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

COVID-19 Clinical Trial

— COVaxFragile  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300853
• Other study ID #: 2023-07
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	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).
Secondary	Whole genome sequencing analysis results		At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).