A Phase 1, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants 18 to 65 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 8
- 主要终点
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
研究概览
简要总结
The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1469
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 18.5 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.
排除标准
- •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 vaccine study for pathogens causing Ebola virus disease.
- •History of confirmed or suspected filovirus exposure or infection or travel to an impacted area within 1 month prior to the Screening Visit (e.g. Ebola Zaire, Sudan, BDBV, and Marburg).
- •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
- •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.
研究组 & 干预措施
mRNA-1469 Dose Level 1
Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1.
干预措施: mRNA-1469 (Biological)
Placebo Matching Dose Level 1
Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1.
干预措施: Placebo (Biological)
mRNA-1469 Dose Level 2
Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1.
干预措施: mRNA-1469 (Biological)
mRNA-1469 Dose Level 3
Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
干预措施: mRNA-1469 (Biological)
Placebo Matching Dose Level 3
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.
干预措施: Placebo (Biological)
Placebo Matching Dose Level 2
Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs)
时间窗: Up to Day 169 (6 months follow-up after injection)
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)
时间窗: Up to End of Study (EOS) (Day 337)
次要结局
- Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)(At Day 29 and Up to Day 337)