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CompletedPhase 1ACTRN12610000019000

Safety and immunogenicity of Helicobacter pylori clinical isolates in healthy volunteers.

Sponsor

Ondek Pty Ltd

Enrollment

36 participants

Start Date

Dec 15, 2009

Study Type

Interventional

Conditions

This study will evaluate the safety and immunogenicity of selected Helicobacter Pylori (H.pylori) clinical strains in healthy human volunteers that have not been previously exposed to H. pylori.

Summary

Helicobacter pylori (H. pylori) infection is a common stomach infection affecting ~50 % of people worldwide. In most cases, patients have no symptoms. H. pylori infection does induce immune responses, however they are not protective. For these reasons Ondek Pty Ltd is developing H. pylori as a live bacterial delivery system for vaccines and other therapeutic agents. The aim of this study is to find strains of Helicobacter pylori which can be safely used as a vehicle for the delivery of vaccines such as that used to treat Influenza in humans. Here we would like to assess the suitability of H. pylori strains as a live bacterial vector, and identify clinical isolates with a safe profile in humans.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether specific strains of the stomach bacteria H. pylori can safely be given to healthy volunteers aged 18 to 70 to study the immune response. Participants must test negative for H. pylori and not have digestive problems. People who live with or have daily contact with children aged 12 or younger cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study will evaluate the safety and immunogenicity of selected H. pylori clinical strains in healthy human volunteers that have not been previously exposed to H. pylori. The study will include 5 c

This study will evaluate the safety and immunogenicity of selected H. pylori clinical strains in healthy human volunteers that have not been previously exposed to H. pylori. The study will include 5 clinical isolates and a placebo group. Subjects will be randomised into 6 groups of 6, totally 36 subjects in total. Each participant will only receive either a single oral dose (30 mls) of one of the five H. pylori strains, or the placebo. The H. pylori inoculum or placebo will be administered 90 days after screening, and eradication therapy commenced 30 days after inoculum or placebo administration. The eradication therapy consists of NEXIUM Hp7 (Esomeprazole 20mg, amoxycillin trihydrate 1000mg, and clarithromycin 500mg); the tablets are taken twice a day for one week.

Locations(1)

WA, Australia

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ACTRN12610000019000