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

NCT05633927 | Completed

• 1 other identifier: CoVa-VIH-2021
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 RNA Vaccines; HIV Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Immunological responder

Patients with \>350 CD4+ T cells

Biological: SARS-CoV-2 Vaccine

Interventions

SARS-CoV-2 Vaccine BIOLOGICAL

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

Immunological responder; Non-immunological responder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study was designed as a cohort study comparing the immune response after vaccination of HIV-infected subjects with the hypothesis that subjects with ≤200 CD4/μL will have a worse response than those with CD4 count ≥ 350/μL.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (1)

Virgen del Rocio University Hospital

Seville, 41013, Spain

Location

Related Publications (1)

• Lopez-Cortes LF, Saborido-Alconchel A, Trujillo-Rodriguez M, Serna-Gallego A, Llaves-Flores S, Munoz-Muela E, Perez-Santos MJ, Lozano C, Mejias-Trueba M, Roca C, Espinosa N, Gutierrez-Valencia A. Humoral and cellular immunity to SARS-COV-2 after vaccination with mRNA vaccines in PLWH with discordant immune response. Influence of the vaccine administered. Front Immunol. 2023 Mar 15;14:1129753. doi: 10.3389/fimmu.2023.1129753. eCollection 2023.

  PMID: 37006309 RESULT

Related Links

• Related Info
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MeSH Terms

Conditions

HIV Infections

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: April 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: December 1, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)