Measurement of immune response to vaccination against COVID19 of immunocompromised leukemic patients

Significance of T cell response to vaccination against SARS-CoV2 for leukemic patients with weakend immune system - UHKT-COVID19

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000302-10-CZ

Enrollment

Registered

2022-01-25

Start date

2022-01-24

Completion date

Unknown

Last updated

2024-09-02

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

Conditions

Recipients of cell therapy (allo HSCT, CAR19 T cells) indicated to vaccination against COVID19

Interventions

Trade Name: Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Pharmaceutical Form: Concentrate and solvent for solution for injection Trade Name: Spikevax

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult recipients of cell therapy (allo-HSCT, CAR19 T cells) indicated to vaccination against COVID19. 30 patients, 20 healthy volunteers vaccinated against COVID19. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Uncompleted vaccination schedule.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): From data measured according main goal we will be able to evaluate vaccination efficacy, obtain information for selection of proper diagnostic assays for measurement of virus specific immune response to vaccination, to characterize T cell response of patients to vaccination in comparison with healthy subjects, and to compare response to vaccination of patients with various types of cell therapy. Measurement of baseline immune status by number of blood cells and total IGRA test will allow to determine the state of immune system of the patient, and evaluate its impact on vaccination efficacy and frequency of eventual side effects. Monitoring of complications of allo-HSCT such as acute and chronic GVHD, relaps, graft dysfunction and infectious complications in connection to vaccination will help to evaluate safety of vaccination.;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated using complete data gained during the entire study period at the end 2023.	—

Measure

Time frame

Secondary end point(s): From data measured according main goal we will be able to evaluate vaccination efficacy, obtain information for selection of proper diagnostic assays for measurement of virus specific immune response to vaccination, to characterize T cell response of patients to vaccination in comparison with healthy subjects, and to compare response to vaccination of patients with various types of cell therapy. Measurement of baseline immune status by number of blood cells and total IGRA test will allow to determine the state of immune system of the patient, and evaluate its impact on vaccination efficacy and frequency of eventual side effects. Monitoring of complications of allo-HSCT such as acute and chronic GVHD, relaps, graft dysfunction and infectious complications in connection to vaccination will help to evaluate safety of vaccination.;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated using complete data gained during the entire study period at the end 2023.

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Primary

Measure	Time frame
Main Objective: In this trial we aim to measure the humoral and immune response after vaccination with one of 2 types of COVID-19 vaccines, recently approved by the EMA for use in the European Union: the Comirnaty BNT162b2 mRNA COVID-19 vaccine from BioNTec/Pfizer and the Spikevax previous SARS-CoV-2 mRNA-1273 vaccine from Moderna. This in adult recipients of cell therapy (allo HSCT, CAR19 T cells) indicated to vaccination against COVID19, in comparison with healthy volunteers. Blood samples 18 ml will be taken during standart blood sampling. In the healthy volunteers blood will be drawn. Exact timing of blood draws will be point zero (time of indication to vaccination) and +1 month and 3 months after second dose administration and 1 month after third booster dose administration. Subjects will be patients of Institute of hematology and blood transfusion. ;Secondary Objective: Secondary aims are 1) Selection of proper diagnostic assays for measurement of virus specific immune response to vaccination, 2) Characterization of T cell response of patients to vaccination and comparison with healthy subjects, 3) Comparison of response to vaccination of patients with various types of cell therapy, 4) Monitoring of the state of immune system of the patient, and evaluation its impact on vaccination efficacy and frequency of eventual side effects.;Primary end point(s): Measurement of anti-S and anti-NC IgG by ELISA and AEC2 binding assay (EUROIMMUNE). Measurement of interferon gamma and IL2 producing cellls by dual ELISPOT, and AIM test by flow cytometry. Measurement of baseline immune status by number of blood cells and total IGRA test. Monitoring of complications of allo-HSCT such as acute and chronic GVHD, relaps, graft dysfunction and infectious complications in connection to vaccination ;Timepoint(s) of evaluation of this end point: Vaccination efficacy and detection of baseline immune status at timing of blood draws: point zero (time of indication to vaccination) and	—

Measure

Time frame

Main Objective: In this trial we aim to measure the humoral and immune response after vaccination with one of 2 types of COVID-19 vaccines, recently approved by the EMA for use in the European Union: the Comirnaty BNT162b2 mRNA COVID-19 vaccine from BioNTec/Pfizer and the Spikevax previous SARS-CoV-2 mRNA-1273 vaccine from Moderna. This in adult recipients of cell therapy (allo HSCT, CAR19 T cells) indicated to vaccination against COVID19, in comparison with healthy volunteers. Blood samples 18 ml will be taken during standart blood sampling. In the healthy volunteers blood will be drawn. Exact timing of blood draws will be point zero (time of indication to vaccination) and +1 month and 3 months after second dose administration and 1 month after third booster dose administration. Subjects will be patients of Institute of hematology and blood transfusion. ;Secondary Objective: Secondary aims are 1) Selection of proper diagnostic assays for measurement of virus specific immune response to vaccination, 2) Characterization of T cell response of patients to vaccination and comparison with healthy subjects, 3) Comparison of response to vaccination of patients with various types of cell therapy, 4) Monitoring of the state of immune system of the patient, and evaluation its impact on vaccination efficacy and frequency of eventual side effects.;Primary end point(s): Measurement of anti-S and anti-NC IgG by ELISA and AEC2 binding assay (EUROIMMUNE). Measurement of interferon gamma and IL2 producing cellls by dual ELISPOT, and AIM test by flow cytometry. Measurement of baseline immune status by number of blood cells and total IGRA test. Monitoring of complications of allo-HSCT such as acute and chronic GVHD, relaps, graft dysfunction and infectious complications in connection to vaccination ;Timepoint(s) of evaluation of this end point: Vaccination efficacy and detection of baseline immune status at timing of blood draws: point zero (time of indication to vaccination) and

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Countries

Czech Republic

Contacts

Public ContactAcademical clinical trials center

Institute of hematology and blood transfusion

jana.brzonova@uhkt.cz420221977111

Outcome results

None listed

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