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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 )
January 31, 2008
February 13, 2008
June 11, 2013
February 2001
December 2001   (Final data collection date for primary outcome measure)
Safety measures: injection site and systemic reactions [ Time Frame: 5 months ]
Same as current
Complete list of historical versions of study NCT00613665 on ClinicalTrials.gov Archive Site
Immunogencity measures: antigen-specific antibodies and cellular immune response [ Time Frame: 5 months ]
Same as current
Not Provided
Not Provided
 
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
This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
  • Helicobacter Pylori
  • Gastritis
  • Gastric Cancer
  • Gastroduodenal Ulcers
  • Lymphoma
  • 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
  • Experimental: 1
    Intervention: Biological: helicobacter pylori vaccine
  • Experimental: 2
    Intervention: Biological: helicobacter pylori vaccine
  • Experimental: 3
    Intervention: Biological: helicobacter pylori vaccine
  • Experimental: 4
    Intervention: Biological: helicobacter pylori vaccine
  • Placebo Comparator: 5
    Intervention: Biological: Placebo
  • Experimental: 6
    Intervention: Biological: helicobacter pylori vaccine
  • Experimental: 7
    Intervention: Biological: helicobacter pylori vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
April 2002
December 2001   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00613665
HPP002
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP