Human Vaccines Project: scRNAseq Characterization of HepB Vaccine Response

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Inclusion Criteria

Healthy adult aged 40–80 years
No history of hepatitis B disease
No prior receipt of any hepatitis B-containing vaccine
Undetectable level of anti-HBs and anti-HBV core (HBc) antibody and HBs antigen at study enrollment
Generally good health (stable chronic conditions acceptable)
Living independently or with minimal assistance (clinical frailty score 1–5) and able to attend all study visits
Willing and able to comply with the requirements of the protocol
Provided informed consent for participation in the study

Exclusion Criteria

Individual on the study delegation log
History of being a household contact of a known hepatitis B-infected individual
Planned receipt of any investigational drug during the study
Confirmed or suspected immunodeficiency
Family history of congenital or hereditary immunodeficiency
Receipt of >1 week of systemic immunosuppressants or immune modifying drugs in the 3 months prior to dose 1 of vaccine
Taking any anti-platelet or anti-coagulant medications (excluding daily low-dose aspirin)
Bleeding disorder or thrombocytopenia, that contraindicates intramuscular injection, blood collection and/or lymph node fine needle aspiration
Administration of immunoglobulins within the prior 12 months and/or any other blood products within the prior 3 months or planned during the study period
Current pregnancy or planning to become pregnant in the 6 months post-dose 1 vaccination
History of allergy to any component of the vaccine
Unstable medical condition, as indicated by a requirement for hospitalization or a substantial medication change to stabilize said condition within previous 3 months
History of any neurologic disorders or seizures, including a history of Guillain-Barré syndrome
Clinical Frailty score of 6-7 (moderately frail or severely frail)
Scheduled elective surgery or other procedures requiring general anaesthesia from 1 month pre- to the 1 month post-1st dose of vaccine
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

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