Immunogenicity of COVID-19 Vaccination in PLWH (HIV-COV)

CIHR Canadian HIV Trials Network

Status

Unknown

Conditions

HIV Infections

Treatments

Biological: COVID-19 Vaccine

Study type

Observational

Funder types

Other

NETWORK

Identifiers

NCT04894448

CTN 328

Details and patient eligibility

About

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).

Enrollment

500 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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