COVID-19 VaccinesNCT04832932
The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes
An observational study of COVID-19 Vaccines, run by Mebo Research, Inc. at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- COVID-19 vaccines
- Type of treatment
- Vaccines
- How many people
- 2,000 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 5 Jan 2021to 5 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals 18 or older interested in vaccinating
Who may be able to join
- Individuals 18 or older at the time of consent
- Intention to vaccinate and of being available for entire study period
Who cannot join
- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
MEBO Research, Inc
Miami, Florida, 33175
Kahite
Vonore, Tennessee, 37885
About this study
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
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.
Read the 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.
- Conditions
- COVID-19 Vaccines
- Being tested
- COVID-19 vaccines
- Keywords
- Drug-Related Side Effects and Adverse Reactions, Long-term adverse effects, Immunogenicity, Vaccine, COVID-19
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Long Term Adverse Effects, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinesBiological
Also called BNT162b2, mRNA-1273, JNJ-78436735, AZD1222
Emergency-use authorized COVID-19 vaccines
| Study group | Role | What they receive |
|---|---|---|
| 80 years of age or older | Individuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine Receives: Biological: COVID-19 vaccines | |
| 60-79 years of age | Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine Receives: Biological: COVID-19 vaccines | |
| 40-59 years of age | Individuals in 40-49, 50-59 age range who received COVID-19 vaccine Receives: Biological: COVID-19 vaccines | |
| 18-39 years of age | Individuals in 18-29, 30-39 age range who received COVID-19 vaccine Receives: Biological: COVID-19 vaccines | |
| MEBO/PATM | Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine Receives: Biological: COVID-19 vaccines | |
| Chronic Disease | Individuals with self-reported chronic health conditions who received COVID-19 vaccine Receives: Biological: COVID-19 vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions/events
Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2
Measured: 10 days after any dose of study intervention.
Secondary outcomes (2)
Long-term adverse events
Percentage of occurrence, types, duration and severity of adverse events throughout study period
Measured: Throughout the study period, until 12 months post-final-dose
Incidence of COVID-19 cases
The number of COVID-19 cases occurring <=14 or ≥ 15 days after any dose of study intervention.
Measured: From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start5 Jan 2021
- Primary completion5 Jan 2023
- Study completion5 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mebo Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Aurametrix
- Responsible party
- Sponsor
- Investigators
- Irene Gabashvili, PhD, Principal investigator, Mebo Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832932
- Sponsor's protocol ID
- 20210103MEBO
- Status last verified
- Jan 2024
- First submitted
- 2 Apr 2021
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will remain confidential, unless specifically requested to be shared by the participant
Publications
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.
PubMed 36309347
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04832932
- Acronym / sponsor ID
- 20210103MEBO
- Conditions
- COVID-19 Vaccines
- Keywords
- Drug-Related Side Effects and Adverse Reactions, Long-term adverse effects, Immunogenicity, Vaccine, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Mebo Research, Inc.University, hospital or other
- Collaborators
- Aurametrix
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2025 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 80 years of age or older | – | Biological: COVID-19 vaccinesIndividuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine |
| 60-79 years of age | – | Biological: COVID-19 vaccinesIndividuals 60-69 and 70-79 years of age who received COVID-19 vaccine |
| 40-59 years of age | – | Biological: COVID-19 vaccinesIndividuals in 40-49, 50-59 age range who received COVID-19 vaccine |
| 18-39 years of age | – | Biological: COVID-19 vaccinesIndividuals in 18-29, 30-39 age range who received COVID-19 vaccine |
| MEBO/PATM | – | Biological: COVID-19 vaccinesIndividuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine |
| Chronic Disease | – | Biological: COVID-19 vaccinesIndividuals with self-reported chronic health conditions who received COVID-19 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals 18 or older interested in vaccinating
Key inclusion criteria (2 listed)
- Individuals 18 or older at the time of consent
- Intention to vaccinate and of being available for entire study period
Key exclusion criteria (1 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccinesAlso: BNT162b2, mRNA-1273, JNJ-78436735, AZD1222Emergency-use authorized COVID-19 vaccines | Biological | 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 |
Primary outcome
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
2 secondary outcomes
Long-term adverse events
Time frame: Throughout the study period, until 12 months post-final-dose
Incidence of COVID-19 cases
Time frame: From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Results publication: PubMed 36309347Gabashvili 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.
- Study updatesLink provided by the sponsor.
- Individual participant dataSharing planned: No. individual participant data will remain confidential, unless specifically requested to be shared by the participant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Gabashvili, PhD principal investigator
Mebo Research, Inc.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccines, run by Mebo Research, Inc. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Georgia, Kenya, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reactions/events (time frame: 10 days after any dose of study intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.