NCT07561294进行中（未招募）2 期
A Phase 2, Randomized, Observer-blind, Dose-finding, Placebo-controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982, an mRNA Vaccine to Prevent Lyme Disease in Healthy Adult Participants (18 to 70 Years of Age)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 366
- 试验地点
- 16
研究概览
简要总结
This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good general health in the opinion of the investigator as determined by medical evaluation including medical history and physical examination at screening.
- •Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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.
- •Have chronic illness related to Lyme disease or an active symptomatic Lyme disease infection as suspected or diagnosed by a physician.
- •Received treatment for Lyme disease within the prior 3 months.
- •Previously vaccinated against Lyme disease or participated in the past in any vaccine study for Lyme disease.
- •Had a tick bite within 4 weeks prior to Day
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Dose-finding Phase
Experimental
Participants will receive mRNA-1982 or placebo as an intramuscular injection.
干预措施: Placebo (Biological)
Booster Phase
Experimental
Participants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection.
干预措施: Placebo (Biological)
研究者
研究点 (16)
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