A Phase 1, Randomized, Modified Double-blind, Multi-center, Parallel Group, Multi-arm Study to Investigate the Safety and Immunogenicity of an RSV/hMPV Vaccine Candidate in Adult Participants Aged 60 to 75 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 6
- 主要终点
- Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
研究概览
简要总结
VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.
详细描述
The duration of participation will be approximately 6 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, Care Provider, Investigator)
盲法说明
Modified double-blinded for the sentinel and main cohorts.
- Blinding for vaccine group assignment: participants, outcome assessors, Investigators, laboratory personnel (for both sentinel and main cohort); Sponsor study staff (except biostatistician) and Sponsor SMT (Safety Management Team) for main cohort
- No blinding for vaccine group assignment: those preparing and administering the study interventions; Sponsor study staff and Sponsor SMT for sentinel cohorts
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 60 to 75 years on the day of inclusion
- •A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile
排除标准
- •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
Group 1 RSV/hMPV dose A1
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose A1 (Biological)
Group 2 RSV/hMPV dose A2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose A2 (Biological)
Group 3 RSV/hMPV dose A3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose A3 (Biological)
Group 4 RSV/hMPV dose B1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose B1 (Biological)
Group 5 RSV/hMPV dose B2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose B2 (Biological)
Group 6 RSV/hMPV dose B3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose B3 (Biological)
Group 7 RSV/hMPV dose C1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose C1 (Biological)
Group 8 RSV/hMPV dose C2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose C2 (Biological)
Group 9 RSV/hMPV dose C3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose C3 (Biological)
Group 10 RSV/hMPV dose 1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose 1 (Biological)
Group 11 RSV/hMPV dose 2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose 2 (Biological)
Group 12 RSV/hMPV dose 3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
干预措施: RSV/hMPV vaccine dose 3 (Biological)
Group 13 Monovalent RSV Vaccine
Participants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule.
干预措施: Monovalent RSV Vaccine (Biological)
结局指标
主要结局
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
时间窗: On Day 1
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
时间窗: Day 1 through day 8
Presence of unsolicited AEs reported through 28 days after vaccination
时间窗: Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination
时间窗: SAE: Screening through day 181; AESI: Day 1 through day 181
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
时间窗: Screening through day 8
次要结局
- RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants(At day 1 and day 29)
- hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine(At day 1 and day 28)
- RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants(At day 1, day 29, day 91, and day 181)
- RSV A serum anti-F IgG (immunoglobulin type G) Ab (Antibody) titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants(At day 1, day 29, day 91, and day 181)
- hMPV A nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine(At day 1, day 29, day 91, and day 181)
- hMPV serum anti-F IgG Ab titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine(At day 1, day 29, day 91, and day 181)