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健康成人对不同剂量巨细胞病毒疫苗的安全性和免疫反应研究

2026年7月16日 更新者：GlaxoSmithKline

一项 1/2 期、首次人体 (FTiH)、随机、观察者盲法、安慰剂对照、剂量递增研究，以评估包含重组蛋白和佐剂的候选巨细胞病毒 (CMV) 疫苗的安全性、反应原性和免疫原性在健康成人中肌肉注射

本研究的目的是评估候选 CMV 重组蛋白亚基 (CMVsu) 疫苗的安全性、反应原性和免疫原性，该疫苗由糖蛋白 B (gB) 和五聚体抗原组成的佐剂组合组成，无论基线 CMV 血清状态如何。 这项 FTiH 研究将在 18 至 50 岁的健康成年人中进行，其中疫苗的 4 个剂量水平将根据安全性判定以逐步剂量递增的方式进行。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

333

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Anaheim、California、美国、92806
        • GSK Investigational Site
      • Long Beach、California、美国、90806
        • GSK Investigational Site
      • Los Angeles、California、美国、90017
        • GSK Investigational Site
    • Florida
      • Hallandale、Florida、美国、33009
        • GSK Investigational Site
      • Miami、Florida、美国、33143
        • GSK Investigational Site
    • Kentucky
      • Lexington、Kentucky、美国、40536-0084
        • GSK Investigational Site
    • Michigan
      • Dearborn、Michigan、美国、48127
        • GSK Investigational Site
    • Missouri
      • Springfield、Missouri、美国、65802
        • GSK Investigational Site
    • Nebraska
      • Lincoln、Nebraska、美国、68510
        • GSK Investigational Site
      • Omaha、Nebraska、美国、68134
        • GSK Investigational Site
    • Nevada
      • Las Vegas、Nevada、美国、89109
        • GSK Investigational Site
    • New Jersey
      • Newark、New Jersey、美国、07103
        • GSK Investigational Site
      • Secaucus、New Jersey、美国、07094
        • GSK Investigational Site
    • New York
      • New York、New York、美国、10065
        • GSK Investigational Site
    • Texas
      • Austin、Texas、美国、78744-1645
        • GSK Investigational Site
      • Cedar Park、Texas、美国、78613
        • GSK Investigational Site
      • Galveston、Texas、美国、77573
        • GSK Investigational Site
    • Washington
      • Puyallup、Washington、美国、98371
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

是的

描述

纳入标准：

  • 研究者认为能够并且将会遵守方案要求的参与者。
  • 在执行任何研究特定程序之前从参与者那里获得的书面知情同意书。
  • 一名健康的成年人（女性或男性），在第一次研究干预管理时年龄在 18 至 50 岁之间。
  • 在进入研究之前根据病史和临床检查确定的健康参与者。
  • 无生育能力的女性参与者可以参加该研究。
  • 具有生育潜力的女性参与者可以参加研究，如果参与者：
  • 在研究干预实施前 30 天采取了充分的避孕措施，并且
  • 在研究干预实施当天妊娠试验呈阴性，并且
  • 已同意在整个治疗期间和完成研究干预管理系列后的 3 个月内继续采取充分的避孕措施。
  • 同意采取适当的感染控制措施以防止在研究期间感染 SARS-CoV2 的参与者。
  • 最初因 COVID-19 感染而未通过筛选的参与者可能会在筛选窗口期内重新筛选并纳入研究。
  • 具有提示活动性 COVID-19 体征/症状（即发烧、咳嗽等）的参与者应在体征/症状开始且症状消失后按照 CDC 推荐的时间隔离。
  • 与已知 COVID-19 阳性接触者的参与者应在 CDC 建议的暴露时间段内隔离，自暴露以来且参与者保持无症状或 COVID 测试阴性。
  • 被诊断患有 COVID-19 的参与者可以接受后续的 CMVsu 疫苗接种，前提是他们没有发烧，并且研究人员认为他们的病情稳定（例如，可能有轻度持续咳嗽，但没有呼吸急促或呼吸困难）原来的时间表。
  • 最初因其他活动性感染而未通过筛选的参与者可能会在筛选窗口期内重新筛选并纳入研究，如果现场调查员判断他们不再有活动性感染的体征或症状。
  • 如果参与者在 CMV 血清诊断筛查试验中有模棱两可的结果，如果在 60 天的筛查窗口内，他们将被允许重新筛查。 在活动时间表的时间间隔内，将允许进行安全性血液评估的灵活性。

排除标准：

医疗条件

  • • 在任何时间点除了研究干预 (CMVsu) 之外的任何 CMV 疫苗接种史或计划接种疫苗。
  • 在首次给药前 30 天开始的期间内使用其他研究或未注册产品，或在研究期间按计划使用。
  • 在每次研究疫苗接种给药之前 30 天和之后 30 天计划给药或给药研究方案未预见的任何疫苗，但可以在接种疫苗之前或之后 > 15 天给药的任何许可流感疫苗除外。

  • 如果公共卫生当局在常规免疫计划之外组织了针对不可预见的公共卫生威胁的紧急大规模疫苗接种，必要时可以缩短该大规模疫苗接种疫苗的时间，该疫苗可能已获得紧急使用授权。

    • 应在 GSK 研究疫苗接种前后至少 30 天接种 COVID-19 疫苗。 但是，如果公共卫生当局建议根据紧急使用授权下每种 COVID-19 疫苗平台类型适用的当地/国家指南建议进行紧急疫苗接种，则此间隔时间可缩短至 > 14 天。
    • 不允许使用未获得紧急使用授权且仅作为临床试验的一部分使用的候选 COVID-19 疫苗。
  • 在接种疫苗前 3 个月内长期服用免疫抑制剂或其他免疫调节药物。 允许吸入和局部使用类固醇。
  • 研究期间随时服用长效免疫调节药物。
  • 免疫球蛋白和/或任何血液制品在研究期间首次给药研究干预或计划给药前 3 个月开始的期间给药。

先前/同时进行的临床研究经验

  • 在研究期间的任何时间同时参加另一项临床研究，参与者已经或将接受调查或非调查干预 其他排除
  • 孕妇或哺乳期妇女。 如果一名妇女在研究期间怀孕/哺乳，她将被排除在随后的疫苗剂量之外，但将被跟踪以确保安全。
  • 计划怀孕或计划在最后一次研究疫苗接种后 3 个月内停止避孕措施的妇女。
  • 具有已知 CMV 传播高暴露风险的参与者，以便能够在研究期间区分真正的疫苗效果与自然感染。
  • 计划移动到一个将禁止参与试验的地点，直到研究结束。
  • 根据《精神疾病诊断和统计手册》第 5 版的定义，目前患有慢性饮酒和/或药物滥用的参与者。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Pentamer (low dose)/glycoprotein B (gB) (low dose)/Adjuvant group
Participants received a dose of the candidate cytomegalovirus (CMV) vaccine consisting of a combination of low dose of pentamer and low dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly.
生物：五聚体（低）/gB（低）/佐剂疫苗
三剂候选 CMVsu 疫苗由低剂量五聚体和低剂量 gB 抗原的组合组成，以 0、2、6 个月的时间表在非优势臂的三角肌区域肌内注射佐剂。
实验性的：Pentamer (medium dose)/gB (low dose)/Adjuvant group
Participants received a dose of the candidate CMV vaccine consisting of a combination of medium dose of pentamer and low dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly.
生物：五聚体（中）/gB（低）/佐剂疫苗
三剂候选 CMVsu 疫苗由中剂量五聚体和低剂量 gB 抗原的组合组成，以 0、2、6 个月的时间表在非优势臂的三角肌区域肌内注射佐剂。
实验性的：Pentamer (medium dose)/gB (medium dose)/Adjuvant group
Participants received a dose of the candidate CMV vaccine consisting of a combination of medium dose of pentamer and medium dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly.
生物：五聚体 (med)/gB(med)/佐剂疫苗
三剂候选 CMVsu 疫苗由中等剂量五聚体和中等剂量 gB 抗原组合组成，以 0、2、6 个月的时间表在非优势臂的三角肌区域肌内注射佐剂。
实验性的：Pentamer (high dose)/gB (medium dose)/Adjuvant group
Participants received a dose of the candidate CMV vaccine consisting of a combination of high dose of pentamer and medium dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly.
生物：五聚体（高）/gB（中）/佐剂疫苗
三剂候选 CMVsu 疫苗由高剂量五聚体和中剂量 gB 抗原的组合组成，以 0、2、6 个月的时间表在非优势臂的三角肌区域肌内注射佐剂。
安慰剂比较：Placebo Group
Participants received a dose of placebo at Day 1, Day 61 and Day 181 intramuscularly.
组合产品：Placebo (saline solution)
Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Solicited Administration Site Adverse Events Post Each Dose Administration
大体时间：Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
The assessed solicited administration site adverse events were erythema (injection site redness), pain and swelling.
Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Solicited Systemic Adverse Events Post Each Dose Administration
大体时间：Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
The assessed solicited administration site adverse events were arthralgia, fatigue, headache, fever and myalgia. Fever was defined as body temperature ≥38.0°Celsius/100.4°Fahrenheit.
Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Unsolicited Adverse Events (AEs) Within 7 Days Post Each Dose Administration
大体时间：Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited AEs include both serious and non-serious AEs.
Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Unsolicited Serious Adverse Events (SAEs) Within 7 Days Post Each Dose Administration
大体时间：Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. An unsolicited SAE is defined as an SAE that was not included in a list of solicited events using a Participant Diary.
Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Unsolicited AEs up to 30 Days Post Each Dose Administration
大体时间：Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant Diary. The solicited AEs that had an onset after 7 days post each dose administration are considered unsolicited AEs. Unsolicited AEs include both serious and non-serious AEs.
Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Unsolicited SAEs up to 30 Days Post Each Dose Administration
大体时间：Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Medically Attended Events (MAEs) up to 30 Days Post Each Dose Administration
大体时间：Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
MAE is defined as an AE for which the participant received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.
Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 1
大体时间：On Day 1
The hematological and biochemical parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, white blood cells (WBC). Categories reported when comparing normal range and Day 1 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
On Day 1
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 8
大体时间：On Day 8
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
On Day 8
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 61
大体时间：On Day 61
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 61 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
On Day 61
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 68
大体时间：On Day 68
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
On Day 68
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 181
大体时间：On Day 181
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 181 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
On Day 181
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 188
大体时间：On Day 188
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 188 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
On Day 188

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Unsolicited Events, SAEs, MAEs and Potential Immune Mediated Diseases (pIMDs) From Day 1 to Day 546 (End of Study)
大体时间：Day 1 to Day 546
Unsolicited AE=AE that was not included in a list of solicited events using a Participant Diary; the solicited AEs that had an onset after 7 days post each dose administration are considered unsolicited AEs; both serious and non-serious AEs are included. SAE=any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. MAE=AE for which the participant received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason. pIMDs=a subset of adverse events that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.
Day 1 to Day 546
Geometric Mean Titers (GMT) of Neutralizing Antibodies (nAbs) Against Epithelial Cell Infection (CMV Status: Sero-positive)
大体时间：On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
Neutralizing antibodies (nAbs) against epithelial cell infection were measured with neutralizing assay and the results were expressed as GMT.
On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMT of nAbs Against Epithelial Cell Infection (CMV Status: Sero-negative)
大体时间：On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
Geometric Mean Concentration (GMC) of Anti-pentamer Immunoglobulin G (IgG) (CMV Serostaus: Sero-positive)
大体时间：On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
The vaccine-induced humoral immunity was quantified by measuring the concentration of the anti-pentamer by enzyme-linked immunosorbent assay (ELISA).
On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-pentamer IgG (CMV Serostatus: Sero-negative)
大体时间：On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-glycoprotein B (gB) IgG (CMV Serostaus: Sero-positive)
大体时间：On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
The vaccine-induced humoral immunity was quantified by measuring the concentration of the anti-gB IgG binding antibodies by ELISA.
On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-gB IgG (CMV Serostatus: Sero-negative)
大体时间：On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月14日

初级完成 (实际的)

2025年4月2日

研究完成 (实际的)

2025年4月2日

研究注册日期

首次提交

2021年10月11日

首先提交符合 QC 标准的

2021年10月11日

首次发布 (实际的)

2021年10月22日

研究记录更新

最后更新发布 (实际的)

2026年7月17日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 209976

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

本研究的 IPD 将通过临床研究数据请求网站提供。

IPD 共享时间框架

IPD 将在发布主要终点、关键次要终点和研究安全数据的结果后 6 个月内提供。

IPD 共享访问标准

在提交研究提案并获得独立审查小组的批准以及数据共享协议到位后，才提供访问权限。 最初提供 12 个月的访问权限，但在有正当理由的情况下可以再延长 12 个月。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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