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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736476
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Biological: H.pylori vaccines Biological: Placebo Vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official 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
Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: 1 Biological: H.pylori vaccines
1 dose of H.pylori vaccine at 0, 1, and 2 months

Placebo Comparator: 2 Biological: Placebo Vaccine
Placebo Vaccine at 0, 1, and 2 months

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00736476

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Otto von Guericke Universität Magdeburg
Magdeburg, Germany, 39120
Sponsors and Collaborators
Novartis Vaccines
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Study Chair: Novartis Vaccines Novartis Vaccines
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Vaccines Identifier: NCT00736476    
Other Study ID Numbers: V99P2
First Posted: August 15, 2008    Key Record Dates
Results First Posted: February 28, 2017
Last Update Posted: February 28, 2017
Last Verified: September 2016
Keywords provided by Novartis ( Novartis Vaccines ):
helicobacter pylori infection
Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs