Hema-C19-Vax: Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study

Sponsor
University of Milano Bicocca (Other)
Overall Status
Recruiting
CT.gov ID
NCT05074706
Collaborator
San Gerardo Hospital (Other)
700
1
11.7
59.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: IgG antibodies to Sars-Cov-2
  • Biological: QuantiFERON SARS-CoV-2 test

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 Design

Study Type:
Observational
Anticipated Enrollment :
700 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study
Actual Study Start Date :
Jun 9, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Gerardo Hospital Monza Lombardia Italy 20900

Sponsors and Collaborators

  • University of Milano Bicocca
  • San Gerardo Hospital

Investigators

  • Study Director: Carlo Gambacorti Passerini, Professor, San Gerardo Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT05074706
Other Study ID Numbers:
  • Hema-C19-Vax
First Posted:
Oct 12, 2021
Last Update Posted:
May 4, 2022
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Milano Bicocca
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2022