Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-01 @ 4:04 PM
Study NCT ID:
NCT04832932
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2021-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes
Sponsor:
Mebo Research, Inc.
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: