HHV-6-specific T-cell Reconstitution Among Children and Adolescents After Allogeneic Stem.

NCT06256341 | Completed

• 1 other identifier: CIRAST HHV-6
• Study Type: observational
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Allogeneic Stem Cell Transplantation

Keywords

allogeneic stem cell transplantation; Human herpesvirus 6 (HHV-6); T-lymphocytes; CD4+ or CD8+ T-cells

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  24 month

Study Arms (2)

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.

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.

Other: Cell cultivation, Antigen testing

Interventions

Cell cultivation, Antigen testing OTHER

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.

allogeneic HSCT peripheral blood; healthy blood

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

28 children with adolescent after allogeneic HSCT 25 healthy cildren as control (age and sex mached)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

Biospecimen

Retention: SAMPLES WITH DNA

blood sampling

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: March 14, 2014
• Primary Completion: December 31, 2016
• Study Completion: November 1, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02