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

Primary Purpose

Helicobacter Pylori, Gastritis, Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
helicobacter pylori vaccine
helicobacter pylori vaccine
helicobacter pylori vaccine
helicobacter pylori vaccine
Placebo
helicobacter pylori vaccine
helicobacter pylori vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Helicobacter Pylori

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitaetsklinikum Charité

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

4

5

6

7

Arm Description

Outcomes

Primary Outcome Measures

Safety measures: injection site and systemic reactions

Secondary Outcome Measures

Immunogencity measures: antigen-specific antibodies and cellular immune response

Full Information

First Posted
January 31, 2008
Last Updated
June 10, 2013
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00613665
Brief Title
Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
April 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori, Gastritis, Gastric Cancer, Gastroduodenal Ulcers, Lymphoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Placebo Comparator
Arm Title
6
Arm Type
Experimental
Arm Title
7
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
helicobacter pylori vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
helicobacter pylori vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
helicobacter pylori vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
helicobacter pylori vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
helicobacter pylori vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
helicobacter pylori vaccine
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety measures: injection site and systemic reactions
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Immunogencity measures: antigen-specific antibodies and cellular immune response
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Universitaetsklinikum Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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