The COVID-19 Back-to-Normal Study

Study Overview
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Brief Summary
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During the study, members of different online and offline communities will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference. Hypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.

Detailed Description
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The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a Public Health Emergency of International Concern in January 2020 and upgraded to pandemic in March 2020. First vaccines to prevent COVID-19 were authorized for emergency use in the US in December 2020, but a number of unknowns still remains. One of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. Study groups will be based on age, metabolism, donated diagnostic test results and self-reported symptoms. Data will be collected continuously via surveys and investigator-participant interactions, as needed. Statistical methods used will be the ones with the greatest power.

Official Title
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A Phenotypic Study of Safety, Tolerability, Reactogenicity, Immunogenicity, and Virus Shedding With Post-Vaccination Infections of Emergency-Use-Authorized Vaccines Against COVID-19

Conditions
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COVID-19 Vaccines

Intervention / Treatment
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* Biological: COVID-19 vaccines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals 18 or older at the time of consent Intention to vaccinate and of being available for entire study period Exclusion Criteria: Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.

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 |
| --- | --- |
| 80 years of age or older<br>Individuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine | Biological: COVID-19 vaccines<br>* Emergency-use authorized COVID-19 vaccines<br>* Other names: NVX-CoV2373;|
| 60-79 years of age<br>Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine | Biological: COVID-19 vaccines<br>* Emergency-use authorized COVID-19 vaccines<br>* Other names: NVX-CoV2373;|
| 40-59 years of age<br>Individuals in 40-49, 50-59 age range who received COVID-19 vaccine | Biological: COVID-19 vaccines<br>* Emergency-use authorized COVID-19 vaccines<br>* Other names: NVX-CoV2373;|
| 18-39 years of age<br>Individuals in 18-29, 30-39 age range who received COVID-19 vaccine | Biological: COVID-19 vaccines<br>* Emergency-use authorized COVID-19 vaccines<br>* Other names: NVX-CoV2373;|
| MEBO/PATM<br>Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine | Biological: COVID-19 vaccines<br>* Emergency-use authorized COVID-19 vaccines<br>* Other names: NVX-CoV2373;|
| Chronic Disease<br>Individuals with self-reported chronic health conditions who received COVID-19 vaccine | Biological: COVID-19 vaccines<br>* Emergency-use authorized COVID-19 vaccines<br>* Other names: NVX-CoV2373;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions/events | Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2 | 10 days after any dose of study intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term adverse events | Percentage of occurrence, types, duration and severity of adverse events throughout study period | Throughout the study period, until 12 months post-final-dose | 
| Incidence of COVID-19 cases | The number of COVID-19 cases occurring <=14 or ≥ 15 days after any dose of study intervention. | From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Related Side Effects and Adverse Reactions, Long-term adverse effects, Immunogenicity, Vaccine, COVID-19