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

NCT02302170 | Completed Phase 3

• 1 other identifier: TMMUHP03
• Study Type: interventional
• Target: 4,464
• Locations: 1 country
• Sites: 1

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.

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• The occurrence of Helicobacter pylori infection in participants one year after three-dose vaccinations.

  one year after the third dose

Secondary Outcomes (14)

• 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

• 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

• 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

• 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

• The immune response of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants

  12 months after the third dose

Study Arms (2)

H. pylori vaccine in children

EXPERIMENTAL

H. pylori vaccine (15mg/dose) in children between 6-15 years of age

Biological: H. pylori vaccine

placebo in children

PLACEBO COMPARATOR

placebo (0mg/dose) in children between 6-15 years of age

Biological: placebo

Interventions

H. pylori vaccine BIOLOGICAL

Also known as: Oral Recombinant Helicobacter Pylori Vaccine

H. pylori vaccine in children

placebo BIOLOGICAL

placebo in children

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Subject who had allergic reaction to the last dose
• Subject who had any serious adverse events related to the vaccination

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• National Institutes for Food and Drug Control, China: collaborator
• Kangwei Biological Technology: collaborator
• Third Military Medical University: collaborator

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 26142048 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of Jiangsu Province Centers for Disease Control and Prevention

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: December 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2008
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

CN (1)