Study of Immune Response in Subjects Vaccinated Against SARS-CoV-2 Infection

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

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-28

Study Completion Date

2024-05-15

Brief Summary

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Twelve months after the first SARS-CoV-2 cases in Wuhan, the FDA approved the first COVID-19 vaccine (Pfizer-BioNTech). Early studies on healthcare workers showed that antibody levels, especially against the Spike protein, declined within six months, particularly in those without prior infection. However, previously infected individuals had stronger and longer-lasting responses. The vaccine induces a Th1-type T cell response, linked to milder disease, and activates follicular helper T cells and B cell responses, although antibody levels drop over time. Immune responses also differ by sex, with females showing stronger humoral responses. Key priorities include understanding humoral fluctuations, characterizing cellular immunity, and correlating both responses.

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Detailed Description

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Conditions

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SAR-CoV-2 Cellular Immune Response Antibody Response

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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107 healthcare workers who completed the vaccination cycle for SARS-CoV-2

T cell response in terms of IFN-γ measured by ELISpot

Evaluation of the T cell response in terms of IFN-γ measured by ELISpot

Intervention Type OTHER

The evaluation of the T cell response will be performed by quantifying the frequencies of SARS-CoV-2-specific T cells producing IFN-γ using an enzyme-linked immunospot assay (ELISpot), with cryopreserved PBMC collected at the designated timepoints (T0, T1, T2, T3, and T4)

20 healthy donors who didn't receive SARS-CoV-2 vaccination

T cell response in terms of IFN-γ measured by ELISpot

Evaluation of the T cell response in terms of IFN-γ measured by ELISpot

Intervention Type OTHER

The evaluation of the T cell response will be performed by quantifying the frequencies of SARS-CoV-2-specific T cells producing IFN-γ using an enzyme-linked immunospot assay (ELISpot), with cryopreserved PBMC collected at the designated timepoints (T0, T1, T2, T3, and T4)

Interventions

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Evaluation of the T cell response in terms of IFN-γ measured by ELISpot

The evaluation of the T cell response will be performed by quantifying the frequencies of SARS-CoV-2-specific T cells producing IFN-γ using an enzyme-linked immunospot assay (ELISpot), with cryopreserved PBMC collected at the designated timepoints (T0, T1, T2, T3, and T4)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and/or female sex

Age ≥18 years

Completion of the SARS-CoV-2 vaccination cycle with the Pfizer-BioNTech vaccine

Informed consent for the storage of biological material at the San Raffaele Hospital Biological Resource Center (with protocol related to the BioVAC study approved by the Ethics Committee: 17/INT/2022)

Availability of at least two aliquots of PBMC collected at the completion of the vaccination cycle and frozen at the CRB

\- consent for sample collection and storage in the Biobank between 2016 and 2018