Humoral and Cellular Immunity Against SARS-COV-2 Vaccine in HIV-infected Patients Immunosuppressed

Study Overview
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Brief Summary
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Prospective, non-equality, cohort study, where investigators propose to analyze humoral and cellular immunity after two doses of SARS-CoV-2 RNA vaccines in HIV-infected participants severely immunosuppressed. A total of 92 HIV-infected subjects over 18 years old with ≤200 CD4/μl (experimental group; n=46) and ≥ 350 CD4/μl (as control group; n=46) who have completed two doses vaccination against SARS-CoV-2 will be included in the study. Primary Objectives: To analyze the percentage of participants with SARS-CoV-2-specific IgG after 1, 6, and 12 months after vaccination in subjects with ≤200 vs ≥350 CD4/μL by electrochemiluminescence immunoassay (Elecsys® Anti-SARS-CoV-2. Roche Diagnostics). To analyze the percentage of subjects with specific T and memory B lymphocyte response against SARS-CoV-2 after 1, 6, and 12 months after vaccination with <200 vs ≥350 CD4/μL. Multiparametric flow cytometry in peripheral blood mononuclear cells (PBMCs) will be performed to detect the production of cytokines (IL-2, TNF-α and IFN-γ), cytolytic (perforin and granzyme B) and degranulation (CD107a) molecules from T cells, as well as to identify memory B cells specific to SARS-CoV-2 IgG+. Secondary Objectives: To analyze in participants with <200 vs ≥350 CD4/μl after 1, 6, and 12 months after vaccination: Quantification of specific IgG titers against SARS-CoV-2 The association of the T response to SARS-CoV-2 with humoral response parameters. The association of the T response against SARS-CoV-2 with other parameters of immune activation, inflammation and immunosenescence. The phenotypes of maturation (CD45RA and CD27), activation (HLA-DR and CD38), senescence (CD57+CD28-) and markers of immune exhaustion (TIGIT, LAG-3, TIM-3 and PD-1) in CD4 and CD8 lymphocytes T will be determined by multiparametric flow cytometry.

Official Title
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Prospective Study to Evaluate the Persistence and Characteristics of Humoral and Cellular Immunity Against SARS-COV-2 After Vaccination in HIV-infected Patients Severely Immunosuppressed

Conditions
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SARS-CoV-2 RNA Vaccines, HIV Infection

Intervention / Treatment
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* Biological: SARS-CoV-2 Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected subjects over 18 years old and ≤200 CD4/μl who have completed vaccination against SARS-CoV-2. HIV-infected subjects with ≥350 CD4/μl who have completed vaccination against SARS-CoV-2 matched by age and sex as control group. Sign the informed consent. Exclusion Criteria: Neoplastic or autoimmune disease known. Treatment with steroids, immunomodulators, interferon, chemotherapy or any pathology that may impact immunological parameters after vaccination against SARS-CoV-2. Active infections at the time of sampling.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-immunological responder<br>Patients who start ART with <350 CD4+ T cells, maintaining undetectable viral load, and increasing <200 CD4+ T cell count after 18 months of follow-up. | Biological: SARS-CoV-2 Vaccine<br>* Analyse humoral and cellular response to SARS-CoV-2 Vaccine.<br>|
| Immunological responder<br>Patients with >350 CD4+ T cells | Biological: SARS-CoV-2 Vaccine<br>* Analyse humoral and cellular response to SARS-CoV-2 Vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibodies | Analyse the percentage of subjects with SARS-CoV-2-specific IgG after 1, 6, and 12 months after complete vaccination regimen in HIV-infected subjects and ≤200 vs ≥350 CD4/μL. And to analyse the percentage of subjects with specific T and memory B lymphocyte response against SARS-CoV-2 | 24 months |