A Phase 1/2, Randomized, Observer-Blind, Active-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity and Immunogenicity of mRNA-1468, a Candidate Vaccine to Prevent Herpes Zoster (HZ) in Healthy Adults ≥50 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 659
- 试验地点
- 20
- 主要终点
- Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
研究概览
简要总结
The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1: Is an adult 50 years of age or older at the time of consent. Part 2: Is an adult 50-69 years of age at the time of consent.
- •Has a body mass index of 18 to <40 kilograms/meter squared at the Screening Visit.
- •Females of childbearing potential: have a negative pregnancy test at the Screening Visit and on the day of the first vaccination (Day 1); have practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1; have agreed to continue adequate contraception through 3 months following vaccine administration; are not currently breastfeeding.
排除标准
- •Has a history of HZ within the past 10 years.
- •Has been previously vaccinated against varicella or HZ.
- •Is acutely ill or febrile
- •Body temperature ≥38.0°Celsius/100.4°Fahrenheit 72 hours prior to or at the Screening Visit or on Day
- •Participants meeting this criterion may be rescheduled within the allowed window.
- •Has a current or previous diagnosis of congenital or acquired immunodeficiency, immunocompromizing/immunosuppressive condition, asplenia, or recurrent severe infections. Certain immune-mediated conditions that are well controlled and stable (for example, Hashimoto thyroiditis) as well as those that do not require systemic immunosuppressive therapy (for example, asthma, psoriasis, or vitiligo) may be permitted at the discretion of the Investigator.
- •Has a dermatologic condition that could affect local solicited adverse reaction assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas).
- •Has any medical, psychiatric, or occupational condition, including reported history of substance 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.
- •Has a history of myocarditis, pericarditis, or myopericarditis.
- •Has a reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.
- •Has received systemic immunosuppressants for >14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, intra-articular and topical steroids are allowed.
- •Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, Infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Part 1: mRNA-1468: Dose 4
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
干预措施: mRNA-1468 (Biological)
Part 2: mRNA-1468: Dose 5
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
干预措施: mRNA-1468 (Biological)
Part 1: mRNA-1468: Dose 3
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
干预措施: mRNA-1468 (Biological)
Part 1: mRNA-1468: Dose 1
Participants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57 in Part 1.
干预措施: Placebo (Biological)
Part 2: mRNA-1468: Dose 6
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
干预措施: mRNA-1468 (Biological)
Part 2: Shingrix
Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2.
干预措施: Shingrix (Biological)
Part 1: mRNA-1468: Dose 2
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
干预措施: mRNA-1468 (Biological)
Part 1: Shingrix
Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1.
干预措施: Shingrix (Biological)
Part 1: mRNA-1468: Dose 1
Participants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57 in Part 1.
干预措施: mRNA-1468 (Biological)
结局指标
主要结局
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
时间窗: Up to Day 64 (7 days after each injection)
Number of Participants with Serious AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest
时间窗: Day 1 to End of Study (up to a maximum of Day 1113)
Number of Participants with Medically Attended AEs
时间窗: Day 1 to Day 393 (12 months after last study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 85 (28 days after each injection)
次要结局
- Geometric Mean Concentration of Anti-gE-specific bAb as Measured by Enzyme-linked Immunosorbent Assay(Day 85 and Day 225 (1 and 6 months after the last injection))
- Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Concentration(Baseline, Day 85 and Day 225 (1 and 6 months after the last injection))
- Vaccine Seroresponse Rate of Participants(Day 85 and Day 225 (1 and 6 months after the last injection))