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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00736476
First received: August 13, 2008
Last updated: January 9, 2017
Last verified: September 2016
  Purpose
To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.

Condition Intervention Phase
Helicobacter Pylori Infection Biological: H.pylori vaccines Biological: Placebo Vaccine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Further study details as provided by Novartis ( Novartis Vaccines ):

Primary Outcome Measures:
  • 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).


  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 63
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736476

Locations
Germany
Otto von Guericke Universität Magdeburg
Magdeburg, Germany, 39120
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00736476     History of Changes
Other Study ID Numbers: V99P2
2007-003511-31
Study First Received: August 13, 2008
Results First Received: September 30, 2016
Last Updated: January 9, 2017

Keywords provided by Novartis ( Novartis Vaccines ):
helicobacter pylori infection
vaccination
adults

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2017