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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Incidence of grade III-IV acute graft-versus-host disease (aGVHD) [Срок оценки: Up to 100 days after HSCT]
• Incidence of grade ≥3 treatment related adverse events (TRAEs) [Срок оценки: Up to 180 days after HSCT]

Вторичные конечные точки (6)

• Incidence of EBV viremia [Срок оценки: From Day 30 to Day 180 post-transplant]
• EBV-specific T-cell response measured by IFN-γ ELISpot [Срок оценки: Post-transplant days 37, 44, 51, 58, 81, 88, and 180]
• Incidence of post-transplant lymphoproliferative disorders (PTLD) [Срок оценки: From HSCT (day 0) through 12 months post-transplant]
• Underlying disease relapse rate [Срок оценки: Day 0 to 12 months post-HSCT]
• EBV vaccine-induced humoral and cellular immune responses [Срок оценки: 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) [Срок оценки: Cumulative NRM at day 100 and 12 months post-HSCT]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The General Hospital of Western Theater Command — Чэнду

Идентификаторы

NCT: NCT07674199 · EBV mRNA Vaccine-0401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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