Allogeneic Stem Cell TransplantationCIRAST HHV-6NCT06256341
HHV-6-specific T-cell Reconstitution Among Children and Adolescents After Allogeneic Stem.
An observational study of Allogeneic Stem Cell Transplantation, run by Medical University of Graz.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Allogeneic Stem Cell Transplantation
- What is being tested?
- Cell cultivation, Antigen testing
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2014to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 28 children with adolescent after allogeneic HSCT 25 healthy cildren as control (age and sex mached)
Who may be able to join
- Patients who have undergone allogeneic SCT (stem cell transplantation) at one of the participating centers in the last 24 months or who will undergo allogeneic SCT during the study period (up to 3 months before the end of the study) and complete follow-up care at the respective centers
- Age> 1 year
- Written consent by participant or legal guardian
Who cannot join
- severe SCT-associated complications during the study period: Rejection of the transplant ("graft failure") severe graft-versus-host disease (GVHD grade 3 or 4)
- Relapse of the (malignant) underlying disease or occurrence of another complication (e.g. secondary malignancy), which represents an indication for cytotoxic chemotherapy (or re-transplantation) during the examination period.
About this study
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.
Read the detailed description
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.
- Conditions
- Allogeneic Stem Cell Transplantation
- Being tested
- Cell cultivation, Antigen testing
- Keywords
- allogeneic stem cell transplantation, Human herpesvirus 6 (HHV-6), T-lymphocytes, CD4+ or CD8+ T-cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell cultivation, Antigen testingOther
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, IFN-γ, TNF-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.
No more interventions in human except blood sampling, only basic research.
| Study group | Role | What they receive |
|---|---|---|
| allogeneic HSCT peripheral blood | 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. Receives: Other: Cell cultivation, Antigen testing | |
| healthy blood | One blood sample from a age and sex matched healthy controls without any inflammatory, immunological or infectious disease was taken. mononuclear cells were isolated from patient blood, stimulated with HHV-6-specific antigen (U54) and cultured for 10 days. Receives: Other: Cell cultivation, Antigen testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4+ controls
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
Measured: 1 day
CD8+ patients after allogeneic HSCT
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
Measured: 24 month
CD8+ controls
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
Measured: 1 day
CD4+ patients after allogeneic HSCT
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54 of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) in both
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start14 Mar 2014
- Primary completion31 Dec 2016
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256341
- Sponsor's protocol ID
- CIRAST HHV-6
- Acronym
- CIRAST HHV-6
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HHV-6-specific T-cell Reconstitution Among Children and Adolescents After Allogeneic Stem.
- ClinicalTrials.gov ID
- NCT06256341
- Acronym / sponsor ID
- CIRAST HHV-6 / CIRAST HHV-6
- Conditions
- Allogeneic Stem Cell Transplantation
- Keywords
- allogeneic stem cell transplantation, Human herpesvirus 6 (HHV-6), T-lymphocytes, CD4+ or CD8+ T-cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 14 Mar 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allogeneic HSCT peripheral blood | – | Other: Cell cultivation, Antigen testing3, 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. |
| healthy blood | – | Other: Cell cultivation, Antigen testingOne blood sample from a age and sex matched healthy controls without any inflammatory, immunological or infectious disease was taken. mononuclear cells were isolated from patient blood, stimulated with HHV-6-specific antigen (U54) and cultured for 10 days. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 28 children with adolescent after allogeneic HSCT 25 healthy cildren as control (age and sex mached)
Key inclusion criteria (3 listed)
- Patients who have undergone allogeneic SCT (stem cell transplantation) at one of the participating centers in the last 24 months or who will undergo allogeneic SCT during the study period (up to 3 months before the end of the study) and complete follow-up care at the respective centers
- Age> 1 year
- Written consent by participant or legal guardian
Key exclusion criteria (2 listed)
- severe SCT-associated complications during the study period: Rejection of the transplant ("graft failure") severe graft-versus-host disease (GVHD grade 3 or 4)
- Relapse of the (malignant) underlying disease or occurrence of another complication (e.g. secondary malignancy), which represents an indication for cytotoxic chemotherapy (or re-transplantation) during the examination period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell cultivation, Antigen testingday 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, IFN-γ, TNF-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. No more interventions in human except blood sampling, only basic research. | Other | allogeneic HSCT peripheral blood, healthy blood |
Primary outcome
CD4+ controls
Time frame: 1 day
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
CD8+ patients after allogeneic HSCT
Time frame: 24 month
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
CD8+ controls
Time frame: 1 day
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
CD4+ patients after allogeneic HSCT
Time frame: 24 month
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54 of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) in both
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Stem Cell Transplantation, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4+ controls (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.