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

Hematologic Diseases Clinical Trial

— Hema-C19-Vax  

Official title:

Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05074706
• Other study ID #: Hema-C19-Vax
• Status: Completed
• Start date: June 9, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: January 2023
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

Biological:
• IgG antibodies to Sars-Cov-2
Samples will be collected between 30 and 60 days after second vaccine dose.
• QuantiFERON SARS-CoV-2 test
Samples will be collected within 9 months after completion of the vaccination series

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
University of Milano Bicocca	San Gerardo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine	Seroconversion is defined as a post-vaccination SARS-CoV-2 IgG antibody titer >33.8 Binding Anticorpal Unit (BAU)/ml.	Between 30 and 60 days after the administration of the second vaccine dose
Secondary	To compare the seroconversion rate in haematological patients versus healthy subjects.	Time adjusted rate of seroconversion after vaccination in hematological patient and healthy population.	Between 30 and 60 days after the administration of the second vaccine dose
Secondary	To correlate the rate of seroconversion in hematological patients to the specific haematological diseases.	Rate of seroconversion per type of haematological condition	Between 30 and 60 days after the administration of the second vaccine dose
Secondary	To correlate the rate of seroconversion to previous therapies	Rate of seroconversion per specific treatment.	Between 30 and 60 days after the administration of the second vaccine dose
Secondary	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.	Rate of patients with a positive RT-PCR-SARS-CoV-2 test in the 9 months after the administration of the second vaccine dose	Within 9 months after the administration of the second vaccine dose
Secondary	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	Rate of patients with a positive QuantiFERON-SARS-CoV-2 test after the demonstration of seroconversion failure until the end of the study	Within 9 months after the administration of the second vaccine dose