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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

• Age\> 70 years.

• Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.

• Signed informed consent.

Locations
Other Locations
Italy
IRCCS Sacro Cuore Don Calabria hospital
RECRUITING
Negrar
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2025-11
Participants
Target number of participants: 350
Treatments
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: 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.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Sacro Cuore Don Calabria di Negrar

This content was sourced from clinicaltrials.gov