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
  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
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

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:
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014