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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043558
Receipt No. R000049712
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
Date of disclosure of the study information 2021/03/10
Last modified on 2021/09/22

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Basic information
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
Condition Regardless of the type of disease
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Respiratory Medicine and Infectious Disease, Yamaguchi University Hospital
National Hospital Organization Yamaguchi Ube Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
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.


Management information
Registered date
2021 Year 03 Month 09 Day
Last modified on
2021 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049712

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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