H. Pylori Infection
Conditions
Brief 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.
Interventions
BIOLOGICALH. pylori vaccine
BIOLOGICALplacebo
Sponsors
National Institutes for Food and Drug Control, China
Kangwei Biological Technology
Third Military Medical University
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of Helicobacter pylori infection in participants one year after three-dose vaccinations. | one year after the third dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The immune response of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants | 1 month after the third dose | conversion rates, GMTs, GMFI of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants at month 1 |
| The immune response of anti-UreB IgG antibodies in serum three-dose vaccinations in the immunogenicity subset of participants. | 6 months after the third dose | seroconversion rates, GMTs, GMFI of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants at month 6 |
| The immune response of anti-UreB IgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants | 6 months after the third dose | To evaluate conversion rates, GMTs, GMFI of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants at month 6 |
| Frequency of adverse reactions after taking the H. pylori vaccines in children | within 3 days after each vaccination | Frequency of adverse reactions within 3 days after taking the H. pylori vaccines in children |
| The immune response of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants | 1 month after the third dose | seroconversion rates, GMTs, GMFI of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants at month 1. |
| Anti-UreB IgG antibodies persistency in serum after three-dose vaccinations in the immunogenicity subset of participants | 24 months after the third dose | seroconversion rates, GMTs, GMFI of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants at month 24 |
| Anti-UreB IgA antibodies persistency in saliva after three-dose vaccinations in the immunogenicity subset of participants | 24 months after the third dose | conversion rates, GMTs, GMFI of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants at month 24 |
| The occurrence of Helicobacter pylori infection in participants in the second year after three-dose vaccinations. | in the second year after the third dose | — |
| The occurrence of Helicobacter pylori infection in participants in the third year after three-dose vaccinations. | in the third year after the third dose. | — |
| Occurrence of serious adverse reactions after taking the H. pylori vaccines in children | From day 0 to One year after the third dose | Occurrence of serious adverse reactions within one year after the third dose in children |
Countries
China
Outcome results
None listed