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

• Sponsor: Novartis Vaccines (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00613665
• Collaborator: (none)
• Enrollment: 113
• Location: 1
• Arms: 7
• Duration (Months): 13.9
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori; Gastritis; Gastric Cancer; Gastroduodenal Ulcers; Lymphoma	Biological: helicobacter pylori vaccine; Biological: helicobacter pylori vaccine; Biological: helicobacter pylori vaccine; Biological: helicobacter pylori vaccine; Biological: Placebo; Biological: helicobacter pylori vaccine; Biological: helicobacter pylori vaccine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• 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
• Study Start Date: Feb 1, 2001
• Actual Primary Completion Date: Dec 1, 2001
• Actual Study Completion Date: Apr 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Safety measures: injection site and systemic reactions [5 months]

Secondary Outcome Measures

1. Immunogencity measures: antigen-specific antibodies and cellular immune response [5 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Universitaetsklinikum Charité	Berlin		Germany	10117

Sponsors and Collaborators

• Novartis Vaccines

Investigators

• Study Chair: Novartis Vaccines, Novartis Vaccines

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT00613665
• Other Study ID Numbers: HPP002
• First Posted: Feb 13, 2008
• Last Update Posted: Jun 11, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Gastritis; Peptic Ulcer; Vaccines

Study Results

No Results Posted as of Jun 11, 2013