NCT04832932

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: Mebo Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 vaccines	Emergency-use authorized COVID-19 vaccines

Timeline

• Start date: 2021-01-05
• Primary completion: 2023-01-05
• Completion: 2025-01-05
• First posted: 2021-04-06
• Last updated: 2024-01-26

Locations

5 sites across 4 countries: United States, Georgia, Kenya, United Kingdom

Regulatory

• FDA-regulated drug study