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

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

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

Conditions
-----------------
Helicobacter Pylori, Gastritis, Gastric Cancer, Gastroduodenal Ulcers, Lymphoma

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: helicobacter pylori vaccine<br>* 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<br>|
| Experimental: 2<br> | Biological: helicobacter pylori vaccine<br>* 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<br>|
| Experimental: 3<br> | Biological: helicobacter pylori vaccine<br>* 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<br>|
| Experimental: 4<br> | Biological: helicobacter pylori vaccine<br>* 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<br>|
| Placebo Comparator: 5<br> | Biological: Placebo<br>* Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly<br>|
| Experimental: 6<br> | Biological: helicobacter pylori vaccine<br>* 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<br>|
| Experimental: 7<br> | Biological: helicobacter pylori vaccine<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures: injection site and systemic reactions |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogencity measures: antigen-specific antibodies and cellular immune response |  | 5 months |