UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044316 |
|---|---|
| Receipt number | R000050147 |
| Scientific Title | Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination in lung cancer patients receiving immune checkpoint inhibitors: A multicenter observational study in Japan |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2024/03/26 21:57:01 |
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Basic information
Public title
Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination in lung cancer patients receiving immune checkpoint inhibitors: A multicenter observational study in Japan
Acronym
Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination in lung cancer patients receiving immune checkpoint inhibitors: A multicenter observational study in Japan
Scientific Title
Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination in lung cancer patients receiving immune checkpoint inhibitors: A multicenter observational study in Japan
Scientific Title:Acronym
Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination in lung cancer patients receiving immune checkpoint inhibitors: A multicenter observational study in Japan
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate the safety of the vaccine by comparing the incidence of irAEs in lung cancer patients on ICI with those who had received the novel coronavirus vaccination and those who had not (historical data previously reported), and evaluate the immunogenicity of the vaccine with antibody titers against SARS-CoV-2 before and after the vaccination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the incidence of all irAEs of all grades.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were at least 20 years of age were eligible for enrollment if they had pathologically or cytologically confirmed lung cancer of any histological type; had locally advanced and unresectable, metastatic, and/or recurrent disease; and had been treated with immune checkpoint inhibitors anti-PD1/anti-PDL1 antibodies: Nivolumab, Pembrolizumab, Durvarmab, and Atezolizumab) as monotherapy or in combination with other drugs at least once between 4 weeks prior to the first dose of the SARS-CoV-2 vaccine and 4 weeks after the second dose of the vaccine.
Key exclusion criteria
Patients were excluded if they were in the following condition; (1) having already received the vaccine; (2) not wishing to be vaccinated by their own choice or on the recommendation of their physician; and (3) did not provide informed consent.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Respiratory Medicine
Zip code
251-0041
Address
1-5-1 Tsujido Kandai, Fujisawa, Kanagawa 251-0041, Japan
TEL
0466-35-1177
m-hibino@ctmc.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Respiratory Medicine
Zip code
251-0041
Address
1-5-1 Tsujido Kandai, Fujisawa, Kanagawa 251-0041, Japan
TEL
0466-35-1177
Homepage URL
m-hibino@ctmc.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Fujisawa Tokushukai Hospital
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
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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 | 05 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.jto.org/article/S1556-0864(22)00295-7/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.jto.org/article/S1556-0864(22)00295-7/fulltext
Number of participants that the trial has enrolled
132
Results
A total of 126 patients with lung cancer were enrolled from May to November 2021 and followed up until December 2021. There were 26 patients (20.6%, 95% confidence interval 13.9%-28.8%) and seven patients (5.6%, 95% confidence interval: 2.3%-11.1%) who developed irAEs of any grade pre- and postvaccination, respectively, which was lower than the predicted incidence without vaccination.
Results date posted
| 2024 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 132 patients who were actively treated with ICIs for lung cancer were enrolled in this study at nine hospitals in Japan between May 1, 2021, and November 30, 2021. Six patients did not meet the criteria and were excluded: three patients had their last ICI dose before 4 weeks of the first vaccination, two patients did not receive a second dose of vaccine owing to lung cancer progression, and one patient could not receive a second dose of vaccine because of worsening underlying hemolytic anemia (Fig. 1).
Participant flow
Eight patients were lost to follow-up before the data cutoff on December 2021: five died of lung cancer, two were transferred to hospice, and one was homebound and had an interruption in hospital visits owing to the progression of lung cancer. None of the patients developed COVID-19 during the entire observation period.
Adverse events
Among all 126 participants, irAEs of any grade newly occurred in seven patients after vaccination (5.6%, 95% CI: 2.3%-11.1%; Figs. 1 and 2). Before the vaccination, 26 patients (20.6%, 95% CI: 13.9%-28.8%) had a new irAE (of any grade); none of these 26 patients developed a new irAE or exhibited exacerbation of a preexisting irAE after vaccination. During the entire observation period, irAEs of any grade newly occurred in a total of 33 patients (26.2%, 95% CI: 18.8%-34.8%). The percentage of patients who developed any grade of new-onset irAE was not higher than the expected value of 35% inferred from previously published literature.
Outcome measures
Among all 126 participants, irAEs of any grade newly occurred in seven patients after vaccination (5.6%, 95% CI: 2.3%-11.1%; Figs. 1 and 2). Before the vaccination, 26 patients (20.6%, 95% CI: 13.9%-28.8%) had a new irAE (of any grade); none of these 26 patients developed a new irAE or exhibited exacerbation of a preexisting irAE after vaccination. During the entire observation period, irAEs of any grade newly occurred in a total of 33 patients (26.2%, 95% CI: 18.8%-34.8%). The percentage of patients who developed any grade of new-onset irAE was not higher than the expected value of 35% inferred from previously published literature.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter observational study was conducted in Japan, at nine Educational Institute Certified by the Japanese respiratory society. Patients were enrolled from May to November 2021 and followed until December 2021, which may change depending on the vaccination schedule in Japan.
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050147
