Hematologic DiseasesHema-C19-VaxNCT05074706
Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study
An observational study of Hematologic Diseases, run by University of Milano Bicocca at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- IgG antibodies to Sars-Cov-2 and QuantiFERON SARS-CoV-2 test
- Type of treatment
- Vaccines
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jun 2021to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Haematological patients followed at the Haematological Division, San Gerardo Hospital, Monza, Italy
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study
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
Read the 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.
- Conditions
- Hematologic Diseases
- Being tested
- IgG antibodies to Sars-Cov-2, QuantiFERON SARS-CoV-2 test
- Keywords
- serocoversion, COVID vaccination, cellular immunity, Sars-Cov-2 IgG antibodies, QuantiFERON-SARS-CoV-2 test
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG antibodies to Sars-Cov-2Biological
Also called Blood serum SARS-CoV-2 IgG
Samples will be collected between 30 and 60 days after second vaccine dose.
QuantiFERON SARS-CoV-2 testBiological
Also called Plasma INF-γ
Samples will be collected within 9 months after completion of the vaccination series
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Time adjusted rate of seroconversion after vaccination in hematological patient and healthy population.
Measured: 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.
Rate of seroconversion per type of haematological condition
Measured: Between 30 and 60 days after the administration of the second vaccine dose
To correlate the rate of seroconversion to previous therapies
Rate of seroconversion per specific treatment.
Measured: 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.
Rate of patients with a positive RT-PCR-SARS-CoV-2 test in the 9 months after the administration of the second vaccine dose
Measured: 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
Rate of patients with a positive QuantiFERON-SARS-CoV-2 test after the demonstration of seroconversion failure until the end of the study
Measured: Within 9 months after the administration of the second vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start9 Jun 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- San Gerardo Hospital
- Responsible party
- Sponsor
- Investigators
- Carlo Gambacorti Passerini, Professor, Study director, San Gerardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074706
- Sponsor's protocol ID
- Hema-C19-Vax
- Acronym
- Hema-C19-Vax
- Status last verified
- Jan 2023
- First submitted
- 5 Oct 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study
- ClinicalTrials.gov ID
- NCT05074706
- Acronym / sponsor ID
- Hema-C19-Vax / Hema-C19-Vax
- Conditions
- Hematologic Diseases
- Keywords
- serocoversion, COVID vaccination, cellular immunity, Sars-Cov-2 IgG antibodies, QuantiFERON-SARS-CoV-2 test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- San Gerardo Hospital
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Haematological patients followed at the Haematological Division, San Gerardo Hospital, Monza, Italy
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgG antibodies to Sars-Cov-2Also: Blood serum SARS-CoV-2 IgGSamples will be collected between 30 and 60 days after second vaccine dose. | Biological | – |
| QuantiFERON SARS-CoV-2 testAlso: Plasma INF-γSamples will be collected within 9 months after completion of the vaccination series | Biological | – |
Primary outcome
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.
5 secondary outcomes
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
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
To correlate the rate of seroconversion to previous therapies
Time frame: 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.
Time frame: 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
Time frame: Within 9 months after the administration of the second vaccine dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Gambacorti Passerini, Professor study director
San Gerardo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Diseases, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.