UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045405 |
|---|---|
| Receipt number | R000051846 |
| Scientific Title | Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2021/12/02 14:35:14 |
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Basic information
Public title
Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Acronym
Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Scientific Title
Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Scientific Title:Acronym
Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Basic objectives2
Others
Basic objectives -Others
To confirm antibodies against SARS-CoV-2 variants in adults after vaccination
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons over 20 years old who have received two doses of Pfizer's SARS-CoV-2 vaccine and have been vaccinated for at least two weeks, and who can consent to donating a sample (30 persons)
2.Persons who participated in a clinical study prior to the COVID-19 pandemic outbreak (prior to December 2019) and who consented to their samples being used for measurements other than those in the study at that time (10 persons)
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Ohkuma |
Organization
Research Center for Immunological Analysis, Inc.
Division name
None
Zip code
701-1221
Address
5303 Haga, Kita-ku, Okayama-shi, Okayama
TEL
086-286-9333
a-okuma@menekibunseki.com
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Nagase |
Organization
Research Center for Immunological Analysis, Inc.
Division name
None
Zip code
701-1221
Address
5303 Haga, Kita-ku, Okayama-shi, Okayama
TEL
086-286-9333
Homepage URL
k-nagase@menekibunseki.com
Sponsor or person
Institute
Research Center for Immunological Analysis, Inc.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
Tel
0868-54-1199
rt2067@yamada-bee.com
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 | 09 | 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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051846
