UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053578 |
|---|---|
| Receipt number | R000061139 |
| Scientific Title | Establishing a Registry for Post-COVID-19 Vaccination Syndromes and Comprehensive Analysis of COVID-19 Vaccine-Related Outcomes |
| Date of disclosure of the study information | 2024/02/09 |
| Last modified on | 2026/08/20 12:33:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Establishing a Registry for Post-COVID-19 Vaccination Syndromes and Comprehensive Analysis of COVID-19 Vaccine-Related Outcomes
Acronym
Establishing a Registry for Post-COVID-19 Vaccination Syndromes and Comprehensive Analysis of COVID-19 Vaccine-Related Outcomes
Scientific Title
Establishing a Registry for Post-COVID-19 Vaccination Syndromes and Comprehensive Analysis of COVID-19 Vaccine-Related Outcomes
Scientific Title:Acronym
Establishing a Registry for Post-COVID-19 Vaccination Syndromes and Comprehensive Analysis of COVID-19 Vaccine-Related Outcomes
Region
| Japan |
Condition
Condition
Post-COVID-19 vaccination syndromes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our research seeks to create a registry of patients experiencing post-vaccination syndromes to meet this requirement. This initiative aims to illuminate the health effects post-COVID-19 vaccination, assist in formulating diagnostic criteria, and enhance patient care. It will pinpoint individuals with post-vaccination syndrome and those exhibiting symptoms associated with COVID-19 vaccination. Additionally, this study will concentrate on establishing diagnostic criteria and seek to impact the development of testing methodologies and suitable treatment approaches. Consequently, this research represents a critical step in assisting individuals impacted by health issues following vaccination, markedly contributing to the continuous battle against the COVID-19 pandemic. Our endeavors guarantee that vaccine deployment and usage are underpinned by extensive, transparent safety data, offering crucial insights for refining vaccine strategies and confirming their effectiveness.
Basic objectives2
Others
Basic objectives -Others
Collection of adverse events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of the study is the characterization of adverse events that are definitely or almost certainly related to the novel coronavirus vaccine.
Key secondary outcomes
- Occurrence or non-occurrence of Grade3 or above adverse events
- Presence or absence of adverse events(adverse reactions) for which acausal relationship could not be ruled out
- Time to onset of adverse events, Grade3 or above adverse events and adverse reactions
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients providing written consent for registry inclusion will be incorporated into the study.
- Patients who visited or were admitted to a research institution between December 2020 and August 31, 2023, and exhibited symptoms deemed by researchers as definitively or likely related to the vaccine.
Key exclusion criteria
No exclusion criteria
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Fujisawa |
Organization
Honbetsu Cardiovascular Medicine Clinic
Division name
Not applicable
Zip code
089-3314
Address
1-6-10 Minami, Honbetsu, Nakagawa, Hokkaido, 089-3314, Japan
TEL
0156-22-8888
fujisawa.peace@mac.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kodama |
Organization
Japanese Society for Vaccine-related Complications
Division name
Not applicable
Zip code
665-0842
Address
#205, 5-10-32 Kawamo, Takarazuka, Hyogo, 665-0842, Japan
TEL
0797-86-1313
Homepage URL
info@jsvrc.jp
Sponsor or person
Institute
Japanese Society for Vaccine-related Complications
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2024 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-026-43949-z
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-026-43949-z
Number of participants that the trial has enrolled
279
Results
A total of 493 AEs were reported: 69.4% occurred within 90 days and 12.4% occurred >=360 days after vaccination. The most common SOCs were General Disorders (29.2%), Nervous System Disorders (22.3%), and Musculoskeletal Disorders (10.1%). Common symptoms were malaise, brain fog, arthralgia, gait disturbance, and hypoesthesia. Outcomes were complete recovery 27%, partial remission 38%, unresolved 29%, and death 1%. PVS Type 1 had the highest non-recovery rate (63%). Median recovery time was 150-300 days.
Results date posted
| 2026 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 03 | Month | 14 | Day |
Baseline Characteristics
Among the 179 patients included in the analysis, 119 (66.5%) were female and 60 (33.5%) were male. Ages ranged from 14 to 91 years, with a mean age at consent of 59.3 years. The number of COVID-19 vaccine doses received was one dose in 17 patients (9.5%), two doses in 37 (20.7%), three doses in 76 (42.4%), four doses in 24 (13.4%), and five or more doses in 25 (14.0%). Forty-seven patients (26%) had a history of confirmed COVID-19 infection, while 131 (73%) had no reported confirmed COVID-19 infection.
Participant flow
A total of 279 patients who visited or were admitted to the study institution between December 2020 and August 2023 were enrolled. Of these, 179 patients who were definitively diagnosed with persistent adverse reactions following SARS-CoV-2 mRNA lipid nanoparticle vaccination were included in the analysis.
Adverse events
Refer to "Results"
Outcome measures
-Presence of adverse events (AEs)
-Presence of severe AEs (Grade >= 3)
-Presence of vaccine-related AEs for which a causal relationship could not be excluded
-Time from vaccination to onset of AEs, severe AEs (Grade >= 3), and vaccine-related AEs
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Study design: Non-controlled, unblinded, non-interventional observational study (voluntary reporting study)
- Data collection items:
1) Patient consent (date of consent and details of the consenting individual)
2) Patient background (date of birth, gender, comorbidities, medical history, COVID-19 vaccination history)
3) History of COVID-19 infection and consultations regarding post-vaccination adverse reactions
4) Details of adverse events (adverse events name, onset date, severity, related vaccine)
5) Treatment details (treatment categories, degree of effectiveness)
6) Test results (test categories, dates, results)
7) Preserved specimen information (type, quantity, collection date, preservation method)
8) Feasibility of specimen collection
Management information
Registered date
| 2024 | Year | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061139
