Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: vaccination against COVID19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Age under 18 years old Under guardianship or deprived of liberty Pregnant or lactating woman Not eligible for anti-COVID-19 vaccination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Healthy Volunteers that are not to be vaccinated against COVID19<br>Healthy Volunteers that are not eligible to be vaccinated against COVID19 | |
| Experimental: Healthy Volunteers that are assigned to be vaccinated against COVID19<br>Healthy Volunteers that are eligible to be vaccinated against COVID19 | Diagnostic Test: vaccination against COVID19<br>* subjects will undergo breath biopsy sampling before, 4-7 days post-first vaccination dose, and 7-10 days post-second vaccination dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |