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

Novartis

Status and phase

Completed

Phase 1

Conditions

Gastritis

Gastroduodenal Ulcers

Gastric Cancer

Helicobacter Pylori

Lymphoma

Treatments

Biological: helicobacter pylori vaccine

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00613665

HPP002

Details and patient eligibility

About

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

Enrollment

113 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

113 participants in 7 patient groups, including a placebo group

1

Experimental group

Treatment:

Biological: helicobacter pylori vaccine

2

Experimental group

Treatment:

Biological: helicobacter pylori vaccine

3

Experimental group

Treatment:

Biological: helicobacter pylori vaccine

4

Experimental group

Treatment:

Biological: helicobacter pylori vaccine

5

Placebo Comparator group

Treatment:

Biological: Placebo

6

Experimental group

Treatment:

Biological: helicobacter pylori vaccine

7

Experimental group

Treatment:

Biological: helicobacter pylori vaccine

Trial contacts and locations

1

Loading...