Hepatitis BPhase 4NCT00240539
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
A Phase 4 study testing Blood sampling in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Thailand.
Trial summary
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study. Read more about this study
- Who is it for?
- Ages 16 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Blood sampling
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2003to Jul 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 16 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects who had participated in the primary study.
- Written informed consent obtained from the subject.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-Up Studies at Years 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers in Comparison With a Historical Control Group
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (HBsAg+) mothers. Results from the primary study have shown that the vaccine was immunogenic and protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The present study is carried out to evaluate the anti-HBs persistence and the prevalence and incidence of other hepatitis B markers (HBsAg, anti-hepatitis B core antigen {anti-HBc}, HBeAg, Alanine aminotransferase/Aspartate aminotransferase {ALT/AST}), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term from year 16-20. No vaccine will be administered during the long term follow up period.
- Conditions
- Hepatitis B
- Being tested
- Blood sampling
- Keywords
- Hepatitis B
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B™ vaccine.
| Study group | Role | What they receive |
|---|---|---|
| HBsAg(+) & HBeAg(-) 4-dose Group | Experimental | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study. Receives: Procedure: Blood sampling |
| HBsAg(+) & HBeAg(+) 4-dose Group | Experimental | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 4 doses of Engerix™ in the primary study. Receives: Procedure: Blood sampling |
| HBsAg(+) & HBeAg(+) 5-dose Group | Experimental | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study. Receives: Procedure: Blood sampling |
| HBsAg(-) & HBeAg(-) 4-dose Group | Experimental | Newborns of anti-hepatitis B surface antigen negative [HBsAg(-)] and hepatitis B envelope antigen negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study. Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.
Measured: At Years 16, 17, 18, 19 and 20 after primary vaccination
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).
Measured: At Years 16, 17, 18,19 and 20 after primary vaccination
Number of Subjects With Chronic and With Clinical HBV Infection
- Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points.
- Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point.
Measured: From year 16 through to year 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startOct 2003
- Primary completionJul 2008
- Study completionJul 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 (3)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT00240539
- Sponsor's protocol ID
- 100449
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2005
- Last updated
- 8 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, Srinivasa K, Hutagalung Y, Bock HL, Hoet B. Long-term benefit of hepatitis B vaccination among children in Thailand with transient hepatitis B virus infection who were born to hepatitis B surface antigen-positive mothers. J Infect Dis. 2009 Jul 1;200(1):33-8. doi: 10.1086/599331.
PubMed 19473096Poovorawan Y et al. Persistence of anti-HBs antibodies and immune memory 20-years after hepatitis B vaccination among children in Thailand. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand. 18-20 October 2011.
Poovorawan Y, Chongsrisawat V, Theamboonlers A, Crasta PD, Messier M, Hardt K. Long-term anti-HBs antibody persistence following infant vaccination against hepatitis B and evaluation of anamnestic response: a 20-year follow-up study in Thailand. Hum Vaccin Immunother. 2013 Aug;9(8):1679-84. doi: 10.4161/hv.24844. Epub 2013 May 31.
PubMed 23732904
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-Up Studies at Years 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers in Comparison With a Historical Control Group
- ClinicalTrials.gov ID
- NCT00240539
- Acronym / sponsor ID
- 100449
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Posted 17 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (HBsAg+) mothers. Results from the primary study have shown that the vaccine was immunogenic and protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The present study is carried out to evaluate the anti-HBs persistence and the prevalence and incidence of other hepatitis B markers (HBsAg, anti-hepatitis B core antigen {anti-HBc}, HBeAg, Alanine aminotransferase/Aspartate aminotransferase {ALT/AST}), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term from year 16-20. No vaccine will be administered during the long term follow up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HBsAg(+) & HBeAg(-) 4-dose Group | Experimental | Procedure: Blood samplingNewborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study. |
| HBsAg(+) & HBeAg(+) 4-dose Group | Experimental | Procedure: Blood samplingNewborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 4 doses of Engerix™ in the primary study. |
| HBsAg(+) & HBeAg(+) 5-dose Group | Experimental | Procedure: Blood samplingNewborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study. |
| HBsAg(-) & HBeAg(-) 4-dose Group | Experimental | Procedure: Blood samplingNewborns of anti-hepatitis B surface antigen negative [HBsAg(-)] and hepatitis B envelope antigen negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Subjects who had participated in the primary study.
- Written informed consent obtained from the subject.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood samplingA blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B™ vaccine. | Procedure or surgery | HBsAg(+) & HBeAg(+) 4-dose Group, HBsAg(+) & HBeAg(+) 5-dose Group, HBsAg(+) & HBeAg(-) 4-dose Group, HBsAg(-) & HBeAg(-) 4-dose Group |
Primary outcome
Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Time frame: At Years 16, 17, 18, 19 and 20 after primary vaccination
Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus
Time frame: At Years 16, 17, 18,19 and 20 after primary vaccination
Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).
Number of Subjects With Chronic and With Clinical HBV Infection
Time frame: From year 16 through to year 20
* Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points. * Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19473096Poovorawan Y, Chongsrisawat V, Theamboonlers A, Srinivasa K, Hutagalung Y, Bock HL, Hoet B. Long-term benefit of hepatitis B vaccination among children in Thailand with transient hepatitis B virus infection who were born to hepatitis B surface antigen-positive mothers. J Infect Dis. 2009 Jul 1;200(1):33-8. doi: 10.1086/599331.
- BackgroundPoovorawan Y et al. Persistence of anti-HBs antibodies and immune memory 20-years after hepatitis B vaccination among children in Thailand. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand. 18-20 October 2011.
- Derived from this study: PubMed 23732904Poovorawan Y, Chongsrisawat V, Theamboonlers A, Crasta PD, Messier M, Hardt K. Long-term anti-HBs antibody persistence following infant vaccination against hepatitis B and evaluation of anamnestic response: a 20-year follow-up study in Thailand. Hum Vaccin Immunother. 2013 Aug;9(8):1679-84. doi: 10.4161/hv.24844. Epub 2013 May 31.
- 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 Blood sampling 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 2 inclusion and 0 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 8 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 17 Nov 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 Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies (time frame: At Years 16, 17, 18, 19 and 20 after primary vaccination). The study lists 3 primary outcomes in all. 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 NCT00240539, which also lists 3 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 8 Dec 2016.