Clinical trial NCT06300853: Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.
Official title: Understanding Adaptive Immune Response Elicited After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Cellular response evaluation: flow cytometry profiles (proportions of cells)
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD)
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD)
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml)
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml)
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml)
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml)
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Secondary outcomes:
measure: Neutralization assays against different human Coronavirus (hCoV).
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
measure: Whole genome sequencing analysis results
timeFrame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References: