A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years

Exclusion Criteria

• •Medical conditions
• •Previous vaccination against Hepatitis B.
• •Positive for anti-HBs antibodies or anti-HBc antibodies or HBsAg.
• •Any previous administration of monophosphoryl lipid (MPL) and/or AS37.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• •Any confirmed or suspected autoimmune disease.
• •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
• •Recurrent history or uncontrolled neurological disorders or seizures.
• •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• •Any clinically significant\* haematological and/or biochemical laboratory abnormality.
• •\*The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.
• •Any past or current malignancies and lymphoproliferative disorders.
• •Prior/Concomitant therapy
• •Use of any investigational or non-registered product (drug or vaccine) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) or their planned use during the study period.
• •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study intervention(s) administration with the exception of influenza vaccine (pandemic or seasonal).
• •A vaccine not foreseen by the study protocol administered during the period starting at Visit 1 or 30 days before each dose and ending 30 days after the last dose of study intervention(s) administration\*, with the exception of influenza vaccine (pandemic or seasonal).
• •\*In case emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by public health authorities outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine, provided it is licensed/authorised and used according to its Product Information.
• •Administration of long-acting immune-modifying drugs at any time during the study period.
• •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months before the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled and topical steroids are allowed.
• •Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration during the study period.
• •Prior/Concurrent clinical study experience
• •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational intervention.
• •Other exclusions
• •Pregnant or lactating female.
• •Female planning to become pregnant or planning to discontinue contraceptive precautions.
• •History of chronic alcohol consumption and/or drug abuse.
• •Any study personnel or their immediate depandants, family, or household members.
• •Specific exclusion for MRI-assessable subgroup participants (post-randomization procedure)
• •Presence of pacemakers, metal implants and/or prostheses.
• •Claustrophobia.