Skip to main content
OpenTrials
Completed

NCT Number: NCT00613665

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Helicobacter Pylori Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Gastric Cancer Gastritis Gastroduodenal Ulcers Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Peptic Ulcer Stomach Diseases Stomach Neoplasms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitaetsklinikum Charité

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • Ages 18-40
  • Negative for H. pylori infection
  • Contraception for females

Exclusion criteria

  • Present or past H. pylori infection
  • Medically significant gastroduodenal disease
  • Recent corticosteroid use
  • Bleed diathesis
  • Use of antibiotics used to treat H. pylori infection

Treatment and study plan

helicobacter pylori vaccine

Biological

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

Placebo

Biological

Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly

Primary outcomes

  1. Safety measures: injection site and systemic reactions

    Time frame: 5 months

Secondary outcomes

  1. Immunogencity measures: antigen-specific antibodies and cellular immune response

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2001
Study completion
2002
First posted
Feb 13, 2008
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.