Hepatitis B VaccinePhase 4NCT03962803
Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients
A Phase 4 study testing 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6, 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 and 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 in people with Hepatitis B Vaccine, run by Shanxi Medical University at 1 site in China.
Trial summary
At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal. 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?
- 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6, 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 and 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2019to Dec 2023
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
- Sign informed consent, willing to participate in this study
Who cannot join
- Being pregnant
- Intolerance or allergy to any component of the vaccine
- Any vaccination during the month preceding enrollment
- CD4 cell count ≤ 200 cells/µL
- Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
- The use of immunosuppressive agents in patients with nearly three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in HIV-Infected Patients
At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.
This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients
Read the detailed description
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
- Conditions
- Hepatitis B Vaccine
- Being tested
- 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6, 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6, 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
- Keywords
- Hepatitis B Vaccine, Randomized Controlled Trial, HIV-Infected Patients, Immunogenicity, Long-term Immune Response
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 µg recombinant hepatitis B vaccine at months 0, 1, and 6Biological
three-dose, 20 µg per dose
20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6Biological
four-dose, 20 µg per dose
60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6Biological
four-dose, 60 µg per dose
| Study group | Role | What they receive |
|---|---|---|
| 20 µg at months 0, 1, and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 Receives: Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 |
| 20 µg at months 0, 1, 2,and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 Receives: Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 |
| 60 µg at months 0, 1, 2,and 6 | Experimental | 60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 Receives: Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs Seroconversion Rate at Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Measured: Month 7
Secondary outcomes (10)
Anti-HBs concentration at month 7
Anti-HBs concentration at month 7 as measured by CMIA
Measured: Month 7
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis
Measured: Within 7 days after the vaccination
Anti-HBs Seroconversion Rate at month 12
Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
Measured: Month 12
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 18
Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
Measured: Month 18
Anti-HBs concentration at month 18
Anti-HBs concentration at month 18 as measured by CMIA
Measured: Month 18
Anti-HBs Seroconversion Rate at month 30
Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
Measured: Month 30
Anti-HBs concentration at month 30
Anti-HBs concentration at month 30 as measured by CMIA
Measured: Month 30
Anti-HBs Seroconversion Rate at month 42
Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
Measured: Month 42
Anti-HBs concentration at month 42
Anti-HBs concentration at month 42 as measured by CMIA
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 posted24 May 2019
- Study start5 Jun 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 300 participants (estimated)
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, PhD, Principal investigator, Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962803
- Sponsor's protocol ID
- 2018ZX10721202001002001
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng Y, Chen Z, Xie R, Yao T, Wu Y, Yang F, Yuan C, Nie X, Wang F, Liang X, Wang S. Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1.
PubMed 35312441
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT03962803
- Acronym / sponsor ID
- 2018ZX10721202001002001
- Conditions
- Hepatitis B Vaccine
- Keywords
- Hepatitis B Vaccine, Randomized Controlled Trial, HIV-Infected Patients, Immunogenicity, Long-term Immune Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanxi Medical UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China
- Study start
- 5 Jun 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 May 2019 (actual)
- 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.
At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.
This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients
Detailed description
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 µg at months 0, 1, and 6 | Experimental | Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 620 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
| 20 µg at months 0, 1, 2,and 6 | Experimental | Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 620 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 |
| 60 µg at months 0, 1, 2,and 6 | Experimental | Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 660 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
- Sign informed consent, willing to participate in this study
Key exclusion criteria (6 listed)
- Being pregnant
- Intolerance or allergy to any component of the vaccine
- Any vaccination during the month preceding enrollment
- CD4 cell count ≤ 200 cells/µL
- Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
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 |
|---|---|---|
| 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6three-dose, 20 µg per dose | Biological | 20 µg at months 0, 1, and 6 |
| 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6four-dose, 20 µg per dose | Biological | 20 µg at months 0, 1, 2,and 6 |
| 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6four-dose, 60 µg per dose | Biological | 60 µg at months 0, 1, 2,and 6 |
Primary outcome
Anti-HBs Seroconversion Rate at Month 7
Time frame: Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
10 secondary outcomes
Anti-HBs concentration at month 7
Time frame: Month 7
Occurrence of Adverse Events After Vaccination
Time frame: Within 7 days after the vaccination
Anti-HBs Seroconversion Rate at month 12
Time frame: Month 12
Anti-HBs concentration at month 12
Time frame: Month 12
Anti-HBs Seroconversion Rate at month 18
Time frame: Month 18
Anti-HBs concentration at month 18
Time frame: Month 18
Anti-HBs Seroconversion Rate at month 30
Time frame: Month 30
Anti-HBs concentration at month 30
Time frame: Month 30
Anti-HBs Seroconversion Rate at month 42
Time frame: Month 42
Anti-HBs concentration at month 42
Time frame: Month 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Derived from this study: PubMed 35312441Feng Y, Chen Z, Xie R, Yao T, Wu Y, Yang F, Yuan C, Nie X, Wang F, Liang X, Wang S. Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1.
- 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, PhD principal investigator
Shanxi Medical University
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 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6, 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 and 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 in people with Hepatitis B Vaccine, run by Shanxi Medical 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 2 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: status not confirmed, as of the sponsor's last update on 24 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suping Wang, PhD (#86-351-4135103, spwang88@163.com), or a site near the patient. 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 NCT03962803, 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 24 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.