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NCT05150834 Clinical Trial

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

Covid-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05150834
Other study ID # 2021GR0097
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 25, 2021
Est. completion date December 31, 2023

Study information
Verified date December 2021
Source Korea University Guro Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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

Recruitment information / eligibility
Status Recruiting
Enrollment 53
Est. completion date December 31, 2023
Est. primary completion date July 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Koera University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Taxonomic biomarkers predicting immune responses This study aimed to analyze whether fecal microbiota composition before vaccination was associated with immmune response level before the administration of first-dose
Secondary Antibody titres after the first dose vaccination This study aimed to analyze maximum immune response after first dose vaccination 3weeks from the first-dose administration in BNT162b2 group, 8-12weeks from the first-dose administration in ChAdOx1
Secondary Antibody titres after the second dose vaccination This study aimed to analyze maximum immune response after second dose vaccination 3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groups
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