UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047043 |
|---|---|
| Receipt number | R000053669 |
| Scientific Title | Neutralizing antibody titer after COVID-19 vaccination in Japanese elderly population |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/08/31 18:16:07 |
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Basic information
Public title
Neutralizing antibody titer after COVID-19 vaccination in Japanese elderly population
Acronym
Neutralizing antibody titer after COVID-19 vaccination in Japanese elderly population
Scientific Title
Neutralizing antibody titer after COVID-19 vaccination in Japanese elderly population
Scientific Title:Acronym
Neutralizing antibody titer after COVID-19 vaccination in Japanese elderly population
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to evaluate the neutralizing antibody titer (NAT) after two doses of messenger RNA vaccine inoculation (mRNA-VA) for SARS-CoV-2 in Japanese Elderly population
Basic objectives2
Others
Basic objectives -Others
The proportion of subjects who had more than or equal to 1280 NAT of convalescent plasm after SARS-CoV-2 infection is suitable for convalescent plasm therapy mentioned by US Food and Drug Administratio
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
neutralizing antibody titer (NAT) after two doses of messenger RNA vaccine inoculation
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age >= 12 years old
2. Two dose inoculation of mRNA vaccine for COVID-19
3. signature of informed consent for participating the study
Key exclusion criteria
No signature of informed consent
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Handa |
Organization
Medical Corporation, Forkmore
Division name
Clinic Ian South Center
Zip code
224-0032
Address
Chigasaki-cyuou 40-3, Tuzuki-ku, Yokohama-shi, Kanagawa, 224-0032, Kanagawa, Japan
TEL
045-945-1125
nobuhiro.handa@c-ian.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takahashi |
Organization
Medical Corporation, Forkmore
Division name
Clinic Ian South Center
Zip code
224-0032
Address
Chigasaki-cyuou 40-3, Tuzuki-ku, Yokohama-shi, Kanagawa, 224-0032, Kanagawa, Japan
TEL
045-945-1125
Homepage URL
https://www.c-ian-centerminami.com/archives/category/information/antibody
hiroshi.takahashi@c-ian.jp
Sponsor or person
Institute
Medical Corporation, Forkmore
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation, Forkmore
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
Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, 173-0015,Japan
Tel
03-3964-1141 (2275)
fumiko_watanabe@tmghig.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R21-066
Org. issuing International ID_1
Tokyo Metropolitan Institute of Gerontology
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人 社団 フォルクモア、クリニック医庵センター南（横浜市）、同 クリニック医庵あざみの（横浜市）、同 クリニック医庵青葉台（横浜市）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.c-ian-centerminami.com/archives/710
Number of participants that the trial has enrolled
181
Results
The geometric means of the first neutralizing antibody titer (NAT: AU/ml) were 645[49-8745] in OLD group (>= 65: N=119) and 1777 [159-19821] in YOUNG Group (< 65: N=62) respectively. The proportion of subjects (>=1280 AU/ml) were 39/119(32.8%) vs 39/62(62.9%) in the first measurement and 0/16(0.0%) vs 3/16(18.8%) in the second. Negative test results (<50) were 7/119(3.9%) vs (6/62(5.0%) vs 1/61(0.2%)) in the first NAT and (3/16(4.8%) vs 0/13(0.0%) in the second.
Results date posted
| 2022 | Year | 03 | Month | 01 | Day |
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As third dose of mRNA vaccine inoculation was initiated, protocol of the study was modified. The modification was approved on 01/06/22 by ethical committee at Tokyo Metropolitan Institute of Gerontology
Management information
Registered date
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053669
