A Phase Ⅲ Clinical Trial With Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children
Condition: H. Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): H. pylori vaccine; placebo
Intervention type(s): Biological; Biological
Other intervention name(s): Oral Recombinant Helicobacter Pylori Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention