Group B Streptococcus Trivalent Vaccine(Novartis Vaccines)(Group B Streptococcus Trivalent Vaccine(Novartis Vaccines))

概要

基本信息

药物类型

预防性疫苗、多价疫苗

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染

在研适应症-

非在研适应症

链球菌感染

原研机构

Novartis Vaccines & Diagnostics, Inc.

在研机构-

非在研机构

Novartis AG

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-

登录后查看时间轴

关联

5

项与 Group B Streptococcus Trivalent Vaccine(Novartis Vaccines) 相关的临床试验

NCT02270944

/ Completed临床2期

A Phase II, Randomized, Comparative, Observer-Blind, Multi-Center Study Evaluating the Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine in Healthy Non-Pregnant Women Aged 18 to 40 Years

The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.

开始日期2014-11-20

申办/合作机构

GSK Plc

NCT02046148

/ Completed临床2期

A Phase II, Multicenter, Randomized, Observer-Blind, Controlled Study to Evaluate Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.

开始日期2014-03-18

申办/合作机构

GSK Plc

NCT01446289

/ Completed临床2期

A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.

开始日期2011-09-01

申办/合作机构

Novartis AG

[+1]

100 项与 Group B Streptococcus Trivalent Vaccine(Novartis Vaccines) 相关的临床结果

登录后查看更多信息

100 项与 Group B Streptococcus Trivalent Vaccine(Novartis Vaccines) 相关的转化医学

登录后查看更多信息

100 项与 Group B Streptococcus Trivalent Vaccine(Novartis Vaccines) 相关的专利（医药）

登录后查看更多信息

142

项与 Group B Streptococcus Trivalent Vaccine(Novartis Vaccines) 相关的文献（医药）

2025-02-06·Journal of the Pediatric Infectious Diseases Society

Mechanisms and Manifestations of Group B Streptococcus Meningitis in Newborns

Review

作者: Cutts, William D ; Hooven, Thomas A ; Alexander, Natalie G ; Kim, Brandon J

AbstractGroup B Streptococcus (GBS; Streptococcus agalactiae) is a gram-positive colonizer of the healthy intestinal and genitourinary microbiota. During and shortly after birth, neonates and infants can be opportunistically infected leading to sepsis, pneumonia, or meningitis among other illnesses. GBS is the leading cause of neonatal meningitis globally, and while prophylactic treatments have been successful for reducing early-onset disease, no decrease in the incidence of late-onset disease has occurred and no vaccine is currently available. In this review, we describe GBS both from a clinical and molecular standpoint. We first describe the history of GBS perinatal disease and its clinical presentation and treatment, as well as patient outcomes. We then present recently discovered GBS interactions at the blood–brain barrier that contribute to disease and inflammatory responses, and efforts to develop a broadly effective GBS vaccine.

2025-02-01·Infection

Maternal Streptococcus agalactiae colonization in Europe: data from the multi-center DEVANI study

Article

作者: Berner, Reinhard ; Rinaudo, Daniela ; Afshar, Baharak ; Křížová, Pavla ; Rodriguez-Granger, Javier ; Karstens, L ; Rigat, F ; Telford, John ; Creti, Roberta ; Margarit, Immaculada ; De La Rosa Fraile, Manuel ; Sørensen, Uffe B Skov ; Hufnagel, Markus ; Decheva, Antoaneta ; Baldassarri, L ; Sørensen, Uffe B. Skov ; Maione, Domenico ; Poulsen, K ; Orefici, Graziella ; Melin, Pierrette ; Kunze, Mirjam ; Kilian, Mogens ; Imperi, M ; Kozáková, Jana ; Berardi, A ; Efstratiou, Androulla ; Lohrmann, Florens

AbstractIntroductionDespite national guidelines and use of intrapartum antibiotic prophylaxis (IAP), Streptococcus agalactiae (group B streptococci (GBS)) is still a leading cause of morbidity and mortality in newborns in Europe and the United States. The European DEVANI (Design of a Vaccine Against Neonatal Infections) program assessed the neonatal GBS infection burden in Europe, the clinical characteristics of colonized women and microbiological data of GBS strains in colonized women and their infants with early-onset disease (EOD).MethodsOverall, 1083 pregnant women with a GBS-positive culture result from eight European countries were included in the study. Clinical obstetrical information was collected by a standardized questionnaire. GBS strains were characterized by serological and molecular methods.ResultsAmong GBS carriers included in this study after testing positive for GBS by vaginal or recto-vaginal sampling, 13.4% had at least one additional obstetrical risk factor for EOD. The five most common capsular types (i.e., Ia, Ib, II, III and V) comprised ~ 93% of GBS carried. Of the colonized women, 77.8% received any IAP, and in 49.5% the IAP was considered appropriate. In our cohort, nine neonates presented with GBS early-onset disease (EOD) with significant regional heterogeneity.ConclusionsScreening methods and IAP rates need to be harmonized across Europe in order to reduce the rates of EOD. The epidemiological data from eight different European countries provides important information for the development of a successful GBS vaccine.

2025-02-01·Pediatric Infectious Disease Journal

Sociodemographic Factors Associated With Established and Novel Antenatal Vaccination Uptake in a Cohort of Pregnant Women in Uganda

Article

作者: Kipyeko, Sam ; Komugisha, Cleophas ; Sturrock, Sarah ; Sekikubo, Musa ; Mboizi, Robert ; Davies, Hannah ; Nakabembe, Eve ; Le Doare, Kirsty ; Rukundo, Gordon

Introduction:Vaccination is a key strategy to safeguard the health of pregnant women and newborns. Although vaccine acceptance is often higher in low- and middle-income countries, the COVID-19 pandemic has highlighted increasing vaccine hesitancy. Vaccine hesitancy, specifically in pregnant women, must be understood to increase uptake. We used data from a Ugandan pregnancy registry study to examine sociodemographic factors linked to uptake of vaccines (tetanus toxoid and later COVID-19) in pregnancy.Methods:Pregnant women were recruited in Kampala, Uganda, as part of the PREPARE (Prevention of invasive Group B Streptococcus disease in young infants: a pathway for the evaluation & licensure of an investigational maternal GBS vaccine) study from September 1, 2020 until February 24, 2022. Demographic, socioeconomic and obstetric data were collected alongside COVID-19 and tetanus vaccination.Results:One thousand five hundred sixty-eight participants were included: 151 (10%) were unvaccinated, 11 (1%) received COVID-19 vaccine only, 1230 (78%) received a tetanus vaccine only and 176 (11%) received both. Lower vaccination rates were seen in participants attending fewer than 4 antenatal care episodes (P < 0.001), and those with higher parity (P = 0.036). Higher vaccination rates were seen with a managerial or professional occupation or higher maternal education level, but paternal occupation was not significantly associated with maternal vaccination. Parish vaccination rates varied from 0% to 100%, with 49 (29%) of parishes showing a vaccination rate <90%.Conclusions:This study highlights antenatal care as a key route for health promotion, and the stark difference in uptake between new and established antenatal vaccines. Further qualitative studies should investigate effective interventions to establish the safety and benefit of newer maternal vaccines across all demographic groups.

100 项与 Group B Streptococcus Trivalent Vaccine(Novartis Vaccines) 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
链球菌感染	临床2期	比利时	Novartis AG	2011-09-01
链球菌感染	临床2期	加拿大	Novartis AG	2011-09-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02046148 (Pubmed \| Vaccine) 人工标引	临床2期	链球菌感染	75	trivalent group B streptococcus vaccine	(積齋簾積網膚夢蓋窪窪) = 網鬱壓糧鏇獵憲憲鬱鏇膚範齋醖鹹淵簾艱蓋築 (簾膚簾製襯齋蓋築壓衊 ) 更多	积极	2020-10-14
				Placebo	(積齋簾積網膚夢蓋窪窪) = 醖繭繭鏇襯繭網製齋鏇膚範齋醖鹹淵簾艱蓋築 (簾膚簾製襯齋蓋築壓衊 ) 更多
NCT02270944 (CTgov)	临床2期	链球菌感染	1,053	GBS Vaccine (Liquid GBS Trivalent Vaccine)	獵蓋願範齋憲鏇鏇網顧(廠衊憲餘積廠衊製醖淵) = 鏇襯製廠觸鹹範鹽衊餘網顧窪築構範範蓋顧鹹 (窪繭醖鏇鏇壓憲繭憲齋, 餘選齋糧積獵襯艱衊窪 ~ 齋醖遞製鹽襯淵衊憲簾) 更多	-	2017-07-28
				GBS Vaccine (Lyophilized GBS Trivalent Vaccine)	獵蓋願範齋憲鏇鏇網顧(廠衊憲餘積廠衊製醖淵) = 選網遞築積簾鹽顧膚憲網顧窪築構範範蓋顧鹹 (窪繭醖鏇鏇壓憲繭憲齋, 簾觸糧網鏇窪鏇壓膚廠 ~ 觸鬱鹹膚構鬱窪積鏇餘) 更多
NCT02046148 (CTgov)	临床2期	链球菌感染 \| 格林-巴利综合征	75	GBS trivalent vaccine (GBS Group)	鏇襯衊醖顧齋積醖鬱齋(壓蓋艱構積選築餘蓋憲) = 鏇獵鹹鹹襯遞獵鏇選願醖願憲願構壓壓願觸簾 (範遞選繭獵觸餘齋醖膚, 積積憲憲網艱窪窪糧淵 ~ 糧製糧繭顧簾網構範壓) 更多	-	2017-05-30
				Placebo (Placebo Group)	鏇襯衊醖顧齋積醖鬱齋(壓蓋艱構積選築餘蓋憲) = 齋製鬱願範繭遞鬱衊遞醖願憲願構壓壓願觸簾 (範遞選繭獵觸餘齋醖膚, 淵願範網淵蓋憲製齋顧 ~ 鹹齋積窪顧製淵鬱範築) 更多