Clinical trial NCT04894448: Immunogenicity of COVID-19 Vaccination in PLWH
Official title: Immunogenicity Outcomes in People Living With HIV Following Vaccination for COVID-19 (HIV-COV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: CIHR Canadian HIV Trials Network
Sponsor class: NETWORK
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: The Ottawa Hospital (TOH)
First posted: 2021-05-20
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PLWH and HIV negative controls who have received at least one dose of COVID-19 vaccine

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).


Eligibility criteria: 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

Primary outcomes:
measure: immunogenicity of COVID-19 vaccination
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of individuals with COVID-19-specific IgG
timeFrame: 12 months
measure: Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity
timeFrame: 12 months
measure: Proportion and activation status of CD4 T cells, CD8 T cells, B cells, natural killer cells and monocytes, pre- and post-vaccination
timeFrame: 12 months
measure: 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
timeFrame: 7 and 30 days, post-injection
Other outcomes:
measure: Proportion of individuals with COVID-19-specific IgG at 6 months
timeFrame: 6 months
measure: Proportion of individuals with COVID-19-specific IgG at 6 months that cross-recognizes S protein variants of interest, including N501Y and/or E484K.
timeFrame: 12 months
measure: Proportion of individuals with COVID-19-specific T cell responses at 6 months, stratified by HLA genotype and immunodominant epitopes in S protein.
timeFrame: 12 months
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital (TOH)
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (UHN)
state: Ontario
city: Montreal
country: Canada
facility: Chronic Viral Illness Service (CVIS) McGill University Health Centre (MUHC)
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Cecilia Costiniuk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital (TOH)
name: Curtis Cooper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIHR Canadian HIV Trials Network
name: Aslam Anis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costiniuk CT, Singer J, Langlois MA, Kulic I, Needham J, Burchell A, Jenabian MA, Walmsley S, Ostrowski M, Kovacs C, Tan D, Harris M, Hull M, Brumme Z, Brockman M, Margolese S, Mandarino E, Angel JB, Routy JP, Anis AH, Cooper C. CTN 328: immunogenicity outcomes in people living with HIV in Canada following vaccination for COVID-19 (HIV-COV): protocol for an observational cohort study. BMJ Open. 2021 Dec 16;11(12):e054208. doi: 10.1136/bmjopen-2021-054208.