Clinical Trials Register

Summary
EudraCT Number:	2022-000302-10
Sponsor's Protocol Code Number:	UHKT-COVID19
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-01-25
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2022-000302-10

A.3

Full title of the trial

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

Význam specifické T buněčné odpovědi po vakcinaci proti SARS-CoV2 pro leukemické pacienty se sníženou imunitou

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Stanovení odpovědi na očkování proti COVID19 u leukemických pacientů s oslabenou imunitou

A.3.2

Name or abbreviated title of the trial where available

UHKT-COVID19

A.4.1

Sponsor's protocol code number

UHKT-COVID19

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Institute of hematology and blood transfusion
B.1.3.4	Country	Czechia
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Institute of hematology and blood transfusion
B.4.2	Country	Czechia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Institute of hematology and blood transfusion
B.5.2	Functional name of contact point	Academical clinical trials center
B.5.3	Address:
B.5.3.1	Street Address	U Nemocnice 2094/1
B.5.3.2	Town/ city	Praha 2
B.5.3.3	Post code	128 00
B.5.3.4	Country	Czechia
B.5.4	Telephone number	420221977111
B.5.6	E-mail	jana.brzonova@uhkt.cz

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
D.2.1.1.2	Name of the Marketing Authorisation holder	BioNTech Manufacturing GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Czechia
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Spikevax COVID-19 Vaccine Moderna dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
D.2.1.1.2	Name of the Marketing Authorisation holder	MODERNA BIOTECH SPAIN, S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Czechia
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

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

Příjemci buněčné terapie (allo-HSCT, CAR19 T buňky) indikovaní k očkování proti COVID19.

E.1.1.1

Medical condition in easily understood language

Recipients of bone marrow or CAR T cells

Příjemci po transplantaci kostní dřeně nebo CAR T buněk

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

Ve studii budeme měřit protilátkovou a T buněčnou odpověď po vakcinaci jednou ze dvou vakcín proti COVID19, které jsou autorizovány EMA pro použití v Evropské Unii: Comirnaty BNT162b2 mRNA COVID19 od firmz BioNTec/Pfizer a Spikevax SARS-CoV-2 mRNA-1273 od Moderny. Studie bude prováděna u příjemců buněčné terapie (allo HSCT, CAR19 T cells) indikovaných k vakcinaci proti COVID19 ve srovnání se zdravými dobrovolníky. Vzorky krve 18 ml budou získány současně se standartními odběry. Dobrovolníci budou zváni. První odběr se uskuteční v době indikace k očkování, následné odběry pak 1 a 3 měsíce po druhé dávce a 1 měsíc po třetí posilující dávce vakcíny. Zkoušené osoby budou pacienty Ústavu hematologie a krevní transfuze.

E.2.2

Secondary objectives of the trial

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.

Dílčími cíli jsou: 1) Výběr vhodných diagnostických testů pro měření virově specifické imunitní odpovědi na vakcínu, 2) Charakterizace buněčné odpovědi pacientů na vakcinaci a její porovnání s odpovědí zdravých očkovaných jedinců, 3) Porovnání odpovědi na vakcinaci u pacientů s různými typy buněčné terapie, 4) Monitorování celkového stavu imunitního systému (IS) pacienta, vyhodnocení jeho dopadu na účinnost vakcinace a na případný výskyt nežádoucích vedlejších účinků.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

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.

E.4

Principal exclusion criteria

Uncompleted vaccination schedule.

Kritériem pro vyřazení ze studie bude nedokončené očkovací schéma.

E.5 End points

E.5.1

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

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.

E.5.1.1

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 +1 month and 3 months after second dose administration and 1 month after third booster dose administration.
Safety will be evaluated during the first year after therapy.

Stanovení účinnosti vakcinace a základních parametrů imunity v čase odběrů: v době indikace k očkování, a pak 1 a 3 měsíce po druhé dávce a 1 měsíc po třetí posilující dávce vakcíny . Bezpečnost se bude hodnotit během prvého roku po terapii.

E.5.2

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.

Pomocí dat získaných podle specifikace hlavního cíle budeme moci vyhodnotit účinnost očkování, provést výběr vhodných diagnostických testů pro měření virově specifické imunitní odpovědi na vakcínu, charakterizovat buněčné odpovědi pacientů na vakcinaci a porovnat je s odpovědí zdravých očkovaných jedinců, srovnat odpovědi na vakcinaci u pacientů s různými typy buněčné terapie. Stanovení celkového stavu imunitního systému (IS) pacienta, vyhodnocení jeho dopadu na účinnost vakcinace a na případný výskyt nežádoucích vedlejších účinků. Monitorování komplikací buněčné terapie jako je aktutní a chronická GVHD, relaps, selhání štěpu a infekční komplikace v souvislosti s vakcinací napomůže vyhodnocení bezpečnosti očkování.

E.5.2.1

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.

V\hodnocení sekundárních cílů proběhne po skončení sběru dat na konci roku 2023.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Studie neovlivní rutinní postup pro vakcinaci proti COVIDu kromě dalších odběrů krve

The trial follows the routine practice of COVID-vaccination, except for additional blood sampling

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

allo HSCT vs. CAR T buňkz vs. ydravé kontroly

allo HSCT vs. CAR Tcells vs. healthy controls

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Poslední odběr posledního pacienta

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Žádná

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-01-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-11-22

P. End of Trial
P.	End of Trial Status	Ongoing

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