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

Phase 1CompletedNCT00736476

Novartis Vaccines63 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Helicobacter Pylori Infection

Interventions

H.pylori vaccinesBIOLOGICAL

1 dose of H.pylori vaccine at 0, 1, and 2 months

Placebo VaccineBIOLOGICAL

Placebo Vaccine at 0, 1, and 2 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Otto von Guericke Universität Magdeburg

Magdeburg, Germany

Outcomes

Primary Outcomes

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

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).

Time frame: 12 weeks post HP challenge

Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination

To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local\* and systemic adverse events.

Time frame: Day 1-7 post vaccination

Secondary Outcomes

The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups

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.

Time frame: 12 months

The Geometric Mean Concentrations After HP 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.

Time frame: upto 1 month after 3rd vaccination

Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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