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

Phase 1

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Biological: H.pylori vaccines; Biological: Placebo Vaccine

• Registration Number: NCT00736476
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-15
• Study Start: 2008-10
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2016-09
• Results First Submitted: 2016-09-30
• Results First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Results First Posted: 2017-02-28
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	H.pylori vaccines	-
2	Placebo Vaccine	-

Primary Outcome Measures

Name	Time	Method
The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.	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	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

Name	Time	Method
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.	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	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.
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups	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.
Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)	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.
The Geometric Mean Concentrations After HP Vaccination.	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.

Trial Locations

Locations (1)

Otto von Guericke Universität Magdeburg; 🇩🇪 Magdeburg, Germany