Hepatitis B
Conditions
Keywords
Hepatitis B vaccine, Challenge dose
Brief 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. 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.
Interventions
BIOLOGICALEngerix™-B
Intramuscular injection, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) | During the 31-day follow-up period after the challenge dose of hepatitis B vaccine. | 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. |
| Number of Participants Reporting Any Serious Adverse Events (SAEs). | Up to 1 month after the challenge dose. | 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. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Engerix™-B Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination | 76 |
| Total | 76 |
Baseline characteristics
| Characteristic | Group Engerix™-B |
|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 0.59 |
| Gender Female | 36 Participants |
| Gender Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 76 |
| serious Total, serious adverse events | 0 / 76 |
Outcome results
Primary
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.
Time frame: One month after the hepatitis B vaccine challenge dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (including all evaluable subjects who had received the challenge dose of hepatitis B vaccine and for whom immunogenicity data were available at the post-hepatitis B vaccine challenge dose timepoint).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group Engerix™-B | Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values | ≥ 3.3 mIU/mL | 72 participants |
| Group Engerix™-B | Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values | ≥ 10 mIU/mL | 71 participants |
| Group Engerix™-B | Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values | ≥ 100 mIU/mL | 64 participants |
Secondary
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.
Time frame: Up to 1 month after the challenge dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group Engerix™-B | Number of Participants Reporting Any Serious Adverse Events (SAEs). | 0 participants |
Secondary
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.
Time frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group Engerix™-B | Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) | Any AEs | 1 participants |
| Group Engerix™-B | Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) | Severe AEs | 0 participants |
| Group Engerix™-B | Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) | Related AEs | 0 participants |