UMIN-CTR Clinical Trial

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
Email	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
Email	hiroshi.takahashi@c-ian.jp

Sponsor
Institute	Medical Corporation, Forkmore
Institute
Department

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)
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053669