The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes

Mebo Research, Inc.2,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

COVID-19 Vaccines

Interventions

COVID-19 vaccinesBIOLOGICAL

Emergency-use authorized COVID-19 vaccines

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

MEBO Research, Inc

Miami, Florida, United States

Kahite

Vonore, Tennessee, United States

Gabashvili

Tbilisi, Georgia

MEBO Research Africa

Kilifi, Kenya

Mebo Research (Uk)

Outcomes

Primary Outcomes

Adverse reactions/events

Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2

Time frame: 10 days after any dose of study intervention.

Secondary Outcomes

Long-term adverse events

Percentage of occurrence, types, duration and severity of adverse events throughout study period

Time frame: 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.

Time frame: From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose

Data from ClinicalTrials.gov

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