COVID-19 Vaccines
Conditions
Keywords
Drug-Related Side Effects and Adverse Reactions, Long-term adverse effects, Immunogenicity, Vaccine, COVID-19
Brief summary
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
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.
Interventions
BIOLOGICALCOVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Sponsors
Aurametrix
Mebo Research, Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions/events | 10 days after any dose of study intervention. | Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term adverse events | Throughout the study period, until 12 months post-final-dose | Percentage of occurrence, types, duration and severity of adverse events throughout study period |
| Incidence of COVID-19 cases | From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose | The number of COVID-19 cases occurring \<=14 or ≥ 15 days after any dose of study intervention. |
Countries
Georgia, Kenya, United Kingdom, United States
Outcome results
None listed