None listed
Conditions
Brief 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.
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 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 d
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.
Sponsors
Ondek Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria 1. Healthy men and women 2. Aged 18-70 years inclusive 3. Use their own mobile phone 4. Sero-negative for H. pylori 5. Asymptomatic with regard to dyspepsia. Mild symptomatic but endoscopy negative gastro-oesophageal reflux disease is not an exclusion providing the condition does not require the regular use of Proton Pump Inhibitors or H2 blockers (occasional use permitted). However the participants with the following medical conditions will be excluded: a.)Peptic Ulcer Disease b.)History of major gastrointestinal surgery e.g. gastric banding 6. No known allergy to principal medications / antibiotics used to treat H. pylori in this study (esomeprazole, amoxycillin, clarithromycin and tinidazole). No known intolerances or allergy to 2nd and 3rd line medications /antibiotics used to treat H. pylori, including macrolides, tetracycline, fluoroquinolones, furazolidone, colloidal bismuth subcitrate. 7. Living in Australia for duration of trial (approximately 12 months) 8. Provide written informed consent
Exclusion criteria
Exclusion Criteria 1. Pregnant or breast feeding women; women who are less than 2 years postmenopausal; or women of child bearing potential not using adequate contraception for the duration of the study (adequate contraception is the use of oral contraceptives, contraceptive injections, intra-uterine device, contraceptive patches or the use of a double barrier contraception method e.g. use of condom and spermicidal cream simultaneously). Women of child bearing potential will be required to have a negative serum Beta Human Chorionic Gonadotropin (BHCG) pregnancy test before continuing in the study. 2. Current or probable requirement to use any of the following medications: anticoagulants, aspirin, clopidogrel, antibiotics, regular use of proton pump inhibitors (occasional use permitted) or regular use of non steroidal anti-inflammatory drugs (more often than twice weekly). 3. Positive Helicobacter pylori serology at visit 1 4. Current enrolment in another clinical trial involving a medication or device. 5. Living with or having daily contact with children aged 12 years or younger at home, school, day care or equivalent facilities.
Outcome results
None listed