Vaccines in a Time of Dual Pandemic: COVID-19 Vaccine in People With HIV

NCT06731127 | Completed

• 1 other identifier: 40713
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-randomized observational study to examine SARS-CoV-2 vaccine immunogenicity, immune activation and HIV reservoirs in people with HIV infection in comparison with HIV-negative individuals, in those aged 55 or more. As Canada is currently rolling out COVID-19 vaccines, the two most imminent vaccines are mRNA vaccines. These are the Pfizer-BioNTech COVID-19 vaccine given 3 weeks apart and the Moderna COVID-19 vaccine given 4 weeks apart. Given the unique storage requirements of these vaccines, it is expected that the Moderna vaccine will be used primarily in primary care clinics such as Maple Leaf Medical Clinic, Toronto. However, the protocol will also allow observational study of individuals being administered with the Pfizer-BioNTech vaccine if it is also available. The investigators predict general availability of both vaccines to the primary care population by March 1, 2021. Vaccination will occur as per clinical and public health guidelines. COVID-19 vaccines will not be administered as a part of this research study. This is a single site longitudinal study where 75 participants in total are followed over 48 weeks with blood draws and saliva sampling. The breakdown of study arms is described here:

• PWH Immune responders (n= 35): undetectable viral load for 1+ year, CD4 \>500/uL, CD4/CD8 ratio \>1 including individuals with a historical, low CD4 nadir
• PWH Immune non-responders (n= 10): undetectable viral load, CD4 \<350/uL or CD4/CD8 ratio \<0.75 for 1+ year
• PWH Low-level viremics (n= 10): low-level viremia (\<1,000 copies/mL) for 1+ year, any CD4, any CD4/CD8 ratio
• HIV-negative control (n= 20): age and sex matched

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Primary

  Serum SARS-CoV-2 Neutralization assay (plaque reduction microneutralization assay) will be compared between HIV-positive and negative groups.

  Week 24

Secondary Outcomes (10)

• Neutralization titers

  Baseline and Week 48

• IgG; RBD; NCP

  Weeks 0, 1, 2, 5, 6, 8, 24 and 48

• T cell

  Week 24 and Week 48

• Salivary IgA

  Week 5 and Week 24

• COVID-19 Infection

  Up to week 48

Study Arms (4)

People with HIV (PWH) Immune responders (n=35)

undetectable viral load for 1+ year, CD4 \>500/uL, CD4/CD8 ratio \>1 including individuals with a historical, low CD4 nadir

People with HIV (PWH) Immune non-responders (n= 10)

undetectable viral load, CD4 \<350/uL or CD4/CD8 ratio \<0.75 for 1+ year

People with HIV (PWH) Low-level viremics (n= 10)

low-level viremia (\<1,000 copies/mL) for 1+ year, any CD4, any CD4/CD8 ratio

HIV-negative control (n= 20)

age and sex matched

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People diagnosed with HIV (1+ year), 55 years of age or older, on antiretroviral therapy for 1+ year with good general health as per medical history and lab tests. HIV negative individuals, 55 years old or older with stable clinical status, without acute illnesses as per medical history and lab tests will also be recruited for control. Blood and saliva sampling at described timepoint prior to 1st dose of COVID-19 vaccination and after the second dose of the COVID-19 vaccination. Evaluations will be taken at screening, baseline and at 8 additional time points during the study. 75 participants will be followed over 48 weeks.

You may qualify if:

• Ability to provide signed written informed consent
• Documented HIV diagnosis for 1+ year
• Antiretroviral therapy for 1+ year
• years of age or older
• Good general health as shown by medical history and screening laboratory tests at the screening visit:
• Hemoglobin ≥ 85 g/L White blood cell (WBC) count = 3300 to 12,000 cells/mm3
• Total lymphocyte count ≥ 800 cells/mm3
• Platelets = 50,000 to 550,000/mm3
• Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase \< 5 times the institutional upper limit of normal (ULN); creatinine (Cr) ≤ institutional upper limit of normal; creatine phosphokinase (CPK) ≤ 2 times the institutional upper limit of normal not related to physical exertion
• Ability to provide signed written informed consent
• Negative HIV test at the screening visit
• years of age or older
• Stable clinical status and absence of acute illnesses as shown by medical history and screening laboratory tests at the screening visit:
• Hemoglobin ≥ 85 g/L White blood cell (WBC) count = 3300 to 12,000 cells/mm3
• Total lymphocyte count ≥ 800 cells/mm3

You may not qualify if:

• Participants who would have difficulty participating in a trial due to non-compliance
• Participants with a history of anaphylaxis reaction to the COVID-19 vaccine components
• Participants with any of the following abnormal laboratory results at the screening visit:
• Hemoglobin \< 85 g/L
• Lymphocyte count \< .750 X109/L
• Platelet count \< 50 X109/L or \> 550 X109/L
• AST or ALT \> 5X the upper limit of normal
• Creatinine \> 250 µmol/L
• Participant with a malignancy or undergoing chemotherapy
• Participant with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death
• Active infection with hepatitis virus (HAV, HBV, HCV) or tuberculosis
• Prior surgery or radiation therapy within 30 days of study screening or receipt of any other experimental compound within 30 days of signing informed consent
• Any concurrent condition requiring the continued use of immunoglobulin, antineoplastic agents, glucocorticoids (other than corticosteroid nasal spray for allergic rhinitis; topical or ophthalmic corticosteroids for acute, uncomplicated dermatitis or conjunctivitis; over the counter medications for acute, uncomplicated dermatitis for treatment period not longer than 14 days) or other immunomodulator medications (other than NSAIDS which will be allowed for any length of time)
• Receipt of any blood product within 3 months prior to screening
• Receipt of any vaccine within 1 month prior to screening

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Maple Leaf Medical Clinic

Toronto, Ontario, M5G 1K2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and Saliva

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mario Ostrowski, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 12, 2024
• Study Start: April 10, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 2, 2025

Record last verified: 2024-12

Locations

CA (1)