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

Completed

• Conditions: SARS-CoV-2 RNA Vaccines; HIV Infection
• Interventions: Biological: SARS-CoV-2 Vaccine

• Registration Number: NCT05633927
• Lead Sponsor: Hospitales Universitarios Virgen del Rocío

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:

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2022-03-31
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study Completion: 2022-12-01
• Study First Posted: 2022-12-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-immunological responder	SARS-CoV-2 Vaccine	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.
Immunological responder	SARS-CoV-2 Vaccine	Patients with \>350 CD4+ T cells

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Virgen del Rocio University Hospital; 🇪🇸 Sevilla, Spain