Adult subjects who received a primary vaccination course with Twinrix Adult following a two-dose schedule or Twinrix Junior following a three-dose schedule as adolescents (12-15 years) approximately 11 to 15 years ago.
Conditions
Interventions
Trade Name: Engerix-B
Product Name: Engerix-B
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B vaccine (recombinant)
Concentration unit: µg/ml microgram(s)/millilitre
Con
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at entry into each of the time-points of the long-term follow-up phase: • 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 who received the complete primary vaccination course according to his/her group allocation in the primary study HAB-084. • Written informed consent obtained from the subject. All subjects must satisfy the following criteria at entry into the challenge dose phase: • A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study HAB-084. • Subjects who participated in the long-term follow-up phase of the HAB-084 study and for whom the antibody concentrations were below 15 mIU/ml for anti-HAV antibodies and/ or 10 mIU/ml for anti-HBs antibodies at the last available follow-up time-points. • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. • Written informed consent obtained from the subject. • Healthy subjects as established by medical history and clinical examination before entering into the challenge dose phase of this study. • If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following criteria should be checked at each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit. • Use of any investigational or non-registered product (drug or vaccine) since the last blood sampling visit. • Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine since the primary vaccination course of the study HAB-084. • History of hepatitis A or hepatitis B infection. • Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within 3 months prior to blood sampling. The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase: • Use of any investigational or non-registered product (drug or vaccine) within 30 days before the administration of the challenge dose or planned use during the study period outside the context of the study. • Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine between the primary vaccination course of the study HAB-084 and the challenge dose visit. • History of hepatitis A or hepatitis B infection. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed). • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. • Acute disease at the time of enrolment (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C/ Axillary temperature <37.5°C). • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the challenge dose or planned administration before the final blood sampling point (one month after the challenge dose). • Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For the long-term follow-up phase: To evaluate anti-HAV and anti-HBs antibody persistence at Years 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose Twinrix Adult or a three-dose Twinrix Junior primary vaccination course. For the Challenge dose phase: To evaluate the immune memory 15 years after primary vaccination with a two-dose Twinrix Adult versus a three-dose Twinrix Junior vaccination course in subjects who became seronegative for anti-HAV antibodies (less than 15 mIU/ml) or whose anti-HBs antibody concentrations decreased below 10 mIU/ml during the long-term follow-up period. ;Secondary Objective: For the long-term follow-up phase: To retrospectively record all SAEs causally related to study procedures or to hepatitis A or B infection. For the Challenge dose phase: To evaluate the immune memory 15 years after primary vaccination with a two-dose Twinrix Adult versus a three-dose Twinrix Junior vaccination course in subjects who became seronegative for anti-HAV antibodies (less than 15 mIU/ml) or whose anti-HBs antibody concentrations decreased below 10 mIU/ml during the long-term follow-up period. To evaluate the safety and reactogenicity of a challenge dose of Engerix-B and/or Havrix in terms of solicited, unsolicited symptoms and serious adverse events (SAE).;Primary end point(s): For the long-term follow-up phase (at Years 11, 12, 13, 14 and 15): • Anti-HAV: percentage of seropositive subjects and GMCs calculated on seropositive subjects. • Anti-HBs: percentage of seropositive subjects and subjects with anti-HBs concentrations =10 mIU/ml as well as GMCs calculated on seropositive subjects. For the challenge dose phase • Anti-HAV anamnestic response to the challenge dose (for challenge dose with HAV vaccine). Anamnestic response is defined as the following: ? Anti-HAV antibody concentrations = 15 mIU/ml at one month post-challenge dose in subjects, seronegative at the pre-challenge time-points. ? At least a 2-fold increas | — |
Countries
Belgium, Czech Republic
Outcome results
None listed