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H. Pylori InfectionPhase 3NCT02302170

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

A Phase 3 study testing H. pylori vaccine in people with H. Pylori Infection, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 15 years
Conditions the study is for
H. Pylori Infection
What is being tested?
H. pylori vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,464 participants
Where
1 siteChina
Study dates
Dec 2004to Sep 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Center for Diseases Control and Prevention

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Phase Ⅲ Clinical Trial for Efficacy, Immunogenicity, Safety and Immune Persistence of Oral Recombinant Helicobacter Pylori Vaccine in Chinese Children Aged From 6-15 Years Old.

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.

Read the 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.

Being tested
H. pylori vaccine, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H. pylori vaccineBiological

    Also called Oral Recombinant Helicobacter Pylori Vaccine

  • placeboBiological

Study groups in NCT02302170
Study groupRoleWhat they receive
H. pylori vaccine in childrenExperimentalH. pylori vaccine (15mg/dose) in children between 6-15 years of age
Receives: Biological: H. pylori vaccine
placebo in childrenPlacebo comparatorplacebo (0mg/dose) in children between 6-15 years of age
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: one year after the third dose

Secondary outcomes (14)

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

    seroconversion rates, GMTs, GMFI of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants at month 1.

    Measured: 1 month after the third dose

  2. The immune response of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants

    conversion rates, GMTs, GMFI of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants at month 1

    Measured: 1 month after the third dose

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

    seroconversion rates, GMTs, GMFI of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants at month 6

    Measured: 6 months after the third dose

  4. The immune response of anti-UreB IgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants

    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

    Measured: 6 months after the third dose

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

    seroconversion rates, GMTs, GMFI of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants at month 12

    Measured: 12 months after the third dose

  6. The immune response of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants

    conversion rates, GMTs, GMFI of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants at month 12

    Measured: 12 months after the third dose

  7. Frequency of adverse reactions after taking the H. pylori vaccines in children

    Frequency of adverse reactions within 3 days after taking the H. pylori vaccines in children

    Measured: within 3 days after each vaccination

  8. Occurrence of serious adverse reactions after taking the H. pylori vaccines in children

    Occurrence of serious adverse reactions within one year after the third dose in children

    Measured: From day 0 to One year after the third dose

  9. Anti-UreB IgG antibodies persistency in serum after three-dose vaccinations in the immunogenicity subset of participants

    seroconversion rates, GMTs, GMFI of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants at month 24

    Measured: 24 months after the third dose

  10. Anti-UreB IgA antibodies persistency in saliva after three-dose vaccinations in the immunogenicity subset of participants

    conversion rates, GMTs, GMFI of anti-UreB sIgA antibodies in saliva after three-dose vaccinations in the immunogenicity subset of participants at month 24

    Measured: 24 months after the third dose

  11. Anti-UreB IgG antibodies persistency in serum after three-dose vaccinations in the immunogenicity subset of participants

    seroconversion rates, GMTs, GMFI of anti-UreB IgG antibodies in serum after three-dose vaccinations in the immunogenicity subset of participants at month 36

    Measured: 36 months after the third dose

  12. Anti-UreB IgA antibodies persistency in saliva after three-dose vaccinations in the immunogenicity subset of participants

    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 36

    Measured: 36 months after the third dose

  13. The occurrence of Helicobacter pylori infection in participants in the second year after three-dose vaccinations.

    Measured: in the second year after the third dose

  14. The occurrence of Helicobacter pylori infection in participants in the third year after three-dose vaccinations.

    Measured: in the third year after the third dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2014 (estimated)
  2. Study startDec 2004
  3. Primary completionSep 2006
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
4,464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02302170
Sponsor's protocol ID
TMMUHP03
Status last verified
Nov 2014
First submitted
24 Nov 2014
Last updated
26 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26142048

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing H. pylori vaccine in people with H. Pylori Infection, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of Helicobacter pylori infection in participants one year after three-dose vaccinations. (time frame: one year after the third dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02302170, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.

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