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The purpose of this clinical trial is to investigate the efficacy of the EBV mRNA vaccine (WGc-0401 injection) in preventing EBV-related diseases after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and to evaluate the safety and efficacy of this vaccine in patients following allo-HSCT.
The main study questions are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBV mRNA Vaccine (WGc-0401) | Experimental | Drug: EBV mRNA vaccine (WGc-0401 injection) Description: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) |
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| Observation Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) | Biological | Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade III-IV acute graft-versus-host disease (aGVHD) | Assessed according to the modified Glucksberg criteria (or the MAGIC criteria), with clinical staging comprehensively determined by the attending physician based on the involvement of skin, upper and lower gastrointestinal tract, and liver. | Up to 100 days after HSCT |
| Incidence of grade ≥3 treatment related adverse events (TRAEs) | AEs graded per CTCAE v6.0. Grade ≥3 AEs with causality assessed as possibly, probably, or definitely related to the vaccine are captured. Systematic AE assessment at each visit covers: local injection site reactions, systemic symptoms (fever, fatigue), laboratory abnormalities (cytopenias, transaminitis), and hypersensitivity. Causality determined by investigator based on temporal association, biological plausibility, and exclusion of other causes. | Up to 180 days after HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of EBV viremia | EBV-DNA load measured in plasma by quantitative real-time PCR (qPCR). Abnormal viremia defined as either: (1) ≥10³ copies/mL on two consecutive measurements (with an interval of at least 1 day), or (2) a single measurement ≥10⁴ copies/mL. | From Day 30 to Day 180 post-transplant |
| EBV-specific T-cell response measured by IFN-γ ELISpot |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shan zhang | Contact | +8618382430038 | 952750480@qq.com | |
| hai yi | Contact | +8613699418229 | yihaimail@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of Western Theater Command | Chengdu | Sichuan | China |
Describe which specific IPD will be shared.
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EBV-specific T-cell immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay using peripheral blood mononuclear cells (PBMCs) stimulated with EBV peptide pools (e.g., LMP2, EBNA1, BZLF1). Results expressed as spot-forming cells (SFC) per 2×10⁵ PBMCs. Positive response defined as ≥25 SFC/2×10⁵ PBMCs and at least 2-fold above negative control. Samples collected at protocol-specified time points. |
| Post-transplant days 37, 44, 51, 58, 81, 88, and 180 |
| Incidence of post-transplant lymphoproliferative disorders (PTLD) | PTLD confirmed by tissue biopsy per WHO classification. EBV status by EBER in situ hybridization. Subtypes: early lesions, polymorphic, monomorphic, or classic Hodgkin lymphoma-type. Clinical presentation, sites, and response recorded. | From HSCT (day 0) through 12 months post-transplant |
| Underlying disease relapse rate | Relapse defined as recurrence of primary disease post-HSCT. Confirmed by bone marrow (≥5% blasts), flow cytometry, cytogenetics/FISH, molecular markers, or extramedullary biopsy/imaging as indicated. | Day 0 to 12 months post-HSCT |
| EBV vaccine-induced humoral and cellular immune responses | Immunogenicity indicators: (1) EBV-specific antibodies (VCA-IgG, EBNA1-IgG) by ELISA; (2) EBV-specific T-cell responses by IFN-γ ELISpot; (3) serum cytokines/chemokines (IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ, MCP-1) by multiplex assay. All samples processed at central lab. | Pre-vaccination (baseline) and 24h post-vaccination (antibodies/T-cells); pre-vaccination and 6h, 24h post-vaccination (cytokines). Per vaccination dose. |
| Non-relapse mortality (NRM) | Death from any cause except relapse/progression post-HSCT. Causes: infection, organ failure, GVHD, second malignancy, hemorrhage, other transplant-related causes. Deaths without documented relapse included as NRM. | Cumulative NRM at day 100 and 12 months post-HSCT |