The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes
- Conditions
- COVID-19 Vaccines
- Interventions
- Biological: COVID-19 vaccines
- Registration Number
- NCT04832932
- Lead Sponsor
- Mebo Research, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- Individuals 18 or older at the time of consent
- Intention to vaccinate and of being available for entire study period
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Disease COVID-19 vaccines Individuals with self-reported chronic health conditions who received COVID-19 vaccine 60-79 years of age COVID-19 vaccines Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine 80 years of age or older COVID-19 vaccines Individuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine 40-59 years of age COVID-19 vaccines Individuals in 40-49, 50-59 age range who received COVID-19 vaccine 18-39 years of age COVID-19 vaccines Individuals in 18-29, 30-39 age range who received COVID-19 vaccine MEBO/PATM COVID-19 vaccines Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (5)
MEBO Research, Inc
🇺🇸Miami, Florida, United States
MEBO Research Africa
🇰🇪Kilifi, Kenya
Gabashvili
🇬🇪Tbilisi, Georgia
Kahite
🇺🇸Vonore, Tennessee, United States
Mebo Research (Uk)
🇬🇧London, England, United Kingdom