Hepatitis B VaccinationNCT02166671
Immune Response to Hepatitis B Virus Booster Vaccination After 20-23 Years
A study testing HBV booster vaccination 1dose in people with Hepatitis B Vaccination, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine booster in healthy adults which received a full course of neonatal hepatitis B vaccination 20-23 years ago. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Vaccination
- What is being tested?
- HBV booster vaccination 1dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2014to 31 Dec 2015
- Phase
- Interventional
- 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults 20-25 years old
Who cannot join
- Hepatitis B surface antigen (+)
- Hepatitis B core antibody (+)
- any history of liver disorders including hepatitis
- HIV Ag or Ab(+)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Humoral and Cellular Immune Responses to a Hepatitis B Vaccine Booster 20-23 Years After Neonatal Immunization
This study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine booster in healthy adults which received a full course of neonatal hepatitis B vaccination 20-23 years ago.
- Conditions
- Hepatitis B Vaccination
- Being tested
- HBV booster vaccination 1dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV booster vaccination 1doseBiological
| Study group | Role | What they receive |
|---|---|---|
| HBV booster vaccination | Experimental | Not described Receives: Biological: HBV booster vaccination 1dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of HBsAb titer
Measured: 28 days after HBV booster vaccination
Secondary outcomes (1)
HBsAg-specific cell mediated immunity
Measured: 28 days after HBV booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study start25 Apr 2014
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Why it stopped: Participants were not recruited promptly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VaccinationStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166671
- Sponsor's protocol ID
- HBV_VAX_DUR_2014
- Status last verified
- May 2017
- First submitted
- 16 Jun 2014
- Last updated
- 15 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral and Cellular Immune Responses to a Hepatitis B Vaccine Booster 20-23 Years After Neonatal Immunization
- ClinicalTrials.gov ID
- NCT02166671
- Acronym / sponsor ID
- HBV_VAX_DUR_2014
- Conditions
- Hepatitis B Vaccination
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participants were not recruited promptly
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 18 Jun 2014 (estimated)
- 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 study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine booster in healthy adults which received a full course of neonatal hepatitis B vaccination 20-23 years ago.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBV booster vaccination | Experimental | Biological: HBV booster vaccination 1dose |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adults 20-25 years old
Key exclusion criteria (4 listed)
- Hepatitis B surface antigen (+)
- Hepatitis B core antibody (+)
- any history of liver disorders including hepatitis
- HIV Ag or Ab(+)
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 |
|---|---|---|
| HBV booster vaccination 1dose | Biological | HBV booster vaccination |
Primary outcome
change of HBsAb titer
Time frame: 28 days after HBV booster vaccination
1 secondary outcome
HBsAg-specific cell mediated immunity
Time frame: 28 days after HBV booster vaccination
Results and safety
The study was stopped early (reason given: Participants were not recruited promptly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBV booster vaccination 1dose in people with Hepatitis B Vaccination, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 May 2017. 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 South Korea. 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?
The study was stopped early (reason given: Participants were not recruited promptly). Results are not available in the source record.
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?
change of HBsAb titer (time frame: 28 days after HBV booster vaccination). 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 15 May 2017.