An Exploratory Study of EBV mRNA Vaccine for the Prevention of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of grade III-IV acute graft-versus-host disease (aGVHD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Observation Group
EBV mRNA Vaccine (WGc-0401)
Drug: EBV mRNA vaccine (WGc-0401 injection) Description: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection)
干预措施: Intramuscular injection of EBV mRNA vaccine (WGc-0401 injection) (Biological)
结局指标
主要结局
Incidence of grade III-IV acute graft-versus-host disease (aGVHD)
时间窗: 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)
时间窗: 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.
次要结局
- Incidence of EBV viremia(From Day 30 to Day 180 post-transplant)
- EBV-specific T-cell response measured by IFN-γ ELISpot(Post-transplant days 37, 44, 51, 58, 81, 88, and 180)
- Incidence of post-transplant lymphoproliferative disorders (PTLD)(From HSCT (day 0) through 12 months post-transplant)
- Underlying disease relapse rate(Day 0 to 12 months post-HSCT)
- EBV vaccine-induced humoral and cellular immune responses(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)(Cumulative NRM at day 100 and 12 months post-HSCT)
研究者
Zhangshan
Hematologist
The General Hospital of Western Theater Command