Hepatitis BPhase 4NCT00240500

Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

A Phase 4 study testing Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. 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?: Engerix™-B
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 siteThailand
Study dates: Oct 2003to Nov 2007
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 received at least one dose of the study vaccine in the primary study (103860/064)
Written informed consent obtained from each subject before each blood sampling visit

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

GSK Investigational Site
Bangkok, 10330

Other trials in Thailand

About this study

Official title: Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers

Read the detailed description

The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.

The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Conditions: Hepatitis B
Being tested: Engerix™-B
Keywords: Long-term follow-up, Hepatitis B antibody persistence
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
In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.

Study groups in NCT00240500
Study group	Role	What they receive
HBV-1 Group	Experimental	neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) Receives: Biological: Engerix™-B
HBV-2 Group	Experimental	neonates born to HBsAg+ and HBeAg+ mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) Receives: Biological: Engerix™-B
HBV-3 Group	Experimental	neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) Receives: Biological: Engerix™-B
HBV-4 Group	Experimental	neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) Receives: Biological: Engerix™-B
HBV-5 Group	Experimental	neonates born to HBsAg- and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) Receives: Biological: Engerix™-B
HBV-6 Group	Experimental	neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) Receives: Biological: Engerix™-B

What is being measured

The primary outcome is the main question the study is designed to answer.

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.
Measured: Years 17, 18, 19 and 20.
Prevalence of Serological Markers for Hepatitis B Infection
It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg \& anti-HBe
Measured: Years 17, 18, 19 and 20.
Clinical Review for Hepatitis B Infection Status
Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points
Measured: Over the entire 4 year follow up period (17 - 20 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2003Nov 2007

First posted18 Oct 2005 (estimated)
Study startOct 2003
Primary completionNov 2007
Study completionNov 2007

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 (2)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: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00240500
Sponsor's protocol ID: 100448
Status last verified: Nov 2016
First submitted: 13 Oct 2005
Last updated: 21 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, 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 20384962
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 19892043

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers
ClinicalTrials.gov ID: NCT00240500
Acronym / sponsor ID: 100448
Conditions: Hepatitis B
Keywords: Long-term follow-up, Hepatitis B antibody persistence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2003
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 18 Oct 2005 (estimated)
Results: Posted 1 May 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
HBV-1 Group	Experimental	Biological: Engerix™-Bneonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV-2 Group	Experimental	Biological: Engerix™-Bneonates born to HBsAg+ and HBeAg+ mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
HBV-3 Group	Experimental	Biological: Engerix™-Bneonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV-4 Group	Experimental	Biological: Engerix™-Bneonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
HBV-5 Group	Experimental	Biological: Engerix™-Bneonates born to HBsAg- and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV-6 Group	Experimental	Biological: Engerix™-Bneonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)

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 received at least one dose of the study vaccine in the primary study (103860/064)
Written informed consent obtained from each subject before each blood sampling visit

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
Engerix™-BIn the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.	Biological	HBV-1 Group, HBV-2 Group, HBV-3 Group, HBV-4 Group, HBV-5 Group, HBV-6 Group

Primary outcome

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Time frame: Years 17, 18, 19 and 20.
During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.
Prevalence of Serological Markers for Hepatitis B Infection
Time frame: Years 17, 18, 19 and 20.
It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg \& anti-HBe
Clinical Review for Hepatitis B Infection Status
Time frame: Over the entire 4 year follow up period (17 - 20 years)
Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points

Results and safety

Results posted to the registry on 1 May 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HBV 5 Group	17	16
HBV 2 Group	20	17
HBV 1 Group	17	14
HBV 4 Group	23	19
HBV 3 Group	29	26
HBV 6 Group	3	2

Primary outcome: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

Time frame: Years 17, 18, 19 and 20.. Mean (95% Confidence Interval). Unit: mIU/mL

Measure	HBV 5 Group n = 17	HBV 2 Group n = 20	HBV 1 Group n = 17	HBV 4 Group n = 23	HBV 3 Group n = 29	HBV 6 Group n = 3
Year 17	87.6 (27.6 to 278.2)	43.8 (22.0 to 87.4)	143.4 (39.2 to 523.9)	34.4 (12.3 to 95.8)	90.9 (45.8 to 180.3)	10.6 (0.4 to 251.0)
Year 18	96.2 (37.8 to 244.8)	63.9 (32.2 to 126.6)	121.6 (31.8 to 465.0)	33.1 (15.2 to 72.2)	89.1 (43.8 to 181.3)	19.2 (0.0 to 2615400000)
Year 19	37.4 (14.8 to 94.4)	34.5 (20.6 to 57.7)	108.1 (30.6 to 382.8)	22.5 (11.7 to 43.6)	62.1 (30.7 to 125.6)	26.9 (2.0 to 363.6)
Year 20	46.4 (19.6 to 109.8)	25.8 (14.4 to 46.3)	101.8 (28.7 to 361.7)	20.3 (10.2 to 40.6)	55.5 (30.1 to 102.1)	12.8 (0.0 to 7642461)

Primary outcome: Prevalence of Serological Markers for Hepatitis B Infection

Time frame: Years 17, 18, 19 and 20.. Number. Unit: Percentage of participants (%)

Measure	HBV 5 Group n = 17	HBV 2 Group n = 20	HBV 1 Group n = 17	HBV 4 Group n = 23	HBV 3 Group n = 29	HBV 6 Group n = 3
Year 17, HBsAg Negative	100	93.7	100	100	96.3	100
Year 17, HBsAg Positive	0	6.3	0	0	3.7	0
Year 17, Anti HBc Negative	100	68.7	78.6	100	100	100
Year 17, Anti HBc Positive	0	31.3	21.4	0	0	0
Year 17, HBeAg Negative	0	100	100	0	100	0
Year 17, HBeAg Positive	0	0	0	0	0	0
Year 17, Anti HBeAg Negative	0	80	100	0	100	0
Year 17, Anti HBeAg Positive	0	20	0	0	0	0

Primary outcome: Clinical Review for Hepatitis B Infection Status

Time frame: Over the entire 4 year follow up period (17 - 20 years). Number. Unit: participants

Measure	HBV 5 Group n = 17	HBV 2 Group n = 20	HBV 1 Group n = 17	HBV 4 Group n = 23	HBV 3 Group n = 29	HBV 6 Group n = 3
Chronic HB carriers	0	1	1	0	0	0
Chronic HB carriers among primary study responders	0	0	0	0	0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: 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.
Derived from this study: 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.
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.

Related trials for Hepatitis B

Active, not recruitingPhase 2
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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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 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 21 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 1 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?

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations (time frame: Years 17, 18, 19 and 20.). 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 NCT00240500, which also lists 2 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 21 Dec 2016.