E. coli vaccine (Intercell USA)(E. coli vaccine (Intercell USA))

概要

基本信息

药物类型

预防性疫苗

别名

heat-labile enterotoxin of E. coli (LT)

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

其他疾病

在研适应症-

非在研适应症

旅行者腹泻

原研机构

Intercell USA, Inc.

在研机构-

非在研机构

Intercell USA, Inc.

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

3

项与 E. coli vaccine (Intercell USA) 相关的临床试验

NCT01067781

/ Completed临床2期

A Phase 2, Gender-Stratified, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Two Vaccination Regimen With the Travelers' Diarrhea Vaccine System in Healthy Adults

The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing

开始日期2010-02-01

申办/合作机构

Intercell USA, Inc.

NCT00751777

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults

To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.

开始日期2008-09-01

申办/合作机构

Intercell USA, Inc.

NCT00565461

/ Completed临床2期

A Phase 2, Randomized, Open-Label Study to Compare the Immunogenicity and Safety of a Self-Administered LT Vaccine Patch With an LT Vaccine Patch Administered by a Clinician

To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.

开始日期2007-11-01

申办/合作机构

Intercell USA, Inc.

100 项与 E. coli vaccine (Intercell USA) 相关的临床结果

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100 项与 E. coli vaccine (Intercell USA) 相关的转化医学

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100 项与 E. coli vaccine (Intercell USA) 相关的专利（医药）

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4

项与 E. coli vaccine (Intercell USA) 相关的文献（医药）

2017-05-01·The Lancet Infectious Diseases1区 · 医学

Safety, immunogenicity, and preliminary clinical efficacy of a vaccine against extraintestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, placebo-controlled phase 1b trial

1区 · 医学

Article

作者: Christoph Hatz ; Anette Kuhn ; Cristina Alaimo ; Serge de Vallière ; Tanja Hülder ; Germie van den Dobbelsteen ; Anita M Dreyer ; Kellen Fae ; Jan Poolman ; Alena Hornacek ; Stéphan Juergen Harbarth ; Gloria Ryu ; Patricia Martin ; Volker Viereck ; Rahel Frölich ; Todd Davies ; Sabine Gröger ; David Scheiner ; Tilemachos Kavvadias ; Enos Bernasconi ; Ingrid van den Nieuwenhof ; Angela Csaki Huttner ; Kerstin Kling ; Stefan Thoelen ; Darren Abbanat ; Veronica Gambillara Fonck

BACKGROUNDEscherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V).METHODSIn this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov, number NCT02289794.FINDINGSBetween Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 10³ or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥10⁵ colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002).INTERPRETATIONThis tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings.FUNDINGGlycoVaxyn, Janssen Vaccines.

2013-11-01·Journal of Travel Medicine2区 · 医学

Efficacy of a Travelers' Diarrhea Vaccine System in Travelers to India: Table 1

2区 · 医学

Article

作者: Kerstin Westritschnig ; Zhi Dong Jiang ; Tomas Jelinek ; Jakob P. Cramer ; Gerd Burchard ; Ute Schwarz ; Herbert L. Dupont ; Shailesh Dewasthaly ; Santanu Chatterjee ; Robert Steffen ; Ronald H. Behrens ; Prabhugaunker Ramdas

BACKGROUNDA patch vaccine containing heat-labile toxin (LT) from enterotoxigenic Escherichia coli (ETEC) has demonstrated to be beneficial in reducing the rate and severity of travelers' diarrhea in Latin America. To evaluate the efficacy of this transdermal vaccine system in an area with a different diarrheal pathogen profile, an additional phase 2 study was conducted in European travelers to India.METHODSFor this multicenter, randomized, double-blinded, placebo-controlled field study 723 subjects were recruited; 603 (299 LT vaccine, 304 placebo) were included in the per-protocol-population (PPP).RESULTSAlthough the LT patch induced a measurable LT immune response in recipients, it failed to protect against LT ETEC or all-cause diarrhea. In the PPP the incidence rate of diarrhea as per primary endpoint was 6.0% (18 of 299) in the vaccine group and 5.9% (18 of 304) in the placebo group. Additionally, lower than expected rates of LT ETEC diarrheas were observed in India. The vaccine delivery system frequently produced rash and pruritus at the site of application, long term hyperpigmentation persisted in a minority of LT recipients, and also few site reactions were noted in the placebo group.CONCLUSIONSThe evaluated patch vaccine failed to satisfy mainly with respect to protective efficacy. Noninvasive prophylactic agents against travelers' diarrhea, particularly vaccines against the most frequent pathogens, thus continue to be badly needed.

2010-10-01·Current Opinion in Infectious Diseases2区 · 医学

Travelersʼ diarrhea

2区 · 医学

Review

作者: Beeching, Nick J ; Hill, David R

PURPOSE OF REVIEWTravelers' diarrhea affects 20-60% of travelers to low-income regions of the world. Much of the evidence for the clinical description and management of travelers' diarrhea was generated years ago, however, there is new information on geographic and host risk, etiology, and prevention strategies.RECENT FINDINGSTravel to South Asia, followed by sub-Saharan Africa and South America, carries the highest risk for diarrheal syndromes in returned travelers. Women are more susceptible to travel-related diarrhea than men. Host genetic studies have demonstrated that single nucleotide polymorphisms in the lactoferrin, osteoprotegerin, and IL-10 genes are associated with small but increased risks for diarrhea and enteric pathogens. Enterotoxigenic Bacteroides fragilis is likely to be a new agent identified as causing travelers' diarrhea, and heat-stable toxin-producing Escherichia coli appears to be more common than heat-labile toxin E. coli. Overall levels of sanitation at the travel destination, including individual eating establishments, are strong predictors for acquisition of travelers' diarrhea. A new transdermal LT vaccine shows promise in modifying the severity of travelers' diarrhea. It remains uncertain whether prophylaxis or prompt self-treatment of travelers' diarrhea will prevent late-onset irritable bowel syndrome. For self-treatment, azithromycin is the drug of choice in travelers to areas where there is a high risk of fluoroquinolone-resistant Campylobacter spp., such as South and Southeast Asia and possibly North Africa, Central and South America.SUMMARYThere is increased understanding of the determinants of travelers' diarrhea. Despite this travelers' diarrhea remains one of the most common illnesses in travelers. Continued focus on intervention strategies may ultimately lead to decreased incidence.

100 项与 E. coli vaccine (Intercell USA) 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
旅行者腹泻	临床2期	美国	Intercell USA, Inc.	2007-11-01

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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


NCT00751777 (CTgov)	临床2期	旅行者腹泻	120	heat-labile enterotoxin of E. coli (LT) (Group 1: 37.5 µg LT Patch)	餘繭鹽構繭艱蓋遞膚醖(範積築顧網鑰壓襯觸廠) = 願齋襯獵鑰觸願積壓積鬱觸積襯糧網廠網夢選 (願醖齋廠鬱醖鬱簾鏇獵, 窪艱鑰選築夢製鬱顧顧 ~ 壓選製觸鑰齋鹹選齋艱) 更多	-	2014-04-21
				Placebo (Group 2: 0 µg LT Patch (Placebo))	餘繭鹽構繭艱蓋遞膚醖(範積築顧網鑰壓襯觸廠) = 衊襯鏇繭憲願艱艱顧衊鬱觸積襯糧網廠網夢選 (願醖齋廠鬱醖鬱簾鏇獵, 顧膚餘觸壓積衊艱鑰顧 ~ 襯襯餘夢積繭觸範餘鹽) 更多