Hepatitis B VaccinePhase 4NCT02991599
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
A Phase 4 study testing 60 µg dose hepatitis B vaccine and 20 µg dose hepatitis B vaccine in people with Hepatitis B Vaccine, run by Shanxi Medical University.
Trial summary
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B Vaccine
- What is being tested?
- 60 µg dose hepatitis B vaccine and 20 µg dose hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years at the enrolment
- Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- Willing to adhere to the study protocol
Who cannot join
- Being pregnant
- Intolerance or allergy to any component of the vaccine
- Any vaccination during the month preceding enrollment
- Ongoing opportunistic infection
- Liver disease
- Hematological disorder
- Cancer
- Unexplained fever the week before enrollment
About this study
Official title: Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients.
Read the detailed description
Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment
Intervention:
Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;
Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
- Conditions
- Hepatitis B Vaccine
- Being tested
- 60 µg dose hepatitis B vaccine, 20 µg dose hepatitis B vaccine
- Keywords
- Hepatitis B, Vaccine, Immunogenicity, methadone maintenance treatment, Randomized Controlled Trial
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 µg dose hepatitis B vaccineBiological
three-dose, 60 µg per dose
20 µg dose hepatitis B vaccineBiological
three-dose, 20 µg per dose
| Study group | Role | What they receive |
|---|---|---|
| 60 µg dose hepatitis B vaccine | Experimental | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 Receives: Biological: 60 µg dose hepatitis B vaccine |
| 20 µg dose hepatitis B vaccine | Experimental | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 Receives: Biological: 20 µg dose hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Measured: Month 7
Secondary outcomes (11)
Anti-HBs Concentration at Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Measured: Month 7
Anti-HBs Concentration at Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Measured: Month 12
Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml
Measured: Month 12
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
Measured: Within 7 days after the vaccination, at Month 0, 1, and 6
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
Measured: Within 28 days after the vaccination, at Month 0, 1, and 6
Anti-HBs Concentration at Month 18
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Measured: Month 18
Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml
Measured: Month 18
Anti-HBs Concentration at Month 30
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Measured: Month 30
Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml
Measured: Month 30
Anti-HBs Concentration at Month 42
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Measured: Month 42
Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml
Measured: Month 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionMay 2018
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 B VaccineStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China
- Responsible party
- Principal investigator, Suping Wang, Shanxi Medical University
- Investigators
- Suping Wang, Principal investigator, Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991599
- Sponsor's protocol ID
- 2012ZX10002001003004003
- Status last verified
- Nov 2021
- First submitted
- 10 Dec 2016
- Last updated
- 23 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23.
PubMed 28343774
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02991599
- Acronym / sponsor ID
- 2012ZX10002001003004003
- Conditions
- Hepatitis B Vaccine
- Keywords
- Hepatitis B, Vaccine, Immunogenicity, methadone maintenance treatment, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Shanxi Medical UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients.
Detailed description
Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment
Intervention:
Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;
Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60 µg dose hepatitis B vaccine | Experimental | Biological: 60 µg dose hepatitis B vaccine60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
| 20 µg dose hepatitis B vaccine | Experimental | Biological: 20 µg dose hepatitis B vaccine20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 70 years at the enrolment
- Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- Willing to adhere to the study protocol
Key exclusion criteria (8 listed)
- Being pregnant
- Intolerance or allergy to any component of the vaccine
- Any vaccination during the month preceding enrollment
- Ongoing opportunistic infection
- Liver disease
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 |
|---|---|---|
| 60 µg dose hepatitis B vaccinethree-dose, 60 µg per dose | Biological | 60 µg dose hepatitis B vaccine |
| 20 µg dose hepatitis B vaccinethree-dose, 20 µg per dose | Biological | 20 µg dose hepatitis B vaccine |
Primary outcome
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
Time frame: Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml.
11 secondary outcomes
Anti-HBs Concentration at Month 7
Time frame: Month 7
Anti-HBs Concentration at Month 12
Time frame: Month 12
Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
Time frame: Month 12
Occurrence of Adverse Events After Vaccination
Time frame: Within 7 days after the vaccination, at Month 0, 1, and 6
Occurrence of Adverse Events After Vaccination
Time frame: Within 28 days after the vaccination, at Month 0, 1, and 6
Anti-HBs Concentration at Month 18
Time frame: Month 18
Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
Time frame: Month 18
Anti-HBs Concentration at Month 30
Time frame: Month 30
Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
Time frame: Month 30
Anti-HBs Concentration at Month 42
Time frame: Month 42
Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
Time frame: Month 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28343774Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23.
- Individual participant dataSharing planned: No
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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.
Suping Wang principal investigator
Shanxi Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 60 µg dose hepatitis B vaccine and 20 µg dose hepatitis B vaccine in people with Hepatitis B Vaccine, run by Shanxi Medical University.
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 3 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 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 30 Jul 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?
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 (time frame: Month 7). 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 NCT02991599, 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 23 Dec 2021.