A Phase I/IIa, Randomized, Observer-blind Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an RSV/hMPV Vaccine, in Adult Participants Aged 60 Years and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 646
- 试验地点
- 13
- 主要终点
- Presence of unsolicited systemic immediate adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
详细描述
Study duration per participant:
12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort.
Treatment Duration:
Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sentinel, Main, and Booster Cohorts: observer-blind; for safety evaluation purposes, the Sponsor will be unblinded
- Investigators, laboratory personnel, and participants will be blinded
- Sponsor study staff and study staff preparing/administering the study interventions will be unblinded
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
- •A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential.
- •Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion Note: Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any screening laboratory parameter with laboratory abnormalities deemed clinically significant by the investigator
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy. Persons living with stable human immunodeficiency virus (HIV) are not excluded
- •Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine
- •History of RSV and/or hMPV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
- •Previous history of myocarditis, pericarditis, and/or myopericarditis
- •Screening electrocardiogram 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
- •Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) injection based on investigator's judgment
- •Receipt of anticoagulants in the 3 weeks preceding inclusion
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
- •History of acute infection symptoms or a positive severe acute respiratory syndrome coronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) or antigen test in the 10 days prior to the visit. A prospective participant should not be included in the study until the condition has resolved
- •Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
- •Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
- •Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)
- •Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- •Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Sentinel Cohort: RSV/hMPV Group 0 (Dose L)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
干预措施: RSV/hMPV vaccine candidate Dose L (Biological)
Sentinel Cohort: RSV/hMPV Group 1 (Dose A)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
干预措施: RSV/hMPV vaccine candidate Dose A (Biological)
Sentinel Cohort: RSV/hMPV Group 2 (Dose B)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
干预措施: RSV/hMPV vaccine candidate Dose B (Biological)
Sentinel Cohort: Placebo-Group 3
Participants will be randomized to receive a single IM injection of placebo
干预措施: Placebo (Biological)
Main Cohort: RSV/hMPV Group 1 (Dose A)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
干预措施: RSV/hMPV vaccine candidate Dose A (Biological)
Main Cohort: RSV/hMPV Group 2 (Dose B)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
干预措施: RSV/hMPV vaccine candidate Dose B (Biological)
Main Cohort: Placebo-Group 3
Participants will be randomized to receive a single IM injection of placebo
干预措施: Placebo (Biological)
Booster Cohort-RSV/hMPV
Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort
干预措施: RSV/hMPV vaccine candidate Dose A (Biological)
Booster Cohort-RSV/hMPV
Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort
干预措施: RSV/hMPV vaccine candidate Dose B (Biological)
Booster Cohort-Placebo
Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort
干预措施: Placebo (Biological)
结局指标
主要结局
Presence of unsolicited systemic immediate adverse events (AEs)
时间窗: Within 30 minutes after primary vaccination
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Presence of solicited injection site or systemic reactions
时间窗: Within 7 days after primary vaccination
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
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: Up to 6 months after primary injection
Number of participants experiencing MAAEs
Presence of serious adverse events (SAEs)
时间窗: Up to 6 months after primary injection
Number of participants experiencing SAEs
Presence of adverse events of special interest (AESIs)
时间窗: Up to 6 months after primary injection
Number of participants experiencing AESIs
Presence of related SAEs
时间窗: Throughout study (approximately 24 months)
Number of participants experiencing related SAEs
Presence of related AESIs
时间窗: Throughout study (approximately 24 months)
Number of participants experiencing related AESIs
Presence of fatal SAEs
时间窗: Throughout study (approximately 24 months)
Number of participants experiencing fatal SAEs
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)
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
时间窗: Day 1 and Day 29
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29)
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
时间窗: Day 1 and Day 29
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29)
次要结局
- RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)(Day 1 and Day 29)
- RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)(Day 1 and Day 29)
- RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- hMPV serum nAb titers at pre vaccination (D01), 28 days post-primary vaccination (D29)(Day 1 and Day 29)
- hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)
- hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination(Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12)