MicrobiomeNCT05150834
Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines
An observational study of Microbiome and Vaccine, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Vaccination is the best way to mitigate the coronavirus disease 2019 (COVID-19) pandemic, but the vaccine immunogenicity may be quite variable from person to person. There is increasing evidence suggesting that the gut microbiome is a major determinant of vaccine immunogenicity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiome, Vaccine, Covid-19
- What is being tested?
- This is observational study
- Type of treatment
- Vaccines
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2021to 31 Dec 2023
- 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: From Febrary 25, 2021 to July 16, 2021, 53 healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get either BNT162b2 (n=27) or ChAdOx1 (Oxford/AstraZeneca) (n=26) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results.
Who may be able to join
- People assigned to get either BNT162b2 or ChAdOx1 vaccines
- informed concents
Who cannot join
- Participants were excluded if they had a history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Koera University Guro Hospital
Seoul, 08308
Hye Seong, MD.PhD, +82-10-4840-5965, msmjoonhoo@gmail.com
Joon Young Song, MD.PhD
About this study
Official title: Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines: Adenovirus-vectored Vaccine Versus mRNA Vaccine
Vaccination is the best way to mitigate the coronavirus disease 2019 (COVID-19) pandemic, but the vaccine immunogenicity may be quite variable from person to person. There is increasing evidence suggesting that the gut microbiome is a major determinant of vaccine immunogenicity. Thus, the investigators investigated the relationship between gut microbiota and humoral immune response after COVID-19 vaccination.
- Conditions
- Microbiome, Vaccine, Covid-19, SARS-CoV-2, Immunogenicity
- Being tested
- This is observational study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is observational studyOther
We enrolled the healthcare workers assigned to get either BNT162b2 or ChAdOx1 by the Korean government.
| Study group | Role | What they receive |
|---|---|---|
| ChAdOx1 vaccinated group | From Febrary 25, 2021 to July 16, 2021, healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get ChAdOx1 (Oxford/AstraZeneca) (n=26) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results. Receives: Other: This is observational study | |
| BNT162b2 vaccinated group | From Febrary 25, 2021 to July 16, 2021, 53 healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get BNT162b2 (n=27) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results. Receives: Other: This is observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taxonomic biomarkers predicting immune responses
This study aimed to analyze whether fecal microbiota composition before vaccination was associated with immmune response level
Measured: before the administration of first-dose
Secondary outcomes (2)
Antibody titres after the first dose vaccination
This study aimed to analyze maximum immune response after first dose vaccination
Measured: 3weeks from the first-dose administration in BNT162b2 group, 8-12weeks from the first-dose administration in ChAdOx1
Antibody titres after the second dose vaccination
This study aimed to analyze maximum immune response after second dose vaccination
Measured: 3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start25 Feb 2021
- Primary completion16 Jul 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye Seong, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150834
- Sponsor's protocol ID
- 2021GR0097
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines: Adenovirus-vectored Vaccine Versus mRNA Vaccine
- ClinicalTrials.gov ID
- NCT05150834
- Acronym / sponsor ID
- 2021GR0097
- Conditions
- Microbiome, Vaccine, Covid-19, SARS-CoV-2, Immunogenicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Dec 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.
Vaccination is the best way to mitigate the coronavirus disease 2019 (COVID-19) pandemic, but the vaccine immunogenicity may be quite variable from person to person. There is increasing evidence suggesting that the gut microbiome is a major determinant of vaccine immunogenicity. Thus, the investigators investigated the relationship between gut microbiota and humoral immune response after COVID-19 vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChAdOx1 vaccinated group | – | Other: This is observational studyFrom Febrary 25, 2021 to July 16, 2021, healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get ChAdOx1 (Oxford/AstraZeneca) (n=26) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results. |
| BNT162b2 vaccinated group | – | Other: This is observational studyFrom Febrary 25, 2021 to July 16, 2021, 53 healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get BNT162b2 (n=27) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From Febrary 25, 2021 to July 16, 2021, 53 healthy healthcare workers were prospectively recruited at a tertiary hospital in Seoul, Republic of Korea, and they were assigned to get either BNT162b2 (n=27) or ChAdOx1 (Oxford/AstraZeneca) (n=26) vaccines. Participants were excluded if they had history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs; previous history of positive SARS-CoV-2 test on nasopharyngeal PCR; or positive serum Spike IgG results.
Key inclusion criteria (2 listed)
- People assigned to get either BNT162b2 or ChAdOx1 vaccines
- informed concents
Key exclusion criteria (1 listed)
- Participants were excluded if they had a history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs.
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 |
|---|---|---|
| This is observational studyWe enrolled the healthcare workers assigned to get either BNT162b2 or ChAdOx1 by the Korean government. | Other | BNT162b2 vaccinated group, ChAdOx1 vaccinated group |
Primary outcome
Taxonomic biomarkers predicting immune responses
Time frame: before the administration of first-dose
This study aimed to analyze whether fecal microbiota composition before vaccination was associated with immmune response level
2 secondary outcomes
Antibody titres after the first dose vaccination
Time frame: 3weeks from the first-dose administration in BNT162b2 group, 8-12weeks from the first-dose administration in ChAdOx1
Antibody titres after the second dose vaccination
Time frame: 3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiome and Vaccine, run by Korea University Guro Hospital at 1 site in South Korea.
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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taxonomic biomarkers predicting immune responses (time frame: before the administration of first-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2021.