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Trial - EUCTR2022-000302-10-CZ


Column Value
Trial registration number EUCTR2022-000302-10-CZ
Full text link
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000302-10/CZ

First author
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Institute of hematology and blood transfusion - Academical clinical trials center

Contact
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

jana.brzonova@uhkt.cz

Registration date
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

2022-01-25

Recruitment status
Last imported at : Aug. 30, 2024, 8 a.m.
Source : EU Clinical Trials Register

Completed

Study design
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Adult recipients of cell therapy (allo-HSCT, CAR19 T cells) indicated to vaccination against COVID19. 30 patients, 20 healthy volunteers vaccinated against COVID19. Do studie budou zařazeni dospělí příjemci buněčné terapie (allo-HSCT, CAR19 T buňky) indikovaní k očkování proti COVID. Plánujeme zařazení cca 30 pacientů. Kontrolní skupinu 20 jedinců pro ověření a výběr testů budou tvořit zdraví dobrovolníci očkovaní vakcínou proti COVID19.

Exclusion criteria
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Uncompleted vaccination schedule. Kritériem pro vyřazení ze studie bude nedokončené očkovací schéma.

Number of arms
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Institute of hematology and blood transfusion

Inclusion age min
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Czech Republic

Type of patients
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

High risk patients

Severity scale
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

30

primary outcome
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

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 Měření anti-S a anti-NC IgG testem ELISA a AEC2 vazebným testem (EUROIMMUNE). Měření interferonu gama a IL2 produkujících T buněk pomocí dual ELISPOT testu, a AIM testu průtokovou cytometrií. Stanovení základních parametrů imunity: krevní obraz a test celkové buněčné odpovědi total IGRA test. Monitorování komplikací souvisejících s alo-HSCT jako jsou akutní a chronická GVHD, relaps, nefunkčnost štěpu a infekční komplikace.

Notes
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Declared number of arm (1.0) differs from found arms (2.0)

Phase
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : Jan. 27, 2022, 4:38 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "3", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]