SARS-CoV-2 vaccination response in patients with haematological disease

SARS-CoV-2 vaccination response in patients with haematological disease - CovVhaem

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001107-33-NL

Enrollment

196

Registered

2021-03-10

Start date

2021-03-10

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma chronic lymphocytic leukemia, non-Hodgkin lymphoma, MedDRA version: 21.1 Level: LLT Classification code 10066481 Term: Hematological malignancy System Organ Class: 100000004864

Interventions

Trade Name: Moderna Product Name: Moderna Pharmaceutical Form: Suspension for injection in pre-filled injector Trade Name: Comirnaty Product Name: Comirnaty Pharmaceutical Form: Suspension for injec

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: all of the following criteria: • Currently treated, previously treated and non-treated patients diagnosed with the hematological malignancy multiple myeloma, chronic lymphocytic leukemia, non-Hodgkin lymphoma. "Previously treated patient" is defined as: treatment =65 years) yes F.1.3.1 Number of subjects for this age range 160

Exclusion criteria

Exclusion criteria: excluded from participation in this study: • Patients previously vaccinated for SARS-CoV-2. • Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent. • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy in terms of Anti-SARS-COV-2 RBD antibody responses in patients diagnosed with and/or under treatment for a haematological disorder to SARS-CoV-2 vaccination?;Secondary Objective: 1. What is the efficacy of Anti-SARS-COV-2 vaccination 3. What is the cumulative incidence of severe COVID-19 after SARS-CoV- 2 vaccination? 4. Is there a correlation between cellular and humoral immune responses after vaccination. 5. Is the quality of immune responses induced by vaccination associated with the risk of symptomatic COVID-19? 6. Is there a relationship between pre-vaccination immune status on responses after vaccination? 7. Is there a relationship between hematological diagnosis and immune responses after SARS-CoV-2 vaccination? 8. Is there a relationship between recent or current treatment and quality responses after SARS-CoV-2 vaccination? 9. What time point after hematological treatment is best to receive SARS-CoV-2 vaccination? 10. What is the persistence of SARS-CoV-2 antibody and specific T cell responses after SARS-CoV-2 vaccination? 11. Safety of SARS-CoV-2 vaccination in haematological patients?;Primary end point(s): after vaccination (yes/no) of hematological patients that were seronegative for these antibodies before vaccination.;Timepoint(s) of evaluation of this end point: Presence of Anti-SARS-CoV-2 S-protein specific antibodies one month after vaccination (yes/no) of hematological patients that were seronegative for these antibodies before vaccination.	—

Measure

Time frame

Main Objective: To assess the efficacy in terms of Anti-SARS-COV-2 RBD antibody responses in patients diagnosed with and/or under treatment for a haematological disorder to SARS-CoV-2 vaccination?;Secondary Objective: 1. What is the efficacy of Anti-SARS-COV-2 vaccination 3. What is the cumulative incidence of severe COVID-19 after SARS-CoV- 2 vaccination? 4. Is there a correlation between cellular and humoral immune responses after vaccination. 5. Is the quality of immune responses induced by vaccination associated with the risk of symptomatic COVID-19? 6. Is there a relationship between pre-vaccination immune status on responses after vaccination? 7. Is there a relationship between hematological diagnosis and immune responses after SARS-CoV-2 vaccination? 8. Is there a relationship between recent or current treatment and quality responses after SARS-CoV-2 vaccination? 9. What time point after hematological treatment is best to receive SARS-CoV-2 vaccination? 10. What is the persistence of SARS-CoV-2 antibody and specific T cell responses after SARS-CoV-2 vaccination? 11. Safety of SARS-CoV-2 vaccination in haematological patients?;Primary end point(s): after vaccination (yes/no) of hematological patients that were seronegative for these antibodies before vaccination.;Timepoint(s) of evaluation of this end point: Presence of Anti-SARS-CoV-2 S-protein specific antibodies one month after vaccination (yes/no) of hematological patients that were seronegative for these antibodies before vaccination.

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Secondary

Measure	Time frame
Secondary end point(s): * Titers of anti- SARS-CoV-2 S protein specific antibodies in AU/ml prevaccination and 1, 3 and 6 months post-vaccination. • Presence and percentage of SARS-CoV-2 S protein specific peptideactivated CD8 and CD4 cells pre-vaccination and 1 and 6 months postvaccination. This will only be analyzed in a subpopulation of patients that did not develop any SARS-CoV-2 S specific antibodies. In addition, a disease and treatment matched control group that did show an antibody response will be tested for SARS-CoV-2 specific T cell responses. * Incident of severe COVID-19 infection within 12 months after vaccination, defined by hospitalization and/or death due to COVID-19 and positive SARS-CoV-2 PCR. Clinical severity will be scored according to the Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th edition) * SAE and SUSARS within 12 months after vaccination.;Timepoint(s) of evaluation of this end point: * Titers of anti- SARS-CoV-2 S protein specific antibodies in AU/ml prevaccination and 1, 3 and 6 months post-vaccination. • Presence and percentage of SARS-CoV-2 S protein specific peptideactivated CD8 and CD4 cells pre-vaccination and 1 and 6 months postvaccination. This will only be analyzed in a subpopulation of patients that did not develop any SARS-CoV-2 S specific antibodies. * Incident of severe COVID-19 infection within 12 months after vaccination, defined by hospitalization and/or death due to COVID-19 and positive SARS-CoV-2 PCR. Clinical severity will be scored according to the Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th edition). * SAE and SUSARS within 12 months after vaccination.	—

Measure

Time frame

Secondary end point(s): * Titers of anti- SARS-CoV-2 S protein specific antibodies in AU/ml prevaccination and 1, 3 and 6 months post-vaccination. • Presence and percentage of SARS-CoV-2 S protein specific peptideactivated CD8 and CD4 cells pre-vaccination and 1 and 6 months postvaccination. This will only be analyzed in a subpopulation of patients that did not develop any SARS-CoV-2 S specific antibodies. In addition, a disease and treatment matched control group that did show an antibody response will be tested for SARS-CoV-2 specific T cell responses. * Incident of severe COVID-19 infection within 12 months after vaccination, defined by hospitalization and/or death due to COVID-19 and positive SARS-CoV-2 PCR. Clinical severity will be scored according to the Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th edition) * SAE and SUSARS within 12 months after vaccination.;Timepoint(s) of evaluation of this end point: * Titers of anti- SARS-CoV-2 S protein specific antibodies in AU/ml prevaccination and 1, 3 and 6 months post-vaccination. • Presence and percentage of SARS-CoV-2 S protein specific peptideactivated CD8 and CD4 cells pre-vaccination and 1 and 6 months postvaccination. This will only be analyzed in a subpopulation of patients that did not develop any SARS-CoV-2 S specific antibodies. * Incident of severe COVID-19 infection within 12 months after vaccination, defined by hospitalization and/or death due to COVID-19 and positive SARS-CoV-2 PCR. Clinical severity will be scored according to the Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th edition). * SAE and SUSARS within 12 months after vaccination.

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Countries

Netherlands

Contacts

Public ContactCatharina Van elssen

MUMC

janine.van.elssen@mumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026