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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: vaccination against COVID19

• Registration Number: NCT04842708
• Lead Sponsor: Scentech Medical Technologies Ltd

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-24
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2021-04-11
• Study First Posted: 2021-04-13
• Primary Completion: 2021-12-24
• Study Completion: 2021-12-24
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers that are assigned to be vaccinated against COVID19	vaccination against COVID19	Healthy Volunteers that are eligible to be vaccinated against COVID19

Primary Outcome Measures

Name	Time	Method
Association between breath VOCs and IgG in blood following second vaccination dose.	Through the study completion, up to 1 month.	VOCs profile found in breath will be correlatated with IgG profile in blood.

Secondary Outcome Measures

Name	Time	Method
Association between VOCs profile and participants' clinical or demographic characteristics	Through the study completion, up to 1 month.	Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.)

Trial Locations

Locations (1)

Shamir Medical Center; 🇮🇱 Be'er Ya'aqov, Israel