Hepatitis B VaccinePhase 4NCT02963714
Immunogenicity of Hepatitis B Vaccination in Hemodialysis 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 Suping Wang.
Trial summary
Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge. This is a randomized, controlled trial. 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
- 352 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jul 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
- Having end-stage renal disease (ESRD) on maintenance hemodialysis
- Aged between 18 and 70 years at enrollment
- 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
- Acute cytolysis in the last three months before enrollment
- Any vaccination during the month preceding enrollment
- Intolerance or allergy to any component of the vaccine
- Ongoing opportunistic infection
- Hepatitis C virus infection
Show all 14Show fewer
- Hematological disorder
- Cancer
- Unexplained fever the week before enrollment
- Immunosuppressive or immunomodulating treatment in the last six months
- Renal transplantation or upcoming renal transplantation
- Liver disease
- Other immunocompromised condition not related to ESRD
- An expected survival of < 6 months
About this study
Official title: Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial
Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.
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 hemodialysis patients.
Read the detailed description
Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
- Conditions
- Hepatitis B Vaccine
- Being tested
- 60 µg dose hepatitis B vaccine, 20 µg dose hepatitis B vaccine
- Keywords
- Hepatitis B, Vaccine, Randomized Controlled Trial, Hemodialysis, Immunogenicity
- 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.
Anti-HBs Seroconversion Rate at Month 7
Measured: Month 7
Secondary outcomes (10)
Anti-HBs Seroconversion Rate at Month 42
Measured: Month 42
Anti-HBs Seroconversion Rate at Month 36
Measured: Month 36
Anti-HBs Seroconversion Rate at Month 30
Measured: Month 30
Anti-HBs Seroconversion Rate at Month 24
Measured: Month 24
Anti-HBs Concentration at Month 7
Anti-HBs concentration at month 7 as measured by CMIA
Measured: Month 7
Anti-HBs Concentration at Month 12
Anti-HBs concentration at month 12 as measured by CMIA
Measured: Month 12
Anti-HBs Seroconversion Rate at Month 12
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
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
Anti-HBs Seroconversion Rate at Month 18
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startDec 2014
- Primary completionJul 2015
- Study completionJul 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
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suping Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China
- Responsible party
- Sponsor-investigator, Suping Wang, Shanxi Medical University
- Investigators
- Suping Wang, Principal investigator, Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963714
- Sponsor's protocol ID
- 2012ZX10002001003004001
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2016
- Last updated
- 14 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 X, Shi J, Gao L, Liu G, Cheng Y, Pan M, Li C, Wang J, Guo X, Zhang Y, Liang X, Wang S. Immunogenicity, antibody persistence, and safety of the 60 mug hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial. Expert Rev Vaccines. 2017 Oct;16(10):1045-1052. doi: 10.1080/14760584.2017.1367667. Epub 2017 Aug 21.
PubMed 28803502
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. 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 Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02963714
- Acronym / sponsor ID
- 2012ZX10002001003004001
- Conditions
- Hepatitis B Vaccine
- Keywords
- Hepatitis B, Vaccine, Randomized Controlled Trial, Hemodialysis, Immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Suping WangUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 14 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.
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 hemodialysis patients.
Detailed description
Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
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 (4 listed)
- Having end-stage renal disease (ESRD) on maintenance hemodialysis
- Aged between 18 and 70 years at enrollment
- 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 (14 listed)
- Being pregnant
- Acute cytolysis in the last three months before enrollment
- Any vaccination during the month preceding enrollment
- Intolerance or allergy to any component of the vaccine
- Ongoing opportunistic infection
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
Anti-HBs Seroconversion Rate at Month 7
Time frame: Month 7
10 secondary outcomes
Anti-HBs Seroconversion Rate at Month 42
Time frame: Month 42
Anti-HBs Seroconversion Rate at Month 36
Time frame: Month 36
Anti-HBs Seroconversion Rate at Month 30
Time frame: Month 30
Anti-HBs Seroconversion Rate at Month 24
Time frame: Month 24
Anti-HBs Concentration at Month 7
Time frame: Month 7
Anti-HBs Concentration at Month 12
Time frame: Month 12
Anti-HBs Seroconversion Rate at Month 12
Time frame: Month 12
Occurrence of Adverse Events After Vaccination
Time frame: Within 7 days after the vaccination
Occurrence of Adverse Events After Vaccination
Time frame: Within 28 days after the vaccination
Anti-HBs Seroconversion Rate at Month 18
Time frame: Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28803502Feng Y, Shi X, Shi J, Gao L, Liu G, Cheng Y, Pan M, Li C, Wang J, Guo X, Zhang Y, Liang X, Wang S. Immunogenicity, antibody persistence, and safety of the 60 mug hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial. Expert Rev Vaccines. 2017 Oct;16(10):1045-1052. doi: 10.1080/14760584.2017.1367667. Epub 2017 Aug 21.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B Vaccine
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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 Suping Wang.
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 14 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 14 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 14 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?
Anti-HBs Seroconversion Rate 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 NCT02963714, 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 14 Feb 2022.