UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045097 |
|---|---|
| Receipt number | R000051522 |
| Scientific Title | Prospective study on evaluation of immunological response after SARS-CoV-2 vaccination |
| Date of disclosure of the study information | 2021/08/09 |
| Last modified on | 2023/08/08 16:49:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective study on evaluation of immunological response after SARS-CoV-2 vaccination
Acronym
Prospective study on evaluation of immunological response after SARS-CoV-2 vaccination
Scientific Title
Prospective study on evaluation of immunological response after SARS-CoV-2 vaccination
Scientific Title:Acronym
Prospective study on evaluation of immunological response after SARS-CoV-2 vaccination
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate immunological response in those who get SARS-CoV-2 vaccine.
In addition, we evaluate the relation between serum neutralizing antibody titer and SARS-CoV-2 infection by analyzing with the result from "Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination" which we conduct parallelly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antibody titer for virus neutralization activity
Key secondary outcomes
- IgG antibody titer to SARS-CoV-2 spike protein
- Cell-mediated immunity (Number of cell producing cytokines)
- Th1/Th2 balance
- SARS-CoV-2 infection
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who are vaccinated against SARS-CoV-2 (Participation to this study from the 2nd vaccination is permitted.)
2. Those who consented to this study and signed in the ICF.
3. Those who have no comorbidity of HIV infection or hepatitis b/c, and those who were confirmed by medical interview that they were not carriers of HIV, HBV and HBV.
Key exclusion criteria
1. For male, those who more than 200 mL of their whole blood or blood component has been lost within 12 weeks before consent acquisition, or those who more than 100 mL of their whole blood or blood component has been lost within 4 weeks before consent acquisition. For female, those who more than 200 mL of their whole blood or blood component has been lost within 16 weeks before consent acquisition, or those who more than 100 mL of their whole blood or blood component has been lost within 4 weeks before consent acquisition.
2. Those who participated in other clinical studies within 30 days before consent acquisition, or are participating in other clinical studies except for "Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination" conducted by Shionogi & Co., Ltd.
Target sample size
7380
Research contact person
Name of lead principal investigator
| 1st name | Shinzo |
| Middle name | |
| Last name | Hiroi |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Japan
TEL
06-6202-2161
shinzo.hiroi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Tanaka |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
100-0005
Address
1-8-2, Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-5219-7306
Homepage URL
shintarou.tanaka@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
Social Medical Corporation Sanshikai Ethics committee on Clinical Research
Address
232, Funako, Atsugi-Shi, Kanagawa-Ken, 243-8571, Japan
Tel
046-229-2221
chiken@tomei.or.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 | 08 | Month | 09 | 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
205
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 | 04 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2021 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051522
