RIS-COV: Spike-specific Cellular Immune Response After COVID-19 Vaccination

• Sponsor: IRCCS San Raffaele Roma (Other)
• Overall Status: Completed
• CT.gov ID: NCT05102669
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

Aim of this study is to evaluate whether COVID-19 vaccination induces a persistent cellular immune response.

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.

Condition or Disease	Intervention/Treatment	Phase
COVID19; Vaccination; Immune Response	Other: analysis of immunological response; Diagnostic Test: analysis of serum antibodies

Detailed Description

After providing written informed consent, 28 vaccinated and 25 non vaccinated subjects were included in the study. All subjects were enrolled among healthcare workers in the Research Centre of IRCCS San Raffaele Roma in Rome.

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 53 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Spike-specific Cellular Immune Response After COVID-19 Vaccination
• Actual Study Start Date: Mar 12, 2021
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Oct 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
vaccinated COVID19 vaccinated subjects	Other: analysis of immunological response; collection and analysis of SARS-CoV2 Spike specific blood cells; Diagnostic Test: analysis of serum antibodies; analysis of anti-SARS-CoV2 Spike specific antibodies
non vaccinated COVID19 non vaccinated subjects	Other: analysis of immunological response; collection and analysis of SARS-CoV2 Spike specific blood cells

Outcome Measures

Primary Outcome Measures

1. measurement of cellular response [7 months]

   evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• vaccinated and non vaccinated subjects

• subjects that never tested positive for COVID19

Exclusion Criteria:

• subjects that tested positive for COVID-19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS San Raffaele Roma	Roma		Italy	00163

Sponsors and Collaborators

• IRCCS San Raffaele Roma

Investigators

• Principal Investigator: Laura Vitiello, PhD, IRCCS San Raffaele Roma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Vitiello, PhD, Principal Investigator, IRCCS San Raffaele Roma
• ClinicalTrials.gov Identifier: NCT05102669
• Other Study ID Numbers: RIS-COV
• First Posted: Nov 1, 2021
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Antibodies

Study Results

No Results Posted as of Nov 10, 2021