A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 2,400
- 试验地点
- 17
- 主要终点
- RSV A serum nAb (neutralizing antibodies) titers
研究概览
简要总结
This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.
The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV [6 dose levels], placebo and 4 control groups).
The duration of the study will be approximately 12 months for each participant.
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)
盲法说明
Observer-blind:
- Blinding for vaccine group assignment: participants, outcome assessors, investigators, site staff, laboratory personnel, Sponsor study staff.
- No blinding for site staff who prepare and administer the study interventions.
- Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohort.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 60 years or older on the day of inclusion
- •Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)
排除标准
- •History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
- •Previous history of myocarditis, pericarditis, and/or myopericarditis
- •Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •Previous history of Guillain-Barré Syndrome
- •Any vaccine given 4 weeks before or 4 weeks after study intervention
- •Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine
- •Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration
- •Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
- •Any screening laboratory parameter with laboratory abnormality > Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
RSV A serum nAb (neutralizing antibodies) titers
时间窗: At Day 1 and Day 29
nAb titers expressed as geometric mean titers (GMTs)
RSV B serum nAb titers
时间窗: At Day 1 and Day 29
nAb titers expressed as GMTs
HMPV A serum nAb titers
时间窗: At Day 1 and Day 29
nAb titers expressed as GMTs
HMPV B serum nAb titers
时间窗: At Day 1 and Day 29
nAb titers expressed as GMTs
Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination
时间窗: Within 30 minutes after vaccination
Number of participants reporting immediate unsolicited systemic AEs
Presence of solicited injection site and systemic reactions
时间窗: For 8 days, including the day of vaccination
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue and myalgia
Presence of Unsolicited AEs
时间窗: For 28 days, including day of vaccination
Number of participants reporting unsolicited AEs
Presence of medically attended AEs (MAAEs)
时间窗: Within 6 months after vaccination
Number of participants reporting MAAEs
Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs)
时间窗: Throughout the study (approximately 12 months)
Number of participants reporting SAEs, fatal SAEs and AESIs
Presence of out-of-range biological test results
时间窗: At Day 09
Number of participants with biological safety assessment values out of normal range (including shift from baseline values)
次要结局
- RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination(3, 6, 9, and 12-months post-vaccination)
- RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination(3, 6, 9, and 12 months post-vaccination)
- HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination(3, 6, 9, and 12 months post-vaccination)
- HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination(3, 6, 9, and 12 months post-vaccination)
- Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination(pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination)
- Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination(pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination)
- Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)(Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01))
- Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)(Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01))