Hepatitis BIRHBRVDNCT04970836
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
A study testing recombinant hepatitis B vaccine in people with Hepatitis B and Vaccination; Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This prospective cohort study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer<10 mIU/mL) need to take. Read more about this study
- Who is it for?
- Ages 20 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Vaccination; Infection, Preventable Disease, Vaccine
- What is being tested?
- recombinant hepatitis B vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The actual age at the time of admission was higher than 20 years old and birth year after 1987
- Born in Taiwan and had received a full course of hepatitis B vaccines at least three doses at infant period.
- Those who have tested negative for hepatitis B surface antibody and surface antigen at baseline
- Have never been vaccinated against hepatitis B in childhood and adolescence by questionnaire
- Consent to administer 1-2 doses of hepatitis B vaccine according to the assigned group after sharing decision making process
- In good health
Who cannot join
- Those who were previously allergic to hepatitis B vaccine or its components (such as yeast)
- Those who have been vaccinated against hepatitis B during childhood and adolescence
- Those who have a positive test for hepatitis B surface antibody or a positive test for hepatitis B surface antigen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Family Medicine, NTUH
Taipei, Taipei, 100
CHYI-FENG JAN, MD, PhD, +886-2-23123456 ext. 66824, jcf036@ntuh.gov.tw
About this study
This prospective cohort study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer<10 mIU/mL) need to take.
Read the detailed description
Purpose For young adults born after the neonatal hepatitis B immunization program, especially those who were 20-33 years old after 1987, additional hepatitis B vaccination may have the benefit of strengthening protection from acute hepatitis B infection among high-risk groups. However, how many doses are most appropriate for the protection of high-risk groups is still an issue to be resolved. This study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer<10 mIU/mL) need to take.
Materials and Methods From August 2021 to July 2024, the investigator will invite young adults born in Taiwan over the age of 20 and born after 1987, who have received a full course of hepatitis B vaccine at least three doses at their infant period. Those who are all negative for hepatitis B surface antibodies (anti-HBs) and surface antigens (HBsAg) are enrolled to 4 groups according to the anti-HBs titer concentration (anti-HBs titer between 2.5-10 mIU/mL is a low concentration, anti-HB titer less than 2.5 mIU/mL is an extreme low concentration) with one or two doses of hepatitis B vaccine (Engerix-B) administered, respectively. Each group recruits 60 cases to reach a total of 240 participants. Each participant was followed for 12 months, and the anti-HBs titer concentration was measured in 0, 7-10 days, 28 days, 24- 28 weeks, and 48-52 weeks. The investigator will calculate the anti-HBs titer reaction rate and immune response after receiving hepatitis B vaccine(s) at each stage, and do further univariate and multivariate analysis.
Expected Results This prospective cohort study can help understand the difference in the anti-HBs titer response after 1 or 2 revaccination doses by the anti-HBs titer concentration as well as the two different types of hepatitis B vaccination in childhood It is expected to provide an important reference for the administration of hepatitis B vaccine in young adults of high-risk groups.
- Being tested
- recombinant hepatitis B vaccine
- Keywords
- hepatitis B vaccine, revaccination, young adult, booster
- Medical subject headings
- Hepatitis B, Infections, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant hepatitis B vaccineBiological
Also called Engerix-B
Hepatitis B vaccine (Engerix-B) will be administered to the eligible participants by 4 groups. Each case will be tracked for 12 months, at 0, 7-10 days, 28 days, 24-28 weeks, 48-52 weeks anti-HBs titer concentration and 4 follow-up questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Low titer with two doses of HB Vaccines | Experimental | anti-HBs titer 2.5-10 mIU/mL with two doses of HB Vaccines at Day 0 and Day 28 Receives: Biological: recombinant hepatitis B vaccine |
| Low titer with one dose of HB Vaccine | Active comparator | anti-HBs titer 2.5-10 mIU/mL with one dose of HB Vaccine at Day 0 Receives: Biological: recombinant hepatitis B vaccine |
| Extremely low titer with two doses of HB Vaccines | Active comparator | anti-HBs titer lower than 2.5 mIU/mL with two doses of HB Vaccines at Day 0 and Day 28 Receives: Biological: recombinant hepatitis B vaccine |
| Extremely low titer with one dose of HB Vaccine | Active comparator | anti-HBs titer lower than 2.5 mIU/mL with one dose of HB Vaccine at Day 0 Receives: Biological: recombinant hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-HBs titer response rate at 7-10 days
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Measured: 7-10 days
anti-HBs titer response rate at one month
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Measured: 28 days
anti-HBs titer response rate at 6 months
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Measured: 24-28 weeks
anti-HBs titer response rate at 12 months
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Measured: 48-52 weeks
anti-HBs titer immune response change at 12 months
anti-HBs titer immune response change at 12 months after 1-2 doses of hepatitis B vaccine(s)
Measured: 48-52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Aug 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective cohort study
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academia Sinica, Taiwan, Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- CHYI-FENG JAN, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970836
- Sponsor's protocol ID
- 202012221MINB
- Other IDs
- 110-2314-B-002-132
- Acronym
- IRHBRVD
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2021
- Last updated
- 21 Oct 2026
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
- ClinicalTrials.gov ID
- NCT04970836
- Acronym / sponsor ID
- IRHBRVD / 202012221MINB
- Keywords
- hepatitis B vaccine, revaccination, young adult, booster
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Academia Sinica, Taiwan, Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jul 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.
This prospective cohort study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer<10 mIU/mL) need to take.
Detailed description
Purpose For young adults born after the neonatal hepatitis B immunization program, especially those who were 20-33 years old after 1987, additional hepatitis B vaccination may have the benefit of strengthening protection from acute hepatitis B infection among high-risk groups. However, how many doses are most appropriate for the protection of high-risk groups is still an issue to be resolved. This study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer<10 mIU/mL) need to take.
Materials and Methods From August 2021 to July 2024, the investigator will invite young adults born in Taiwan over the age of 20 and born after 1987, who have received a full course of hepatitis B vaccine at least three doses at their infant period. Those who are all negative for hepatitis B surface antibodies (anti-HBs) and surface antigens (HBsAg) are enrolled to 4 groups according to the anti-HBs titer concentration (anti-HBs titer between 2.5-10 mIU/mL is a low concentration, anti-HB titer less than 2.5 mIU/mL is an extreme low concentration) with one or two doses of hepatitis B vaccine (Engerix-B) administered, respectively. Each group recruits 60 cases to reach a total of 240 participants. Each participant was followed for 12 months, and the anti-HBs titer concentration was measured in 0, 7-10 days, 28 days, 24- 28 weeks, and 48-52 weeks. The investigator will calculate the anti-HBs titer reaction rate and immune response after receiving hepatitis B vaccine(s) at each stage, and do further univariate and multivariate analysis.
Expected Results This prospective cohort study can help understand the difference in the anti-HBs titer response after 1 or 2 revaccination doses by the anti-HBs titer concentration as well as the two different types of hepatitis B vaccination in childhood It is expected to provide an important reference for the administration of hepatitis B vaccine in young adults of high-risk groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Low titer with two doses of HB Vaccines | Experimental | Biological: recombinant hepatitis B vaccineanti-HBs titer 2.5-10 mIU/mL with two doses of HB Vaccines at Day 0 and Day 28 |
| Low titer with one dose of HB Vaccine | Active comparator | Biological: recombinant hepatitis B vaccineanti-HBs titer 2.5-10 mIU/mL with one dose of HB Vaccine at Day 0 |
| Extremely low titer with two doses of HB Vaccines | Active comparator | Biological: recombinant hepatitis B vaccineanti-HBs titer lower than 2.5 mIU/mL with two doses of HB Vaccines at Day 0 and Day 28 |
| Extremely low titer with one dose of HB Vaccine | Active comparator | Biological: recombinant hepatitis B vaccineanti-HBs titer lower than 2.5 mIU/mL with one dose of HB Vaccine at Day 0 |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The actual age at the time of admission was higher than 20 years old and birth year after 1987
- Born in Taiwan and had received a full course of hepatitis B vaccines at least three doses at infant period.
- Those who have tested negative for hepatitis B surface antibody and surface antigen at baseline
- Have never been vaccinated against hepatitis B in childhood and adolescence by questionnaire
- Consent to administer 1-2 doses of hepatitis B vaccine according to the assigned group after sharing decision making process
Key exclusion criteria (3 listed)
- Those who were previously allergic to hepatitis B vaccine or its components (such as yeast)
- Those who have been vaccinated against hepatitis B during childhood and adolescence
- Those who have a positive test for hepatitis B surface antibody or a positive test for hepatitis B surface antigen
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 |
|---|---|---|
| recombinant hepatitis B vaccineAlso: Engerix-BHepatitis B vaccine (Engerix-B) will be administered to the eligible participants by 4 groups. Each case will be tracked for 12 months, at 0, 7-10 days, 28 days, 24-28 weeks, 48-52 weeks anti-HBs titer concentration and 4 follow-up questionnaires. | Biological | Extremely low titer with one dose of HB Vaccine, Extremely low titer with two doses of HB Vaccines, Low titer with one dose of HB Vaccine, Low titer with two doses of HB Vaccines |
Primary outcome
anti-HBs titer response rate at 7-10 days
Time frame: 7-10 days
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
anti-HBs titer response rate at one month
Time frame: 28 days
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
anti-HBs titer response rate at 6 months
Time frame: 24-28 weeks
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
anti-HBs titer response rate at 12 months
Time frame: 48-52 weeks
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
anti-HBs titer immune response change at 12 months
Time frame: 48-52 weeks
anti-HBs titer immune response change at 12 months after 1-2 doses of hepatitis B vaccine(s)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- 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.
CHYI-FENG JAN, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recombinant hepatitis B vaccine in people with Hepatitis B and Vaccination; Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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 Taiwan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHYI-FENG JAN, MD, PHD (+886-2-23123456 ext. 66824, jcf036@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-HBs titer response rate at 7-10 days (time frame: 7-10 days). The study lists 5 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 21 Oct 2026.