Early Clinical Development of a Live, Attenuated Combination Vaccine Against Shigella and ETEC Diarrhoea: Phase 1b Clinical Trial of ShigETEC Vaccine in Bangladeshi Adults and Three Paediatric Age Groups

The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5 years, 12-23 months and 6-11 months).
The main question[s] it aims to answer are:
* Safety and clinical tolerability of the vaccine
* Immune responses generated by the vaccine In the age-descending dose-escalating study
* Adult participants will be divided into 2 escalating dose cohorts
* Each age group of paediatric participants will be divided into 3 escalating dose cohorts
* Participants in each cohort will receive three doses of vaccine/placebo two weeks apart
* Solicited and unsolicited adverse events (AE) and serious adverse events (SAE) will be monitored after each vaccination dose
* Stool samples will be collected for immunological analysis and shedding of vaccine strain
* Blood samples will be collected for immunological analysis

开始日期2023-11-26

申办/合作机构

EveliQure Biotechnologies GmbH

NCT05409196 / Completed临床1期

Phase 1 Two Stage Randomized, Double-blind, Placebo Controlled Dose- and Schedule Ranging Trial to Assess the Acute Safety, Tolerability, and Immunogenicity of a Live, Attenuated Shigella/ETEC Combination Vaccine Delivered Orally to Healthy Adults Age 18 to 45 Years Old

This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.
The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world.
This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.

开始日期2020-09-16

申办/合作机构

EveliQure Biotechnologies GmbH

100 项与 Escherichia coli/Shigella oral vaccine (Eveliqure Biotechnologies) 相关的临床结果

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100 项与 Escherichia coli/Shigella oral vaccine (Eveliqure Biotechnologies) 相关的转化医学

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100 项与 Escherichia coli/Shigella oral vaccine (Eveliqure Biotechnologies) 相关的专利（医药）

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项与 Escherichia coli/Shigella oral vaccine (Eveliqure Biotechnologies) 相关的文献（医药）

1976-01-01·Developments in biological standardization

Standardization of Escherichia coli oral vaccines.

Article

作者: Felsenfeld, O

The proof of the efficacy of a vaccine can be rendered only by field trials. Nevertheless, a number of in vitro and in vivo tests has to be employed before large-scale testing can be carried out. This particularly holds true about vaccines used to prevent intestinal infections, which were the center of our interest. Seven strains, four of them causing diarrhea in man, and three in animals, have been investigated as potential oral immunizing agents. The strains were made apathogenic by heating, or developing streptomycin-dependence, or by chemical agents. The efficacy of the vaccines was tested by feeding vervet monkeys with them, by determining their potency in the ligated rabbit and rat intestinal loop, by determining coproantibody formation and by estimating the circulating anti-enterotoxin as well as precipitating and bacteriolytic antibodies. Enterotoxin developed by human pathogens differed in its action from that of animalpathogenic strains. According to the penetrating ability of the strains, there was a difference between the circulating antibody evoking capability. Therefore in fundamental assay of the vaccines, the dose-response, the length of the administration of the immunizing agents, and their dosage had to be investigated before and after challenge with homologous and heterologous E. coli strains. It is suggested that coproantibody determination together with monitoring circulating antibodies after vaccination and after challenge be used to standardize these vaccines.

Vaccines3区 · 医学

Evaluation of the Safety, Tolerability and Immunogenicity of ShigETEC, an Oral Live Attenuated Shigella-ETEC Vaccine in Placebo-Controlled Randomized Phase 1 Trial

3区 · 医学

ArticleOA

作者: Neuhauser, Irene ; Szijártó, Valéria ; Szarka, Krisztina ; Nagy, Eszter ; Malinoski, Frank J. ; Harutyunyan, Shushan ; Glaninger, Katharina ; Korda, Orsolya ; Nagy, Gábor ; Kardos, Gábor ; Pall, Denes ; Henics, Tamás ; Girardi, Petra

Background: Shigella spp. and enterotoxigenic Escherichia coli (ETEC) cause high morbidity and mortality worldwide, yet no licensed vaccines are available to prevent corresponding infections. A live attenuated non-invasive Shigella vaccine strain lacking LPS O-antigen and expressing the ETEC toxoids, named ShigETEC was characterized previously in non-clinical studies. Methods: ShigETEC was evaluated in a two-staged, randomized, double-blind and placebo-controlled Phase I clinical trial. A single dose of increasing amounts of the vaccine was given to determine the maximum tolerated dose and increasing number of immunizations were administered with an interval based on the duration of shedding observed. Results: Oral immunization with ShigETEC was well tolerated and safe up to 4-time dosing with 5 × 1010 colony forming units. ShigETEC induced robust systemic immune responses against the Shigella vaccine strain, with IgA serum antibody dominance, as well as mucosal antibody responses evidenced by specific IgA in stool samples and in ALS (Antibodies in Lymphocyte Supernatant). Anti- ETEC toxin responses were detected primarily in the 4-times immunized cohort and for the heat-labile toxin correlated with neutralizing capacity. Conclusion: ShigETEC is a promising vaccine candidate that is scheduled for further testing in controlled human challenge studies for efficacy as well as in children in endemic setting for safety and immunogenicity.

100 项与 Escherichia coli/Shigella oral vaccine (Eveliqure Biotechnologies) 相关的药物交易

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