Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05633927
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2022-11-21
Brief Title:
Humoral and Cellular Immunity Against SARS-COV-2 Vaccine in HIV-infected Patients Immunosuppressed
Sponsor:
Hospitales Universitarios Virgen del Rocío
Organization:
Hospitales Universitarios Virgen del Rocío
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CD4μl experimental group n46 and 350 CD4μl as control group n46 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 CD4μL 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 CD4μL 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 CD4μl 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 CD57CD28- 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
A total of 92 HIV-infected subjects over 18 years old with 200 CD4μl experimental group n46 and 350 CD4μl as control group n46 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 CD4μL 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 CD4μL 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 CD4μl 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 CD57CD28- 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None