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

NCT07049497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2025-07-14

No results posted yet for this study

Summary

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.

Conditions

  • SAR-CoV-2
  • Cellular Immune Response
  • Antibody Response

Interventions

OTHER

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)

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Patrizia Rovere Querini, PhD, MD · IRCCS Ospedale San Raffaele

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2022-07-20
Completion
2024-05-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07049497 on ClinicalTrials.gov