A phase II, randomized, multicentre, observer-blind study to compare and characterize the immunoginicity and safety parameters induced by various GSK Biologicals’ Adjuvant Systems in combination with the Hepatitis B surface antigen (HBsAg), according to a 0, 1 month schedule with a booster at Month 12, in healthy, Hepatitis B virus (HBV) naïve, adults. - EARLY-CLINRES-002

• Conditions: Hepatitis B surface antigen (HBsAg) vaccine administred in HBV naïve adult subjects aged between 18 and 45 years old, inclusive, in good general health.

• Registration Number: EUCTR2008-004455-29-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 710

Inclusion Criteria

All Subjects must satisfy the following criteria at study entry :
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•A male or female between, and including, 18 and 45 years at the time of the first vaccination.
•Written informed consent obtained from the subject.
•Healthy subjects as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
•If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, 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 vaccination series.

Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent).

For azoospermia, documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records.

Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g. > 45 years.

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

•Previous vaccination against Hepatitis B.
•Positive for anti-HBs antibodies, antiHBc antibodies, HBsAg, HCV antibodies and/or HIV.
•Any previous administration of MPL® and/or QS21.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, =0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the influenza vaccine (pandemic or seasonal) which can be administered > 21 days preceding or > 21 days following each primary vaccine dose (Doses 1 and 2) AND > 7 days preceding or > 7 days following the booster dose. .
•Administration of immunoglobulins and/or any blood products within the last 3 months.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
•Current serious neurologic or mental disease.
•Any past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders.
•Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, renal functional abnormality, autoimmune disease or anemia, as determined by physical examination or laboratory screening tests at the discretion of the investigator.
•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.
•Pregnant or lactating female.
•History of chronic alcohol consumption and/or drug abuse.
•Other conditions that the principal investigator judges may interfere with study findings.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified