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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: December 7, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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:

Primary Outcome Measures:
  • Efficacy (defined as prevention of infection) of the HP vaccine candidate vs. placebo. [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • To assess the tolerability of an HP vaccine vs placebo. Measures to evaluate safety will include monitoring of local and systemic adverse events and clinical laboratory tests. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To define the HP-specific humoral and cellular immune responses among vaccinees versus placebo recipients. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To identify potential immune markers to distinguish HP vaccination from natural HP infection. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To correlate mucosal and systemic cellular immune responses as assessed by sampling of gastric mucosa and peripheral blood cells, respectively [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To define potential immune correlates of protection. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00736476     History of Changes
Other Study ID Numbers: V99P2, 2007-003511-31
Study First Received: August 13, 2008
Last Updated: December 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
helicobacter pylori infection
vaccination
adults

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013