Hepatitis B
Conditions
Keywords
Hepatitis B
Brief 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. 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.
Interventions
PROCEDUREBlood sampling
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who had participated in the primary study. * Written informed consent obtained from the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | 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 | 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 | 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. |
Countries
Thailand
Participant flow
Pre-assignment details
Participant Flow and Baseline measures are given for the year 20 time point in order to account for all subjects participating in this long-term follow-up study. Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Participants by arm
| Arm | Count |
|---|---|
| HBsAg(+) & HBeAg(+) 5-dose Group 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. | 2 |
| HBsAg(+) & HBeAg(-) 4-dose Group Newborns of HBsAg(+) and HBeAg negative \[HBeAg(-)\] mothers, who received 4 doses of Engerix™ in the primary study. | 2 |
| HBsAg(+) & HBeAg(+) 4-dose Group Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study. | 31 |
| HBsAg(-) & HBeAg(-) 4-dose Group Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study. | 1 |
| Total | 36 |
Baseline characteristics
| Characteristic | HBsAg(+) & HBeAg(+) 5-dose Group | HBsAg(+) & HBeAg(-) 4-dose Group | HBsAg(+) & HBeAg(+) 4-dose Group | HBsAg(-) & HBeAg(-) 4-dose Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 31 Participants | 1 Participants | 36 Participants |
| Gender Female | 2 Participants | 2 Participants | 18 Participants | 1 Participants | 23 Participants |
| Gender Male | 0 Participants | 0 Participants | 13 Participants | 0 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: At Years 16, 17, 18, 19 and 20 after primary vaccination
Population: The analyses were performed on the Long-Term According to protocol (ATP) cohort for immunogenicity. Due to subjects being lost to follow up or eliminated from the ATP cohort for immunogenicity, no data from subjects in HBsAg(+) \& HBeAg(-) 4-dose Group and HBsAg(-) \& HBeAg(-) 4-dose Group were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 17 (n= 2, 24) | 2 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 19 (n= 2, 22) | 2 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 18 (n= 1, 22) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 20 (n= 2, 25) | 2 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 16 (n= 0, 25) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 20 (n= 2, 25) | 23 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 16 (n= 0, 25) | 22 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 17 (n= 2, 24) | 21 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 18 (n= 1, 22) | 20 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Year 19 (n= 2, 22) | 19 subjects |
Primary
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).
Time frame: At Years 16, 17, 18,19 and 20 after primary vaccination
Population: The analyses were performed on the ATP cohort for immunogenicity. Only subjects positive for HBsAg or anti-HBc markers were tested for HBeAg and anti-HBe markers for Year 17 to Year 20.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 19] (n= 1, 4) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 19] (n= 1, 4) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 16] (n= 1, 25) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 20] (n= 2, 25) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 17] (n= 2, 25) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 20] (n= 1, 5) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 18] (n= 1, 22) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 17] (n= 1, 3) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 19] (n= 1, 22) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 16] (n= 1, 23) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 20] (n= 2, 25) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 20] (n= 1, 5) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 16] (n= 1, 25) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 17] (n= 1, 4) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 17] (n= 2, 25) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 18] (n= 1, 2) | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 18] (n= 1, 22) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 18] (n= 1, 2) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 19] (n= 2, 22) | 1 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 16] (n= 1, 23) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 19] (n= 2, 22) | 2 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 20] (n= 2, 25) | 3 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 16] (n= 1, 23) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 17] (n= 1, 3) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 18] (n= 1, 2) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 19] (n= 1, 4) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBeAg [Year 20] (n= 1, 5) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 16] (n= 1, 23) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 17] (n= 1, 4) | 1 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 18] (n= 1, 2) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 20] (n= 1, 5) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 16] (n= 1, 25) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 17] (n= 2, 25) | 1 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 18] (n= 1, 22) | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 19] (n= 1, 22) | 2 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | HBsAg [Year 20] (n= 2, 25) | 2 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 16] (n= 1, 25) | 4 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 17] (n= 2, 25) | 3 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBc [Year 18] (n= 1, 22) | 2 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Anti-HBe [Year 19] (n= 1, 4) | 0 subjects |
Primary
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.
Time frame: From year 16 through to year 20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects With Chronic and With Clinical HBV Infection | Chronic HBV infection | 0 subjects |
| HBsAg(+) & HBeAg(+) 5-dose Group | Number of Subjects With Chronic and With Clinical HBV Infection | Clinical HBV infection | 0 subjects |
| HBsAg(+) & HBeAg(-) 4-dose Group | Number of Subjects With Chronic and With Clinical HBV Infection | Clinical HBV infection | 0 subjects |
| HBsAg(+) & HBeAg(-) 4-dose Group | Number of Subjects With Chronic and With Clinical HBV Infection | Chronic HBV infection | 0 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects With Chronic and With Clinical HBV Infection | Chronic HBV infection | 1 subjects |
| HBsAg(+) & HBeAg(+) 4-dose Group | Number of Subjects With Chronic and With Clinical HBV Infection | Clinical HBV infection | 0 subjects |
| HBsAg(-) & HBeAg(-) 4-dose Group | Number of Subjects With Chronic and With Clinical HBV Infection | Chronic HBV infection | 0 subjects |
| HBsAg(-) & HBeAg(-) 4-dose Group | Number of Subjects With Chronic and With Clinical HBV Infection | Clinical HBV infection | 0 subjects |