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OpenTrials
Completed

NCT Number: NCT00736476

Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults

To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Otto von Guericke Universität Magdeburg

Magdeburg, 39120, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults 18 - 40 years of age in good health
  • HP uninfected
  • not pregnant and agree to use birth control throughout the study (females who can become pregnant)

Exclusion criteria

  • remote or current HP infection

Treatment and study plan

H.pylori vaccines

Biological

1 dose of H.pylori vaccine at 0, 1, and 2 months

Placebo vaccine

Biological

Placebo Vaccine at 0, 1, and 2 months

Primary outcomes

  1. The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.

    Time frame: 12 weeks post HP challenge

    The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo).

    Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT).

  2. Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination

    Time frame: Day 1-7 post vaccination

    To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local* and systemic adverse events.

Secondary outcomes

  1. The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups

    Time frame: 12 months

    The time course of HP infection following HP challenge in subjects of the HP vaccine and placebo groups, were assessed by non-invasive HP tests.

  2. The Geometric Mean Concentrations After HP Vaccination.

    Time frame: upto 1 month after 3rd vaccination

    The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP)after HP vaccination as compared to placebo are reported.

  3. Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.

    Time frame: 12 months

    The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP) after HP challenge were compared between vaccinated and placebo groups.

  4. Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge

    Time frame: 12 weeks post HP challenge

    The response to 3 doses of HP vaccine and the oral HP challenge was assessed with respect their ability to induce differentiation and changes in the phenotype of a subset of regulatory T-cells CD4+CD25+Foxp3+ that expresses Treg Markers PD-1 and/or HLA-DR.

  5. Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)

    Time frame: 12 weeks post HP challenge

    The proliferation of H. pylori-specific Peripheral blood mononuclear cells (PBMCs) following HP antigen stimulation was assessed to measure the magnitude of the cell mediated immune response.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

Phase I/II, Randomized, Observer-blind, Placebo-controlled, Single-Center Study of the Tolerability, Immunogenicity, and Efficacy of an Novartis' Investigational H. Pylori Vaccine in H. Pylori-Negative Adults

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 15, 2008
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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