Oral Side Effects of COVID-19 Vaccine

Study Overview
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Brief Summary
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This study is a multicenter cross-sectional survey-based study conducted in four European countries (Czech Republic, Germany, Slovak Republic, and Turkey). An online questionnaire will be utilized to collect data from volunteer subjects following the STROBE reporting guidelines of cross-sectional studies.

Detailed Description
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The primary objective of this multicentre cross-sectional survey-based study is to estimate the prevalence of oral side effects of COVID-19 vaccine in the short term. The secondary objectives are: to identify the risk factors of COVID-19 vaccine oral side effects in the short term. to evaluate the relationship between oral side effects and other inflammatory side effects of COVID-19 vaccine in the short term. The target population is healthcare workers as they are identified among the priority groups of COVID-19 vaccine deployment plans in the EU/EEA and the UK. One more reason to select the healthcare workers among different groups of the population, their higher awareness about the possible vaccine-related oral side-effects so that more accurate and reliable results can be obtained. A self-administered questionnaire will be developed, and its content validity will be tested using a panel of experts. The test re-test reliability of the questionnaire will be tested by 30 volunteers (10 Czech, 10 Turkish, 10 German) to achieve at least a Cronbach's alpha of 0.70. The questionnaire will be available in five languages; Czech, English, German, Slovak and Turkish. Dual forward translation and expert panels will produce equivalent Czech, German, Slovak and Turkish versions of the questionnaire. The questionnaire will be composed of multiple-choice items divided into four main categories; a) demographic data including gender, age, location of practice, profession, and experience, b) medical anamnesis including medical comorbidities, medications, and recent oral symptoms, c) COVID-19 related anamnesis including vaccination date, previous infection, and exposure to infected cases, and d) vaccine side effects including inflammatory symptoms, cutaneous symptoms, and oral symptoms. (Annex 1)

Official Title
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Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study

Conditions
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Oral Manifestations, Covid19, Vaccine Adverse Reaction

Intervention / Treatment
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* Biological: COVID-19 Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthcare workers who received COVID-19 vaccine during the last 30 days. Participating subjects should be at least 18-year-old and able to give their informed consent independently. Exclusion Criteria: The healthcare workers who did not receive the COVID-19 vaccine recently. Non-healthcare workers who received the COVID-19 vaccine recently.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccinated Healthcare Workers (CZ)<br>Czech healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) | Biological: COVID-19 Vaccine<br>* Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine<br>|
| Vaccinated Healthcare Workers (DE)<br>German healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) | Biological: COVID-19 Vaccine<br>* Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine<br>|
| Vaccinated Healthcare Workers (SK)<br>Slovak healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) | Biological: COVID-19 Vaccine<br>* Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine<br>|
| Vaccinated Healthcare Workers (TR)<br>Turkish healthcare workers who received COVID-19 vaccine during the last 30 days (n=385) | Biological: COVID-19 Vaccine<br>* Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Side Effects | Dichotomous outcome for the emergence of oral side effects (e.g. ulcers, vesicles, blisters, plaque, mouth odour, bleeding gum, burning gingiva, etc) following receiving the COVID-19 vaccine. | 0-30 days after the COVID-19 vaccine shot | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatologic Side Effects | Dichotomous outcome for the emergence of dermatologic side effects (e.g. injection site swelling, or redness, rash, urticaria, angioedema, etc) following receiving the COVID-19 vaccine. | 0-30 days after the COVID-19 vaccine shot | 
| General (common) Side Effects | Dichotomous outcome for the emergence of typical side effects (e.g. injection site pain, injection site swelling, injection site redness, tiredness, headache, nausea, muscle pain, joint pain, fever, swollen lymph nodes (lymphadenopathy), etc) following receiving the COVID-19 vaccine. | 0-30 days after the COVID-19 vaccine shot | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Oral Manifestations, Vaccine Adverse Reaction