A Phase 1, Double-blind, Randomized Trial to Evaluate Safety and Immunogenicity of Fluzone® High-Dose Influenza Vaccine When Concomitantly Administered With CD388, a Novel Long-Acting Antiviral Conjugate for the Prevention of Influenza
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 710
- 试验地点
- 4
- 主要终点
- Immune Responses in Participants Receiving Concomitant Fluzone HD and CD388 Compared to Participants Who Receive Fluzone HD and Placebo
研究概览
简要总结
Approximately one billion cases of seasonal influenza occur annually. Of these, 3 to 5 million illnesses are severe and responsible for up to 650,000 deaths per year (WHO 2025). Yearly administration of an influenza vaccine for the prevention of influenza is currently recommended. However, the real-world vaccine effectiveness varied from 10% to 60% in the general population across the years of 2004 to 2024, with effectiveness in most years below 50% (CDC 2025) and decreasing to as low as 5% in immunocompromised individuals (Hughes 2021). Researchers are looking for other ways to prevent severe illness from the influenza virus.
The goals of this study are to learn if:
- MK-1406 (formerly CD388) is safe to take with Fluzone®
- MK-1406 affects the immune response to Fluzone®
详细描述
This is a Phase 1, double-blind, randomized trial to evaluate the immunogenicity of Fluzone® HD influenza vaccine when concomitantly administered with either MK-1406 or placebo, in healthy participants. This study will also evaluate the safety and tolerability of MK-1406 when administered with Fluzone® High-Dose (HD) compared to Fluzone® HD with placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Be ≥18 to ≤49 years of age
- •Be deemed healthy by the Investigator
- •Have not received any seasonal influenza vaccine and have not had a diagnosed or suspected influenza infection within 12 months prior to Day 1 of the trial
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Had an active malignancy within 5 years prior to screening, except basal cell or squamous cell skin cancer. Any history of breast cancer or melanoma is exclusionary.
- •Has previously been diagnosed with Guillain-Barre Syndrome following a previous influenza vaccination.
研究组 & 干预措施
Fluzone® High-Dose (HD) plus MK-1406
Participants will receive open-label Fluzone® HD influenza vaccine by intramuscular (IM) injection plus MK-1406 by subcutaneous (SC) injection on Day 1.
干预措施: Fluzone® High-Dose (HD) influenza vaccine (Biological)
Fluzone® High-Dose (HD) plus MK-1406
Participants will receive open-label Fluzone® HD influenza vaccine by intramuscular (IM) injection plus MK-1406 by subcutaneous (SC) injection on Day 1.
干预措施: MK-1406 Injection (Combination Product)
Fluzone® HD plus Placebo
Participants will receive open-label Fluzone® HD influenza vaccine by IM injection plus placebo by SC injection on Day 1.
干预措施: Fluzone® High-Dose (HD) influenza vaccine (Biological)
Fluzone® HD plus Placebo
Participants will receive open-label Fluzone® HD influenza vaccine by IM injection plus placebo by SC injection on Day 1.
干预措施: Placebo (Combination Product)
结局指标
主要结局
Immune Responses in Participants Receiving Concomitant Fluzone HD and CD388 Compared to Participants Who Receive Fluzone HD and Placebo
时间窗: On Day 1 (pre-intervention baseline), Day 15 (±1 day), and Day 29/End of Trial (EOT) (±2 days)
Evaluation of immune responses at 2- and 4-weeks post intervention measured by hemagglutinin inhibition (HAI) titers (geometric mean titers \[GMTs\] and seroconversion rates) against the influenza strains contained in the vaccine among participants receiving concomitant Fluzone HD influenza vaccine and CD388 compared to participants who receive Fluzone HD and placebo for CD388.
Geometric Mean of Hemagglutinin Inhibition (HAI) Titers Against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® High-Dose (HD) and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo
时间窗: Predose (Day 1), Day 15 and Day 29
Geometric mean of HAI titers at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. HAI testing will be performed using validated methods in accordance with applicable Good Clinical Laboratory Practice (GCLP) and laboratory Standard Operating Procedures (SOPs). Geometric Mean Titers (GMTs) will be summarized by treatment group and influenza strain.
Percentage of Participants with Seroconversion Rates against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® HD and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo
时间窗: Predose (Day 1), Day 15 and Day 29
Seroconversion is defined as a 4-fold increase in influenza titer as measured by HAI assay at each visit compared to baseline. Seroconversion rates at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. Seroconversion rates will be summarized by treatment group and influenza strain.
次要结局
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) in Participants Receiving Concomitant Fluzone HD and CD388 Compared to Participants Who Receive Fluzone HD and Placebo(From Day 1 through Day 29/EOT after concomitant intervention administration)
- Percentage of participants with ≥1 Adverse Event (AE)(Up to approximately Day 29)
- Percentage of Participants Who Discontinued from the Study Due to an Adverse Event(Up to approximately Day 29)
- Percentage of Participants with a Solicited Injection-site Adverse Event(Up to approximately Day 8 post-dose)
- Percentage of Participants with a Solicited Systemic Adverse Event(Up to approximately Day 29)