Characterizing Late-season Influenza Vaccine Responses to Compare the 2023 and 2024 Vaccine Formulations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Magnitude of Antibody Response After the Late-season 2023 Vaccine
研究概览
简要总结
Every 1-2 years, the seasonal influenza vaccine composition changes to include updated viruses, yet the precise effects of updating the vaccine remain understudied. Since the vaccine formulation for each season (with a season defined as starting in July and ending the following June) expires on June 30, vaccine formulations cannot be compared head-to-head. Thus, the 2023 and 2024 vaccines have only been compared by analyzing people given the former vaccine in the fall of 2023 and people given the latter vaccine in the fall of 2024, and baseline repertoires may have greatly changed over the course of that year. To that end, the investigators will vaccinate a cohort with the 2023 influenza vaccine between May-June 2024, in order to compare responses between individuals receiving the 2023 vaccine last fall, the 2023 vaccine late in the season (this cohort), and the 2024 vaccine next fall. The investigators will further assess whether the late-season 2023 vaccine primed this cohort to respond better to the standard 2024 vaccine with standard timing (vaccine administered around September-October).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Be between 18-64 years of age
- •Males or non-pregnant, non-nursing females
- •Weigh at least 85 pounds for whole blood draw
- •Ability to provide signed informed consent
- •Subjects must plan to receive the intramuscular influenza vaccine at the La Jolla Institute for Immunology
排除标准
- •Received an influenza vaccine in the past year
- •Infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
- •History of certain anemias
- •Presence of significant cardiovascular disease, systemic diseases including, but not limited to, diabetes which is not controlled, renal disease, liver disease, malignancy, infection, or blood clotting disorder
- •Inability to provide informed consent
- •Recent whole blood donation within 56 days or leukapheresis within 112 days
- •Children (under 18 years of age), elderly (65 years of age or older), pregnant or nursing females
- •Individuals with egg allergies
- •Has ever had Guillain-Barré syndrome
研究组 & 干预措施
Late season influenza vaccine
Every participant receives the 2023 influenza vaccine between May-June 2024, and then the 2024 influenza vaccine in September-October 2024. Blood draws are taken at Day 0, 30, and 90 post-vaccination.
干预措施: Influenza Fluzone vaccine (Biological)
结局指标
主要结局
Magnitude of Antibody Response After the Late-season 2023 Vaccine
时间窗: 0, 30, and 90 days after the 2023 vaccine
The antibody response will be measured by hemagglutination inhibition (HAI) in adults between 18 and 64 years old who have not had an influenza vaccination prior to the study.
Magnitude of the Antibody Response After the 2024 Vaccine
时间窗: Day 0, 30, and 90 after the 2024 vaccine
The antibody response will be measured by hemagglutination inhibition (HAI) in adults between 18 and 64 years old who have not had an influenza vaccination prior to the study. This outcome was only performed on Arm 2.
次要结局
未报告次要终点
研究者
Tal Einav
Assistant Professor
La Jolla Institute for Immunology