A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity

Inclusion criteria

• Able to read and understand the informed consent form (ICF), and understand study procedures
• Signed the ICF
• Healthy male aged 18'Äì55 years inclusive
• BMI 19'Äì27 kg/m2
• Pre-immunised with hepatitis B vaccine on the basis of immunisation history if Fendrix or Engerix B is to be the study vaccine
• Available for follow-up for the duration of the study
• Is, in the opinion of the investigator, healthy on the basis of a medical history, symptom directed medical examination and vital signs
• Have not undergone research radiation exposures, and agree to avoid such exposures, for 12 months before/after this study
• Be willing to avoid vigorous exercise or contact sports between vaccination and PET scan (e.g. gym workouts, prolonged cycling, rowing, martial arts or rugby)

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
• Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of the PET scan. (Topical/ocular/nasal/inhaled steroids are allowed.)
• Expression of only TSPO with low-affinity to PBR28, on the basis of TSPO genotype
• Currently participating in a clinical study with a drug or device
• Any condition that, in the investigator'Äôs opinion, compromises the participant'Äôs ability to meet protocol requirements or to complete the study
• Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent