A Phase Ⅲ Clinical Trial With Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase

Completed

Phase 3

Conditions

H. Pylori Infection

Treatments

Biological: placebo

Biological: H. pylori vaccine

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02302170

TMMUHP03

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,464 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Healthy children aged from 6-15 years old as established by medical history and clinical examination
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

Exclusion criteria for the first dose

Subject who has a medical history of stomach illness
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

Exclusion criteria for the second and third dose Subjects will not be eligible for the second or third dose if any of following happened after first dose

Subject who had allergic reaction to the last dose
Any situation meet the exclusion criteria occurred after 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