Immunogenicity of COVID-19 Vaccination in PLWH

HIV Infections Clinical Trial

— HIV-COV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894448
• Other study ID #: CTN 328
• Status: Recruiting
• Start date: June 10, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2021
• Source: CIHR Canadian HIV Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2023
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• COVID-19 Vaccine
Any COVID-19 vaccine (1 or more doses)

Locations

Country	Name	City	State
Canada	Chronic Viral Illness Service (CVIS) McGill University Health Centre (MUHC)	Montreal	Quebec
Canada	The Ottawa Hospital (TOH)	Ottawa	Ontario
Canada	University Health Network (UHN)	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
CIHR Canadian HIV Trials Network	McGill University Health Centre/Research Institute of the McGill University Health Centre, The Ottawa Hospital (TOH)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of individuals with COVID-19-specific IgG at 6 months	stratified by various sub-populations of PLWH	6 months
Other	Proportion of individuals with COVID-19-specific IgG at 6 months that cross-recognizes S protein variants of interest, including N501Y and/or E484K.	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
Other	Proportion of individuals with COVID-19-specific T cell responses at 6 months, stratified by HLA genotype and immunodominant epitopes in S protein.	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
Primary	immunogenicity of COVID-19 vaccination	as assessed by COVID-19-specific IgG ELISA 6 months following vaccination	6 months
Secondary	Percentage of individuals with COVID-19-specific IgG	Percentage of individuals with COVID-19-specific IgG at 12 months	12 months
Secondary	Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity	as assessed by a pseudotyped viral infection assay	12 months
Secondary	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
Secondary	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