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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid-19; SARS-CoV-2; Vaccine; Microbiome; Immunogenicity
• Intervention / Treatment: Other: This is observational study

• Study Type: Observational
• Enrollment (Anticipated): 53

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Koera University Guro Hospital
    • Contact: Hye Seong, MD.PhD; Phone Number: +82-10-4840-5965; Email: msmjoonhoo@gmail.com
    • Sub-Investigator: Joon Young Song, MD.PhD
    • Principal Investigator: Hye Seong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 either BNT162b2 (n=27) or 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): July 16, 2021
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021GR0097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No