Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.; EngerixTM-B; Placebo
Intervention description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adults; Reactogenicity; Naive; Immune responses; Read-outs; Hepatitis B; Healthy

Summary:

      This study aims to develop innovative immunological read-outs and new technologies in order
      to further characterise the early immune response and its kinetics as well as the adaptive
      immune responses to adjuvanted vaccines.

      This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults
      vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals'
      Adjuvant System.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol

          -  A male or female between, and including, 18 and 45 years of age at the time of first
             study product administration

          -  Written informed consent obtained from the subject

          -  Healthy subjects, in the opinion of the investigator, as established by medical
             history, clinical examination, and clinical laboratory assessment with no active
             disease that could interfere with the study endpoints, before entering into the study

          -  Body Mass Index (BMI) between 18.5 and 30 kg/m2

          -  Female subjects of non-childbearing potential may be enrolled in the study

             - Non-childbearing potential is defined as pre-menarche, current tubal ligation,
             hysterectomy, ovariectomy or post-menopause.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to first study product
                  administration and

               -  has a negative pregnancy test on the day of placebo administration/ vaccination,
                  and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the study.

        Exclusion Criteria:

          -  Known history of HBV infection.

          -  Previous vaccination against hepatitis B.

          -  Positive for anti-hepatitis B surface (HBs) antibodies, anti-hepatitis B core (HBc)
             antibodies, HBsAg, HCV antibodies and/or HIV.

          -  Any previous administration of vaccine components.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first study product administration, or
             planned use during the study period.

          -  No significant dietary restrictions or life-threatening food allergies.

          -  Regular use of non steroidal anti-inflammatory drugs within 1 month prior to first
             study product administration.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within 6 months prior to the first study product
             administration.. Inhaled and topical steroids are allowed.

          -  Planned administration / administration of a vaccine not foreseen by the study
             protocol in the period starting 30 days before the first study product administration
             and during the entire study period (both Steps), with the exception of the influenza
             vaccine (pandemic or seasonal) which can be administered > 21 days preceding or > 21
             days following each placebo/vaccine administration.

          -  Administration of immunoglobulins and/or any blood products within the last 3 months
             preceding the first study product administration or planned administration during the
             study period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             HIV based on screening evaluations and on medical history and physical examination.

          -  History of or current bleeding or coagulation disorder.

          -  Any known or clinical signs of anaemia or any clinical condition (including vascular
             disorder) that would preclude frequent blood drawings.

          -  Poor venous access as assessed at screening by the investigator.

          -  Blood loss, including blood donation, of more than 300 mL within 90 days before the
             first study product administration.

          -  History of or current autoimmune or other immune-mediated disease.

          -  Any haematological or biochemical level out of normal range before entering into the
             study, as follows:

          -  Haemoglobin level < lower normal limit (LNL).

          -  Platelet counts out of normal range.

          -  Alanine aminotransferase [ALT] > upper normal limit (UNL).

          -  Aspartate aminotransferase [AST] > UNL.

          -  Creatinine > UNL.

          -  c-reactive protein [CRP] > UNL.

          -  Creatine phosphokinase [CPK] > UNL without any plausible explanation for this
             abnormality (such as sport activity).

        In case of haematological and/or biochemical value out of range for parameters mentioned
        here above, one re-testing of out of range value may be performed.

          -  Any acute or chronic, clinically significant disease, as determined by medical
             history, physical examination or laboratory screening tests.

          -  Known or suspected reaction or hypersensitivity likely to be exacerbated by any
             component of the vaccines.

          -  Acute disease and/or fever at the time of enrolment.

          -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
             infection) without fever may, be enrolled at the discretion of the investigator.

          -  Fever is defined as temperature ≥ 37.5°C for oral route.

          -  Pregnant or lactating female.

          -  Recent history of chronic alcohol consumption and/or drug abuse.

          -  Other conditions that the principal investigator judges may interfere with study
             findings.