Hepatitis BNCT01441609
Expression of Th9 Cells and Poor/Non-responsiveness to Hepatitis B Vaccination
An observational study of Hepatitis B, run by Beijing Municipal Science & Technology Commission at 1 site in China.
Trial summary
An observational study will be performed in subjects aged 3-65 years old to describe the dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find out the expression levels of Th9 cells and IL9 in subjects with different response to the primary immunization (3 single -dose injunctions). Read more about this study
- Who is it for?
- Ages 3 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- Type of treatment
- Vaccines
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to May 2012
- Phase
- Observational
- 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 3 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 94 subjects divided into 4 groups
Who may be able to join
- volunteer
- between 3-60 years old
- healthy
- have the history of vaccination of hepatitis B.
- Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative.
- informed consent
- not allergic to the component of the vaccine
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Li xuezhen contact
About this study
Official title: Effect of the Expression Level of Th9 Cells and IL-9 In Poor/Non-responsiveness to Hepatitis B Vaccination
An observational study will be performed in subjects aged 3-65 years old to describe the dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find out the expression levels of Th9 cells and IL9 in subjects with different response to the primary immunization (3 single -dose injunctions).
Read the detailed description
This study selected 74 volunteers which had the hepatitis B vaccine (immunization programs 0,1,6) , anti-HBs≤10mIU as the research subjects, and choose 20 volunteers which anti-HBs≥1000mIU as the control group, revaccination the groups according to the normal immunization programs, then the blood samples would be collected at 7th day, separate the PBMC and detect the expression levels of Th9 cells and IL9 by FCM, trying to find out the effects of Th9 and IL9 of non/poor -responsiveness subjects to hepatitis B.
- Conditions
- Hepatitis B
- Keywords
- Th9 cells, IL9, non/poor responsiveness to hepatitis B, collect blood samples after vaccination
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the value of anti-HBs =0 mIU/ml | Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs be zero. | |
| the value of anti-HBs≤5mIU/ml | Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs≤5mIU/ml. | |
| 5mIU≤anti-HBs≤10mIU/ml | Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of 5mIU≤anti-HBs≤10mIU | |
| anti-HBs≥1000mIU | Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs≥1000mIU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Th9 cells
Measured: blood sample of 7th day after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Science & Technology Commission
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Jiang, Centers for Disease Control and Prevention
- Investigators
- Wu Jiang, Study director, main investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441609
- Sponsor's protocol ID
- BJCDCWJ201103
- Status last verified
- Sep 2011
- First submitted
- 26 Sep 2011
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Expression Level of Th9 Cells and IL-9 In Poor/Non-responsiveness to Hepatitis B Vaccination
- ClinicalTrials.gov ID
- NCT01441609
- Acronym / sponsor ID
- BJCDCWJ201103
- Conditions
- Hepatitis B
- Keywords
- Th9 cells, IL9, non/poor responsiveness to hepatitis B, collect blood samples after vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Beijing Municipal Science & Technology CommissionUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study will be performed in subjects aged 3-65 years old to describe the dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find out the expression levels of Th9 cells and IL9 in subjects with different response to the primary immunization (3 single -dose injunctions).
Detailed description
This study selected 74 volunteers which had the hepatitis B vaccine (immunization programs 0,1,6) , anti-HBs≤10mIU as the research subjects, and choose 20 volunteers which anti-HBs≥1000mIU as the control group, revaccination the groups according to the normal immunization programs, then the blood samples would be collected at 7th day, separate the PBMC and detect the expression levels of Th9 cells and IL9 by FCM, trying to find out the effects of Th9 and IL9 of non/poor -responsiveness subjects to hepatitis B.
Study design
- Observational model
- Case-control
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| the value of anti-HBs =0 mIU/ml | – | –Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs be zero. |
| the value of anti-HBs≤5mIU/ml | – | –Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs≤5mIU/ml. |
| 5mIU≤anti-HBs≤10mIU/ml | – | –Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of 5mIU≤anti-HBs≤10mIU |
| anti-HBs≥1000mIU | – | –Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs≥1000mIU. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 94 subjects divided into 4 groups
Key inclusion criteria (7 listed)
- volunteer
- between 3-60 years old
- healthy
- have the history of vaccination of hepatitis B.
- Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Th9 cells
Time frame: blood sample of 7th day after each vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li xuezhen contact
Wu Jiang study director
main investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Beijing Municipal Science & Technology Commission 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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 28 Sep 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li xuezhen (0476-5891156), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Th9 cells (time frame: blood sample of 7th day after each vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2011.