UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051510 |
|---|---|
| Receipt number | R000058760 |
| Scientific Title | Efficacy, safety and antibody response of sixth dose of COVID-19 vaccination in healthcare workers |
| Date of disclosure of the study information | 2023/07/05 |
| Last modified on | 2025/01/07 16:44:15 |
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Basic information
Public title
Efficacy, safety and antibody response of sixth dose of COVID-19 vaccination in healthcare workers
Acronym
Efficacy, safety and antibody response of sixth dose of COVID-19 vaccination in healthcare workers
Scientific Title
Efficacy, safety and antibody response of sixth dose of COVID-19 vaccination in healthcare workers
Scientific Title:Acronym
Efficacy, safety and antibody response of sixth dose of COVID-19 vaccination in healthcare workers
Region
| Japan |
Condition
Condition
healthy individual
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the sixth vaccination for Covid-19 and examines the following:
The degree of increase in antibody titer due to vaccination
The relationship between vaccine efficacy and antibody titer
The degree of adverse reactions
At the same time, seroprevalence will be examined to determine the effect of hybrid immunity of infection and vaccine on the rise in antibody titer before and after vaccination and its efficacy. The evaluation of seroprevalence will also reveal the proportion of hospital staff who are unaware of their infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antibody titer before and after the 6th vaccination.
Key secondary outcomes
Adverse reactions due to the 6th vaccination.
Serum prevalence rate and prevalence rate of previously undiagnosed patients.
Preventive effect against onset.
The effect of hybrid immunity due to previous infection and vaccination on preventive effect against onset and antibody levels.
Relationship between the antibody titer this time and the antibody
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
| Maneuver |
Interventions/Control_1
Draw Blood
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
Healthcare workers at Chiba University School of Medicine Hospital who is eligible for vaccination at our hospital as the sixth opportunity, including people in the fourth, fifth, and sixth rounds who can receive vaccination at our hospital. A person who has received sufficient explanation for participation in this study and has obtained written consent from the patient himself/herself based on sufficient understanding.
Key exclusion criteria
those who are unable to use the vaccine at this time due to contraindications or other reasons.
those who have been deemed unsuitable as subjects by the principal investigator or co-investigator.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Misuzu |
| Middle name | |
| Last name | Yahaba |
Organization
Chiba University Hospital
Division name
Department of Infection Control
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432227171
m_yahaba@chiba-u.jp
Public contact
Name of contact person
| 1st name | Misuzu |
| Middle name | |
| Last name | Yahaba |
Organization
Chiba University Hospital
Division name
Department of Infection Control
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432227171
Homepage URL
m_yahaba@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Misuzu Yahaba
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Official English name is currently under construction
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
| 2023 | Year | 07 | Month | 05 | 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
179
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
| 2023 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058760
