A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants
A Phase 1, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants 18 to 55 Years of Age
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1519
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Moderna WeCareTeam
- 电话号码:+1-866-663-3762
- 邮箱:WeCareClinicalTrials@modernatx.com
学习地点
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-
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Oxford、英国、OX3 7LE
- University of Oxford
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Body mass index within the range 18 to 39 kg/m2 (inclusive).
- Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
Key Exclusion Criteria:
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
- History of participation in a prior filovirus (Ebola Zaire, Sudan, Bundibugyo, and Marburg) vaccine study.
- History of confirmed or suspected filovirus infection.
- Other conditions that in the Investigator's opinion could interfere with interpretation of study results or limit the participant's participation in the study.
- Acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior to or at the Screening Visit or Day 1.
- Abnormal screening clinical laboratory values >Grade 1 for total white blood cell count, hemoglobin, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, total bilirubin, or platelets.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
Note: Other inclusion and exclusion criteria may apply.
学习计划
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:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:mRNA-1519 Dose Level 1 Single Dose
Participants will receive 1 injection of mRNA-1519 at Dose Level 1 on Day 1 |
Sterile liquid for injection |
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安慰剂比较:Placebo Matching Dose Level 1 Single Dose
Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1 |
Sterile liquid for injection |
|
实验性的:mRNA-1519 Dose Level 1 Two-Dose
Participants will receive 2 injections of mRNA-1519 at Dose Level 1, on Day 1 and Day 57 |
Sterile liquid for injection |
|
安慰剂比较:Placebo Matching Dose Level 1 Two-Dose
Participants will receive 2 injections of Placebo matching Dose Level 1, on Day 1 and Day 57 |
Sterile liquid for injection |
|
实验性的:mRNA-1519 Dose Level 2
Participants will receive 1 injection of mRNA-1519 at Dose Level 2 on Day 1 |
Sterile liquid for injection |
|
安慰剂比较:Placebo Matching Dose Level 2
Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1 |
Sterile liquid for injection |
|
实验性的:mRNA-1519 Dose Level 3
Participants will receive 1 injection of mRNA-1519 at Dose Level 3 on Day 1 |
Sterile liquid for injection |
|
安慰剂比较:Placebo Matching Dose Level 3
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1 |
Sterile liquid for injection |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of Participants with Serious Adverse Events (SAEs), Any AEs Leading to Discontinuation From Study Participation and/or Study Vaccination, and AEs of Special Interest (AESIs)
大体时间:Up to End of Study (EOS) (Day 337)
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Up to End of Study (EOS) (Day 337)
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Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
大体时间:Through 7 days after each study intervention
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Through 7 days after each study intervention
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Number of Participants with Unsolicited Adverse Events (AEs)
大体时间:Through 28 days after each study intervention
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Through 28 days after each study intervention
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Number of Participants with Medically Attended Adverse Events (MAAEs)
大体时间:From Day 1 to 6 months after the last study intervention
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From Day 1 to 6 months after the last study intervention
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Geometric Mean Titer of Marburg Virus (MARV)-Specific Binding Antibodies (bAbs)
大体时间:At Day 29 (Single Dose), at Day 85 (Two-Dose), and Up to EOS (Day 337)
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At Day 29 (Single Dose), at Day 85 (Two-Dose), and Up to EOS (Day 337)
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Geometric Mean Titer of Marburg Virus (MARV)-Specific Neutralizing Antibodies (nAbs)
大体时间:Throughout the study (Up to EOS/Day 337)
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Throughout the study (Up to EOS/Day 337)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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