Spike-specific Cellular Immune Response After COVID-19 Vaccination
NCT ID: NCT05102669
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
53 participants
OBSERVATIONAL
2021-03-12
2021-10-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group.
Cells isolated from blood samples are tested in vitro to assess the percentage of spike-specific T and B lymphocytes 1 and 7 months after a second dose of Comirnaty vaccine.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Security Efficacy COVID-19 Vaccination
NCT05743361
Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics
NCT04870411
Evaluation of Prevalence and Risk Factors of Persistent COVID-19 in Immunocompromised Patients
NCT06576102
Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People
NCT04844489
Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients
NCT05286242
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All the subjects declared that they never tested positive for COVID19. Blood and serum samples were drowned twice from vaccinated subjects: 1 and 7 months after a second dose of vaccine to evaluate T and B response to vaccine; blood was drowned once in not vaccinated subjects.
Cells were collected form peripheral blood samples, while anti-S1 IgG titre was assessed in serum.
Flow-cytometry was used to assess the percentage of circulating spike-specific T and B lymphocytes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
vaccinated
COVID19 vaccinated subjects
analysis of immunological response
collection and analysis of SARS-CoV2 Spike specific blood cells
analysis of serum antibodies
analysis of anti-SARS-CoV2 Spike specific antibodies
non vaccinated
COVID19 non vaccinated subjects
analysis of immunological response
collection and analysis of SARS-CoV2 Spike specific blood cells
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
analysis of immunological response
collection and analysis of SARS-CoV2 Spike specific blood cells
analysis of serum antibodies
analysis of anti-SARS-CoV2 Spike specific antibodies
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* subjects that never tested positive for COVID19
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS San Raffaele Roma
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura Vitiello, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Roma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS San Raffaele Roma
Roma, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RP 20/09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.