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
Brief Summary

During the study, members of different online and offline communities will be followedpost COVID-19 vaccination.Injection-site (local) and systemic reaction data will be assessed on vaccination day andafterwards using either web surveys or personal communication, depending on studyparticipant preference.Hypothesis to be tested: The safety profile and the magnitude and durability of immuneresponses to the COVID-19 vaccines as well as adverse reactions depend on healthconditions, 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.

Active, not recruiting
COVID-19 Vaccines

Biological: COVID-19 vaccines

Emergency-use authorized COVID-19 vaccines
Other Name: BNT162b2,mRNA-1273,JNJ-78436735,AZD1222,Gam-KOVID-Vak,CoronaVac/Sinovac,BBIBP-CorV,BBV152,NVX-CoV2373

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Georgia
Kenya
United Kingdom
United States
Locations

MEBO Research, Inc
Miami, Florida, United States

Kahite
Vonore, Tennessee, United States

Gabashvili
Tbilisi, Georgia

MEBO Research Africa
Kilifi, Kenya

Mebo Research (Uk)
London, England, United Kingdom

Irene Gabashvili, PhD, Principal Investigator
Mebo Research, Inc.

NCT Number
Keywords
Drug-Related Side Effects and Adverse Reactions
Long-term adverse effects
Immunogenicity, Vaccine
Covid-19
MeSH Terms
COVID-19