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

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Biological: COVID-19 Vaccine

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Canada
  • 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: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

PLWH and HIV negative controls who have received at least one dose of COVID-19 vaccine

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PLWH; HIV positive	Biological: COVID-19 Vaccine; Any COVID-19 vaccine (1 or more doses)
Control; HIV negative	Biological: COVID-19 Vaccine; 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	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	Percentage of individuals with COVID-19-specific IgG at 12 months	12 months
Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity	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	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	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	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.	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.	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: CIHR Canadian HIV Trials Network
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre; The Ottawa Hospital (TOH)
• 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

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: CTN 328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared with Canada's COVID-19 Immunity Task Force (CITF) in accordance with the CITF data sharing agreement. Coded participant data (core data elements: demographics, COVID-19 infection history, health conditions, vaccination, blood testing results) will be deposited into the CITF database every two months for future research concerning COVID-19 and related health outcomes. To request coded centralized data, researchers apply to the CITF Data Access Committee (DAC). The DAC will ask researchers to confirm their intended research activities have received necessary ethics approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No