Humoral and Cellular Immunity Against SARS-COV-2 Vaccine in HIV-infected Patients Immunosuppressed
Study Details
Study Description
Brief Summary
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:
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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).
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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:
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Quantification of specific IgG titers against SARS-CoV-2
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The association of the T response to SARS-CoV-2 with humoral response parameters.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Non-immunological responder 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
Analyse humoral and cellular response to SARS-CoV-2 Vaccine.
|
| Immunological responder Patients with >350 CD4+ T cells |
Biological: SARS-CoV-2 Vaccine
Analyse humoral and cellular response to SARS-CoV-2 Vaccine.
|
Outcome Measures
Primary Outcome Measures
- Antibodies [24 months]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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HIV-infected subjects over 18 years old and ≤200 CD4/μl who have completed vaccination against SARS-CoV-2.
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HIV-infected subjects with ≥350 CD4/μl who have completed vaccination against SARS-CoV-2 matched by age and sex as control group.
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Sign the informed consent.
Exclusion Criteria:
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Neoplastic or autoimmune disease known.
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Treatment with steroids, immunomodulators, interferon, chemotherapy or any pathology that may impact immunological parameters after vaccination against SARS-CoV-2.
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Active infections at the time of sampling.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virgen del Rocio University Hospital | Sevilla | Spain | 41013 |
Sponsors and Collaborators
- Hospitales Universitarios Virgen del Rocío
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CoVa-VIH-2021