A Phase Ⅲ Clinical Trial With Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children
NCT ID: NCT02302170
Last Updated: 2014-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
4464 participants
INTERVENTIONAL
2004-12-31
2008-09-30
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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H. pylori vaccine in children
H. pylori vaccine (15mg/dose) in children between 6-15 years of age
H. pylori vaccine
placebo in children
placebo (0mg/dose) in children between 6-15 years of age
placebo
Interventions
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H. pylori vaccine
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subjects' guardians are able to understand and sign the informed consent
* Subjects who can and will comply with the requirements of the protocol
* Subjects with temperature \<=37.0°C on axillary setting before vaccination
Exclusion Criteria
* Positive in either serology ELISA test for Helicobacter pylori diagnose kit or 13C urea breath test
* Subject who has suffered from heart, liver, and kidney disease
* Subject who has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine (for example: mannitol)
* Subject who is suffering from thrombocytopenia or other coagulation disorder
* Subject who has a diminished function of the immune system or autoimmune disease
* Subject who is suffering from congenital deformities, developmental disorders or serious chronic diseases
* Family history of seizures or progressive neurological disease
* Severe malnutrition or dysgenopathy, major congenital defects or serious chronic illness, including perinatal brain damage
* Any acute infections in last 7 days
* Any prior administration of immunodepressant or corticosteroids in last 6 month
* Any prior administration of other research medicines in last 1 month
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
* Subject who had allergic reaction to the last dose
* Subject who had any serious adverse events related to the vaccination
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
6 Years
15 Years
ALL
No
Sponsors
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National Institutes for Food and Drug Control, China
OTHER
Kangwei Biological Technology
OTHER
Third Military Medical University
OTHER
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Fengcai Zhu
Vice director of Jiangsu Province Centers for Disease Control and Prevention
Locations
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Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Countries
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References
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Zeng M, Mao XH, Li JX, Tong WD, Wang B, Zhang YJ, Guo G, Zhao ZJ, Li L, Wu DL, Lu DS, Tan ZM, Liang HY, Wu C, Li DH, Luo P, Zeng H, Zhang WJ, Zhang JY, Guo BT, Zhu FC, Zou QM. Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 Oct 10;386(10002):1457-64. doi: 10.1016/S0140-6736(15)60310-5. Epub 2015 Jun 30.
Other Identifiers
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TMMUHP03
Identifier Type: -
Identifier Source: org_study_id