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

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Enrolling

Conditions: COVID-19

Treatments: Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses

Study type: Interventional

Funder types: Other

Identifiers

NCT06300853

2023-07

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Cancer patients

Other group

Description:

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.

Treatment:

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

Elderly subjects

Other group

Description:

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.

Treatment:

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