Gene Expression Profiles in Muscle After Immunisation

Inclusion criteria

• The participant is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
• The participant has signed the ICF.
• Healthy male participants aged 18-45 years inclusive.
• BMI between 19-27 kg/m2.
• Pre-immunised with Hepatitis B vaccine
• Hepatitis B sAb positive (evidence of vaccine-induced immunity)
• Hepatitis B sAg and cAb negative (evidence of lack of prior/current HBV infection)
• Hepatitis C and HIV seronegative.
• Available for follow-up for the duration of the study.
• Agree to abstain from donating blood during the study.
• The participant is, in the opinion of the investigator, healthy on the basis of a, medical history, a symptom directed medical examination and vital signs.

Exclusion criteria

• History of hypersensitivity to any of the vaccine components or a history of any allergy that in the opinion of the investigator would contraindicate participant participation
• Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (particularly myasthenia gravis), immunological, or haematological disease or abnormality, as determined by the study physician.
• Known immune or coagulation disorder or clinically significant abnormalities of platelets, Hb or coagulation on screening labs
• Known allergy to injected local anaesthetics
• Unwilling to undergo muscle biopsies
• Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of visit 1.
• Currently participating in a clinical trial with an investigational or non- investigational drug or device, or has participated in another clinical trial within the 3 months preceding the study.
• Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
• Receipt of blood products or immunoglobin, within 3 months of visit 1.
• Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.