Maelstrom Research Staging | PWH_COVID19_Immune_non_responders

PWH_COVID19_Immune_non_responders_Visit8

Networks -

Variables -

Associated study PWH-COVID19 Contingency Table

Population

PWH-COVID19 - Immune non-responders

The population is composed of HIV positive individuals with undetectable viral load for 1+ year, CD4 cell count less than 350/uL, CD4/CD8 ratio less than 0.75 for 1+ year.

Selection Criteria

Minimum age

Newborns

Twins

Countries

Canada

Territory

Ethnic Origin

Health Status

Inclusion criteria: * Documented HIV diagnosis for 1+ year. Exlusion criteria: * Participant with a malignancy or undergoing chemotherapy. * Active infection with hepatitis virus (HAV, HBV, HCV) or tuberculosis. * 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). * 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.

Other Criteria

Inclusion criteria: * Antiretroviral therapy for 1+ year. Exclusion criteria: * 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 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. * 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. * 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).

Recruitment

Sources of recruitment

General population

General Population

Volunteer enrolment

Supplementary Information

With the progression of the enrolment, the study will recruit more people in the PWH Immune non-responders arms with appropriate procedures and feasibility

Number of Participants

Number of Participants: 20
Number of Participants with Biological Samples: 20

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Data Collection Event

PWH-COVID19 - Immune non-responders - Visit 8

Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample if the participant was hospitalized) that is positive for SARS-CoV-2 by reverse-transcriptase-polymerase-chain-reaction (RT-PCR) test. Immediate vaccine reactogenicity is assessed. Concomitant medication history and cART regimen are documented. Saliva and routine blood work in addition to viral load, CD4 count, CD4/CD8 ratio are also collected.

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Collected Dataset / PWH_COVID19_Immune_non_responders_Visit8

PWH_COVID19_Immune_non_responders_Visit8

Population

PWH-COVID19 - Immune non-responders

Data Collection Event

PWH-COVID19 - Immune non-responders - Visit 8

Files

Variables Classifications