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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-12-01

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.

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Detailed Description

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Conditions

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SARS-CoV-2 RNA Vaccines HIV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

SARS-CoV-2 Vaccine

Intervention Type BIOLOGICAL

Analyse humoral and cellular response to SARS-CoV-2 Vaccine.

Immunological responder

Patients with \>350 CD4+ T cells

SARS-CoV-2 Vaccine

Intervention Type BIOLOGICAL

Analyse humoral and cellular response to SARS-CoV-2 Vaccine.

Interventions

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SARS-CoV-2 Vaccine

Analyse humoral and cellular response to SARS-CoV-2 Vaccine.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. HIV-infected subjects over 18 years old and ≤200 CD4/μl who have completed vaccination against SARS-CoV-2.
2. HIV-infected subjects with ≥350 CD4/μl who have completed vaccination against SARS-CoV-2 matched by age and sex as control group.
3. Sign the informed consent.

Exclusion Criteria

1. Neoplastic or autoimmune disease known.
2. Treatment with steroids, immunomodulators, interferon, chemotherapy or any pathology that may impact immunological parameters after vaccination against SARS-CoV-2.
3. Active infections at the time of sampling.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No