A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV/hMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 17
- 主要终点
- Presence of solicited injection site or systemic reactions
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older.
Treatment:
- RSV/hMPV mRNA / LNP 1 at 3-4 different doses or,
- RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or,
- RSV mRNA / LNP 1 at 1 dose or,
- hMPV mRNA / LNP 1 at 1 dose
详细描述
Study duration per participant is approximately 6 months.
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, Care Provider, Investigator)
盲法说明
- Participants, Investigators and site staff remain blinded during study conduct, except dedicated study staff preparing/administering the study intervention.
- Sponsor study staff will remain unblinded, except laboratory staff who handle primary/secondary endpoints
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
- •Informed consent form (ICF) has been signed and dated
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- •-The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
RSV/hMPV mRNA / LNP 1 Group 1
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.
干预措施: RSV/hMPV mRNA LNP 1 (Biological)
RSV/hMPV mRNA / LNP 1 Group 2
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.
干预措施: RSV/hMPV mRNA LNP 1 (Biological)
RSV/hMPV mRNA / LNP 1 Group 3
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.
干预措施: RSV/hMPV mRNA LNP 1 (Biological)
RSV/hMPV mRNA / LNP 2 Group 4
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.
干预措施: RSV/hMPV mRNA LNP 2 (Biological)
RSV mRNA / LNP 1 Group 5
Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.
干预措施: RSV mRNA LNP 1 (Biological)
hMPV mRNA / LNP 1 Group 6
Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.
干预措施: hMPV mRNA LNP 1 (Biological)
RSV/hMPV mRNA / LNP 1 Group 7
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.
干预措施: RSV/hMPV mRNA LNP 1 (Biological)
结局指标
主要结局
Presence of solicited injection site or systemic reactions
时间窗: Within 7 days after vaccination
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Presence of adverse events of special interest (AESIs)
时间窗: Throughout study (up to approximately 6 months)
Number of participants experiencing AESIs
RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
时间窗: Day 1 and Day 29
RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
Presence of serious adverse events (SAEs)
时间窗: Throughout study (up to approximately 6 months)
Throughout study (up to approximately 6 months)
Presence of out-of-range biological test results
时间窗: Within 7 days after vaccination
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
Presence of unsolicited systemic immediate adverse events (AEs)
时间窗: Within 30 minutes after vaccination
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Presence of unsolicited AEs
时间窗: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Presence of medically attended adverse events (MAAEs)
时间窗: Throughout study (up to approximately 6 months)
Number of participants experiencing MAAEs
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
时间窗: Day 1 and Day 29
RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations
时间窗: Day 1 and Day 29
hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
次要结局
- hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations(Day 1, Day 29, Day 91 and Day 181)
- RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation(Day 1, Day 29, Day 91 and Day 181)
- RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation(Day 1, Day 29, Day 91 and Day 181)
- RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation(Day 1, Day 29, Day 91 and Day 181)
- hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations(Day 1, Day 29, Day 91 and Day 181)