Clinical trial NCT04832932: The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Vaccines
Keywords: Drug-Related Side Effects and Adverse Reactions
Long-term adverse effects
Immunogenicity, Vaccine
COVID-19
Lead sponsor: Mebo Research, Inc.
Sponsor class: OTHER
Collaborators: name: Aurametrix
First posted: 2021-04-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals 18 or older interested in vaccinating

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.

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.

Eligibility 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.

Primary outcomes:
measure: Adverse reactions/events
timeFrame: 10 days after any dose of study intervention.
Secondary outcomes:
measure: Long-term adverse events
timeFrame: Throughout the study period, until 12 months post-final-dose
measure: Incidence of COVID-19 cases
timeFrame: From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: MEBO Research, Inc
state: Florida
city: Vonore
country: United States
facility: Kahite
state: Tennessee
city: Tbilisi
country: Georgia
facility: Gabashvili
city: Kilifi
country: Kenya
facility: MEBO Research Africa
city: London
country: United Kingdom
facility: Mebo Research (Uk)
state: England
Study officials:
affiliation: Mebo Research, Inc.
name: Irene Gabashvili, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.