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

NCT05074706 | Completed

• 1 other identifier: Hema-C19-Vax
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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

Conditions

Hematologic Diseases

Keywords

serocoversion; COVID vaccination; cellular immunity; Sars-Cov-2 IgG antibodies; QuantiFERON-SARS-CoV-2 test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To compare the seroconversion rate in haematological patients versus healthy subjects.

  Between 30 and 60 days after the administration of the second vaccine dose

• 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

• To correlate the rate of seroconversion to previous therapies

  Between 30 and 60 days after the administration of the second vaccine dose

• 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

• 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

Interventions

IgG antibodies to Sars-Cov-2 BIOLOGICAL

Samples will be collected between 30 and 60 days after second vaccine dose.

Also known as: Blood serum SARS-CoV-2 IgG

QuantiFERON SARS-CoV-2 test BIOLOGICAL

Samples will be collected within 9 months after completion of the vaccination series

Also known as: Plasma INF-γ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Haematological patients followed at the Haematological Division, San Gerardo Hospital, Monza, Italy

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Milano Bicocca: lead
• San Gerardo Hospital: collaborator

Study Sites (1)

San Gerardo Hospital

Monza, Lombardy, 20900, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral Blood

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Carlo Gambacorti Passerini, Professor

  San Gerardo Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 12, 2021
• Study Start: June 9, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

IT (1)