Shamir Medical Center
Be’er Ya‘aqov, Israel
NCT Number: NCT04842708
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Be’er Ya‘aqov, Israel
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.
Since this is an unknown metabolic volatile compound mixture, the goal will be to identify compounds and quantify them with a high level of precision and subsequently correlate them with the disease.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
subjects will undergo breath biopsy sampling before, 4-7 days post-first vaccination dose, and 7-10 days post-second vaccination dose.
Time frame: Through the study completion, up to 1 month.
VOCs profile found in breath will be correlatated with IgG profile in blood.
Time frame: Through the study completion, up to 1 month.
Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.)
Scentech Medical Technologies Ltd
Industry
Acronym: COVID-19
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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