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

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05150834
Collaborator
(none)
53
1
34.1
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: This is observational study

Study Design

Study Type:
Observational
Anticipated Enrollment :
53 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines: Adenovirus-vectored Vaccine Versus mRNA Vaccine
Actual Study Start Date :
Feb 25, 2021
Actual Primary Completion Date :
Jul 16, 2021
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Other: This is observational study
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.

Other: This is observational study
We enrolled the healthcare workers assigned to get either BNT162b2 or ChAdOx1 by the Korean government.

Outcome Measures

Primary Outcome Measures

  1. Taxonomic biomarkers predicting immune responses [before the administration of first-dose]

    This study aimed to analyze whether fecal microbiota composition before vaccination was associated with immmune response level

Secondary Outcome Measures

  1. Antibody titres after the first dose vaccination [3weeks from the first-dose administration in BNT162b2 group, 8-12weeks from the first-dose administration in ChAdOx1]

    This study aimed to analyze maximum immune response after first dose vaccination

  2. Antibody titres after the second dose vaccination [3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groups]

    This study aimed to analyze maximum immune response after second dose vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Koera University Guro Hospital Seoul Korea, Republic of 08308

Sponsors and Collaborators

  • Korea University Guro Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hye Seong, clinical professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT05150834
Other Study ID Numbers:
  • 2021GR0097
First Posted:
Dec 9, 2021
Last Update Posted:
Dec 9, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2021