Assessing Safety of COVID-19 mRNA Vaccine Administration in the Setting of a Previous Adverse Reaction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related allergic reaction adverse events
研究概览
简要总结
This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal history of allergic reaction. In addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to a natural COVID-19 infection ("long COVID").
Eligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalent vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits.
We hypothesize that individuals who have had adverse reactions to a previous dose of an mRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mRNA COVID-19 bivalent vaccine, as indicated.
The study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pfizer-BioNTech mRNA COVID-19 vaccine
Subject will receive an initial or additional dose of the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine
干预措施: Pfizer-BioNTech mRNA COVID-19 vaccine (Biological)
结局指标
主要结局
Number of participants with treatment-related allergic reaction adverse events
时间窗: up to approximately 7 days after the vaccine is given
The safety of administering an initial or additional dose will be determined by using the grading of systemic allergic reactions will be based on a scale of 1-5 according to criteria set forth in the Consortium of Food Allergy Research (CoFAR) grading scale (version 3.0) modified for adults as well as the Brighton Collaboration to grade the diagnostic certainty of anaphylaxis.
Percent of participants that have a reaction to an initial or additional dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine
时间窗: up to approximately 7 days after the vaccine is given
次要结局
- Number of clinical adverse reaction types (non-allergic)(up to approximately 7 days after the vaccine is given)
研究者
James Baker Jr MD
Professor of Internal Medicine in Allergy/Clinical Immunology
University of Michigan