Helicobacter Pylori Infected SubjectsPhase 1IMX-02NCT03270800
Phase 1a/b Study on Safety of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers
A Phase 1 study testing IMX101 vaccine in people with Helicobacter Pylori Infected Subjects and Helicobacter Pylori Naive Subjects, run by ImevaX at 2 sites in Germany.
Trial summary
A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected healthy volunteers. The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each containing 8 subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infected Subjects, Helicobacter Pylori Naive Subjects
- What is being tested?
- IMX101 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesGermany
- Study dates
- 30 Jan 2017to 23 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- H. pylori-infected subjects: Confirmed H. pylori infection by urea breath test and serology.
- pylori-negative subjects: Presenting no H. pylori infection by urea breath test and serology.
- Men and women aged ≥18 years and ≤ 50 years.
- Female subjects must either be of non-childbearing potential or use highly effective methods of contraception for at least 1 month prior to Screening and 1 month after end of study participation (see section pregnancy and contraceptives).
- Women with a negative serum test at Screening (V2) and women of childbearing potential additionally with a negative urine pregnancy test at each visit (except V1 and FU V10/V12).
- Have given written informed consent prior to admission to the study in accordance with ICH-GCP and local legislation.
- Ability to comply with the requirements of the study protocol.
Who cannot join
- History of successful treatment for H. pylori infection.
- Regular use (once a week or more) of diclofenac, other non-steroidal anti-inflammatory drugs (NSAIDs), e.g. acetylsalicylic acid (Aspirin®), or proton pump inhibitor (PPI). Additionally, PPI is used within 2 weeks prior to V1 and V11.
- Use of anticoagulants (i.e. heparin, coumarin derivatives, e.g. Marcumar®).
- Use of antibiotics employed in H. pylori therapy within the month prior to study entry (V1) as well as 1 month prior to each endoscopy (V3 and V9/V11).
- Recent or current (within the last 6 months) systemic corticosteroid use including inhaled corticosteroids. Topical corticosteroid medication is allowed.
- Current or previous gastric ulcer diseases or preneoplastic changes in the stomach mucosa according to medical records or endoscopy findings confirmed by histological assessment at Baseline (V3).
Show all 21Show fewer
- Current or previous medically significant gastroduodenal disease.
- Preceding cholera immunisation or disease.
- Uncontrolled hypertension or orthostatic hypotension.
- Body mass index (BMI) ≤ 18 or ≥ 30.
- Poorly-controlled type I or type II diabetes mellitus (glycosylated haemoglobin [HbA1c] ≥ 7.5% within the last 6 weeks) and subjects requiring insulin treatment.
- History, evidence or suspicion of tumour burden.
- Epilepsy or seizure disorder.
- Bleeding diathesis.
- Positive viral serology screening result for hepatitis B surface antigen (HBS Ag), antibodies to hepatitis C virus (HCV Ab), or human immunodeficiency virus (HIV) type 1 and 2.
- Known significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalisation.
- A history of active alcohol abuse or drug addiction.
- Administration of a live vaccine within 90 days prior to the first study immunisation (V4) and throughout the study.
- Receipt of blood, blood products or plasma derivatives 30 days prior to study entry (V1).
- Pregnancy or lactation.
- Participation in a clinical study within 30 days prior to admission to the study if investigational or marketed drug were employed. Any disease or condition which in the Investigator's opinion would exclude the subject from the study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Double-blind, Adjuvant-controlled Phase 1a/b Study on Safety and Tolerability With Ascending Multiple Doses of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers
A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected healthy volunteers.
The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each cohort.
Read more
Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the DSMB, as soon as the results of the safety and efficacy analyses are available.
Up to 72 subjects collectively in Phases A \& B will be recruited. depending on immunogenicity status.
- Being tested
- CTA control, IMX101 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTA controlBiological
Sublingual and intradernal application of a mucosal adjuvance, drug product is not yet on the market.
IMX101 vaccineBiological
Sublingual and intradermal application of a vaccine, drug product is not yet on the market.
| Study group | Role | What they receive |
|---|---|---|
| IMX101 vaccine as intradermal and sublingual application | Experimental | IMX101 vaccine will be administered intradermally and sublingually Receives: Biological: IMX101 vaccine |
| CTA control as intradermal and sublingual application | Experimental | CTA mucosal adjuvans will be administered intradermally and sublingually Receives: Biological: CTA control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of IMX101
All subjects who received at least one dose of the IMP will be included in the safety analysis by following parameters:
-Adverse events: AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA). Separate analyses will be conducted using severity, seriousness, and relationship to the IMP. Treatment-emergent adverse events (TEAEs) will be summarised and tabulated according to the primary system organ class and preferred term.
- Clinical laboratory and other safety measures Haematology and clinical chemistry will be summarised with descriptive statistics for absolute values und changes from Baseline by visit. Urine dipstick test will be summarised with frequency tables by visit.
- Vital signs Vital signs will be summarised with descriptive statistics for absolute values und changes from Baseline by visit.
- Local tolerability Injection site assessments will be summarised in frequency tables when the collected data allow for this.
Measured: 215 days
Secondary outcomes (1)
Determination of immune Responses
Humoral and cellular immune Response towards IMX101 and detection of inhibitory antibodies
Secondary Endpoint(s):
- Detection of vaccine-antigen specific antibodies by Enzyme linked immunosorbent assay (ELISA) at V6, V7, V8 and V9 in the non-infected subjects and at V6, V7, V8, V9, V10 and V11 in the H.pylori infected subjects.
- Detection of inhibitory antibodies blocking H.pylori gGT enzymatic activity at V6, V7, V8 and V9 in the non-infected subjects and at V6, V7, V8, V9, V10 and V11 in the H.pylori-infected subjects.
Measured: 215 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start30 Jan 2017
- Primary completion23 Dec 2018
- Study completion23 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Infected SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImevaX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Zivotic, Principal investigator, CTC-NORTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270800
- Sponsor's protocol ID
- 2015-004761-82
- Other IDs
- 2015
- Acronym
- IMX-02
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Adjuvant-controlled Phase 1a/b Study on Safety and Tolerability With Ascending Multiple Doses of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03270800
- Acronym / sponsor ID
- IMX-02 / 2015-004761-82
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ImevaXIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected healthy volunteers.
The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each cohort.
Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the DSMB, as soon as the results of the safety and efficacy analyses are available.
Up to 72 subjects collectively in Phases A \& B will be recruited. depending on immunogenicity status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMX101 vaccine as intradermal and sublingual application | Experimental | Biological: IMX101 vaccineIMX101 vaccine will be administered intradermally and sublingually |
| CTA control as intradermal and sublingual application | Experimental | Biological: CTA controlCTA mucosal adjuvans will be administered intradermally and sublingually |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- H. pylori-infected subjects: Confirmed H. pylori infection by urea breath test and serology.
- pylori-negative subjects: Presenting no H. pylori infection by urea breath test and serology.
- Men and women aged ≥18 years and ≤ 50 years.
- Female subjects must either be of non-childbearing potential or use highly effective methods of contraception for at least 1 month prior to Screening and 1 month after end of study participation (see section pregnancy and contraceptives).
- Women with a negative serum test at Screening (V2) and women of childbearing potential additionally with a negative urine pregnancy test at each visit (except V1 and FU V10/V12).
Key exclusion criteria (21 listed)
- History of successful treatment for H. pylori infection.
- Regular use (once a week or more) of diclofenac, other non-steroidal anti-inflammatory drugs (NSAIDs), e.g. acetylsalicylic acid (Aspirin®), or proton pump inhibitor (PPI). Additionally, PPI is used within 2 weeks prior to V1 and V11.
- Use of anticoagulants (i.e. heparin, coumarin derivatives, e.g. Marcumar®).
- Use of antibiotics employed in H. pylori therapy within the month prior to study entry (V1) as well as 1 month prior to each endoscopy (V3 and V9/V11).
- Recent or current (within the last 6 months) systemic corticosteroid use including inhaled corticosteroids. Topical corticosteroid medication is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTA controlSublingual and intradernal application of a mucosal adjuvance, drug product is not yet on the market. | Biological | CTA control as intradermal and sublingual application |
| IMX101 vaccineSublingual and intradermal application of a vaccine, drug product is not yet on the market. | Biological | IMX101 vaccine as intradermal and sublingual application |
Primary outcome
Safety and tolerability of IMX101
Time frame: 215 days
All subjects who received at least one dose of the IMP will be included in the safety analysis by following parameters: -Adverse events: AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA). Separate analyses will be conducted using severity, seriousness, and relationship to the IMP. Treatment-emergent adverse events (TEAEs) will be summarised and tabulated according to the primary system organ class and preferred term. * Clinical laboratory and other safety measures Haematology and clinical chemistry will be summarised with descriptive statistics for absolute values und changes from Baseline by visit. Urine dipstick test will be summarised with frequency tables by visit. * Vital signs Vital signs will be summarised with descriptive statistics for absolute values und changes from Baseline by visit. * Local tolerability Injection site assessments will be summarised in frequency tables when the collected data allow for this.
1 secondary outcome
Determination of immune Responses
Time frame: 215 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Zivotic principal investigator
CTC-NORTH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMX101 vaccine in people with Helicobacter Pylori Infected Subjects and Helicobacter Pylori Naive Subjects, run by ImevaX at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of IMX101 (time frame: 215 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.