Immunogenicity of COVID-19 Vaccination in PLWH

Study Overview
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Brief Summary
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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).

Official Title
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Immunogenicity Outcomes in People Living With HIV Following Vaccination for COVID-19 (HIV-COV)

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: COVID-19 Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PLWH<br>HIV positive | Biological: COVID-19 Vaccine<br>* Any COVID-19 vaccine (1 or more doses)<br>|
| Control<br>HIV negative | Biological: COVID-19 Vaccine<br>* Any COVID-19 vaccine (1 or more doses)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunogenicity of COVID-19 vaccination | as assessed by COVID-19-specific IgG ELISA 6 months following vaccination | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of individuals with COVID-19-specific IgG | Percentage of individuals with COVID-19-specific IgG at 12 months | 12 months | 
| Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity | as assessed by a pseudotyped viral infection assay | 12 months | 
| Proportion and activation status of CD4 T cells, CD8 T cells, B cells, natural killer cells and monocytes, pre- and post-vaccination | Proportion and activation status of CD4 T cells, CD8 T cells, B cells, natural killer cells and monocytes, pre- and post-vaccination | 12 months | 
| Percentage of persons with local or systemic adverse events or use of antipyretic or pain medication within 7 days and 30 days of either first or second injection | Percentage of persons with local or systemic adverse events or use of antipyretic or pain medication within 7 days and 30 days of either first or second injection | 7 and 30 days, post-injection |