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

• Conditions: Vaccine; SARS-CoV-2; Immunogenicity; Microbiome; Covid-19
• Interventions: Other: This is observational study

• Registration Number: NCT05150834
• Lead Sponsor: Korea University Guro Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-25
• Primary Completion: 2021-07-16
• Status Verified: 2021-12
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-08
• Last Update Submitted: 2021-12-08
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ChAdOx1 vaccinated group	This is observational study	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.
BNT162b2 vaccinated group	This is observational study	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Koera University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of