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

NCT06300853 | Recruiting

• 1 other identifier: 2023-07
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (9)

• Cellular response evaluation: flow cytometry profiles (proportions of cells)

  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)

  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)

  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)

  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)

  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).

  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)

  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)

  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).

  At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).

Secondary Outcomes (2)

• Neutralization assays against different human Coronavirus (hCoV).

  At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).

• Whole genome sequencing analysis results

  At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).

Study Arms (2)

Cancer patients

OTHER

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

Elderly subjects

OTHER

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

Interventions

Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses OTHER

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

Cancer patients; Elderly subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years.
• Absence of signed informed consent.
• Elderly subjects
• Age\> 70 years.
• Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.
• Signed informed consent.
• Age \< 70 years.
• Absence of signed informed consent.

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, 37024, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 8, 2024
• Study Start: November 14, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

IT (1)