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

NCT00736476 Phase 1 COMPLETED Results posted

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

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 1
Status	COMPLETED
Enrolment	63
Start date	2008-10
Completion	2010-04

Conditions

• Helicobacter Pylori Infection

Interventions

• H.pylori vaccines
• Placebo Vaccine

Primary outcomes

• 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.

Countries

Germany