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Not yet recruiting NCT07674199

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

Early Phase I Interventional Patients After Hematopoietic Stem Cell Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection).
Who it may be relevant to
Registry conditions: Patients After Hematopoietic Stem Cell Transplantation. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of grade III-IV acute graft-versus-host disease (aGVHD) [Time frame: Up to 100 days after HSCT]
  • Incidence of grade ≥3 treatment related adverse events (TRAEs) [Time frame: Up to 180 days after HSCT]
Secondary outcome measures (6)
  • Incidence of EBV viremia [Time frame: 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]
  • Incidence of post-transplant lymphoproliferative disorders (PTLD) [Time frame: From HSCT (day 0) through 12 months post-transplant]
  • Underlying disease relapse rate [Time frame: 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.]
  • Non-relapse mortality (NRM) [Time frame: Cumulative NRM at day 100 and 12 months post-HSCT]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The General Hospital of Western Theater Command — Chengdu

Identifiers

NCT: NCT07674199 · EBV mRNA Vaccine-0401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗