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Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines

NCT ID: NCT05150834

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-25

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Microbiome Vaccine Covid-19 SARS-CoV-2 Immunogenicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

This is observational study

Intervention Type OTHER

We enrolled the healthcare workers assigned to get either BNT162b2 or ChAdOx1 by the Korean government.

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.

This is observational study

Intervention Type OTHER

We enrolled the healthcare workers assigned to get either BNT162b2 or ChAdOx1 by the Korean government.

Interventions

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This is observational study

We enrolled the healthcare workers assigned to get either BNT162b2 or ChAdOx1 by the Korean government.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* People assigned to get either BNT162b2 or ChAdOx1 vaccines
* informed concents

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hye Seong

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Koera University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Hye Seong, MD.PhD

Role: primary

Other Identifiers

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2021GR0097

Identifier Type: -

Identifier Source: org_study_id