NCT04144348已完成1 期
A Phase 1b, Randomized, Observer-Blind, Placebo-Controlled, Dose Ranging Trial to Evaluate the Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine When Administered to Adults, and to Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 35
- 主要终点
- Proportion of Participants with Unsolicited Adverse Events (AEs)
研究概览
简要总结
This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Observer blind
入排标准
- 年龄范围
- 12 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 to 49 years of age and children 12 to 59 months of age at the time of consent who, in the opinion of the Investigator, are in good health based on review of medical history and screening physical examination
- •Adult participant or parent(s)/legal guardian(s) has provided written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol
- •Screening laboratory values Grade ≤1
- •Specific inclusion criteria for adults 18 to 49 years of age:
- •Body mass index (BMI) from ≥18 kg/m^2 and ≤35 kg/m^2
- •Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if the participant: 1) has a negative pregnancy test at Screening and on the day of vaccination, and 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, and 3) has agreed to continue adequate contraception through 3 months following the last vaccination, and 4) is not currently breastfeeding
- •Specific inclusion criteria for children 12 to 59 months of age:
- •Seropositive for both hMPV and PIV3 neutralizing antibody at Screening
- •Has received routine immunizations appropriate for age per the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP)
- •Current height and weight above the third percentile for age
排除标准
- •Adult and pediatric participants eligible for this study must not meet any of the following criteria:
- •Acutely ill or febrile (temperature ≥38.0℃/100.4°F, regardless of route) on the day of the first vaccination
- •Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- •Receipt of, or plans for receipt of an inactivated vaccine(s) 14 days prior to though 14 days following each study injection or a live virus vaccine(s) within 28 days prior to, or plans to through 28 days following each study injection. The exception is any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
- •Any chronic administration of an immunosuppressant or other immune modifying drug
- •Prior administration of investigational agent using lipid nanoparticle formulations
- •Donation of blood or blood products ≥450 mL within 28 days of the Screening visit (for the Adult Cohort)
- •Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment
- •Participated in an interventional clinical trial within 28 days prior to the day of enrollment, or plans to do so while enrolled in this trial
- •Has a family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
结局指标
主要结局
Proportion of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to 28 days after each dose administration
Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to 7 days after each dose administration
Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs
时间窗: Up to 1 year after the last dose administration
次要结局
- Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline(Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants)
- Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies(Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants)
- Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies(Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants)
研究者
研究点 (35)
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