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OpenTrials
Completed

NCT Number: NCT04842708

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shamir Medical Center

Be’er Ya‘aqov, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Association between breath VOCs and IgG in blood following 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.

Secondary outcomes

  1. Association between VOCs profile and participants' clinical or demographic characteristics

    Time frame: Through the study completion, up to 1 month.

    Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.)

Sponsors and collaborators

Lead sponsor

Scentech Medical Technologies Ltd

Industry

Registry information

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2021
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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