Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2025-12-17 @ 8:15 AM
Study NCT ID:
NCT06256341
Status:
None
Last Update Posted:
2024-02-13 00:00:00
First Post:
2024-02-05 00:00:00
Brief Title:
HHV-6-specific T-cell Reconstitution Among Children and Adolescents After Allogeneic Stem.
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
HHV-6-specific T-cell Reconstitution Among Children and Adolescents After Allogeneic Stem.
Status:
None
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIRAST HHV-6
Brief Summary:
Background:
Human herpesvirus 6 (HHV-6) causes only minor symptoms in healthy individuals but in immunosuppressed patients, e.g., patients after allogeneic stem cell transplantation (HSCT), HHV-6 reactivations can lead to diseases in different organ systems. HHV-6 reactivations have also been reported to be a cause for delayed engraftment, a trigger of graft-versus-host disease and a co-factor for other virus reactivations. T-lymphocytes play an important role in the control of virus reactivations. Little is known about the development of virus-specific T-cells after allogeneic HSCT.
Objective:
The aim of this study was the description of the HHV-6 specific cellular immunity in children and adolescents after allogeneic HSCT in the context of the clinical course.
Study design and participants:
For this prospective, cross-sectional study, 28 children and adolescents after allogeneic HSCT who received follow-up support at the respective centers were included. Patients were enrolled up to 24 months after allogeneic HSCT.. Peripheral venous blood was drawn 3, 6, 9, 12, 18, and 24 months after allogeneic HSCT. Furthermore, a blood sample was taken from 25 age- and sex-matched healthy controls without any inflammatory, immunological, or infectious diseases. This study was approved by the Institutional Review Board of the Medical University Graz and patients, parents or legal guardians of patients gave written informed consent in accordance with the Declaration of Helsinki.
Methods:
3, 6, 9, 12, 18 and 24 months after allogeneic HSCT peripheral blood mononuclear cells were isolated from patient blood, stimulated with HHV-6-specific antigen (U54) and cultured for 10 days. Furthermore, a blood sample was taken from 25 age- and sex-matched healthy controls without any inflammatory, immunological, or infectious diseases.
On day 10, peripheral blood mononuclear cells were re-stimulated with the virus antigen U54 for 6 hours and, thereafter, stained for surface markers (CD3, CD4, CD8, CD56) and intracytoplasmatic activation markers IL-2 (Interleukin-2), IFN-γ (Interferon-γ), TNF-α (tumor necrosis factor-α) for flow cytometric detection of virus-specific T-cells. T-cells with intracytoplasmic expression of activation markers after stimulation with the virus antigen are HHV-6-specific T-cells. This indicated HHV-6 specific cellular immunity.
The virus-specific immunity of patients to HHV-6 was compared to the virus-specific immunity of children and adolescents of a control group.
Human herpesvirus 6 (HHV-6) causes only minor symptoms in healthy individuals but in immunosuppressed patients, e.g., patients after allogeneic stem cell transplantation (HSCT), HHV-6 reactivations can lead to diseases in different organ systems. HHV-6 reactivations have also been reported to be a cause for delayed engraftment, a trigger of graft-versus-host disease and a co-factor for other virus reactivations. T-lymphocytes play an important role in the control of virus reactivations. Little is known about the development of virus-specific T-cells after allogeneic HSCT.
Objective:
The aim of this study was the description of the HHV-6 specific cellular immunity in children and adolescents after allogeneic HSCT in the context of the clinical course.
Study design and participants:
For this prospective, cross-sectional study, 28 children and adolescents after allogeneic HSCT who received follow-up support at the respective centers were included. Patients were enrolled up to 24 months after allogeneic HSCT.. Peripheral venous blood was drawn 3, 6, 9, 12, 18, and 24 months after allogeneic HSCT. Furthermore, a blood sample was taken from 25 age- and sex-matched healthy controls without any inflammatory, immunological, or infectious diseases. This study was approved by the Institutional Review Board of the Medical University Graz and patients, parents or legal guardians of patients gave written informed consent in accordance with the Declaration of Helsinki.
Methods:
3, 6, 9, 12, 18 and 24 months after allogeneic HSCT peripheral blood mononuclear cells were isolated from patient blood, stimulated with HHV-6-specific antigen (U54) and cultured for 10 days. Furthermore, a blood sample was taken from 25 age- and sex-matched healthy controls without any inflammatory, immunological, or infectious diseases.
On day 10, peripheral blood mononuclear cells were re-stimulated with the virus antigen U54 for 6 hours and, thereafter, stained for surface markers (CD3, CD4, CD8, CD56) and intracytoplasmatic activation markers IL-2 (Interleukin-2), IFN-γ (Interferon-γ), TNF-α (tumor necrosis factor-α) for flow cytometric detection of virus-specific T-cells. T-cells with intracytoplasmic expression of activation markers after stimulation with the virus antigen are HHV-6-specific T-cells. This indicated HHV-6 specific cellular immunity.
The virus-specific immunity of patients to HHV-6 was compared to the virus-specific immunity of children and adolescents of a control group.
Detailed Description:
Background
Human herpesvirus 6 HHV-6 causes only minor symptoms in healthy individuals but in immunosuppressed patients eg patients after allogeneic stem cell transplantation HSCT HHV-6 reactivations can lead to diseases in different organ systems HHV-6 reactivations have also been reported to be a cause for delayed engraftment a trigger of graft-versus-host disease and a co-factor for other virus reactivations T-lymphocytes play an important role in the control of virus reactivations Little is known about the development of virus-specific T-cells after allogeneic HSCT
Objective
The aim of this study was the description of the HHV-6 specific cellular immunity in children and adolescents after allogeneic HSCT in the context of the clinical course
Study design and participants
For this prospective cross-sectional study 28 children and adolescents after allogeneic HSCT who received follow-up support at the respective centers were included Patients were enrolled up to 24 months after allogeneic HSCT Peripheral venous blood was drawn 3 6 9 12 18 and 24 months after allogeneic HSCT Furthermore a blood sample was taken from 25 age- and sex-matched healthy controls without any inflammatory immunological or infectious diseases This study was approved by the Institutional Review Board of the Medical University Graz and patients parents or legal guardians of patients gave written informed consent in accordance with the Declaration of Helsinki
Methods
3 6 9 12 18 and 24 months after allogeneic HSCT peripheral blood mononuclear cells were isolated from patient blood stimulated with HHV-6-specific antigen U54 and cultured for 10 days Furthermore a blood sample was taken from 25 age- and sex-matched healthy controls without any inflammatory immunological or infectious diseases
On day 10 peripheral blood mononuclear cells were re-stimulated with the virus antigen U54 for 6 hours and thereafter stained for surface markers CD3 CD4 CD8 CD56 and intracytoplasmatic activation markers IL-2 Interleukin-2 IFN-γ Interferon-γ TNF-α tumor necrosis factor-α for flow cytometric detection of virus-specific T-cells T-cells with intracytoplasmic expression of activation markers after stimulation with the virus antigen are HHV-6-specific T-cells This indicated HHV-6 specific cellular immunity
The virus-specific immunity of patients to HHV-6 was compared to the virus-specific immunity of children and adolescents of a control group
Human herpesvirus 6 HHV-6 causes only minor symptoms in healthy individuals but in immunosuppressed patients eg patients after allogeneic stem cell transplantation HSCT HHV-6 reactivations can lead to diseases in different organ systems HHV-6 reactivations have also been reported to be a cause for delayed engraftment a trigger of graft-versus-host disease and a co-factor for other virus reactivations T-lymphocytes play an important role in the control of virus reactivations Little is known about the development of virus-specific T-cells after allogeneic HSCT
Objective
The aim of this study was the description of the HHV-6 specific cellular immunity in children and adolescents after allogeneic HSCT in the context of the clinical course
Study design and participants
For this prospective cross-sectional study 28 children and adolescents after allogeneic HSCT who received follow-up support at the respective centers were included Patients were enrolled up to 24 months after allogeneic HSCT Peripheral venous blood was drawn 3 6 9 12 18 and 24 months after allogeneic HSCT Furthermore a blood sample was taken from 25 age- and sex-matched healthy controls without any inflammatory immunological or infectious diseases This study was approved by the Institutional Review Board of the Medical University Graz and patients parents or legal guardians of patients gave written informed consent in accordance with the Declaration of Helsinki
Methods
3 6 9 12 18 and 24 months after allogeneic HSCT peripheral blood mononuclear cells were isolated from patient blood stimulated with HHV-6-specific antigen U54 and cultured for 10 days Furthermore a blood sample was taken from 25 age- and sex-matched healthy controls without any inflammatory immunological or infectious diseases
On day 10 peripheral blood mononuclear cells were re-stimulated with the virus antigen U54 for 6 hours and thereafter stained for surface markers CD3 CD4 CD8 CD56 and intracytoplasmatic activation markers IL-2 Interleukin-2 IFN-γ Interferon-γ TNF-α tumor necrosis factor-α for flow cytometric detection of virus-specific T-cells T-cells with intracytoplasmic expression of activation markers after stimulation with the virus antigen are HHV-6-specific T-cells This indicated HHV-6 specific cellular immunity
The virus-specific immunity of patients to HHV-6 was compared to the virus-specific immunity of children and adolescents of a control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None