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

Korea University

Status: Unknown

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

Treatments: Other: This is observational study

Study type: Observational

Funder types: Other

Identifiers

NCT05150834

2021GR0097

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

53 participants in 2 patient groups

ChAdOx1 vaccinated group

Description:

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.

Treatment:

Other: This is observational study

BNT162b2 vaccinated group

Description:

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.

Treatment:

Other: This is observational study