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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00613665

Enrollment

113

Registered

2008-02-13

Start date

2001-02-28

Completion date

2002-04-30

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

BIOLOGICALhelicobacter 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

BIOLOGICALPlacebo

Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
Safety measures: injection site and systemic reactions	5 months

Secondary

Measure	Time frame
Immunogencity measures: antigen-specific antibodies and cellular immune response	5 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026