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

NCT05150834 | Unknown

• 1 other identifier: 2021GR0097
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Antibody titres after the second dose vaccination

  3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groups

Study Arms (2)

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

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

Interventions

This is observational study OTHER

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

BNT162b2 vaccinated group; ChAdOx1 vaccinated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Koera University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 9, 2021
• Study Start: February 25, 2021
• Primary Completion: July 16, 2021
• Study Completion: December 31, 2023
• Last Updated: December 9, 2021

Record last verified: 2021-12

Locations

KR (1)