Various facts support the study of COVID-19 vaccine immunogenicity in People Living With HIV (PLWH) at this time: (1) Many PLWH in Canada will be eligible to receive COVID-19 vaccination as they are in a high priority risk group, such as residents or staff of shared living facilities for seniors, health care workers with direct patient contact, aged 70 years of age or older, or adults in Indigenous communities; (2) As vaccines against many other pathogens, it is plausible that the current standard vaccination strategy of COVID-19 is less effective in PLWH; (3) The potential burden of significant COVID-19 infection in PLWH is likely large given many PLWH are aging and have co-morbidities known to predispose to worse COVID-19 outcomes; (4) The vaccine clinical trials which include PLWH63, have stringent exclusion criteria, making results non-generalizable to many PLWH such as those with lower CD4 counts.

With the rapid roll-out of COVID-19 vaccination, many PLWH will be receiving the COVID-19 vaccine. Through vaccination, the provision of the same dosage of antigen stimulation to all individuals will result in a controlled method to measure immune response in PLWH. Therefore, we propose to develop a pan-Canadian cohort of PLWH receiving a COVID-19 vaccine(s) to assess a spectrum of immune responses. We also aim to assess the safety and tolerability of the COVID-19 vaccines in PLWH. These data may provide support for the use of one vaccine product over another and for exploring alternate vaccination strategies in PLWH (i.e., increased dose or double-dose vaccination and so forth).

Inclusion Criteria:

• Age >/=16 years (Sites may choose to only enrol adults based on their provincial age of majority)
• HIV positive for HIV group; For HIV negative group, individuals should be immunocompetent and generally in good health (i.e. participants should not have a condition associated with immunodeficiency nor be receiving immunosuppressant medication)
• Receiving at least 1 dose of COVID-19 vaccine, or have received 1 or 2 doses of a COVID-19 vaccine
• Able to provide signed, informed consent
• Able to attend study visits

Exclusion Criteria:

• Signs or symptoms of active COVID-19 infection
• For HIV-uninfected persons: immune-compromising conditions or on medication which suppresses the immune response

PLWH and HIV negative controls who have received at least one dose of COVID-19 vaccine

Data will be shared with Canada's COVID-19 Immunity Task Force (CITF) in accordance with the CITF data sharing agreement. Coded participant data (core data elements: demographics, COVID-19 infection history, health conditions, vaccination, blood testing results) will be deposited into the CITF database every two months for future research concerning COVID-19 and related health outcomes. To request coded centralized data, researchers apply to the CITF Data Access Committee (DAC). The DAC will ask researchers to confirm their intended research activities have received necessary ethics approvals.