Hepatitis B VaccinationPhase 4NCT02959775
Immunogenicity of Hepatitis B Vaccination Among Drug Users
A Phase 4 study testing 60 µg dose hepatitis B vaccine and 20 µg dose hepatitis B vaccine in people with Hepatitis B Vaccination, run by Shanxi Medical University.
Trial summary
Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hepatitis B Vaccination
- 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
- 480 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Oct 2015
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years at the enrolment
- current illicit drug users before drug rehabilitation
- negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- having spent acute physiological detoxification phase
Who cannot join
- any intolerance or allergy to any component of the vaccine
- ongoing opportunistic infection
- liver disease
- hemopathy
- cancer
- unexplained fever in the last week before the recruiting
About this study
Official title: Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial
Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection.
This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
Read the detailed description
Comparison of 2 vaccination strategy against Hepatitis B in Drug Users
Intervention:
Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6;
Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6;
Arm 3 : Receive no vaccination during the study period.
- Conditions
- Hepatitis B Vaccination
- Being tested
- 60 µg dose hepatitis B vaccine, 20 µg dose hepatitis B vaccine
- Keywords
- Hepatitis B vaccination, Immunogenicity, Randomized controlled trial, Drug abuse
- Medical subject headings
- Substance-Related Disorders
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 | Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6 Receives: Biological: 60 µg dose hepatitis B vaccine |
| 20 µg dose hepatitis B vaccine | Experimental | Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6 Receives: Biological: 20 µg dose hepatitis B vaccine |
| Control | No intervention | Receive no vaccination during the study period |
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 (6)
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
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
Measured: Within 28 days after the vaccination, at Month 0, 1, and 6
Serious Adverse Events (SAE) Occurred During Month 12
Measured: Month 0-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completionOct 2015
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 VaccinationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 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
- NCT02959775
- Sponsor's protocol ID
- 2012ZX10002001003004002
- Status last verified
- Dec 2021
- First submitted
- 7 Nov 2016
- Last updated
- 18 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng Y, Shi J, Gao L, Yao T, Feng D, Luo D, Li Z, Zhang Y, Wang F, Cui F, Li L, Liang X, Wang S. Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-7. doi: 10.1080/21645515.2017.1283082. Epub 2017 Mar 16.
PubMed 28301282
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02959775
- Acronym / sponsor ID
- 2012ZX10002001003004002
- Conditions
- Hepatitis B Vaccination
- Keywords
- Hepatitis B vaccination, Immunogenicity, Randomized controlled trial, Drug abuse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Shanxi Medical UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China
- Study start
- Aug 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 18 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection.
This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
Detailed description
Comparison of 2 vaccination strategy against Hepatitis B in Drug Users
Intervention:
Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6;
Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6;
Arm 3 : Receive no vaccination during the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60 µg dose hepatitis B vaccine | Experimental | Biological: 60 µg dose hepatitis B vaccineReceive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6 |
| 20 µg dose hepatitis B vaccine | Experimental | Biological: 20 µg dose hepatitis B vaccineReceive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6 |
| Control | No intervention | –Receive no vaccination during the study period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 70 years at the enrolment
- current illicit drug users before drug rehabilitation
- negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- having spent acute physiological detoxification phase
Key exclusion criteria (6 listed)
- any intolerance or allergy to any component of the vaccine
- ongoing opportunistic infection
- liver disease
- hemopathy
- cancer
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.
6 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
Serious Adverse Events (SAE) Occurred During Month 12
Time frame: Month 0-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28301282Feng Y, Shi J, Gao L, Yao T, Feng D, Luo D, Li Z, Zhang Y, Wang F, Cui F, Li L, Liang X, Wang S. Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-7. doi: 10.1080/21645515.2017.1283082. Epub 2017 Mar 16.
- 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 Vaccination, 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 4 inclusion and 6 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 Feb 2022. 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 18 Feb 2022). 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 NCT02959775, 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 Feb 2022.