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

NCT07674199 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-29

No results posted yet for this study

Summary

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.

Conditions

  • Patients After Hematopoietic Stem Cell Transplantation

Interventions

BIOLOGICAL

Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)

Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)

Sponsors & Collaborators

  • The General Hospital of Western Theater Command

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-18
Primary Completion
2030-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674199 on ClinicalTrials.gov