The COVID-19 Back-to-Normal Study
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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 |
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Recruitment Status :
Recruiting
First Posted : April 6, 2021
Last Update Posted : July 28, 2022
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Sponsor:
Mebo Research, Inc.
Collaborator:
Aurametrix
Information provided by (Responsible Party):
Mebo Research, Inc.
- Study Details
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- No Results Posted
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- How to Read a Study Record
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 |
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 |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| 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 : | June 15, 2021 |
| Estimated Primary Completion Date : | September 15, 2022 |
| Estimated Study Completion Date : | April 15, 2023 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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80 years of age or older
individuals 80 years of age and older who received COVID-19 vaccine
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Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
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65-79 years of age
individuals 65-74 years of age who received COVID-19 vaccine
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Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
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50-64 years of age
Individuals in 18-64 age range who received COVID-19 vaccine
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Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
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18-49 years of age
Individuals in 18-49 age range who received COVID-19 vaccine
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Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
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MEBO/PATM
Individuals in 18-69 age range with present or past MEBO/PATM symptoms who received COVID-19 vaccine
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Biological: COVID-19 vaccines
Emergency-use authorized COVID-19 vaccines
Other Names:
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Primary Outcome Measures :
- 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 :
- 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
- 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.
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.
| 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.
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
| Contact: Maria de la Torre | (786) 228-6880 | studies@aurametrix.com |
Locations
| 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 | |
| Georgia | |
| Irene Gabashvili | Recruiting |
| Tbilisi, Georgia | |
| Contact: Irene Gabashvili, PhD studies@aurametrix.com | |
| Kenya | |
| MEBO Research Africa | Recruiting |
| Kilifi, Kenya, 8 010 | |
| Contact: Oscar Ikinya meboafrica@gmail.com | |
| 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
| Principal Investigator: | Irene Gabashvili, PhD | Mebo Research, Inc. |
Additional Information:
| 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: | July 28, 2022 |
| Last Verified: | July 2022 |
| 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 |
| 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.:
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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 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |