Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 23
- 主要终点
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
研究概览
简要总结
The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and results of electrocardiogram testing.
- •Body mass index of 18 kilograms (kg)/square meter (m^2) to 39 kg/m^2 (inclusive) at the Screening visit.
- •For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.
排除标准
- •Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day
- •History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- •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.
- •Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- •Participant has received any vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
- •Participant has participated in an interventional clinical study within 28 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.
- •Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1
Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5N8 (Biological)
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2
Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5N8 (Biological)
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3
Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5N8 (Biological)
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1
Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5 Only (Biological)
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2
Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5 Only (Biological)
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3
Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5 Only (Biological)
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1
Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H7N9 (Biological)
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2
Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H7N9 (Biological)
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3
Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H7N9 (Biological)
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1
Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H7 Only (Biological)
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2
Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H7 Only (Biological)
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3
Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H7 Only (Biological)
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1
Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5 Only-CG (Biological)
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2
Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5 Only-CG (Biological)
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3
Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22.
干预措施: mRNA-1018 for H5 Only-CG (Biological)
结局指标
主要结局
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to Day 29 (7 days after each injection)
Number of Participants with Medically-Attended AEs (MAAEs)
时间窗: Day 1 to Day 205 (EoS)
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Day 1 to Day 205 (EoS)
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 43 (21 days after each injection)
Number of Participants with AEs Leading to Discontinuation From Study
时间窗: Day 1 to Day 205 (end of study [EoS])
Number of Participants with Adverse Events of Special Interest (AESIs)
时间窗: Day 1 to Day 205 (EoS)
次要结局
- Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43(Days 22, 29, and 43)
- Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay(Baseline (Day 1), Days 22, 29, and 43)
- Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay(Days 22, 29, and 43)
- Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay(Baseline (Day 1) to Days 22, 29, and 43)
- GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay(Days 22, 29, and 43)
- GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay(Baseline (Day 1), Days 22, 29, and 43)
- Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise(Baseline (Day 1) to Days 22, 29, and 43)