Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults
|Helicobacter Pylori Infection||Biological: H.pylori vaccines Biological: Placebo Vaccine||Phase 1|
|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|
- 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.
- 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.
|Study Start Date:||October 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736476
|Otto von Guericke Universität Magdeburg|
|Magdeburg, Germany, 39120|
|Study Chair:||Novartis Vaccines||Novartis Vaccines|