Hepatitis BPhase 4NCT00456625
Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
A Phase 4 study testing Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Thailand.
Trial summary
The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values at the previous long-term time point. Read more about this study
- Who is it for?
- Ages 20 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Engerix™-B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2007to Jan 2008
- Phase
- Phase 4
- 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 20 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female adult who received the complete neonatal primary vaccination course of hepatitis B vaccine in primary study approximately 20 years earlier.
- Documented level of anti-HBs antibody concentrations < specified concentration at the previous long-term time point for which serological results are available for that subject.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the hepatitis B challenge dose.
Who cannot join
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
- Administration of a vaccine not foreseen by the study protocol during the study period.
- Administration of immunoglobulins and/or any blood products during the study period.
- Drug and/or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate Immune Response to a Hepatitis B Vaccine (Engerix™-B ) Challenge Dose in Healthy Subjects Who Received GSK Biologicals' Hepatitis B Vaccine (Engerix™-B ) Approximately 20 Years Ago as Primary Vaccination at 0, 1, 2 and 12 Months.
The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Hepatitis B
- Being tested
- Engerix™-B
- Keywords
- Hepatitis B vaccine, Challenge dose
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engerix™-BBiological
Also called Hepatitis B vaccine
Intramuscular injection, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Group Engerix™-B | Experimental | Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination Receives: Biological: Engerix™-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values
The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.
Measured: One month after the hepatitis B vaccine challenge dose
Secondary outcomes (2)
Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE is considered severe if it prevents normal, everyday activities.
Measured: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.
Number of Participants Reporting Any Serious Adverse Events (SAEs).
An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: Up to 1 month after the challenge dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionJan 2008
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456625
- Sponsor's protocol ID
- 108984
- Status last verified
- Nov 2016
- First submitted
- 4 Apr 2007
- Last updated
- 16 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Poovorawan Y, Chongsrisawat V, Theamboonlers A, Bock HL, Leyssen M, Jacquet JM. Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand. Vaccine. 2010 Jan 8;28(3):730-6. doi: 10.1016/j.vaccine.2009.10.074. Epub 2009 Nov 3.
PubMed 19892043Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Kuriyakose S, Leyssen M, Jacquet JM. Evidence of protection against clinical and chronic hepatitis B infection 20 years after infant vaccination in a high endemicity region. J Viral Hepat. 2011 May;18(5):369-75. doi: 10.1111/j.1365-2893.2010.01312.x.
PubMed 20384962Poovorawan Y et al. 20-year follow-up of immunogenicity and efficacy of infant hepatitis B vaccination. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.
Poovorawan Y et al. 20-year persistence of immune response to infant hepatitis B vaccination in a high endemicity region. Abstract presented at the 13th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Washington DC, US, 20-24 March 2009.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Immune Response to a Hepatitis B Vaccine (Engerix™-B ) Challenge Dose in Healthy Subjects Who Received GSK Biologicals' Hepatitis B Vaccine (Engerix™-B ) Approximately 20 Years Ago as Primary Vaccination at 0, 1, 2 and 12 Months.
- ClinicalTrials.gov ID
- NCT00456625
- Acronym / sponsor ID
- 108984
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B vaccine, Challenge dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Posted 15 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Engerix™-B | Experimental | Biological: Engerix™-BSubjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination |
Who may qualify
- Ages
- 20 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female adult who received the complete neonatal primary vaccination course of hepatitis B vaccine in primary study approximately 20 years earlier.
- Documented level of anti-HBs antibody concentrations < specified concentration at the previous long-term time point for which serological results are available for that subject.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (4 listed)
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
- Administration of a vaccine not foreseen by the study protocol during the study period.
- Administration of immunoglobulins and/or any blood products during the study period.
- Drug and/or alcohol abuse.
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 |
|---|---|---|
| Engerix™-BAlso: Hepatitis B vaccineIntramuscular injection, 1 dose | Biological | Group Engerix™-B |
Primary outcome
Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values
Time frame: One month after the hepatitis B vaccine challenge dose
The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.
2 secondary outcomes
Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs)
Time frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.
Number of Participants Reporting Any Serious Adverse Events (SAEs).
Time frame: Up to 1 month after the challenge dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19892043Poovorawan Y, Chongsrisawat V, Theamboonlers A, Bock HL, Leyssen M, Jacquet JM. Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand. Vaccine. 2010 Jan 8;28(3):730-6. doi: 10.1016/j.vaccine.2009.10.074. Epub 2009 Nov 3.
- Background: PubMed 20384962Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Kuriyakose S, Leyssen M, Jacquet JM. Evidence of protection against clinical and chronic hepatitis B infection 20 years after infant vaccination in a high endemicity region. J Viral Hepat. 2011 May;18(5):369-75. doi: 10.1111/j.1365-2893.2010.01312.x.
- BackgroundPoovorawan Y et al. 20-year follow-up of immunogenicity and efficacy of infant hepatitis B vaccination. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.
- BackgroundPoovorawan Y et al. 20-year persistence of immune response to infant hepatitis B vaccination in a high endemicity region. Abstract presented at the 13th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Washington DC, US, 20-24 March 2009.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Thailand.
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 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: finished, as of the sponsor's last update on 16 Dec 2016. 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 Thailand. 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?
Yes. Results are posted in the registry (first posted 15 May 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?
Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values (time frame: One month after the hepatitis B vaccine challenge dose). 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 NCT00456625, which also lists 4 linked publications.
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 16 Dec 2016.