Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000019000
Ethics application status
Approved
Date submitted
17/12/2009
Date registered
8/01/2010
Date last updated
28/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and immunogenicity of Helicobacter pylori clinical isolates in healthy volunteers.
Scientific title
Safety and immunogenicity of Helicobacter pylori clinical isolates in healthy volunteers.
Secondary ID [1] 1214 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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. 256422 0
Condition category
Condition code
Oral and Gastrointestinal 256595 256595 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 255717 0
Prevention
Comparator / control treatment
The placebo group will relieve a single oral administered dose of soup broth. All participants will undergo eradication therapy.
Control group
Placebo

Outcomes
Primary outcome [1] 257483 0
To observe the clinical effect of Helicobacter pylori infection.

1.Live Helicobacter pylori are administered
to healthy subjects
a.Symptom diary cards are completed
b.Infection status is determined at the
2-week gastroscopy

2.The subject completes the follow-up
period
a. The final endoscopy is completed
b. Eradication treatment is completed
by the patient
c. Follow-up breath tests confirm
eradication of Helicobacter pylori

Selected H. pylori strains will be administered to naive (sero-negative) healthy subjects. Infection status will be determined by histological assessment of gastric tissue (biopsies taken at 0, 2 and 12 weeks after infection), blood profiles, liver function test (LFT), cell counts, pH, acid, and the daily diary and telephone follow-up for adverse events.
Timepoint [1] 257483 0
The primary timepoints are:
a). Gastroscopy at week 2
b). Gastroscopy at week 12
c). Eradication therapy at week 16
Diary cards will be distributed at Screening Visit (V 1) - 14 day Baseline diary card; post-inoculum (V4, week 5) - 21 days diary card; and post-eradication (V9, week 15) - 7 days diary card.
Blood profiles will be collected at Screening (V1), Day 0 (V2), Wk4 (V5), Wk6 (V6), Wk8 (V7), Wk12 (V8), Wk16 (V10), and Wk 20 (V11).
Urease Breath Tests (UBT) will be conducted at Baseline (V1), two weeks post-inoculum (Wk6), pre-gastroscopy (Wk12), and post-eradication therapy (Wk16).
A baseline gastroscopy will be conducted at V2 (Day 0).
Telephone follow-up post-inoculum (V4) will take place at V4 + day 1, V4 + day 2, and V4 + day 3.
Secondary outcome [1] 262679 0
To determine the immunogenicity and metabolites of H. pylori in naive (sero-negative) healthy subjects

1. Immunogenicity will be determined by measuring H. pylori specific immunoglobulin responses and serum cytokine responses in the blood at intervals during the study. Urine samples will be assessed for the presence of H. pylori metabolites.
Timepoint [1] 262679 0
The secondary outcome of this Study is to determine the immunogenicity of the H. pylori strains (ability of host to mount an immune response against H. pylori). Serum will be collected from blood samples at 2, 4, 8, and 12 weeks after the infection step.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are pre-screened to ensure that they meet the Inclusion/Exclusion criteria. A copy of the Patient Information and Consent (PICF) is then emailed to prospective participants for their consideration. If the participant wishes to continue they contact the Trial Coordinator, and come into the hospital clinic for formal discussion, counselling on the Trial, and signing of the PICF. The participant then undergoes a medical review by the Principal Investigator, and baseline data and biologic sampling is collected as per Protocol. Allocation to control and experimental groups is randomised by a randomisation generator with central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants are given a Trial Number generated from a random number generator. This is provided by the Trial Statistician through a central randomisation by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2009
Actual
15/12/2009
Date of last participant enrolment
Anticipated
Actual
27/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 256189 0
Commercial sector/Industry
Name [1] 256189 0
Ondek Pty Ltd
Country [1] 256189 0
Australia
Funding source category [2] 256191 0
Hospital
Name [2] 256191 0
Sir Charles Gairdner Hospital
Country [2] 256191 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ondek Pty Ltd
Address
19A Boundary Street
Rushcutters Bay
NSW 2011
Country
Australia
Secondary sponsor category [1] 251541 0
None
Name [1] 251541 0
Address [1] 251541 0
Country [1] 251541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258297 0
Sir Charles Gairdner Group
Ethics committee address [1] 258297 0
Sir Charles Gairdner Hospital
Hospital Ave.
Nedlands
WA 6009
Ethics committee country [1] 258297 0
Australia
Date submitted for ethics approval [1] 258297 0
Approval date [1] 258297 0
30/10/2009
Ethics approval number [1] 258297 0
2009-062

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30630 0
Dr Hooi Ee
Address 30630 0
Principal Investigator Sir Charles Gairdner Hospital Endoscopy Suite, G75 Hospital Ave. Nedlands WA 6009
Country 30630 0
Australia
Phone 30630 0
(+61) 8 93463677
Fax 30630 0
Email 30630 0
[email protected]
Contact person for public queries
Name 13877 0
Jim Blanchard
Address 13877 0
Clinical Trials Coordinator
Sir Charles Gairdner Hospital
Endoscopy Suite, G75
Hospital Ave.
Nedlands
WA 6009
Country 13877 0
Australia
Phone 13877 0
(+61) 8 93464036
Fax 13877 0
Email 13877 0
[email protected]
Contact person for scientific queries
Name 4805 0
Dr. Hooi Ee
Address 4805 0
Principal Investigator
Sir Charles Gairdner Hospital
Endoscopy Suite, G75
Hospital Ave.
Nedlands
WA 6009
Country 4805 0
Australia
Phone 4805 0
(+61) 8 93463677
Fax 4805 0
Email 4805 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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