UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Regardless of the type of disease

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1) To explore the immunogenicity and persistence of the coronavirus disease 2019 (COVID-19) vaccine and the background factors affecting them; 2) investigate the relationship of the microbiomes in the oral cavity and intestinal tract to the immunogenicity and persistence of the COVID-19 vaccine; and 3) clarify the relationship of the microbiomes in the oral cavity and intestinal tract to subsequent health status.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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.

Key secondary outcomes

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).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

180

Name of lead principal investigator

1st name	Tomoyuki
Middle name
Last name	Kakugawa

Organization

Graduate School of Medicine, Yamaguchi University

Division name

Department of Pulmonology and Gerontology

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

TEL

0836-22-2196

Email

kakugawa@yamaguchi-u.ac.jp

Name of contact person

1st name	Tomoyuki
Middle name
Last name	Kakugawa

Organization

Graduate School of Medicine, Yamaguchi University

Division name

Department of Pulmonology and Gerontology

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

TEL

0836-22-2196

Homepage URL

Email

kakugawa@yamaguchi-u.ac.jp

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Department of Respiratory Medicine and Infectious Disease, Yamaguchi University Hospital
National Hospital Organization Yamaguchi Ube Medical Center

Name of secondary funder(s)

Organization

Center For Clinical Research, Yamaguchi University Hospital

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

Tel

0836-22-2428

Email

me223@yamaguchi-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

03

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2021

Year

03

Month

05

Day

Date of IRB

2021

Year

03

Month

05

Day

Anticipated trial start date

2021

Year

03

Month

10

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Research outline
For those who will be vaccinated with the coronavirus disease 2019 (COVID-19) vaccine, blood will be collected from before the vaccination to after the vaccination, serum antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will be measured, and the reactivity of T cells in peripheral blood mononuclear cells (PBMCs) against the SARS-CoV-2 antigen will be evaluated to evaluate the immunogenicity and persistence of the COVID-19 vaccine. In addition, the microbiome in the oral cavity and intestinal tract will be analyzed to examine the relationship of the microbiome with immunogenicity and persistence of the COVID-19 vaccine. The relationship of the microbiome in the oral cavity and intestinal tract with subsequent health status will be examined.

Laboratory tests for research purposes
1) Antibody measurement against SARS-CoV-2 (using frozen serum samples before and 8 weeks, 12 weeks, 24 weeks, and 48 weeks after the first inoculation of the COVID-19 vaccine) and T cell reactivity in PBMCs to the SARS-CoV-2 antigen (using frozen PBMC specimens before the COVID-19 vaccination and 24 weeks and 48 weeks after the first inoculation)
2) Samples from the periodontal pocket and tongue coating in the oral cavity will be collected during the period after obtaining consent to 12 weeks after the COVID-19 vaccination. In addition, stool will be collected using a stool collection kit, and 16S rRNA microbiome analysis will be performed using these samples.

Registered date

2021

Year

03

Month

09

Day

Last modified on

2021

Year

09

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049712