Phase 1a/b Study on Safety of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers (IMX-02)

February 14, 2019 updated by: ImevaX

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • ClinicalTrial Site
      • Munich, Germany
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • H. pylori-infected subjects: Confirmed H. pylori infection by urea breath test and serology.

H. 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IMX101 vaccine as intradermal and sublingual application
IMX101 vaccine will be administered intradermally and sublingually
Biological: IMX101 vaccine
Sublingual and intradermal application of a vaccine, drug product is not yet on the market.
Experimental: CTA control as intradermal and sublingual application
CTA mucosal adjuvans will be administered intradermally and sublingually
Biological: CTA control
Sublingual and intradernal application of a mucosal adjuvance, drug product is not yet on the market.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
215 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determination of immune Responses
Time Frame: 215 days

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.
215 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ImevaX

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandra Zivotic, CTC-NORTH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-004761-82

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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