Factors Associated With Maintenance of Antibody Responses to Influenza Vaccine in Older, Community-Dwelling Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 510
- 主要终点
- Maintenance of Immune Response using Hemagglutinin inhibition titers
研究概览
简要总结
Little is known about factors associated with maintenance of hemagglutinin inhibition (HAI) antibodies after influenza vaccination in older adults so the investigators enrolled adults ≥50 years.
详细描述
In the United States, yearly influenza vaccination begins in August or September. However, influenza season can extend into April of the following year. The duration of protection from annual vaccination in older adults is unknown, and little is known about factors associated with the maintenance of response throughout the influenza season. This study evaluated factors associated with the immune response of older adults to trivalent influenza vaccine and the maintenance of antibody responses for the duration of the influenza season.
Subjects
Subjects were enrolled at two sites, Vanderbilt University Medical Center (Nashville, TN) and Marshfield Clinic Research Foundation (Marshfield, WI), during September and October 2009. Subjects were eligible for recruitment if they were ≥50 years of age and had no contraindication to influenza vaccination. Subject recruitment included advertisements at Vanderbilt University Medical Center and letters of invitation to older adults who had received an influenza vaccine in the year prior at Marshfield Clinic.1 All subjects were vaccinated either by their usual caregiver or by the study staff. Strain components for the 2009-2010 Northern Hemisphere vaccine included A/Brisbane/59/2007-like (H1N1), A/Brisbane/10/2007-like (H3N2), and B/Brisbane/60/2008-like. Participants were given the trivalent seasonal vaccine because the 2009 H1N1 pandemic vaccine was not available.
Data Collection
All subjects donated serum pre-vaccination (S1) during September through October 2009, 21 - 28 days post-vaccination (S2) and post-influenza season, May through July, 2010, approximately 250 days (8 months) post-vaccination (S3). Study procedures, informed consent documents and data collection forms were reviewed and approved by Institutional Review Boards at each of the study sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >=50 years
排除标准
- •Prior vaccine allergy or history of guillain barre
结局指标
主要结局
Maintenance of Immune Response using Hemagglutinin inhibition titers
时间窗: 1 year
次要结局
未报告次要终点
研究者
Keipp Talbot
Assistant Professor
Vanderbilt University
