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Evaluation of the Immune Response to Sars-Cov-2 Vaccines in Haematological Patients: Prospective Single Center Study (Hema-C19-Vax)

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ClinicalTrials.gov Identifier: NCT05074706
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : October 12, 2021
Sponsor:
Collaborator:
San Gerardo Hospital
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Hematologic Diseases 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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Immune Response to Sars-Cov-2 Vaccines in Haematological Patients: Prospective Single Center Study
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders


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


Primary Outcome Measures :
  1. Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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


Biospecimen Retention:   Samples Without DNA
Peripheral Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Haematological patients followed at the Haematological Division, San Gerardo Hospital, Monza, Italy
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074706


Contacts
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Contact: Elisa Bossi, MD +39 0392339394 carlo.gambacorti@unimib.it
Contact: Andrea Aroldi, M.Sc +39 039 2333435 andrea.aroldi@gmail.com

Locations
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Italy
San Gerardo Hospital Recruiting
Monza, Lombardia, Italy, 20900
Contact: Carlo Gambacorti Passerini, Professor    +39 0392339553    carlo.gambacorti@unimib.it   
Contact: Daniela Ciulla, M.Sc    +39 0392333435    d.ciulla.hsg@gmail.com   
Sponsors and Collaborators
University of Milano Bicocca
San Gerardo Hospital
Investigators
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Study Director: Carlo Gambacorti Passerini, Professor San Gerardo Hospital
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT05074706    
Other Study ID Numbers: Hema-C19-Vax
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021

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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:
serocoversion
COVID vaccination
cellular immunity
Sars-Cov-2 IgG antibodies
QuantiFERON-SARS-CoV-2 test
Additional relevant MeSH terms:
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COVID-19
Hematologic Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs