UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049834 |
|---|---|
| Receipt number | R000056765 |
| Scientific Title | Exploring the utility of enzyme-linked immunospot assays in previous COVID-19 and SARS-CoV-2 vaccinated individuals |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2022/12/19 23:34:25 |
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Basic information
Public title
Exploring the utility of enzyme-linked immunospot assays in previous COVID-19 and SARS-CoV-2 vaccinated individuals
Acronym
Exploring the utility of enzyme-linked immunospot assays in previous COVID-19 and SARS-CoV-2 vaccinated individuals
Scientific Title
Exploring the utility of enzyme-linked immunospot assays in previous COVID-19 and SARS-CoV-2 vaccinated individuals
Scientific Title:Acronym
Exploring the utility of enzyme-linked immunospot assays in previous COVID-19 and SARS-CoV-2 vaccinated individuals
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluated various participants, twice/once vaccinated and with/without a COVID-19 history, using the ELISPOT assay and ELISA to assess cellular and humoral immunity against COVID-19. Participants were asked to complete a questionnaire survey to determine symptoms during infection for those affected by COVID-19 and adverse reactions after vaccination for those vaccinated. These results provide new insights into the relationship between symptomatic infection and cellular immunity.
Basic objectives2
Others
Basic objectives -Others
Same as Objective 1
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COVID-19 immunity status measured by ELISA and ELISPOT assay in populations with different COVID-19 infection histories and vaccinated statuses
Key secondary outcomes
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Group 1: five participants who had recovered from COVID-19 and had received only one dose of COVID-19 mRNA vaccine after COVID-19; Group 2: five participants who had recovered from COVID-19 and had received two doses of COVID-19 mRNA vaccine after COVID-19; and Group 3: 20 participants who had received two doses of COVID-19 mRNA vaccine and had no history of COVID-19
Key exclusion criteria
If the applicant does not meet the age criteria or it is difficult to obtain his/her consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Sawaki |
Organization
The Jikei University School of Medicine
Division name
Department of Infectious Diseases and Infection Control
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
k_sawaki@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Sawaki |
Organization
The Jikei University School of Medicine
Division name
Department of Infectious Diseases and Infection Control
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
k_sawaki@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
crb@jikei.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
| 2022 | Year | 12 | Month | 19 | 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
30
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 | 12 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood test: the T-SPOT Discovery SARS-CoV-2 assay kit (Oxford Immunotec, UK) and the Abbott SARS-CoV-2 IgG II quantification assay (Abbott SARS-CoV-2 IgG II Quant assay; Abbott, Lake Bluff, IL, USA)
Questionnaire: The survey asked the following questions; age, sex, underlying medical conditions, medications, adverse reactions to COVID-19 vaccination, history of COVID-19 infection, and symptoms during infection in those with a history of COVID-19
Management information
Registered date
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056765
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
