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Sponsor: University of Toronto
Conditions: HIV Infections
Countries: Canada
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
Sex: ALL
Age: 55 Years to —
Healthy volunteers: Yes
Study type: OBSERVATIONAL
Inclusion Criteria:
* Participants will fall into any of the HIV-positive arms or the HIV-negative control arm. Inclusion criteria for HIV-positive participants are:
* Ability to provide signed written informed consent
* Documented HIV diagnosis for 1+ year
* Antiretroviral therapy for 1+ year
* 55 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
Inclusion criteria for HIV-negative participants are:
* Ability to provide signed written informed consent
* Negative HIV test at the screening visit
* 55 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
* 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
Exclusion Criteria:
* There will be no exclusion criteria based on gender/gender identity, ethnoracial composition, language, socioeconomic status, mode of HIV acquisition or sexual orientation/identity. Any participant who requires language interpretation can and will be accommodated for by the participation of translators, either at the patient's choice and/or with the assistance of the translator services provided by local ASO organizations. Exclusion criteria include the following:
* 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
* Active drug or alcohol use/dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
* Any illness or conditions including acute illnesses that, in the opinion of the investigator, may affect the safety of the participant or the evaluation of any study endpoints
* Any other conditions judged by the investigator that would limit the evaluation of a participant
* Positivity for sexually transmitted infections at the screening visit
* Use of any unproven registered and unregistered treatments for COVID-19; Administration of immunoglobulins and/ or any blood products within the three months preceding the planned administration of the vaccine candidate
* Any confirmed or suspected immunosuppressive or immunodeficient state (except HIV infection for Group-3), asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed)
* For HIV-negative participants: immune-compromising conditions or on medication which suppresses the immune response.- Toronto, Ontario, Canada