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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Helicobacter Pylori Infection
- Sponsor
- Novartis Vaccines
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.(12 months)
- Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge(12 weeks post HP challenge)
- The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups(12 months)
- Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)(12 weeks post HP challenge)
- The Geometric Mean Concentrations After HP Vaccination.(upto 1 month after 3rd vaccination)