Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study

Completed

• Conditions: Hematologic Diseases

• Registration Number: NCT05074706
• Lead Sponsor: University of Milano Bicocca

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.

Study Timeline

• Study Start: 2021-06-09
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-12
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine	Between 30 and 60 days after the administration of the second vaccine dose	Seroconversion is defined as a post-vaccination SARS-CoV-2 IgG antibody titer \>33.8 Binding Anticorpal Unit (BAU)/ml.

Secondary Outcome Measures

Name	Time	Method
To compare the seroconversion rate in haematological patients versus healthy subjects.	Between 30 and 60 days after the administration of the second vaccine dose	Time adjusted rate of seroconversion after vaccination in hematological patient and healthy population.
To correlate the rate of seroconversion in hematological patients to the specific haematological diseases.	Between 30 and 60 days after the administration of the second vaccine dose	Rate of seroconversion per type of haematological condition
To correlate the rate of seroconversion to previous therapies	Between 30 and 60 days after the administration of the second vaccine dose	Rate of seroconversion per specific treatment.
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.	Within 9 months after the administration of the second vaccine dose	Rate of patients with a positive RT-PCR-SARS-CoV-2 test in the 9 months after the administration of the second vaccine dose
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	Within 9 months after the administration of the second vaccine dose	Rate of patients with a positive QuantiFERON-SARS-CoV-2 test after the demonstration of seroconversion failure until the end of the study

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, Lombardia, Italy