Measuring Immunity Against Circulating Influenza Viruses: Randomized Immunogenicity Study Among US Adults Aged 18-64 Years Comparing Two Approved Influenza Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 606
- 试验地点
- 12
- 主要终点
- Participants with a seroprotective HAI titer (≥1:40)
研究概览
简要总结
This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax®) versus a licensed comparator influenza vaccine (Flublok®). Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Participants will be asked if they wish to also provide saliva specimens at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Serum and peripheral blood mononuclear cells (PBMC) and plasma samples will be isolated from whole blood and tested for biomarkers of vaccine immunogenicity, and duration of antibody responses.
Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms; those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws (acute [<10 days after symptom onset] and convalescent [28 days after acute visit if lab-confirmed positive for influenza]).
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-64 years that have not received the current season's influenza vaccine
- •English literate
- •Email or text message capability for weekly follow-up
- •Intention of receiving influenza vaccine based on ACIP-CDC guidelines
- •Willing to provide written/electronic informed consent
- •Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits
排除标准
- •Receipt of the current season's influenza vaccine (receipt after July 1, 2024)
- •History of severe allergic reaction after a previous dose of any influenza vaccine or to an influenza vaccine component
- •Receipt of any licensed or investigational live vaccine within 6 weeks or non-live vaccine within 2 weeks prior to enrollment in this study or planning receipt of any vaccines between visits 1 and 2 of the study (approximately within 4 weeks after the receipt of study-administered vaccine)
- •History of Guillain-Barré syndrome
- •Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives
- •Temporary Delay Criteria (Visit 1)
- •1. History of febrile illness (> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration
结局指标
主要结局
Participants with a seroprotective HAI titer (≥1:40)
时间窗: Baseline, Day 29
The number (percent) of participants with a seroprotective HAI titer (≥1:40) for each influenza vaccine antigen
The geometric mean titer (GMT) of HAI antibody
时间窗: Baseline, Day 29
The geometric mean titer (GMT) of HAI antibody for each influenza vaccine antigen
Number of participants demonstrating seroconversion from baseline
时间窗: Day 29
The number (percent) of participants in each vaccination group demonstrating seroconversion from Baseline at Day 29 (a titer ≥1:40 at Day 29 if the baseline titer is \<1:10 or a four-fold rise in titer at Day 29 if the baseline titer is \>1:10) as assessed by HAI titer for each vaccine antigen
Geometric mean fold rise (GMFR) in HAI titer from baseline
时间窗: Day 29
The geometric mean fold rise (GMFR) in HAI titer from Baseline to Day 29 across HAI titers for each influenza vaccine antigen
Percent of Participants With a Seroprotective HAI Titer (≥1:40)
时间窗: Visit 2 (Days 28-42, Post-vaccination)
The percent of participants with a seroprotective antibody titer (≥1:40) for each influenza vaccine antigen was determined. Cell-grown A(H1N1)pdm09 and B/Victoria were measured by hemagglutination inhibition (HAI), while A(H3N2) titers were measured by microneutralization.
The Geometric Mean Titer (GMT) of HAI Antibody
时间窗: Up to Visit 2 (Days 28-42, Post-vaccination)
The geometric mean antibody titer (GMT) for each influenza vaccine antigen in the 2024-2025 influenza season. GMTs were calculated as the anti-log of the mean of log-transformed titers. Cell-grown A(H1N1)pdm09 and B/Victoria were assessed by hemagglutination inhibition (HAI), whereas A(H3N2) was assessed by microneutralization.
Percent of Participants Demonstrating Seroconversion From Baseline
时间窗: Day 29 post-vaccination assessment (Visit 2; scheduled for Day 29 with an allowable window of Days 28-42 post-vaccination)
The percent of participants in each vaccination group demonstrating seroconversion from Baseline at Day 29 (defined as a titer ≥1:40 at Day 29 if the baseline titer is \<1:10, or a ≥4-fold rise in titer at Day 29 if the baseline titer is ≥1:10) for each vaccine antigen. Viruses tested were cell-grown A(H1N1)pdm09 and B/Victoria using hemagglutination inhibition (HAI), and A(H3N2) using microneutralization.
Geometric Mean Fold Rise (GMFR) in HAI Titer From Baseline
时间窗: Day 29 post-vaccination assessment (Visit 2; scheduled for Day 29 with an allowable window of Days 28-42 post-vaccination)
The geometric mean fold rise (GMFR) in antibody titers from Baseline to Day 29 for each influenza vaccine antigen. Cell-grown A(H1N1)pdm09 and B/Victoria were assessed using hemagglutination inhibition (HAI), whereas A(H3N2) was assessed using microneutralization.
次要结局
未报告次要终点