Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults
NCT ID: NCT00736476
Last Updated: 2017-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2008-10-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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1
H.pylori vaccines
1 dose of H.pylori vaccine at 0, 1, and 2 months
2
Placebo Vaccine
Placebo Vaccine at 0, 1, and 2 months
Interventions
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H.pylori vaccines
1 dose of H.pylori vaccine at 0, 1, and 2 months
Placebo Vaccine
Placebo Vaccine at 0, 1, and 2 months
Eligibility Criteria
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Inclusion Criteria
* HP uninfected
* not pregnant and agree to use birth control throughout the study (females who can become pregnant)
Exclusion Criteria
18 Years
40 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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Otto von Guericke Universität Magdeburg
Magdeburg, , Germany
Countries
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References
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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.
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.
Other Identifiers
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2007-003511-31
Identifier Type: -
Identifier Source: secondary_id
V99P2
Identifier Type: -
Identifier Source: org_study_id
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