Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04894448
Status:
UNKNOWN
Last Update Posted:
2021-10-15
First Post:
2021-05-18
Brief Title:
Immunogenicity of COVID-19 Vaccination in PLWH
Sponsor:
CIHR Canadian HIV Trials Network
Organization:
CIHR Canadian HIV Trials Network
Study Overview
Official Title:
Immunogenicity Outcomes in People Living With HIV Following Vaccination for COVID-19 HIV-COV
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIV-COV
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 vaccines 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 ie increased dose or double-dose vaccination and so forth
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 vaccines 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 ie increased dose or double-dose vaccination and so forth
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None