A Phase 1, Randomized, Open-label Study to Evaluate Safety, Reactogenicity, and Immunogenicity of an Epstein-Barr Virus Candidate Vaccine, mRNA-1189, Following Intradermal and Intramuscular Delivery in Healthy Adults 18 to 30 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of Participants with Unsolicited Adverse Events (AEs)
研究概览
简要总结
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
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
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by medical evaluation including medical history and physical examination.
- •Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding.
排除标准
- •Have undergone surgical procedures within 7 days prior to Day 1 or Day 57 or are scheduled to undergo a surgical procedure within 28 days after study intervention administration.
- •Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
- •Received corticosteroids at ≥10 milligrams per day (mg/day) of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
- •Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses, within 180 days prior to Day 1 or plans to do so during the study.
- •Received or plans to receive any nonstudy vaccine from 28 days prior to first dose/Day 1 up to 28 days after the second dose/Day
- •History of myocarditis, pericarditis, or myopericarditis prior to Day
- •Has previously received an investigational EBV vaccine.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
mRNA-1189 Dose Level 1 (ID)
Participants will receive 2 intradermal (ID) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57.
干预措施: mRNA-1189 (Biological)
mRNA-1189 Dose Level 2 (ID)
Participants will receive 2 ID injections of mRNA-1189 at Dose Level 2 on Days 1 and 57.
干预措施: mRNA-1189 (Biological)
mRNA-1189 Dose Level 1 (IM)
Participants will receive 2 intramuscular (IM) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57.
干预措施: mRNA-1189 (Biological)
mRNA-1189 Dose Level 2 (IM)
Participants will receive 2 IM injections of mRNA-1189 at Dose Level 2 on Days 1 and 57.
干预措施: mRNA-1189 (Biological)
结局指标
主要结局
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 85 (28-day follow-up after vaccination)
Number of Participants with Medically Attended Adverse Events (MAAEs)
时间窗: Day 1 up to Day 225
Number of Participants With Serious Adverse Events (SAEs), Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)
时间窗: Day 1 to end of study (EOS) (Day 225)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to Day 64 (7-day follow-up after vaccination)
次要结局
- Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb)(Days 1 and 85)
- Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb(Day 85)
- Number of Participants With Seroconversion of Antigen-Specific bAbs(Day 85)