NCT00736476

Brief Summary

To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

February 28, 2017

Completed
Last Updated

February 28, 2017

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

August 13, 2008

Results QC Date

September 30, 2016

Last Update Submit

January 9, 2017

Conditions

Helicobacter Pylori Infection

Keywords

helicobacter pylori infectionvaccinationadults

Outcome Measures

Primary Outcomes (2)

  • The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.

    The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo). Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT).

    12 weeks post HP challenge

  • Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination

    To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local\* and systemic adverse events.

    Day 1-7 post vaccination

Secondary Outcomes (5)

  • The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups

    12 months

  • The Geometric Mean Concentrations After HP Vaccination.

    upto 1 month after 3rd vaccination

  • Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.

    12 months

  • Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge

    12 weeks post HP challenge

  • Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)

    12 weeks post HP challenge

Study Arms (2)

1

EXPERIMENTAL
Biological: H.pylori vaccines

2

PLACEBO COMPARATOR
Biological: Placebo Vaccine

Interventions

H.pylori vaccinesBIOLOGICAL

1 dose of H.pylori vaccine at 0, 1, and 2 months

1
Placebo VaccineBIOLOGICAL

Placebo Vaccine at 0, 1, and 2 months

2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adults 18 - 40 years of age in good health
  • HP uninfected
  • not pregnant and agree to use birth control throughout the study (females who can become pregnant)

You may not qualify if:

  • remote or current HP infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otto von Guericke Universität Magdeburg

Magdeburg, 39120, Germany

Location

Related Publications (2)

  • Malfertheiner P, Selgrad M, Wex T, Romi B, Borgogni E, Spensieri F, Zedda L, Ruggiero P, Pancotto L, Censini S, Palla E, Kanesa-Thasan N, Scharschmidt B, Rappuoli R, Graham DY, Schiavetti F, Del Giudice G. Efficacy, immunogenicity, and safety of a parenteral vaccine against Helicobacter pylori in healthy volunteers challenged with a Cag-positive strain: a randomised, placebo-controlled phase 1/2 study. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):698-707. doi: 10.1016/S2468-1253(18)30125-0. Epub 2018 Jul 2.

    PMID: 30042064DERIVED

  • Nell S, Estibariz I, Krebes J, Bunk B, Graham DY, Overmann J, Song Y, Sproer C, Yang I, Wex T, Korlach J, Malfertheiner P, Suerbaum S. Genome and Methylome Variation in Helicobacter pylori With a cag Pathogenicity Island During Early Stages of Human Infection. Gastroenterology. 2018 Feb;154(3):612-623.e7. doi: 10.1053/j.gastro.2017.10.014. Epub 2017 Oct 21.

    PMID: 29066327DERIVED

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

February 28, 2017

Results First Posted

February 28, 2017

Record last verified: 2016-09

Locations

DE(1)