Patients After Hematopoietic Stem Cell TransplantationEarly Phase 1NCT07674199
EBV mRNA Vaccine for the Prevention of EBV-Related Diseases After Allo-HSCT
A Early Phase 1 study testing Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) in people with Patients After Hematopoietic Stem Cell Transplantation, run by The General Hospital of Western Theater Command at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Patients After Hematopoietic Stem Cell Transplantation
- What is being tested?
- Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2026to 31 Dec 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The General Hospital of Western Theater Command
Chengdu, Sichuan
shan zhang, +8618382430038, 952750480@qq.com
hai yi, +8613699418229, yihaimail@163.com
About this study
Official title: 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:
Read more
- 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.
- 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.
- 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:
- Receive three intramuscular injections of the EBV mRNA vaccine on days 30, 44, and 81 after allogeneic hematopoietic stem cell transplantation (d30, d44, d81).
- 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).
- 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.
- Being tested
- Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)
- Keywords
- HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)Biological
Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)
| Study group | Role | What they receive |
|---|---|---|
| EBV mRNA Vaccine (WGc-0401) | Experimental | Drug: EBV mRNA vaccine (WGc-0401 injection) Description: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) Receives: Biological: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) |
| Observation Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 180 days after HSCT
Secondary outcomes (6)
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.
Measured: From Day 30 to Day 180 post-transplant
EBV-specific T-cell response measured by IFN-γ ELISpot
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cumulative NRM at day 100 and 12 months post-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start18 Jun 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients After Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangshan, The General Hospital of Western Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674199
- Sponsor's protocol ID
- EBV mRNA Vaccine-0401
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Describe which specific IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of EBV mRNA Vaccine for the Prevention of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07674199
- Acronym / sponsor ID
- EBV mRNA Vaccine-0401
- Keywords
- HSCT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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:
- Receive three intramuscular injections of the EBV mRNA vaccine on days 30, 44, and 81 after allogeneic hematopoietic stem cell transplantation (d30, d44, d81).
- 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).
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBV mRNA Vaccine (WGc-0401) | Experimental | Biological: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)Drug: EBV mRNA vaccine (WGc-0401 injection) Description: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) |
| Observation Group | No intervention | – |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) | Biological | EBV mRNA Vaccine (WGc-0401) |
Primary outcome
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. Describe which specific IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) in people with Patients After Hematopoietic Stem Cell Transplantation, run by The General Hospital of Western Theater Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shan zhang (+8618382430038, 952750480@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade III-IV acute graft-versus-host disease (aGVHD) (time frame: Up to 100 days after HSCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.