Hepatitis BPhase 4NCT02203357
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
A Phase 4 study testing Hepatitis B vaccine in people with Hepatitis B, run by Peking University at 1 site in China.
Trial summary
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepatitis B vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
- Written informed consent will be obtained from each subject before the serum screening of HBV markers
- Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
- Have never been immunized with HBV vaccine before
Who cannot join
- Subject has a medical history of allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Autoimmune disease or immunodeficiency
- Women with pregnant
- Bleeding disorder diagnosed by a doctor
- Chronic diseases: hepatitis, tumor, tuberculosis,et.al
- Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
- Subjects had a medical history of serious adverse reactions to vaccines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
- Conditions
- Hepatitis B
- Being tested
- Hepatitis B vaccine
- Keywords
- hepatitis B, hepatitis B vaccine, immunogenicity, adults
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B vaccineBiological
Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
| Study group | Role | What they receive |
|---|---|---|
| 20μg, 0-1-6 | Active comparator | 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule. Receives: Biological: Hepatitis B vaccine |
| 60μg, 0-1 | Experimental | 112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule. Receives: Biological: Hepatitis B vaccine |
| 60μg, 0-2 | Experimental | 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule. Receives: Biological: Hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.
The GMCs of anti-HBs antibody will be compared among the three vaccine groups.
Measured: one month after a series vaccination of the regimen
Secondary outcomes (2)
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.
The GMCs of anti-HBs will be compared among the three vaccine groups.
Measured: 1-year after the first dose of the regimens
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.
The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.
Measured: 2-year after the first dose of the regimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangxi Center for Disease Control and Prevention, Liuzhou City Center for disease control and prevention, Shenzhen Kangtai Biological Products Co., LTD
- Responsible party
- Principal investigator, Xueen Liu, Peking University
- Investigators
- Zhongliao Fang, Dr., Study director, Guangxi provincial center for desease control and preventionHui Zhuang, Dr., Study director, Peking University Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203357
- Sponsor's protocol ID
- HepB-2014
- Status last verified
- Oct 2019
- First submitted
- 18 Jul 2014
- Last updated
- 18 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Wang ZZ, Li MQ, Wang P, Yang ZX, Wei L, Zeng Y, Li YP, Yan L, Liu XE, Zhuang H. Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China. Vaccine. 2016 Feb 17;34(8):1034-9. doi: 10.1016/j.vaccine.2016.01.018. Epub 2016 Jan 19.
PubMed 26801063
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT02203357
- Acronym / sponsor ID
- HepB-2014
- Conditions
- Hepatitis B
- Keywords
- hepatitis B, hepatitis B vaccine, immunogenicity, adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Guangxi Center for Disease Control and Prevention, Liuzhou City Center for disease control and prevention, Shenzhen Kangtai Biological Products Co., LTD
- Study start
- Mar 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20μg, 0-1-6 | Active comparator | Biological: Hepatitis B vaccine117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule. |
| 60μg, 0-1 | Experimental | Biological: Hepatitis B vaccine112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule. |
| 60μg, 0-2 | Experimental | Biological: Hepatitis B vaccine125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
- Written informed consent will be obtained from each subject before the serum screening of HBV markers
- Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
- Have never been immunized with HBV vaccine before
Key exclusion criteria (8 listed)
- Subject has a medical history of allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Autoimmune disease or immunodeficiency
- Women with pregnant
- Bleeding disorder diagnosed by a doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis B vaccineHepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD. | Biological | 20μg, 0-1-6, 60μg, 0-1, 60μg, 0-2 |
Primary outcome
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Time frame: one month after a series vaccination of the regimen
The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups.
2 secondary outcomes
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Time frame: 1-year after the first dose of the regimens
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Time frame: 2-year after the first dose of the regimens
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26801063Wang ZZ, Li MQ, Wang P, Yang ZX, Wei L, Zeng Y, Li YP, Yan L, Liu XE, Zhuang H. Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China. Vaccine. 2016 Feb 17;34(8):1034-9. doi: 10.1016/j.vaccine.2016.01.018. Epub 2016 Jan 19.
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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.
Zhongliao Fang, Dr. study director
Guangxi provincial center for desease control and prevention
Hui Zhuang, Dr. study director
Peking University Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hepatitis B vaccine in people with Hepatitis B, run by Peking University 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 8 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 18 Oct 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults (time frame: one month after a series vaccination of the regimen). 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 NCT02203357, 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 18 Oct 2019.