Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups. (COVaxFragile)

March 7, 2024 updated by: IRCCS Sacro Cuore Don Calabria di Negrar

Understanding Adaptive Immune Response Elicited After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.

This is an experimental study without drug and device, non-profit, single-center.

The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. This study will be relevant to frail populations who are the main targets of repeated vaccinations. Our project will benefit from the availability of a highly cohort characterized of vaccinated people, including cancer patients and elderly people, with prospective collection of samples for an in-depth evaluation of the evolution of the immune response with repeated exposure to doses of infection or vaccine. As part of the study, analyzes will be carried out on samples of patients enrolled in a manner prospective at the oncology departments of the IRCCS (Medical Oncology, Department of Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing in retirement homes of the IRCCS. Patients will also be asked for consent to store any residual samples in the Tropica DITM Biobank.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Recruiting
        • IRCCS Sacro Cuore Don Calabria hospital
        • Contact:
        • Principal Investigator:
          • Chiara Piubelli
        • Sub-Investigator:
          • Stefania Gori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Cancer patients

Inclusion criteria:

  • Age> 18 years.
  • Solid tumor diagnosis [I, II, III, IV stage,].
  • Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.
  • Signed informed consent.

Exclusion criteria

  • Age < 18 years.
  • Absence of signed informed consent.

Elderly subjects

Inclusion criteria:

  • Age> 70 years.
  • Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.
  • Signed informed consent.

Exclusion criteria

  • Age < 70 years.
  • Absence of signed informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cancer patients
Adult patients with a solid tumor diagnosis [I, II, III, IV stage,] and active anti-cancer treatment or treatment discontinued for less than 6 months, followed at IRCCS Sacro Cuore - Don Calabria, Negrar (Verona), Italy will be prospectively recruited at the moment of the future booster doses administration of SARS-CoV-2 vaccine.
Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses

Whole blood and serum samples will be longitudinally collected at the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1). Possible further time points will be collected within 2 years, based on the National recommended future vaccination regimens.

Biological samples will be used for the following exams:

  • Cellular immunity characterization

    • T- and B-cells Immunophenotype.
    • Specific T-cell response.
    • In vitro specific B-cells characterization.
    • Antibody-dependent cellular cytotoxicity.

  • Humoral response characterization

    • Serology assays.
    • Avidity assay.
    • Neutralization assays with different SARS-CoV-2 variants.
    • Presence of specific or cross-reactive antibodies for common hCoV.
  • Genetic and epigenetic analysis
Other: Elderly subjects
Subjects over 70 years of age who live in the nursing home in the social area at the IRCCS Sacro Cuore - Don Calabria Hospital will be prospectively recruited at the moment of the future booster doses administration of SARS-CoV-2 vaccine.
Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses

Whole blood and serum samples will be longitudinally collected at the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1). Possible further time points will be collected within 2 years, based on the National recommended future vaccination regimens.

Biological samples will be used for the following exams:

  • Cellular immunity characterization

    • T- and B-cells Immunophenotype.
    • Specific T-cell response.
    • In vitro specific B-cells characterization.
    • Antibody-dependent cellular cytotoxicity.

  • Humoral response characterization

    • Serology assays.
    • Avidity assay.
    • Neutralization assays with different SARS-CoV-2 variants.
    • Presence of specific or cross-reactive antibodies for common hCoV.
  • Genetic and epigenetic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellular response evaluation: flow cytometry profiles (proportions of cells)
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD)
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD)
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml)
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml)
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml)
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
a) A b) Analysis results of , c) Analysis results of
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml)
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).

Secondary Outcome Measures

Outcome Measure
Time Frame
Neutralization assays against different human Coronavirus (hCoV).
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Whole genome sequencing analysis results
Time Frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe