Clinical trial NCT05074706: Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study
Official title: Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Diseases
Keywords: serocoversion
COVID vaccination
cellular immunity
Sars-Cov-2 IgG antibodies
QuantiFERON-SARS-CoV-2 test
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: San Gerardo Hospital
First posted: 2021-10-12
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haematological patients followed at the Haematological Division, San Gerardo Hospital, Monza, Italy

Brief summary: The main objective of this study is to investigate the humoral immune response to COVID-19 vaccines in haematological patients, by testing SARS-CoV-2 seroconversion

Detailed description: This single-center prospective study will enroll approximately 700 hematologic patients who access to Haematological Division (San Gerardo Hospital, Monza, Italy) in order to perform their routine blood tests to monitor their hematological conditions. Evaluation of Sars-Cov-2 IgG specific antibodies will be performed on left-over biological material (serum or plasma) collected during routine blood tests run between 30 and 60 days after the administration of the second vaccine dose.

Furthermore, in each patient who has failed seroconversion (absence of specific antibodies for circulation), his cellular immune response will be assessed using an additional blood sample collected during routine blood tests.

These samples will be collected within 9 months of the completion of the vaccination series and will be used to evaluate the plasma INF-γ release using QuantiFERON SARS-CoV-2 test.

Eligibility criteria: Inclusion Criteria:

* Signed and dated EC-approved informed consent
* Hematological disease defined according to World Health Organization (WHO) criteria
* Female or male, 18 years of age or older
* ECOG performance status 0-3
* Willingness and ability to comply with routine clinical practice and study procedures
* Regular vaccination against SARS-CoV-2 according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021).
* Routine blood test planned between 30 and 60 days after administration of the second vaccine dose according to regular hematological follow up.
* Routine blood test planned no later than 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).

Exclusion Criteria:

* Preventive vaccination against SARS-CoV-2 not administered according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021)
* Evidence of previous infection with the SARS-Cov-2 virus.
* Routine blood test not planned between 30 and 60 days after administration of the second vaccine dose.
* Routine blood test not planned within 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).

Primary outcomes:
measure: Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine
timeFrame: Between 30 and 60 days after the administration of the second vaccine dose
Secondary outcomes:
measure: To compare the seroconversion rate in haematological patients versus healthy subjects.
timeFrame: Between 30 and 60 days after the administration of the second vaccine dose
measure: To correlate the rate of seroconversion in hematological patients to the specific haematological diseases.
timeFrame: Between 30 and 60 days after the administration of the second vaccine dose
measure: To correlate the rate of seroconversion to previous therapies
timeFrame: Between 30 and 60 days after the administration of the second vaccine dose
measure: To assess the efficacy of vaccine by estimating how many patients will be infected by SARS-CoV-2 in the 9 months after the administration of the second vaccine dose.
timeFrame: Within 9 months after the administration of the second vaccine dose
measure: To analize T-cell response in those patients who will result negative for specific antibodies anti-Sars-Cov-2 after two doses of mRNA SARS-Cov-2 vaccination
timeFrame: Within 9 months after the administration of the second vaccine dose
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
state: Lombardia
Study officials:
affiliation: San Gerardo Hospital
name: Carlo Gambacorti Passerini, Professor
role: STUDY_DIRECTOR
References: