UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043350 |
|---|---|
| Receipt number | R000049495 |
| Scientific Title | Elucidation of immune response behavior and factors by COVID-19 vaccination |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2023/07/20 23:42:32 |
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Basic information
Public title
Clinical trial of laboratory testing for immune response induced by COVID-19 vaccine
Acronym
COVID-19 vaccination/ immune response program
Scientific Title
Elucidation of immune response behavior and factors by COVID-19 vaccination
Scientific Title:Acronym
COVID-19 vaccination/ immune response program
Region
| Japan |
Condition
Condition
Coronavirus disease 2019 (COVID-19)
Classification by specialty
| Infectious disease | Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the behavior of clinical laboratory tests such as SARS-CoV-2 antibody titer, inflammatory cytokines, and cell-mediated immunity by COVID-19 vaccine, and to search for factors related to the magnitude and persistence of vaccine action by clinical laboratory tests.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 antibody titers (neutralizing antibody titers and nucleocapsid-antibody, spike-antibody by multiple reagents): humoral immunity
Key secondary outcomes
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
| Vaccine | Maneuver |
Interventions/Control_1
Since the booster effect of the 3rd vaccination was confirmed, the plan was changed to a total of 15 blood samplings, 6 times after the 3rd vaccination. In addition, follow-up will be conducted for 4 months after the 4th vaccination, and blood will be collected a total of 21 times. The term shall be two years.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who recruited by poster and applied
2. Those who have obtained consent for this research by signing the consent form by the person himself / herself.
Key exclusion criteria
1.Those who cannot tolerate multiple blood draws due to thin blood vessels.
2.Those who have difficulty collecting blood and have strong pain.
3.Those with a history of vasovagal reflex.
4.Those who have already been vaccinated with COVID-19 vaccine.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Maekawa |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2721
mmaekawa@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Yamashita |
Organization
Hamamatsu University School of Medicine
Division name
Department of Laboratory Medicine/Clinical Laboratory
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2723
Homepage URL
keitay@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine Institutional Review Board
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel
053-435-2111
rinri@hama-med.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 | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2076-393X/10/7/1050
Number of participants that the trial has enrolled
51
Results
Interim analysis results up to 2 weeks after the third vaccination (peak phase) were published in Vaccines 2022, 10(7), 1050; https://doi.org/10.3390/vaccines10071050'.
We have clarified the behavior of long-term humoral and cell-mediated immunity against SARS-CoV-2 and characterized the antibody assay system. We are currently analyzing the behavior in the third/fourth vaccination (booster).
Results date posted
| 2021 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
No adverse events occurred. No participants were infected with the new coronavirus until the third vaccination.
After the fourth vaccination, 29 study participants continued.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049495
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