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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers that are not to be vaccinated against COVID19 | No Intervention | Healthy Volunteers that are not eligible to be vaccinated against COVID19 | |
| Healthy Volunteers that are assigned to be vaccinated against COVID19 | Experimental | Healthy Volunteers that are eligible to be vaccinated against COVID19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaccination against COVID19 | Diagnostic Test | subjects will undergo breath biopsy sampling before, 4-7 days post-first vaccination dose, and 7-10 days post-second vaccination dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Association between breath VOCs and IgG in blood following second vaccination dose. | VOCs profile found in breath will be correlatated with IgG profile in blood. | Through the study completion, up to 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Association between VOCs profile and participants' clinical or demographic characteristics | Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.) | Through the study completion, up to 1 month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shai Efrati, MD | Assaf-Harofeh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir Medical Center | Be’er Ya‘aqov | Israel |
IPD is not to be shared with other researchers.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |