H. Pylori Infection Clinical Trial
Official title:
A Phase Ⅲ Clinical Trial for Efficacy, Immunogenicity, Safety and Immune Persistence of Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children Aged From 6-15 Years Old.
Helicobacter pylori (H. pylori) is a Gram-negative, microaerophilic bacterium that
persistently colonizes the human stomach; more than half the human population is infected
worldwide. H. pylori infection is a risk factor for the development of gastritis, peptic
ulcer, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer.
The phaseⅠand Ⅱclinical trial of oral recombinant Helicobacter pylori vaccine had completed
in Jiangsu Province in China. The data from phaseⅠand Ⅱclinical trial suggested that the
oral recombinant Helicobacter pylori vaccine had a clinically acceptable safety and good
immunogenicity for health adults and children. To further explore the safety and
immunogenicity profile of this vaccine, a phase Ⅲ clinical trial was conducted.
Helicobacter pylori (H. pylori) is a Gram-negative, microaerophilic bacterium that
persistently colonizes the human stomach; more than half the human population is infected
worldwide. H. pylori infection is the major risk factor for the development of gastritis,
peptic ulcer, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer.
At present, the main clinical treatment for H. pylori infection is the application of
antibiotics and bismuth agent or H+ antagonists. Due to the widespread drug resistance,
toxic side effects, high medical costs as well as poor patient compliance, it is unworkable
to practice antibiotics therapy for H. pylori eradication on every patient. Vaccination is
the most effective way for prevention H. pylori infection.
Since H. pylori were found, great attention has been given to the H. pylori vaccine,
scientists worldwide have made great efforts to develop both prophylactic and therapeutic H.
pylori vaccine. Numerous H. pylori vaccine approaches have been studied, including
inactivated whole cell H. pylori vaccine, genetic engineering subunit vaccine, live vector
vaccines. Urease is considered to be an excellent candidate antigen for vaccine against H.
pylori. However, no vaccine against H. pylori has been used in clinic.
The phaseⅠand Ⅱclinical trial of oral recombinant Helicobacter pylori vaccine had completed
in Jiangsu Province in China. The data from phaseⅠand Ⅱclinical trial suggested that the
oral recombinant Helicobacter pylori vaccine had a clinically acceptable safety and good
immunogenicity for children. To further explore the safety and immunogenicity profile of
this vaccine, a phase Ⅲ clinical trial was conducted.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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