Hepatitis B VaccinePhase 4NCT05099757
The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
A Phase 4 study testing 20 µg dose hepatitis B vaccine in people with Hepatitis B Vaccine, run by Shanxi Medical University.
Trial summary
The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Vaccine
- What is being tested?
- 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
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2022to 15 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged of 18 years or above
- Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) 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
- Participants with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Study on the Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group.
This study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.
Read the detailed description
Participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis B vaccine according to the antibody production level. 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 dose hepatitis B vaccine
- Keywords
- Hepatitis B Vaccine, Immunogenicity, Booster Dose, Long-term Immune Response, College Students
- 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 dose hepatitis B vaccineBiological
one-dose, two-dose or three-dose, 20 µg per dose
| Study group | Role | What they receive |
|---|---|---|
| 20 µg at month 0, months 0, 1 or 0, 1, and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 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 Months 1
Anti-HBs Seroconversion Rate at Months 1
Measured: Months 1
Anti-HBs Seroconversion Rate at Months 3
Anti-HBs Seroconversion Rate at Months 3
Measured: Months 3
Anti-HBs Seroconversion Rate at Months 7
Anti-HBs Seroconversion Rate at Months 7
Measured: Months 7
Anti-HBs Seroconversion Rate at Months 12
Anti-HBs Seroconversion Rate at Months 12
Measured: Months 12
Anti-HBs Seroconversion Rate at Months 18
Anti-HBs Seroconversion Rate at Months 18
Measured: Months 18
Anti-HBs Seroconversion Rate at Months 24
Anti-HBs Seroconversion Rate at Months 24
Measured: Months 24
Anti-HBs Seroconversion Rate at Months 30
Anti-HBs Seroconversion Rate at Months 30
Measured: Months 30
Secondary outcomes (7)
Anti-HBs Concentration at Months 1
Anti-HBs Concentration at Months 1
Measured: Months 1
Anti-HBs Concentration at Months 3
Anti-HBs Concentration at Months 3
Measured: Months 3
Anti-HBs Concentration at Months 7
Anti-HBs Concentration at Months 7
Measured: Months 7
Anti-HBs Concentration at Months 12
Anti-HBs Concentration at Months 12
Measured: Months 12
Anti-HBs Concentration at Months 18
Anti-HBs Concentration at Months 18
Measured: Months 18
Anti-HBs Concentration at Months 24
Anti-HBs Concentration at Months 24
Measured: Months 24
Anti-HBs Concentration at Months 30
Anti-HBs Concentration at Months 30
Measured: Months 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start20 Feb 2022 (estimated)
- Primary completion25 Nov 2022 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Medical University
- Sponsor type
- University, hospital or other
- 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
- NCT05099757
- Sponsor's protocol ID
- DXSHB20211012
- Status last verified
- Dec 2021
- First submitted
- 13 Oct 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
- ClinicalTrials.gov ID
- NCT05099757
- Acronym / sponsor ID
- DXSHB20211012
- Conditions
- Hepatitis B Vaccine
- Keywords
- Hepatitis B Vaccine, Immunogenicity, Booster Dose, Long-term Immune Response, College Students
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 25 Nov 2022 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 29 Oct 2021 (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.
The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group.
This study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.
Detailed description
Participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis B vaccine according to the antibody production level. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 µg at month 0, months 0, 1 or 0, 1, and 6 | Experimental | Biological: 20 µg dose hepatitis B vaccine20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged of 18 years or above
- Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) at enrollment
- Sign informed consent, willing to participate in this study
Key exclusion criteria (3 listed)
- Being pregnant
- Intolerance or allergy to any component of the vaccine
- Participants 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 dose hepatitis B vaccineone-dose, two-dose or three-dose, 20 µg per dose | Biological | 20 µg at month 0, months 0, 1 or 0, 1, and 6 |
Primary outcome
Anti-HBs Seroconversion Rate at Months 1
Time frame: Months 1
Anti-HBs Seroconversion Rate at Months 1
Anti-HBs Seroconversion Rate at Months 3
Time frame: Months 3
Anti-HBs Seroconversion Rate at Months 3
Anti-HBs Seroconversion Rate at Months 7
Time frame: Months 7
Anti-HBs Seroconversion Rate at Months 7
Anti-HBs Seroconversion Rate at Months 12
Time frame: Months 12
Anti-HBs Seroconversion Rate at Months 12
Anti-HBs Seroconversion Rate at Months 18
Time frame: Months 18
Anti-HBs Seroconversion Rate at Months 18
Anti-HBs Seroconversion Rate at Months 24
Time frame: Months 24
Anti-HBs Seroconversion Rate at Months 24
Anti-HBs Seroconversion Rate at Months 30
Time frame: Months 30
Anti-HBs Seroconversion Rate at Months 30
7 secondary outcomes
Anti-HBs Concentration at Months 1
Time frame: Months 1
Anti-HBs Concentration at Months 3
Time frame: Months 3
Anti-HBs Concentration at Months 7
Time frame: Months 7
Anti-HBs Concentration at Months 12
Time frame: Months 12
Anti-HBs Concentration at Months 18
Time frame: Months 18
Anti-HBs Concentration at Months 24
Time frame: Months 24
Anti-HBs Concentration at Months 30
Time frame: Months 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 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 3 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 6 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?
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, supingwang@sxmu.edu.cn), 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 Months 1 (time frame: Months 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2021.