Profiling Spike Protein Antibody Response Post COVID-19 Booster
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Level of IgG antibody for SARS-CoV-2 spike protein 6 months post COVID booster
研究概览
简要总结
A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster.
详细描述
This is primarily a descriptive study that will quantify with 95% confidence intervals the mean IgG antibodies remaining in vaccinated healthy participants three to nine months after their COVID booster. At specified intervals during this period, a titer will be performed on blood drawn from participants to quantify the IgG antibodies to the SARS-CoV-2 spike protein.
This evaluation will not be performed in a lab with CLIA certification and this study will not be used to seek an EUA from the FDA. The FDA and CLIA regulate diagnostic laboratory testing but do not regulate surveillance testing.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults at Travis Air Force Base who are Active Duty, DoD beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mRNA spike protein COVID vaccine (Moderna, Pfizer, or Johnson & Johnson) and booster.
排除标准
- •Unvaccinated, partially vaccinated, or unable to provide proof of COVID vaccination
- •Unwilling or medically unable to have an initial or follow up blood sample drawn
- •Positive COVID test after receiving COVID booster
- •Current history of a bleeding disorder, cancer, or are immunocompromised
- •Received a COVID vaccine booster seven or more months ago
结局指标
主要结局
Level of IgG antibody for SARS-CoV-2 spike protein 6 months post COVID booster
时间窗: within 6 months post COVID booster
Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 6 months post COVID booster.
Level of IgG antibody for SARS-CoV-2 spike protein at baseline (0-2.5 months post booster)
时间窗: Within 2.5 months post COVID booster
Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants at baseline (0-2.5 months post COVID booster).
Level of IgG antibody for SARS-CoV-2 spike protein 3 months post COVID booster
时间窗: within 3 months post COVID booster
Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 3 months post COVID booster.
Level of IgG antibody for SARS-CoV-2 spike protein 9 months post COVID booster
时间窗: within 9 months post COVID booster
Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 9 months post COVID booster.
次要结局
未报告次要终点
研究者
Nolan Hudson
Research Associate/Medical Technologist
David Grant U.S. Air Force Medical Center