Post Vaccination Antibody Assays and Reactions in Hospital Employees and Medical Staff: An Analysis of Antibody Response Over Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Change in SARS-CoV-2 IgG Titer Over Time
研究概览
简要总结
This research study is studying how healthcare worker recipients react after receiving vaccinations for COVID-19. The objective of the study is to evaluate the immune response to COVID-19 vaccination. The immunity will be evaluated over time by measuring serum semi-quantitative SARS-Co-V2 IgG from blood specimens and analyzing vaccine reaction data. SARS-CoV-2 is the name for the virus responsible for COVID-19 infections. IgG, immunoglobulin G, is an antibody found in the blood that protects against bacterial and viral infections. Study subjects will also be asked to report physical reactions they may have experienced related to vaccinations.
详细描述
As some of the first recipients of SARS-CoV-2 vaccines under emergency authorization use, healthcare workers represent a diverse subpopulation, that are now moving through the immune response to the Pfizer and Moderna mRNA vaccines. As individual responses may vary, this provides an opportunity to evaluate levels of IgG response in relation to age, gender, comorbidities and other factors that may influence immunity. We recognize that, though this is only part of the immune response that may be protective for severe COVID-19 disease, it is a first step in understanding the level and durability of post vaccination SARS-CoV-2 antibodies.
This small, pilot study will evaluate the immune response over time by measuring serum semi-quantitative SARS-CoV-2 IgG from healthcare vaccinees at various timepoints. A high-level review of reactions related to the vaccinations will be performed with the same population of healthcare workers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent for study
- •Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA, (must have valid hospital identification)
- •Must have completed vaccination regimen (two doses if required) no more than 8 weeks ± 5 days before enrollment
- •Must have completed, valid vaccination card, if vaccinations received at a center other than Huntington Hospital
- •Able to read English, sign consent form and complete on-line surveys
排除标准
- •Huntington Hospital employees on leave of absence
- •Anyone not able/willing to provide blood specimens and respond to surveys for the 52-week study period
结局指标
主要结局
Change in SARS-CoV-2 IgG Titer Over Time
时间窗: 8 weeks (± 5 days) post-vaccination regimen completion; 24 weeks (± 5 days) post-vaccination regimen completion; and 52 weeks (± 5 days) post-vaccination regimen completion
Semi-quantitative SARS-CoV-2 IgG titer
次要结局
- Severity of post-vaccine reactions(Within 3 days after vaccine injections)
- Occurrence of post-vaccine reactions(Within 3 days after vaccine injections)