A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, 2-Part, Dose-Ranging Study of an EBV Candidate Vaccine, mRNA-1195, in Healthy Participants 18 Through 55 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 482
- 试验地点
- 54
- 主要终点
- Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.
详细描述
There will be 2 sequential parts to the study:
- Participants 18 through 55 years of age will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening.
- Part B will enroll participants 18 through 30 years of age who are either EBV-seronegative or EBV-seropositive at Screening.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus or Positive EBV serostatus at Screening.
- •According to the assessment of the Investigator, is in good general health and can comply with study procedures.
- •For participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following last study injection and is not currently breast/chest feeding.
排除标准
- •Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day
- •Symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the Investigator).
- •Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- •History of myocarditis, pericarditis, or myopericarditis.
- •Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Topical corticosteroids and tacrolimus are allowed.
- •Participant has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection, with the exception of licensed/authorized influenza vaccines, which may be received more than 14 days before or after any study injection.
- •Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Part A: mRNA-1195.1 Dose Level 3
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.
干预措施: mRNA-1195.1 (Biological)
Part A: mRNA-1195.2 Dose Level 4
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.
干预措施: mRNA-1195.2 (Biological)
Part A: mRNA-1195.1 Dose Level 2
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.
干预措施: mRNA-1195.1 (Biological)
Part A: mRNA-1189
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part A: mRNA-1195.2 Dose Level 3
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.
干预措施: mRNA-1195.2 (Biological)
Part B: Placebo
Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
干预措施: Placebo (Biological)
Part B: mRNA-1195 High Dose
Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.
干预措施: mRNA-1195 (Biological)
Part A: mRNA-1195.1 Dose Level 4
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.
干预措施: mRNA-1195.1 (Biological)
Part B: mRNA-1195 Middle Dose
Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.
干预措施: mRNA-1195 (Biological)
Part B: mRNA-1195 Low Dose
Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.
干预措施: mRNA-1195 (Biological)
Part A: mRNA-1195.2 Dose Level 2
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.
干预措施: mRNA-1195.2 (Biological)
Part A: mRNA-1195.1 Dose Level 1
Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.
干预措施: mRNA-1195.1 (Biological)
Part A: mRNA-1195.2 Dose Level 1
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.
干预措施: mRNA-1195.2 (Biological)
Part A: Placebo
Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
时间窗: Up to Day 176 (7-day follow-up after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 197 (28-day follow-up after vaccination)
Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Discontinuation of Study Intervention and/or Study Participation, and AEs of Special Interest (AESIs)
时间窗: Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505)
次要结局
- Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb(Days 1, 85, and 197)
- Number of Participants With Seroresponse of B-Cell nAbs and/or Antigen-Specific bAbs(Days 1, 85, and 197)
- Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)(Days 1, 85, and 197)