Background factors affecting the effectiveness of the COVID-19 vaccine and their association with the microbiomes in the oral cavity and intestinal tract

Investigation of immunogenicity and persistence of the COVID-19 vaccine, background factors affecting them, and potential of the microbiomes in the oral cavity and intestinal tract as predictive markers of immunogenicity and persistence - Investigation of immunogenicity and persistence of the COVID-19 vaccine, background factors affecting them, and potential of the microbiomes in the oral cavity and intestinal tract as predictive markers of immunogenicity and persistence

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043558

Enrollment

180

Registered

2021-03-10

Start date

2021-03-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regardless of the type of disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those who are planning to receive the COVID-19 vaccine. 2) Patients who are admitted to the Hofu Rehabilitation Hospital Integrated Facility for Medical and Long-Term Care or Hofu Rehabilitation Hospital, patients visiting Hofu Rehabilitation Hospital outpatient clinic, patients undergoing a home visit from Hofu Rehabilitation Hospital, or patients who are visiting the outpatient department of Respiratory Medicine and Infectious Disease, Yamaguchi University Hospital, or who are hospitalized to department of Respiratory Medicine and Infectious Disease, Yamaguchi University Hospital. 3) Persons who have received sufficient explanation regarding participation in this study with voluntary written consent provided by the person or their guardians after sufficient understanding.

Exclusion criteria

Exclusion criteria: Key exclusion criteria 1) Those who do not wish to be vaccinated with COVID-19 vaccine. 2) Those who have a history of COVID-19. 3) Those who are judged to be inappropriate for registration at the discretion of the doctor in charge.

Design outcomes

Primary

Measure	Time frame
Relationship of immunogenicity (serum antibody titer to severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] and T-cell reactivity in peripheral blood mononuclear cells [PBMCs] to SARS-CoV-2 antigen) and its transition at 6 months and at 1 year after COVID-19 vaccination with the clinical background of subjects.	—

Secondary

Measure	Time frame
1) Relationship of immunogenicity (serum antibody titer to SARS-CoV-2) and its transition 8 weeks and 12 weeks after COVID-19 vaccination with the clinical background of subjects. 2) Relationship of immunogenicity and its transition after administration of the COVID-19 vaccine with the subsequent health status of subjects for 1 year (onset of COVID-19, pneumonia, fever >= 37.5 degrees Celsius, influenza, hospitalization episodes, unscheduled hospital visit episodes, death, and adverse reactions after COVID-19 vaccination). 3) Relationship of immunogenicity and its one-year transition after administration of the COVID-19 vaccine with the microbiomes in the oral cavity and intestinal tract. 4) Relationship of the microbiomes in the oral cavity and intestinal tract with the clinical background of subjects. 5) Relationship of the microbiomes in the oral cavity and intestinal tract with subsequent one-year health status of subjects (onset of COVID-19, pneumonia, fever >= 37.5 degrees Celsius, influenza, hospitalization episodes, unscheduled hospital visit episodes, death, and adverse reactions after COVID-19 vaccination).	—

Measure

Time frame

1) Relationship of immunogenicity (serum antibody titer to SARS-CoV-2) and its transition 8 weeks and 12 weeks after COVID-19 vaccination with the clinical background of subjects. 2) Relationship of immunogenicity and its transition after administration of the COVID-19 vaccine with the subsequent health status of subjects for 1 year (onset of COVID-19, pneumonia, fever >= 37.5 degrees Celsius, influenza, hospitalization episodes, unscheduled hospital visit episodes, death, and adverse reactions after COVID-19 vaccination). 3) Relationship of immunogenicity and its one-year transition after administration of the COVID-19 vaccine with the microbiomes in the oral cavity and intestinal tract. 4) Relationship of the microbiomes in the oral cavity and intestinal tract with the clinical background of subjects. 5) Relationship of the microbiomes in the oral cavity and intestinal tract with subsequent one-year health status of subjects (onset of COVID-19, pneumonia, fever >= 37.5 degrees Celsius, influenza, hospitalization episodes, unscheduled hospital visit episodes, death, and adverse reactions after COVID-19 vaccination).

—

Countries

Japan

Contacts

Public ContactTomoyuki Kakugawa

Graduate School of Medicine, Yamaguchi University Department of Pulmonology and Gerontology

kakugawa@yamaguchi-u.ac.jp0836-22-2196

Outcome results