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

Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines: Adenovirus-vectored Vaccine Versus mRNA Vaccine

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05150834
Enrollment
53
Registered
2021-12-09
Start date
2021-02-25
Completion date
2023-12-31
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19, Immunogenicity, Microbiome, SARS-CoV-2, Vaccine

Brief 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. Thus, the investigators investigated the relationship between gut microbiota and humoral immune response after COVID-19 vaccination.

Interventions

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

Sponsors

Korea University Guro Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Taxonomic biomarkers predicting immune responsesbefore the administration of first-doseThis study aimed to analyze whether fecal microbiota composition before vaccination was associated with immmune response level

Secondary

MeasureTime frameDescription
Antibody titres after the first dose vaccination3weeks from the first-dose administration in BNT162b2 group, 8-12weeks from the first-dose administration in ChAdOx1This study aimed to analyze maximum immune response after first dose vaccination
Antibody titres after the second dose vaccination3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groupsThis study aimed to analyze maximum immune response after second dose vaccination

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026