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

January 25, 2024 updated by: Mebo Research, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia
        • Gabashvili
  • Kenya
      • Kilifi, Kenya, 8 010
        • MEBO Research Africa
  • United Kingdom
    • England
      • London, England, United Kingdom, W10 5LE
        • Mebo Research (Uk)
  • United States
    • Florida
      • Miami, Florida, United States, 33175
        • MEBO Research, Inc
    • Tennessee
      • Vonore, Tennessee, United States, 37885
        • Kahite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals 18 or older interested in vaccinating

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
80 years of age or older
Individuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine
Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
  • mRNA-1273
  • BNT162b2
  • NVX-CoV2373
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
60-79 years of age
Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine
Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
  • mRNA-1273
  • BNT162b2
  • NVX-CoV2373
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
40-59 years of age
Individuals in 40-49, 50-59 age range who received COVID-19 vaccine
Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
  • mRNA-1273
  • BNT162b2
  • NVX-CoV2373
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
18-39 years of age
Individuals in 18-29, 30-39 age range who received COVID-19 vaccine
Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
  • mRNA-1273
  • BNT162b2
  • NVX-CoV2373
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
MEBO/PATM
Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine
Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
  • mRNA-1273
  • BNT162b2
  • NVX-CoV2373
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
Chronic Disease
Individuals with self-reported chronic health conditions who received COVID-19 vaccine
Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
  • mRNA-1273
  • BNT162b2
  • NVX-CoV2373
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reactions/events
Time Frame: 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
10 days after any dose of study intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term adverse events
Time Frame: Throughout the study period, until 12 months post-final-dose
Percentage of occurrence, types, duration and severity of adverse events throughout study period
Throughout the study period, until 12 months post-final-dose
Incidence of COVID-19 cases
Time Frame: 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.
From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mebo Research, Inc.

Collaborators

Aurametrix

Investigators

  • Principal Investigator: Irene Gabashvili, PhD, Mebo Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2021

Primary Completion (Actual)

January 5, 2023

Study Completion (Estimated)

January 5, 2025

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210103MEBO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data will remain confidential, unless specifically requested to be shared by the participant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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