The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes

NCT04832932 | Unknown FDA Drug

• 1 other identifier: 20210103MEBO
• Study Type: observational
• Target: 2,000
• Locations: 4 countries
• Sites: 5

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.

Conditions

COVID-19 Vaccines

Keywords

Drug-Related Side Effects and Adverse Reactions; Long-term adverse effects; Immunogenicity, Vaccine; COVID-19

Outcome Measures

Primary Outcomes (1)

• Adverse reactions/events

  Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2

  10 days after any dose of study intervention.

Secondary Outcomes (2)

• Long-term adverse events

  Throughout the study period, until 12 months post-final-dose

• Incidence of COVID-19 cases

  From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose

Study Arms (6)

80 years of age or older

Individuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine

Biological: COVID-19 vaccines

60-79 years of age

Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine

Biological: COVID-19 vaccines

40-59 years of age

Individuals in 40-49, 50-59 age range who received COVID-19 vaccine

Biological: COVID-19 vaccines

18-39 years of age

Individuals in 18-29, 30-39 age range who received COVID-19 vaccine

Biological: COVID-19 vaccines

MEBO/PATM

Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine

Biological: COVID-19 vaccines

Chronic Disease

Individuals with self-reported chronic health conditions who received COVID-19 vaccine

Biological: COVID-19 vaccines

Interventions

COVID-19 vaccines BIOLOGICAL

Emergency-use authorized COVID-19 vaccines

Also known as: BNT162b2, mRNA-1273, JNJ-78436735, AZD1222, Gam-KOVID-Vak, CoronaVac/Sinovac, BBIBP-CorV, BBV152, NVX-CoV2373

18-39 years of age; 40-59 years of age; 60-79 years of age; 80 years of age or older; Chronic Disease; MEBO/PATM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals 18 or older interested in vaccinating

You may qualify if:

• Individuals 18 or older at the time of consent
• Intention to vaccinate and of being available for entire study period

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mebo Research, Inc.: lead
• Aurametrix: collaborator

Study Sites (5)

MEBO Research, Inc

Miami, Florida, 33175, United States

Location

Kahite

Vonore, Tennessee, 37885, United States

Location

Gabashvili

Tbilisi, Georgia

Location

MEBO Research Africa

Kilifi, 8 010, Kenya

Location

Mebo Research (Uk)

London, England, W10 5LE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36309347 RESULT

Related Links

• Study updates

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Long Term Adverse Effects; COVID-19

Interventions

COVID-19 Vaccines; BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273; Ad26COVS1; ChAdOx1 nCoV-19; sinovac COVID-19 vaccine; BIBP COVID-19 vaccine; BBV152 COVID-19 vaccine; NVX-CoV2373 adjuvated lipid nanoparticle

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Vaccines, DNA

Study Officials

• Irene Gabashvili, PhD

  Mebo Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 6, 2021
• Study Start: January 5, 2021
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); US (2); KE (1); GB (1)