A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 867
- 试验地点
- 121
- 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 main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •According to the assessment of the investigator, is in good general health and can comply with study procedures.
- •Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0).
- •Healthy baseline EBV-seronegative adolescents from 12 to <18 years of age at the time of consent (Screening Visit, Day 0).
- •Healthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).
排除标准
- •Has had significant exposure to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 14 days prior to the screening visit, if the participant has not been fully vaccinated against COVID-19 at least 14 days prior to the screening visit.
- •Has 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).
- •Significant, progressive, unstable or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures per investigator judgement.
- •Has a history of myocarditis, and/or pericarditis.
- •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 vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Part A: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
干预措施: Placebo (Biological)
Part B: mRNA-1189 Dose Level 1
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part B: mRNA-1189 Dose Level 2
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part B: mRNA-1189 Dose Level 3
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part B: mRNA-1189 Dose Level 4
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part B: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
干预措施: Placebo (Biological)
Part C: mRNA-1189 Dose Level 1
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part A: mRNA-1189 Dose Level 2
Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part A: mRNA-1189 Dose Level 3
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part A: mRNA-1189 Dose Level 4
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part C: mRNA-1189 Dose Level 2
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part C: mRNA-1189 Dose Level 3
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
干预措施: mRNA-1189 (Biological)
Part C: Placebo
Participants will receive 3 IM injection 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 SAEs, MAAEs, 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 505)
Number of Participants with Laboratory Abnormalities
时间窗: Up to Day 176 (7-day follow-up after vaccination)
次要结局
- Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)(Days 1, 85, and 197)
- Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-Specific bAb(Days 1, 85, and 197)
- Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs(Days 1, 85, and 197)
- Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb)(Days 1, 85, and 197)
- Geometric Mean Concentration (GMC) of Antigen-specific Binding Antibody (bAb)(Days 1, 85, and 197)
- Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-specific bAb(Days 1, 85, and 197)
- Number of Participants with Seroresponse of B-Cell nAbs and Antigen-specific bAbs(Days 1, 85, and 197)