UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043851 |
|---|---|
| Receipt number | R000050049 |
| Scientific Title | Short-term safety of the BNT162b2 mRNA COVID-19 vaccine |
| Date of disclosure of the study information | 2021/04/10 |
| Last modified on | 2024/04/07 10:59:20 |
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Basic information
Public title
Short-term safety of the BNT162b2 mRNA COVID-19 vaccine
Acronym
safety of the mRNA COVID-19 vaccine
Scientific Title
Short-term safety of the BNT162b2 mRNA COVID-19 vaccine
Scientific Title:Acronym
safety of the mRNA COVID-19 vaccine
Region
| Japan |
Condition
Condition
Medical workers / Adult
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary endpoints were the efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The efficacy of the vaccine against laboratory-confirmed Covid-19 (pre, post, 3M, 6M).
Key secondary outcomes
The efficacy of the vaccine safety (pre, post, 3M, 6M).
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
medical workers
Key exclusion criteria
Healthcare workers who have withdrawn their consent to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisakazu |
| Middle name | |
| Last name | Degawa |
Organization
Kawasaki Physicians Association
Division name
President
Zip code
216-0017
Address
2-5-2 kodai, Miyamaeku,Kawasaki-city, Kanagawa,Japan
TEL
044-888-6600
hdegawa@h2.dion.ne.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | Watanabe |
| Last name | Watanabe |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
2168511
Address
2-16-1 Sugao Miyamaeku, Kawasaki-city, Kanagawa, Japan
TEL
0449778111
Homepage URL
http://kawa_nai.umin.jp/
ponponta@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Dept. of Gastroenterology and Hepatology
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
Kanagawa Prefecture Medical Association
Address
3-1 Fujimicho,Nakaku,Yokohama-city, Kanagawa, Japan
Tel
044-888-6600
h-yoda@kanagawa.med.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 | 04 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37342886/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37342886/
Number of participants that the trial has enrolled
200
Results
Through differentially expressed gene analysis we identified genes that showed fluctuating expression levels and gradual increases in expression levels from T1 to T4 as well as genes with increased expression levels at T4 alone
Results date posted
| 2024 | Year | 04 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We assessed the timeserieschanges in the comprehensive gene expression profiles of 200 vaccinatedhealthcare workers by performing bulk transcriptome and bioinformatics analyses,including dimensionality reduction utilizing the uniform manifold approximation andprojection (UMAP) technique. For these analyses, blood samples, includingperipheral blood mononuclear cells (PBMCs), were collected from 214 vaccinerecipients before vaccination (T1) and on Days 22 (T2, after second dose), 90, 180(T3, before a booster dose), and 360 (T4, after a booster dose) after receiving thefirst dose of BNT162b2 vaccine.
Participant flow
We assessed the timeserieschanges in the comprehensive gene expression profiles of 200 vaccinatedhealthcare workers by performing bulk transcriptome and bioinformatics analyses,including dimensionality reduction utilizing the uniform manifold approximation andprojection (UMAP) technique. For these analyses, blood samples, includingperipheral blood mononuclear cells (PBMCs), were collected from 214 vaccinerecipients before vaccination (T1) and on Days 22 (T2, after second dose), 90, 180(T3, before a booster dose), and 360 (T4, after a booster dose) after receiving thefirst dose of BNT162b2 vaccine.
Adverse events
none
Outcome measures
High throughput and temporal bulk RNA based transcriptome analysis is a useful approach for inclusive, diverse, and cost effective large scale clinical studies.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 07 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 22 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 22 | Day |
Other
Other related information
Analysis
1. Anti-SARS-CoV-2 S-RBD protein Human IgM ELISA
2. Anti-SARS-CoV-2 S-RBD protein Human IgG ELISA
3. MBL SARS-CoV-2 Neutralization Antibody Detection
Management information
Registered date
| 2021 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050049
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