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

Observational

Source

NL-OMON

Registry ID

NL-OMON52047

Enrollment

196

Registered

2021-03-10

Start date

2021-03-24

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

diseae of blood hematological disease lymph and bone marrow

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: all of the following criteria: * Currently treated, previously treated and non-treated patients diagnosed with the hematological malignancy multiple myeloma (including MGUS) chronic lymphocytic leukemia and non-Hodgkin lymphoma. Previously treated patient; is defined as: treatment

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
3.6.1 primary endpoints 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.	—

Secondary

Measure	Time frame
3.6.2 secondary endpoints * Titers of anti- SARS-CoV-2 S protein specific antibodies in AU/ml pre-vaccination and 1, 3 and 6 months post-vaccination. * Presence and percentage of SARS-CoV-2 S protein specific peptide-activated CD8 and CD4 cells pre-vaccination and 1 and 6 months post-vaccination. 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 SAE 50% within 24-48 hours. o Critically ill: Respiratory failure requiring mechanical ventilation, shock or patients combined with other organ failure in need of ICU monitoring or treatment	—

Measure

Time frame

3.6.2 secondary endpoints * Titers of anti- SARS-CoV-2 S protein specific antibodies in AU/ml pre-vaccination and 1, 3 and 6 months post-vaccination. * Presence and percentage of SARS-CoV-2 S protein specific peptide-activated CD8 and CD4 cells pre-vaccination and 1 and 6 months post-vaccination. 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 SAE 50% within 24-48 hours. o Critically ill: Respiratory failure requiring mechanical ventilation, shock or patients combined with other organ failure in need of ICU monitoring or treatment

—

Countries

Netherlands

Outcome results