UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043558 |
|---|---|
| Receipt number | 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 13:41:32 |
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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
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
kakugawa@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Pulmonology and Gerontology, Graduate School of Medicine, Yamaguchi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049712
