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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736476
• Other study ID #: V99P2
• Secondary ID: 2007-003511-31
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2008
• Last updated: December 7, 2011
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Biological:
• H.pylori vaccines
1 dose of H.pylori vaccine at 0, 1, and 2 months
• Placebo Vaccine
Placebo Vaccine at 0, 1, and 2 months

Locations

Country	Name	City	State
Germany	Otto von Guericke Universität Magdeburg	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (defined as prevention of infection) of the HP vaccine candidate vs. placebo.		6-12 months	No
Primary	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.		6-12 months	Yes
Secondary	To define the HP-specific humoral and cellular immune responses among vaccinees versus placebo recipients.		12 months	Yes
Secondary	To identify potential immune markers to distinguish HP vaccination from natural HP infection.		12 months	Yes
Secondary	To correlate mucosal and systemic cellular immune responses as assessed by sampling of gastric mucosa and peripheral blood cells, respectively		12 months	Yes
Secondary	To define potential immune correlates of protection.		12 months	Yes