HIV Infection Clinical Trial
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
| Verified date | December 2022 |
| Source | Hospitales Universitarios Virgen del Rocío |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 48 |
| Est. completion date | December 1, 2022 |
| Est. primary completion date | March 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Virgen del Rocio University Hospital | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| Hospitales Universitarios Virgen del Rocío |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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