UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048653 |
|---|---|
| Receipt number | R000055441 |
| Scientific Title | Efficacy and Safety of the fourth dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study. |
| Date of disclosure of the study information | 2022/08/12 |
| Last modified on | 2023/11/07 12:58:21 |
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Basic information
Public title
Efficacy and Safety of the fourth dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study.
Acronym
COVID-19 Vaccine 4th study
Scientific Title
Efficacy and Safety of the fourth dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study.
Scientific Title:Acronym
COVID-19 Vaccine 4th study
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the positivity rate of SARS-CoV-2 IgG antibodies in healthy volunteers before and after the fourth dose of novel coronavirus vaccines, as well as to evaluate the post-vaccination adverse reactions that occurred when these vaccines were administered.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the rate of positivity for SARS-CoV-2 IgG antibodies.
Key secondary outcomes
Secondary endpoints will be SARS-CoV-2 IgG antibody titer, T-cell immune response, peripheral blood lymphocyte fraction, IgG, IgA, IgM, and presence and content of post vaccination adverse reactions.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy adults who, at the time of study participation, have no history or comorbidity requiring ongoing medication or treatment, or who have a history of chronic disease but whose condition is stable and who have not required a change in treatment or hospitalization within the past 6 weeks
2) Willing to receive the SARS-CoV-2 vaccination initiated by the Japanese government or local authorities.
3) Have given written consent to participate in the study.
Key exclusion criteria
1) Those deemed inappropriate for participation in the study by the investigator
2) Patients with a history of or coexisting with immunosuppressive medication, autoimmune diseases (systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis/polymyositis, mixed connective tissue disease, systemic scleroderma, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, spondyloarthritis and its related diseases, vasculitis syndrome, inflammatory bowel disease, Guillain-Barre syndrome, neuromyelitis optica) Multiple sclerosis, neuromyelitis optica).
3) Patients with a history of COVID-19
4) Inability to communicate
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Hematology
Zip code
650-0047
Address
2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
TEL
0783024321
ishikawa@kcho.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Nishikubo |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Hematology
Zip code
6500047
Address
2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
TEL
0783024321
Homepage URL
masashi_nishikubo@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
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
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
Tel
0783024321
rinken@kcho.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 | 08 | Month | 12 | 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
10
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
| 2022 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2022 | Year | 08 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055441
