Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.
- Conditions
- COVID-19
- Interventions
- Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses
- Registration Number
- NCT06300853
- Lead Sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elderly subjects Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses 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. Cancer patients Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses 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.
- Primary Outcome Measures
Name Time Method 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: 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). 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: 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: 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). a) A b) Analysis results of , c) Analysis results of
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). 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). 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 Outcome Measures
Name Time Method Whole genome sequencing analysis results At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1). 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).
Trial Locations
- Locations (1)
IRCCS Sacro Cuore Don Calabria hospital
🇮🇹Negrar, Verona, Italy