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

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

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

Sponsors & Collaborators

• Novartis Vaccines

  lead INDUSTRY

Principal Investigators

• Novartis Vaccines · Novartis Vaccines

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2001-02-28

Primary Completion

2001-12-31

Completion

2002-04-30

Countries

• Germany

Study Locations