Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Association between breath VOCs and IgG in blood following second vaccination dose.
研究概览
简要总结
The objective of this study will be to evaluate the effect of vaccination on breath VOC content.
By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the COVID-19 antigen.
详细描述
The objective of this study will be to evaluate the effect of vaccination on breath VOC content.
By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the COVID-19 antigen.
Rapidly growing serological evidence shows that IgM, IgG, and IgA antibodies against the S or N proteins evolve rapidly in the serum of asymptomatic as well as symptomatic COVID-19 patients within a week of infection or symptom onset and stay elevated with progressing disease.
Since the standard serology testing at Shamir Medical center tracks the presence of IgG only, those serologic tests will be conducted before and 48 hours following the second vaccination dose.
Nevertheless, since IgM antibodies are known to be produced by four to seven days following the first dose of vaccination, although IgM serology testing cannot be performed, the investigators are interested in sampling breath at this time range, in order for them to correlate it with the changes in the subjects' physiologic condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 75 years at the time of consent
- •Capable of understanding written and/or spoken language
- •Able to provide informed consent
- •Assigned to undergo anti-COVID-19 vaccination
排除标准
- •Age under 18 years old
- •Under guardianship or deprived of liberty
- •Pregnant or lactating woman
- •Not eligible for anti-COVID-19 vaccination
研究组 & 干预措施
Healthy Volunteers that are not to be vaccinated against COVID19
Healthy Volunteers that are not eligible to be vaccinated against COVID19
Healthy Volunteers that are assigned to be vaccinated against COVID19
Healthy Volunteers that are eligible to be vaccinated against COVID19
干预措施: vaccination against COVID19 (Diagnostic Test)
结局指标
主要结局
Association between breath VOCs and IgG in blood following second vaccination dose.
时间窗: Through the study completion, up to 1 month.
VOCs profile found in breath will be correlatated with IgG profile in blood.
次要结局
- Association between VOCs profile and participants' clinical or demographic characteristics(Through the study completion, up to 1 month.)