UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048810 |
|---|---|
| Receipt number | R000055572 |
| Scientific Title | Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster |
| Date of disclosure of the study information | 2022/09/10 |
| Last modified on | 2024/09/01 21:08:03 |
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Basic information
Public title
Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster
Acronym
Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster
Scientific Title
Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster
Scientific Title:Acronym
Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the change in immune responses by measuring spike-specific antibody titers and interferon gamma levels approximately 8 months after a BNT162b2 vaccine booster and comparing them to those before and one month after vaccination.
Basic objectives2
Others
Basic objectives -Others
To evaluate the difference in spike-specific antibody and interferon gamma levels after a BNT162b2 vaccine booster due to previous SARS-CoV-2 infection and COVID-19 vaccine history.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in spike-specific antibody titers and interferon gamma levels 8 months after a BNT162b2 vaccine booster.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Employees of Fukuoka City Hospital who have been measured spike-specific antibody titers and interferon gamma levels.
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Tani |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Medicine and Biosystemic Science
Zip code
812-8582
Address
Fukuoka Japan, 3-1-1, Maidashi, Higashi-ku Fukuoka-shi, Fukuoka
TEL
+81-92-642-5229
tani.kyushu.univ@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Tani |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Medicine and Biosystemic Science
Zip code
812-8582
Address
Fukuoka Japan, 3-1-1, Maidashi, Higashi-ku Fukuoka-shi, Fukuoka
TEL
+81-92-642-5229
Homepage URL
tani.kyushu.univ@gmail.com
Sponsor or person
Institute
Fukuoka City 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
Fukuoka City Hospital
Address
13-1 Yoshizukahonmachi, Hakata-ward, Fukuoka-city, Fukuoka 812-0046 JAPAN
Tel
+81-92-801-1011
rinshou@adm.fukuoka-u.ac.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 | 09 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36267253/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36267253/
Number of participants that the trial has enrolled
281
Results
Results: The data of 281 healthcare workers were available. Multivariate analysis extracted fever after the booster dose as being significantly correlated with the specific IgG titers. The analysis of 164 participants with data from the primary series showed that fever after the second dose was associated with the emergence of fever after the booster dose ; however, the IgG titers after the booster dose were not associated with the presence or degree of fever after the second dose.
Results date posted
| 2024 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Methods: This is a prospective observational cohort study in Japan, following our prior investigation of BNT162b2 2-dose primary series. Spike-specific immunoglobulin G (IgG) titers were measured for SARS-CoV-2-naive hospital healthcare workers who received a BNT162b2 booster. The severity of solicited adverse reactions, including the highest body temperature, and self-medicated antipyretics were reported daily for 7 days following vaccination through a web-based self-reporting diary.
Participant flow
Methods: This is a prospective observational cohort study in Japan, following our prior investigation of BNT162b2 2-dose primary series. Spike-specific immunoglobulin G (IgG) titers were measured for SARS-CoV-2-naive hospital healthcare workers who received a BNT162b2 booster. The severity of solicited adverse reactions, including the highest body temperature, and self-medicated antipyretics were reported daily for 7 days following vaccination through a web-based self-reporting diary.
Adverse events
None
Outcome measures
Conclusions: These results suggest an independent correlation between mRNA vaccine-induced specific IgG levels and post-booster vaccination fever, without any significant influence of fever after the primary series. Antipyretic medications for adverse reactions should not interfere with the elevation of specific IgG titers.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation of the changes in antibody responses and T-cell responses to SARS-CoV-2 spike peptides after a BNT162b2 vaccine booster.
Management information
Registered date
| 2022 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055572
