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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613665
• Other study ID #: HPP002
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2008
• Last updated: June 10, 2013
• Start date: February 2001
• Est. completion date: April 2002

Study information

• Verified date: June 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: April 2002
• Est. primary completion date: December 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Cancer
• Gastritis
• Gastroduodenal Ulcers
• Helicobacter Pylori
• Lymphoma
• Peptic Ulcer

Intervention

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

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Charité	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measures: injection site and systemic reactions		5 months	Yes
Secondary	Immunogencity measures: antigen-specific antibodies and cellular immune response		5 months	No