EBV mRNA Vaccine for the Prevention of EBV-Related Diseases After Allo-HSCT

June 23, 2026 updated by: Zhangshan, The General Hospital of Western Theater Command

An Exploratory Study of EBV mRNA Vaccine for the Prevention of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation

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:

  1. The incidence of grade III-IV acute graft-versus-host disease (aGVHD) within 100 days, and the occurrence of ≥ grade 3 adverse events (AEs) that are possibly or definitely related to the vaccine, in patients receiving EBV mRNA vaccination after allo-HSCT.
  2. To determine the optimal biological dose (OBD) of the EBV mRNA vaccine in patients after allo-HSCT among the dose levels of 25μg, 50μg, 75μg, or 100μg.
  3. EBV-ELISpot levels, the incidence of EBV viremia (EBV DNAemia), the incidence of post-transplant lymphoproliferative disorders (PTLD), disease relapse rate during follow-up, non-relapse mortality (NRM), and immunogenicity indicators (IFN-γ+ T cells, immune cell analysis, cytokine profiles, EBV glycoprotein antigen antibodies).

Participants will:

  1. Receive three intramuscular injections of the EBV mRNA vaccine on days 30, 44, and 81 after allogeneic hematopoietic stem cell transplantation (d30, d44, d81).
  2. Be hospitalized for at least 72 hours after each vaccination for close monitoring (with a focus on CRS and aGVHD), and undergo intensive safety assessments throughout the dose-escalation period (at least 28 days).
  3. Return for clinical visits on days 7 (d37, d51, d88), day 14 (d58), and day 180 (d180) after vaccination for EBV-ELISpot, EBV-DNA quantification, and immunogenicity testing, with continued long-term follow-up to evaluate safety and the persistence of vaccine-induced immune responses.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • The General Hospital of Western Theater Command
        • Contact:
        • Contact:
        • Principal Investigator:
          • shan zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥14 years, regardless of gender;
  • Patients undergoing allogeneic hematopoietic stem cell transplantation;
  • Voluntary participation in the clinical study and signing of the informed consent form.

Exclusion Criteria:

  • History of vaccine allergy;
  • Presence of active acute graft-versus-host disease (aGVHD) at screening;
  • Severe impairment of cardiac, hepatic, or renal function;
  • Body temperature >38°C within 72 hours prior to enrollment;
  • Inability to communicate reliably with the investigator or unlikely to comply with study requirements;
  • Any other condition deemed by the investigator to make the patient unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBV mRNA Vaccine (WGc-0401)
Drug: EBV mRNA vaccine (WGc-0401 injection) Description: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)
Biological: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)
Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)
No Intervention: Observation Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade III-IV acute graft-versus-host disease (aGVHD)
Time Frame: Up to 100 days after HSCT
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)
Time Frame: Up to 180 days after HSCT
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of EBV viremia
Time Frame: From Day 30 to Day 180 post-transplant
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
Time Frame: Post-transplant days 37, 44, 51, 58, 81, 88, and 180
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)
Time Frame: From HSCT (day 0) through 12 months post-transplant
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
Time Frame: Day 0 to 12 months post-HSCT
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
Time Frame: Pre-vaccination (baseline) and 24h post-vaccination (antibodies/T-cells); pre-vaccination and 6h, 24h post-vaccination (cytokines). Per vaccination dose.
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)
Time Frame: Cumulative NRM at day 100 and 12 months post-HSCT
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The General Hospital of Western Theater Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 18, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EBV mRNA Vaccine-0401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Describe which specific IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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