NCT00613665

Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults

Phase I, Randomized, Controlled, Single-blind, Dose-Ranging and Schedule-Finding Study of the Safety, Tolerability, and Immunogenicity of Chiron Helicobacter Pylori Vaccine in Healthy, Helicobacter Pylori-negative Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine

Conditions

• Helicobacter Pylori
• Gastritis
• Gastric Cancer
• Gastroduodenal Ulcers
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	helicobacter pylori vaccine	Experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly
BIOLOGICAL	helicobacter pylori vaccine	Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly
BIOLOGICAL	helicobacter pylori vaccine	Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly
BIOLOGICAL	helicobacter pylori vaccine	Eight subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly
BIOLOGICAL	Placebo	Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly
BIOLOGICAL	helicobacter pylori vaccine	Nine subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly
BIOLOGICAL	helicobacter pylori vaccine	Ten subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly

Timeline

• Start date: 2001-02-01
• Primary completion: 2001-12-01
• Completion: 2002-04-01
• First posted: 2008-02-13
• Last updated: 2013-06-11

Locations

1 site across 1 country: Germany