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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00613665
First received: January 31, 2008
Last updated: February 12, 2008
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety measures: injection site and systemic reactions [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogencity measures: antigen-specific antibodies and cellular immune response [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: February 2001
Primary Completion Date: December 2002 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613665

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

No publications provided

Responsible Party: Novartis, Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00613665     History of Changes
Other Study ID Numbers: HPP002
Study First Received: January 31, 2008
Last Updated: February 12, 2008
Health Authority: United States: Institutional Review Board
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Gastritis
Lymphoma
Stomach Neoplasms
Peptic Ulcer
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Duodenal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013