Hepatitis BNCT00792610
The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines
A study testing hepatitis B vaccine in people with Hepatitis B, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Feb 2009
- Phase
- Interventional
- 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 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-23 years
- the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B(anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers.
- Participants should agree to sign inform consent. For younger than 20 years old subjects, one of their parents also help the participate review and sign the inform consent.
- Participants are willing to receive 3 doses of Hepatitis B vaccines without payment.
- General condition is in good health judged by the doctor
Who cannot join
- Allergy to Hepatitis B vaccines or yeast
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significant economic impact on national health care resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the data to support such analyses are lacking. Because an increased risk of HB infection is anticipated when adolescents enter into young adulthood through becoming sexual active, breakthrough infections such as fulminant HB might be the main concern instead of the risk of chronic HB carriage. To address this issue, this study aimed to measure the booster responses after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in Taiwan before.
Read the detailed description
This cohort study was conducted between October 2007 and Jan 2009. The target population was subjects aged 18-23 years who were born after 1984 when the Taiwanese national HB vaccination program was launched. Their vaccination records must have shown a completed neonatal HB vaccination, and they were seronegative for all three HB viral markers including HBsAg(Hepatitis B surface antigen), anti-HBc(core antibody against Hepatitis B), and anti-HBs(Surface antibody against Hepatitis B) within 2 years of entry into the study and at study entry. They were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. The neonatal HB vaccination records were verified through linkage to the Taiwan Center for Disease Control databank. Signed informed consent was obtained from all the participants and their parents or guardians. Pregnant females, persons with a previous history of allergy to HB vaccines, or allergy to yeast were excluded. First 3 months are screen phase to recruit college students for assay of hepatitis B viral markers. Seronegative subjects were approached for enrollment into receiving hepatitis B vaccine booster afterwards.
All participants were tested for HB markers at enrollment, even if they had been tested in the previous months, to confirm their status. A questionnaire was completed at enrolment to record sociodemographic factors including age, gender, self reported family history of hepatitis B carriers, self reported blood type, and so on. The participants then received three intramuscular doses of HB vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20 microgram/ml/vial, GlaxoSmithKline, Belgium) at baseline and at the 1st and 6th month follow-up visits. Their anti-HBs status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of HB vaccine. Adverse effects associated with the vaccine were also reported within one week after each Engerix-B injection.
- Conditions
- Hepatitis B
- Being tested
- hepatitis B vaccine
- Keywords
- youth, hepatitis B, vaccination, booster, immunity 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.
hepatitis B vaccineBiological
Also called Engerix-B
Recombinant HBsAg, 20mcg/ml/vial (GSK) one vial IM at Day 0, Month 1, month 6 during follow-up, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B booster | Experimental | They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine. Receives: Biological: hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)
The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startAug 2007
- Primary completionJan 2009
- Study completionFeb 2009
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Chyi-Feng Jan, Doctor, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792610
- Sponsor's protocol ID
- 200701049M
- Other IDs
- NSC96-2314-B-0020115
- Status last verified
- Aug 2009
- First submitted
- 16 Nov 2008
- Last updated
- 6 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines
- ClinicalTrials.gov ID
- NCT00792610
- Acronym / sponsor ID
- 200701049M
- Conditions
- Hepatitis B
- Keywords
- youth, hepatitis B, vaccination, booster, immunity response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Posted 24 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significant economic impact on national health care resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the data to support such analyses are lacking. Because an increased risk of HB infection is anticipated when adolescents enter into young adulthood through becoming sexual active, breakthrough infections such as fulminant HB might be the main concern instead of the risk of chronic HB carriage. To address this issue, this study aimed to measure the booster responses after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in Taiwan before.
Detailed description
This cohort study was conducted between October 2007 and Jan 2009. The target population was subjects aged 18-23 years who were born after 1984 when the Taiwanese national HB vaccination program was launched. Their vaccination records must have shown a completed neonatal HB vaccination, and they were seronegative for all three HB viral markers including HBsAg(Hepatitis B surface antigen), anti-HBc(core antibody against Hepatitis B), and anti-HBs(Surface antibody against Hepatitis B) within 2 years of entry into the study and at study entry. They were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. The neonatal HB vaccination records were verified through linkage to the Taiwan Center for Disease Control databank. Signed informed consent was obtained from all the participants and their parents or guardians. Pregnant females, persons with a previous history of allergy to HB vaccines, or allergy to yeast were excluded. First 3 months are screen phase to recruit college students for assay of hepatitis B viral markers. Seronegative subjects were approached for enrollment into receiving hepatitis B vaccine booster afterwards.
All participants were tested for HB markers at enrollment, even if they had been tested in the previous months, to confirm their status. A questionnaire was completed at enrolment to record sociodemographic factors including age, gender, self reported family history of hepatitis B carriers, self reported blood type, and so on. The participants then received three intramuscular doses of HB vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20 microgram/ml/vial, GlaxoSmithKline, Belgium) at baseline and at the 1st and 6th month follow-up visits. Their anti-HBs status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of HB vaccine. Adverse effects associated with the vaccine were also reported within one week after each Engerix-B injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B booster | Experimental | Biological: hepatitis B vaccineThey receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18-23 years
- the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B(anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers.
- Participants should agree to sign inform consent. For younger than 20 years old subjects, one of their parents also help the participate review and sign the inform consent.
- Participants are willing to receive 3 doses of Hepatitis B vaccines without payment.
- General condition is in good health judged by the doctor
Key exclusion criteria (2 listed)
- Allergy to Hepatitis B vaccines or yeast
- pregnancy
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 |
|---|---|---|
| hepatitis B vaccineAlso: Engerix-BRecombinant HBsAg, 20mcg/ml/vial (GSK) one vial IM at Day 0, Month 1, month 6 during follow-up, respectively. | Biological | Hepatitis B booster |
Primary outcome
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)
Time frame: 7 months
The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis B
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A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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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.
Chyi-Feng Jan, Doctor study chair
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 hepatitis B vaccine in people with Hepatitis B, 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 5 inclusion and 2 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 6 Oct 2009. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2009). 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?
Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) (time frame: 7 months). 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 Oct 2009.