UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045492 |
|---|---|
| Receipt number | R000051936 |
| Scientific Title | Prospective study on evaluation of immune response after SARS-CoV-2 vaccination |
| Date of disclosure of the study information | 2021/09/16 |
| Last modified on | 2021/09/15 20:01:34 |
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Basic information
Public title
Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Acronym
Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Scientific Title
Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Scientific Title:Acronym
Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Region
| Japan |
Condition
Condition
Healthy Subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine immune response and the relation with background in subjects inoculated with SARS-CoV-2 vaccine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 neutralizing antibody titer
Anti-spike protein IgG antibody titer
Cellular immunity (cytokine-producing cell count)
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
| Other |
Interventions/Control_1
Blood sampling
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Participants who will vaccinate against SARS-CoV-2
2. Participants who signed informed consent.
3. Participants who agreed to participate in "Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination" (UMIN ID:UMIN000045107) conducted by Shionogi & Co., Ltd.
Key exclusion criteria
1. Participants who have been confirmed to have a history of SARS-CoV-2 infection.
2. A loss of > 200 mL of whole blood or blood components within 12 weeks or > 100 mL within 4 weeks of the first dose of study intervention in male participants. A loss of > 200 mL of whole blood or blood components within 16 weeks or > 100 mL within 4 weeks of the first dose of study intervention in female participants.
3. Current enrollment or past participation within the last 30 days before signing of ICF in any other clinical study involving an clinical study or any other type of medical research.
4. Participants who have been confirmed to be positive in human immunodeficiency virus (HIV) antigen/antibody test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody test result.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Toshinobu |
| Middle name | |
| Last name | Iwasaki |
Organization
Shionogi & Co., Ltd.
Division name
Drug Development and Regulatory Science Division
Zip code
541-0045
Address
1-8, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan
TEL
06-6202-2161
Shokuiki_antibody@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Seki |
Organization
Shionogi & Co., Ltd.
Division name
Clinical Research Department
Zip code
541-0045
Address
1-8, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan
TEL
06-6202-2161
Homepage URL
Shokuiki_antibody@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
20-9-401, 5-chome, Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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 | 16 | 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
143
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 | 08 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051936
