UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053552 |
|---|---|
| Receipt number | R000061111 |
| Scientific Title | Research aimed at elucidating the relationship between viral load and mucosal antibody in influenza |
| Date of disclosure of the study information | 2024/02/12 |
| Last modified on | 2026/07/29 11:28:17 |
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Basic information
Public title
Investigation of the relationship between influenza virus and antibodies in nasal swabs
Acronym
The relationship between influenza virus and antibodies
Scientific Title
Research aimed at elucidating the relationship between viral load and mucosal antibody in influenza
Scientific Title:Acronym
The relationship between viral load and mucosal antibody in influenza
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Pneumology | Infectious disease | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the threshold value of mucosal antibody titer required to suppress virus shedding.
Basic objectives2
Others
Basic objectives -Others
the relationship between viral load and mucosal antibody
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Threshold value based on logistic regression and ROC analysis using specific antibody titer against influenza virus antigen and success/failure of virus isolation test
Key secondary outcomes
Sensitivity, specificity, and ROC-AUC were determined by logistic regression and ROC analysis using specific antibody titers against influenza virus antigens and the success or failure of virus isolation tests.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Nasopharyngeal swab collection
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Persons who have completed junior high school or are over 16 years old and under 80 years old at the time of obtaining consent
2) Patients with a positive influenza rapid diagnostic test (RAT) performed using a nasal cavity or nasopharyngeal swab on the day of consent acquisition
3) Subjects who have received sufficient explanation and informed written consent of their own free will to participate in this study.
Key exclusion criteria
Persons who fall under any of the following
1)Patients who have received anti-influenza virus drugs within the past 7 days
2) Other persons deemed unsuitable by the research director
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kohtaro |
| Middle name | |
| Last name | Fujihashi |
Organization
Chiba University Hospital
Division name
Department of Human Mucosal Vaccinology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670 Japan
TEL
043-222-7171
kfujihashi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Morio |
| Middle name | |
| Last name | Nagira |
Organization
Chiba University Hospital
Division name
Department of Human Mucosal Vaccinology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670 Japan
TEL
043-222-7171
Homepage URL
morio.nagira@shionogi.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shionogi Co. Ltd.
The National Institute of Infectious Diseases
Name of secondary funder(s)
Shionogi Co. Ltd.
IRB Contact (For public release)
Organization
Chiba University Hospital Observational Research Ethics Review Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8677 Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
医療法人 緑風会 みどりクリニック(長崎県)、医療法人社団誠和会 藤木内科外科クリニック(宮崎県)、医療法人ロングウッド 前田クリニック(大阪府)、かめざわクリニック(愛知県)、医療法人 光仁会 たかはし内科(神奈川県)、医療法人社団 たむら医院(東京都)、久保クリニック(神奈川県)、医療法人 慈公会 公平病院(埼玉県)、佐藤クリニック(東京都)、医療法人社団 三友会 彩のクリニック(埼玉県)、医療法人 柴崎内科小児科医院(宮城県)、
医療法人社団 弘惠会 杉浦医院(埼玉県)、社会医療法人 恵和会 西岡病院(北海道)、和田耳鼻咽喉科(神奈川県)、たしろ代謝内科クリニック(福岡県)、万代メディカルクリニック(新潟県)/ Midori Clinic(Nagasaki Pref.)、Fujiki Medical and Surgical Clinic(Miyazaki Pref.)、Maeda Clinic(Osaka Pref.)、Kamezawa Clinic(Aichi Pref.)、Takahashi Internal medicine Clinic(Kanagawa Pref.)、Tamura Clinic(Tokyo)、Kubo Clinic(Kanagawa Pref.)、Kodaira Hospital(Saitama Pref.)、Sato Clinic(Tokyo)、Saino Clinic(Saitama Pref.)、Shibasaki Internal medicine and Pediatrics Clinic(Miyagi Pref.)、Sugiura Clinic(Saitama Pref.)、Nishioka Hospital(Hokkaido)、Wada E.N.T Clinic(Kanagawa Pref.)、Tashiro Endocrinology Clinic(Fukuoka Pref.)、Bandai Medical Clinic(Niigata Pref.)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
499
Results
The correlation between mucosal antibody titers and virological markers was generally weak, and it was difficult to determine a clear antibody threshold for suppressing infectivity based on this cohort alone. However, by estimating late-stage antibody titers based on early-stage titers, we were able to derive estimated thresholds corresponding to increases in antibody titers and the transition to negative viral isolation.
Results date posted
| 2026 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion Criteria
Participants who meet all of the following criteria 1) through 3):
1) Participants who have completed junior high school or are 16 years of age or older but under 80 years of age at the time consent is obtained
2) Patients who tested positive on a rapid influenza diagnostic test (RAT) using a nasal or nasopharyngeal swab sample on the day consent was obtained
3) Participants who, after receiving a thorough explanation regarding participation in this study and fully understanding it, provided written informed consent of their own free will
Exclusion Criteria
Participants who meet any of the following criteria
1) Patients who have taken antiviral medication for influenza within the past 7 days
2) Any other participants deemed ineligible by the principal investigator
Translated with DeepL.com (free version)
Participant flow
Visit to the Clinic
Screening via Rapid Diagnostic Test
Obtaining Consent to Participate in the Study
Collecting Diagnostic Information
Specimen Collection
Routine Medical Care
Return Home
Adverse events
None
Outcome measures
Indicators of viral load: viral RNA copy number, success or failure of virus isolation testing, and viral titer
Indicators of viral classification: viral subtype and viral genome
Immunological assessment parameters for the virus: levels of specific antibodies (IgG, IgA, secretory IgA)
Correction factors for specimen collection: total antibody levels (IgG, IgA, secretory IgA)
Correlation between viral load and immunological assessment parameters
As a subanalysis, we will evaluate the basic statistics, confidence intervals, and correlations of the above parameters by stratifying the data according to the number of days since diagnosis, the number of days since onset, viral subtype, severity of the seven influenza symptoms, history of influenza infection, and vaccination history.
For cases in which a single infection resulted in multiple study participations, the correlation between the number of days from onset until negative viral isolation and negative viral RNA results, and the response of specific antibodies (IgG, IgA, secretory IgA) to influenza antigens
As a subanalysis, we will evaluate the basic statistics, confidence intervals, and correlations for the above items, stratified by the date of symptom resolution, by viral subtype, by the severity of the seven influenza symptoms, by history of influenza infection, and by vaccination history.
Reproducibility and accuracy of immunological assessment items
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061111
