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Active, not recruitingNCT04832932Updated Jan 26, 2024

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

An observational study in COVID-19 Vaccines, sponsored by Mebo Research, Inc.. Active, not recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-26.

Sponsored by Mebo Research, Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID-19 Vaccines

Keywords

  • Drug-Related Side Effects and Adverse Reactions
  • Long-term adverse effects
  • Immunogenicity, Vaccine
  • COVID-19
03

In context

Drug-Related Side Effects and Adverse Reactions

449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.

This study's enrollment of 2,000 is above the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

Mebo Research, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Individuals 18 or older interested in vaccinating

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals 18 or older at the time of consent
  • Intention to vaccinate and of being available for entire study period

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
2,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 60-79 years of age

    Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine

    Biological: COVID-19 vaccines

  • 40-59 years of age

    Individuals in 40-49, 50-59 age range who received COVID-19 vaccine

    Biological: COVID-19 vaccines

  • 18-39 years of age

    Individuals in 18-29, 30-39 age range who received COVID-19 vaccine

    Biological: COVID-19 vaccines

  • MEBO/PATM

    Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine

    Biological: COVID-19 vaccines

  • Chronic Disease

    Individuals with self-reported chronic health conditions who received COVID-19 vaccine

    Biological: COVID-19 vaccines

Interventions

  • BiologicalCOVID-19 vaccines

    Emergency-use authorized COVID-19 vaccines

    Also known as: BNT162b2, mRNA-1273, JNJ-78436735, AZD1222, Gam-KOVID-Vak, CoronaVac/Sinovac, BBIBP-CorV, BBV152, NVX-CoV2373

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

07

Study locations

5 sites
  • MEBO Research, Inc
    Miami, Florida 33175, United States
  • Kahite
    Vonore, Tennessee 37885, United States
  • Gabashvili
    Tbilisi, Georgia
  • MEBO Research Africa
    Kilifi, 8 010, Kenya
  • Mebo Research (Uk)
    London, England W10 5LE, United Kingdom
08

References and documents

Publications

  • 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. PubMed 36309347 ↗

Related links

Individual participant data

Plan to share: No — individual participant data will remain confidential, unless specifically requested to be shared by the participant

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04832932
Lead sponsor
Mebo Research, Inc.
Collaborators
Aurametrix
Responsible party
Sponsor
First posted
Apr 6, 2021
Start date
Jan 5, 2021
Primary completion
Jan 5, 2023
Completion
Jan 5, 2025 (estimated)
Last update
Jan 26, 2024

Study contacts

Irene Gabashvili, PhD
principal investigator · Mebo Research, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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