/合作机构

GSK Plc

100 项与 Shigella sonnei vaccine (GlaxoSmithKline) 相关的临床结果

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100 项与 Shigella sonnei vaccine (GlaxoSmithKline) 相关的转化医学

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100 项与 Shigella sonnei vaccine (GlaxoSmithKline) 相关的专利（医药）

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25

项与 Shigella sonnei vaccine (GlaxoSmithKline) 相关的文献（医药）

2022-04-01·Infectious Diseases and Therapy3区 · 医学

GMMA Technology for the Development of Safe Vaccines: Meta-Analysis of Individual Patient Data to Assess the Safety Profile of Shigella sonnei 1790GAHB Vaccine in Healthy Adults, with Special Focus on Neutropenia

3区 · 医学

ArticleOA

作者: Conti, Valentino ; De Ryck, Iris ; Auerbach, Joachim ; Nakakana, Usman ; Vella, Venanzio ; Sarakinou, Eleanna ; Podda, Audino ; Cilio, Giulia Luna ; Granada, Juan-Paolo ; Ndiaye, Augustin

INTRODUCTIONShigellosis is a major health concern among children < 5 years of age from developing countries, and there are no widely available vaccines to prevent it. The GMMA-based 1790GAHB investigational vaccine against Shigella sonnei was well tolerated and immunogenic in phase 1 and 2 studies conducted in healthy adults from Shigella endemic and non-endemic populations. Based on pooled data of five individual trials, we assessed the association between vaccine administration and the risk of neutropenia as well as the overall safety profile of 1790GAHB.METHODSThe risk ratio (RR) of neutropenia was evaluated between participants receiving 1790GAHB (vaccinees) and active comparator/placebo (controls) using different ethnicity-specific absolute neutrophil count (ANC) thresholds established to define neutropenia. Safety was assessed in terms of solicited, unsolicited, and serious adverse events (AEs).RESULTSOf the 279 participants, 11 (5.5%) vaccinees and 4 (5.0%) controls had ANC below the appropriate threshold within 7 days post-vaccination. RR was 0.96 [95% confidence interval (CI) 0.54-1.70]. When neutrophil counts of participants of African descent were measured against an ethnicity non-specific threshold, they resulted in neutropenia episodes in 30 (37.0%) vaccinees and 16 (30.2%) controls, while only 2 (2.5%) vaccinees and 1 (1.9%) control had neutropenia when the ethnicity-specific threshold was applied. RRs were 0.98 (95% CI 0.75-1.28) and 1.30 (95% CI 0.1-17.6), respectively. Solicited and unsolicited AEs were slightly more frequent among vaccinees than controls. No serious AEs, other than neutropenia cases, were recorded in the vaccine group.CONCLUSIONBy applying the appropriate threshold, no increased risk of neutropenia was identified in vaccinees compared with the controls. The frequency of neutropenia events varied drastically when ethnicity-appropriate thresholds were applied. This observation highlights the importance of selecting appropriate cut-off values according to the correct population reference. Overall, the 1790GAHB vaccine demonstrated an acceptable safety profile.

2021-12-20·The Journal of Infectious Diseases2区 · 医学

Functional Antibodies and Innate Immune Responses to WRSS1, a Live Oral Shigella sonnei Vaccine Candidate, in Bangladeshi Adults and Children

2区 · 医学

Article

作者: Mily, Akhirunnesa ; Wierzba, Thomas F ; Sarker, Protim ; Ara, Anjuman ; Walker, Richard I ; Haque, Farjana ; Venkatesan, Malabi M ; Raqib, Rubhana ; Maier, Nicole

AbstractBackgroundWe demonstrated in a randomized placebo-controlled trial that WRSS1, a live oral Shigella sonnei vaccine candidate, is safe in Bangladeshi adults and children, and elicits antigen-specific antibodies. Here, we describe functional antibody and innate immune responses to WRSS1.MethodsAdults (18–39 years) and children (5–9 years) received 3 doses of 3 × 105 or 3 × 106 colony forming units (CFU) of WRSS1 or placebo, 4 weeks apart; children additionally received 3 × 104 CFU. Blood and stool were collected at baseline and 7 days after each dose. Functional antibodies were measured using serum bactericidal antibody (SBA) assay. Cytokine/chemokine concentrations were measured in lymphocyte cultures. Host defense peptides LL-37, HBD-1, and HD-5 were analyzed in plasma and stool.ResultsChildren showed increased SBA titers over baseline after the third dose of 3 × 106 CFU (P = .048). Significant increases of Th-17 and proinflammatory cytokines (TNF-α, G-CSF, MIP-1β), and reduction of anti-inflammatory and Th2 cytokines (IL-10, IL-13, GM-CSF) were observed in children. Plasma HBD-1 and LL-37 decreased in children after vaccination but were increased/unchanged in adults.ConclusionsFunctional antibodies and Th1/Th17 cytokine responses in children may serve as important indicators of immunogenicity and protective potential of WRSS1.Clinical Trials Registration: NCT01813071.

2019-06-03·Human Vaccines & Immunotherapeutics3区 · 医学

A phase I trial of WRSS1, a Shigella sonnei live oral vaccine in Bangladeshi adults and children

3区 · 医学

Article

作者: Qadri, Firdausi ; Walker, Richard I. ; Venkatesan, Malabi M. ; Alam, Nur Haque ; Fix, Alan ; Suvarnapunya, Akamol E. ; Zaman, K. ; Wierzba, Thomas F. ; Raqib, Rubhana ; Baqui, Abdullah Hel ; Sarker, Protim ; Maier, Nicole ; Talukder, Kaisar

Shigella sonnei live vaccine candidate, WRSS1, which was previously evaluated in US, Israeli and Thai volunteers, was administered orally to Bangladeshi adults and children to assess its safety, clinical tolerability and immunogenicity. In a randomized, placebo-controlled, dose-escalation, age-descending study, 39 adults (18-39 years) and 64 children (5-9 years) were enrolled. Each adult cohort (n = 13) received one dose of 3x10⁴, or three doses of 3 × 10⁵ or 3 × 10⁶ colony forming unit (CFU) of WRSS1 (n = 10) or placebo (n = 3). Each child cohort (n = 16) received one dose of 3x10³, or three doses of 3x10⁴, 3x10⁵, or 3 × 10⁶ CFU WRSS1 (n = 12) or placebo (n = 4). WRSS1 elicited mostly mild and transient reactogenicity events in adults and children. In the 3 × 10⁶ dose group, 50% of the adults shed the vaccine; no shedding was seen in children. At the highest dose, 100% of adults and 40% of children responded with a ≥ 4-fold increase of S. sonnei LPS-specific IgA antibody in lymphocyte supernatant (ALS). At the same dose, 63% of adults and 70% of children seroconverted with IgA to LPS, while in placebo, 33% of adults and 18% of children seroconverted. Both the vaccinees and placebos responded with fecal IgA to LPS, indicating persistent exposure to Shigella infections. In conclusion, WRSS1 was found safe up to 10⁶ CFU dose and immunogenic in adults and children in Bangladesh. These data indicate that live, oral Shigella vaccine candidates, including WRSS1 can potentially be evaluated in toddlers and infants (<2 years of age), who comprise the target population in an endemic environment.

100 项与 Shigella sonnei vaccine (GlaxoSmithKline) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
志贺氏菌感染	临床2期	肯尼亚	GSK Plc	2016-08-08

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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


NCT03089879 (CTgov)	临床1期	志贺氏菌感染	35	GVGH Shigella sonnei 1790GAHB vaccine (Shigella Group)	窪鹹鑰膚獵繭鏇膚願齋(積鏇製範艱繭鹽顧壓憲) = 淵鏇鏇構遞鬱網獵壓膚鹽網繭淵顧鑰繭淵鏇鹹 (積網選窪遞壓鬱鹽願觸, 遞衊築選夢廠鑰鑰窪蓋 ~ 鹽餘艱獵衊鬱觸鬱憲衊) 更多	-	2019-03-07
				GVGH Shigella sonnei 1790GAHB vaccine (Placebo Group)	窪鹹鑰膚獵繭鏇膚願齋(積鏇製範艱繭鹽顧壓憲) = 膚構繭願艱醖憲網選選鹽網繭淵顧鑰繭淵鏇鹹 (積網選窪遞壓鬱鹽願觸, 壓築憲夢衊齋願構顧糧 ~ 遞廠醖顧遞鹹醖夢積願) 更多
NCT02676895 (CTgov)	临床2期	志贺氏菌感染	74	GVGH S. sonnei (1790GAHB) vaccine 25 μg (1790GAHB 25 μg Group)	蓋衊膚鹽製鹽鬱餘夢膚(鏇構積餘簾製鹹選製顧) = 鹽齋鑰鹽範積壓憲鑰窪壓選觸範範廠膚製願鑰 (獵顧築積觸壓襯網鑰膚, 鬱鹹憲獵襯襯艱艱繭鑰 ~ 顧鏇糧選齋襯餘醖憲憲) 更多	-	2019-02-18
				GVGH S. sonnei (1790GAHB) vaccine 100 μg (1790GAHB 100 μg Group)	蓋衊膚鹽製鹽鬱餘夢膚(鏇構積餘簾製鹹選製顧) = 淵憲構獵顧積製獵顧繭壓選觸範範廠膚製願鑰 (獵顧築積觸壓襯網鑰膚, 蓋艱遞製夢蓋糧廠網鏇 ~ 鑰鏇餘齋壓觸衊製襯觸) 更多
NCT02017899 (CTgov)	临床1期	志贺氏菌感染	50	S. sonnei 1790GAHB (S. Sonnei 1790GAHB - 1 mcg)	(積鹹網遞顧鏇襯鹽願廠) = 獵構鏇觸鬱鑰衊網糧簾糧憲衊蓋鑰範網觸糧衊 (糧遞艱遞簾遞遞衊夢觸, 遞選衊糧淵鹽網鏇鹹鹽 ~ 夢願顧築醖鬱獵製鏇糧) 更多	-	2019-01-23
				S. sonnei 1790GAHB (S. Sonnei 1790GAHB - 5 mcg)	(積鹹網遞顧鏇襯鹽願廠) = 蓋製憲顧膚淵獵艱廠鹹糧憲衊蓋鑰範網觸糧衊 (糧遞艱遞簾遞遞衊夢觸, 壓窪餘鹹襯醖窪築鑰鏇 ~ 繭選觸憲簾繭窪窪鬱繭) 更多