Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity of COVID-19 Vaccination in PLWH (HIV-COV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04894448
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : October 15, 2021
Sponsor:
Collaborators:
McGill University Health Centre/Research Institute of the McGill University Health Centre
The Ottawa Hospital (TOH)
Information provided by (Responsible Party):
CIHR Canadian HIV Trials Network

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).


Condition or disease Intervention/treatment
HIV Infections Biological: COVID-19 Vaccine

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunogenicity Outcomes in People Living With HIV Following Vaccination for COVID-19 (HIV-COV)
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. immunogenicity of COVID-19 vaccination [ Time Frame: 6 months ]
    as assessed by COVID-19-specific IgG ELISA 6 months following vaccination


Secondary Outcome Measures :
  1. Percentage of individuals with COVID-19-specific IgG [ Time Frame: 12 months ]
    Percentage of individuals with COVID-19-specific IgG at 12 months

  2. Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity [ Time Frame: 12 months ]
    as assessed by a pseudotyped viral infection assay

  3. 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

  4. 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


Other Outcome Measures:
  1. Proportion of individuals with COVID-19-specific IgG at 6 months [ Time Frame: 6 months ]
    stratified by various sub-populations of PLWH

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PLWH and HIV negative controls who have received at least one dose of COVID-19 vaccine
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894448


Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital (TOH) Active, not recruiting
Ottawa, Ontario, Canada
University Health Network (UHN) Recruiting
Toronto, Ontario, Canada
Contact: Lianne Thai    416-340-4800 ext 2240    lianne.thai@uhn.ca   
Principal Investigator: Sharon Walmsley, MD         
Canada, Quebec
Chronic Viral Illness Service (CVIS) McGill University Health Centre (MUHC) Recruiting
Montreal, Quebec, Canada
Contact: Florian Bobeuf    514.934-1934 ext 32225    florian.bobeuf@much.mcgill.ca   
Principal Investigator: Cecilia C Costiniuk, MD         
Sponsors and Collaborators
CIHR Canadian HIV Trials Network
McGill University Health Centre/Research Institute of the McGill University Health Centre
The Ottawa Hospital (TOH)
Investigators
Layout table for investigator information
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: CIHR Canadian HIV Trials Network
ClinicalTrials.gov Identifier: NCT04894448    
Other Study ID Numbers: CTN 328
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases