Immunogenicity of COVID-19 Vaccination in PLWH
- Conditions
- HIV Infections
- Interventions
- Biological: COVID-19 Vaccine
- Registration Number
- NCT04894448
- Lead Sponsor
- CIHR Canadian HIV Trials Network
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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
- Signs or symptoms of active COVID-19 infection
- For HIV-uninfected persons: immune-compromising conditions or on medication which suppresses the immune response
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control COVID-19 Vaccine HIV negative PLWH COVID-19 Vaccine HIV positive
- Primary Outcome Measures
Name Time Method immunogenicity of COVID-19 vaccination 6 months as assessed by COVID-19-specific IgG ELISA 6 months following vaccination
- Secondary Outcome Measures
Name Time Method Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity 12 months as assessed by a pseudotyped viral infection assay
Proportion and activation status of CD4 T cells, CD8 T cells, B cells, natural killer cells and monocytes, pre- and post-vaccination 12 months Proportion and activation status of CD4 T cells, CD8 T cells, B cells, natural killer cells and monocytes, pre- and post-vaccination
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 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 individuals with COVID-19-specific IgG 12 months Percentage of individuals with COVID-19-specific IgG at 12 months
Trial Locations
- Locations (3)
The Ottawa Hospital (TOH)
🇨🇦Ottawa, Ontario, Canada
University Health Network (UHN)
🇨🇦Toronto, Ontario, Canada
Chronic Viral Illness Service (CVIS) McGill University Health Centre (MUHC)
🇨🇦Montreal, Quebec, Canada