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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04832932
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : June 18, 2021
Sponsor:
Collaborator:
Aurametrix
Information provided by (Responsible Party):
Mebo Research, Inc.

Brief Summary:

During the study, members of different neighborhood and digital 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 vaccine

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 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Phenotypic Study of Safety, Tolerability, Reactogenicity, Immunogenicity, and Virus Shedding Potential of Emergency-Use-Authorized Vaccines Against COVID-19
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : December 31, 2022

Group/Cohort Intervention/treatment
75 years of age or older
individuals 75 years of age and older who received COVID-19 vaccine
Biological: COVID-19 vaccine
Emergency-use authorized COVID-19 vaccine
Other Names:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak

65-74 years of age
individuals 65-74 years of age who received COVID-19 vaccine
Biological: COVID-19 vaccine
Emergency-use authorized COVID-19 vaccine
Other Names:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak

16-64 years of age
Individuals in 16-64 age range who received COVID-19 vaccine
Biological: COVID-19 vaccine
Emergency-use authorized COVID-19 vaccine
Other Names:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak

MEBO/PATM
Individuals in 16-69 age range with present or past MEBO/PATM symptoms who received COVID-19 vaccine
Biological: COVID-19 vaccine
Emergency-use authorized COVID-19 vaccine
Other Names:
  • BNT162b2
  • mRNA-1273
  • JNJ-78436735
  • AZD1222
  • Gam-KOVID-Vak




Primary Outcome Measures :
  1. Adverse reactions/events [ Time Frame: 10 days post-doses 1 and 2 ]
    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. Percentage of participants with COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose ]


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:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals 16 or older interested in vaccinating
Criteria

Inclusion Criteria:

  • Individuals 16 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.

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


Contacts
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Contact: Maria de la Torre (786) 228-6880 maria.delatorre@meboresearch.org

Locations
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United States, Florida
MEBO Research, Inc Recruiting
Miami, Florida, United States, 33175
Contact: Maria de la Torre    786-228-6880    maria.delatorre@meboresearch.org   
Contact: Michael Arenibar, MBA         
United States, Tennessee
Kahite Recruiting
Vonore, Tennessee, United States, 37885
Contact: Irene G Allsup, PhD    408-341-9355    studies@aurametrix.com   
Contact: Lavonne Mitchell         
United States, Virginia
Mary Washington Hospital Research Not yet recruiting
Fredericksburg, Virginia, United States, 22401
Contact: Christine Emery, BSN, RN    540-741-4708    Christine.Emery@mwhc.com   
Kenya
MEBO Research Africa Recruiting
Kilifi, Kenya, 8 010
Contact: Oscar Ikinya         
Contact       oscar@meboafrica.org   
United Kingdom
Mebo Research (Uk) Recruiting
London, England, United Kingdom, W10 5LE
Contact: Cole Flaherty       cole@meboresearch.co.uk   
Contact: Maria de la Torre       maria.delatorre@meboresearch.org   
Sponsors and Collaborators
Mebo Research, Inc.
Aurametrix
Investigators
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Principal Investigator: Irene Gabashvili, PhD Mebo Research, Inc.
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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: June 18, 2021
Last Verified: June 2021
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