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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613665
First Posted: February 13, 2008
Last Update Posted: June 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
  Purpose
This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine

Condition Intervention Phase
Helicobacter Pylori Gastritis Gastric Cancer Gastroduodenal Ulcers Lymphoma Biological: helicobacter pylori vaccine Biological: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Vaccines ):

Primary Outcome Measures:
  • Safety measures: injection site and systemic reactions [ Time Frame: 5 months ]

Secondary Outcome Measures:
  • Immunogencity measures: antigen-specific antibodies and cellular immune response [ Time Frame: 5 months ]

Enrollment: 113
Study Start Date: February 2001
Study Completion Date: April 2002
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Experimental: 2 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
Experimental: 3 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
Experimental: 4 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
Placebo Comparator: 5 Biological: Placebo
Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly
Experimental: 6 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
Experimental: 7 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613665


Locations
Germany
Universitaetsklinikum Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00613665     History of Changes
Other Study ID Numbers: HPP002
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: June 11, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Stomach Neoplasms
Gastritis
Peptic Ulcer
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastroenteritis
Duodenal Diseases
Intestinal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs