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The COVID-19 Back-to-Normal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04832932
Recruitment Status : Active, not recruiting
First Posted : April 6, 2021
Last Update Posted : January 17, 2023
Sponsor:
Collaborator:
Aurametrix
Information provided by (Responsible Party):
Mebo Research, Inc.

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
COVID-19 Vaccines Biological: COVID-19 vaccines

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 Design
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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Other
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
Actual Study Start Date : January 5, 2021
Actual Primary Completion Date : January 5, 2023
Estimated Study Completion Date : January 5, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
  • NVX-CoV2373
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:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
  • NVX-CoV2373
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:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
  • NVX-CoV2373
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:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
  • NVX-CoV2373
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:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
  • NVX-CoV2373
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:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak
  • CoronaVac/Sinovac
  • BBIBP-CorV
  • BBV152
  • NVX-CoV2373


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals 18 or older interested in vaccinating
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832932


Locations
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United States, Florida
MEBO Research, Inc
Miami, Florida, United States, 33175
United States, Tennessee
Kahite
Vonore, Tennessee, United States, 37885
Georgia
Gabashvili
Tbilisi, Georgia
Kenya
MEBO Research Africa
Kilifi, Kenya, 8 010
United Kingdom
Mebo Research (Uk)
London, England, United Kingdom, W10 5LE
Sponsors and Collaborators
Mebo Research, Inc.
Aurametrix
Investigators
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Principal Investigator: Irene Gabashvili, PhD Mebo Research, Inc.
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT04832932    
Other Study ID Numbers: 20210103MEBO
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: January 17, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data will remain confidential, unless specifically requested to be shared by the participant

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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
Keywords provided by Mebo Research, Inc.:
Drug-Related Side Effects and Adverse Reactions
Long-term adverse effects
Immunogenicity, Vaccine
COVID-19
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases