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

COVID-19 Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04832932
• Other study ID #: 20210103MEBO
• Status: Active, not recruiting
• Start date: January 5, 2021
• Est. completion date: January 5, 2025

Study information

• Verified date: January 2024
• Source: Mebo Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: January 5, 2025
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Vaccines

Intervention

Biological:
• COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines

Locations

Country	Name	City	State
Georgia	Gabashvili	Tbilisi
Kenya	MEBO Research Africa	Kilifi
United Kingdom	Mebo Research (Uk)	London	England
United States	MEBO Research, Inc	Miami	Florida
United States	Kahite	Vonore	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Mebo Research, Inc.	Aurametrix

Countries where clinical trial is conducted

United States,  Georgia,  Kenya,  United Kingdom, 

References & Publications (1)

Gabashvili IS. The Incidence and Effect of Adverse Events Due to COVID-19 Vaccines on Breakthrough Infections: Decentralized Observational Study With Underrepresented Groups. JMIR Form Res. 2022 Nov 4;6(11):e41914. doi: 10.2196/41914. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Study updates