- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04894448
Immunogenicity of COVID-19 Vaccination in PLWH (HIV-COV)
Immunogenicity Outcomes in People Living With HIV Following Vaccination for COVID-19 (HIV-COV)
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).
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada
- Active, not recruiting
- The Ottawa Hospital (TOH)
-
Toronto, Ontario, Canada
- Recruiting
- University Health Network (UHN)
-
Contact:
- Lianne Thai
- Phone Number: 2240 416-340-4800
- Email: lianne.thai@uhn.ca
-
-
Quebec
-
Montreal, Quebec, Canada
- Recruiting
- Chronic Viral Illness Service (CVIS) McGill University Health Centre (MUHC)
-
Contact:
- Florian Bobeuf
- Phone Number: 32225 514.934-1934
- Email: florian.bobeuf@much.mcgill.ca
-
Principal Investigator:
- Cecilia C Costiniuk, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PLWH
HIV positive
|
Any COVID-19 vaccine (1 or more doses)
|
Control
HIV negative
|
Any COVID-19 vaccine (1 or more doses)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
immunogenicity of COVID-19 vaccination
Time Frame: 6 months
|
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
Time Frame: 12 months
|
Percentage of individuals with COVID-19-specific IgG at 12 months
|
12 months
|
Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 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
|
7 and 30 days, post-injection
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of individuals with COVID-19-specific IgG at 6 months
Time Frame: 6 months
|
stratified by various sub-populations of PLWH
|
6 months
|
Proportion of individuals with COVID-19-specific IgG at 6 months that cross-recognizes S protein variants of interest, including N501Y and/or E484K.
Time Frame: 12 months
|
Proportion of individuals with COVID-19-specific IgG at 6 months that cross-recognizes S protein variants of interest, including N501Y and/or E484K.
|
12 months
|
Proportion of individuals with COVID-19-specific T cell responses at 6 months, stratified by HLA genotype and immunodominant epitopes in S protein.
Time Frame: 12 months
|
Proportion of individuals with COVID-19-specific T cell responses at 6 months, stratified by HLA genotype and immunodominant epitopes in S protein.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cecilia Costiniuk, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Principal Investigator: Curtis Cooper, MD, The Ottawa Hospital (TOH)
- Principal Investigator: Aslam Anis, PhD, CIHR Canadian HIV Trials Network
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTN 328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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