UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041923 |
|---|---|
| Receipt number | R000047847 |
| Scientific Title | Immunogenicity and safety of influenza vaccine in lung cancer patients receiving immune checkpoint inhibitors |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2023/07/24 15:10:25 |
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Basic information
Public title
Immunogenicity and safety of influenza vaccine in lung cancer patients receiving immune checkpoint inhibitors
Acronym
Immunogenicity and safety of influenza vaccine in lung cancer patients receiving immune checkpoint inhibitors
Scientific Title
Immunogenicity and safety of influenza vaccine in lung cancer patients receiving immune checkpoint inhibitors
Scientific Title:Acronym
Immunogenicity and safety of influenza vaccine in lung cancer patients receiving immune checkpoint inhibitors
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the immunogenicity and safety of the quadrivalent influenza vaccine in Japanese patients with lung cancer receiving immune checkpoint inhibitors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
seroprotection rate 3 to 5 weeks after the vaccination
Key secondary outcomes
geometric mean titer before and 3 to 5 weeks after the vaccination
mean fold rises, seroresponse rate, seroconversion rate 3 to 5 weeks after the vaccination
presence of immune-related adverse events within 6 months of the vaccination
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Lung cancer patients aged 50 years or older receiving immune checkpoint inhibitors
And
2 Who receive influenza vaccine at their own will and have voluntarily agreed to participate in this study
Key exclusion criteria
1 Patients who have been vaccinated with influenza vaccine in the 2020/2021 season
2 Patients who have had anaphylaxis due to the components of influenza vaccine, or those who may have allergies
3 Patients with egg allergies
4 Influenza infected patients in 2020/2021 season
5 Patients who suffered from acute febrile illness or other serious illness at the timing of vaccination
6 Those who received a cytotoxic agent within 1 month of vaccination
7 Those who are taking steroids / immunosuppressants (excluding administration as antiemetics)
8 Others who are not suitable for vaccination
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Nakashima |
Organization
Kameda Medical Center
Kameda University of Health Science
Division name
Department of Pulmonology, Research Institute
Zip code
2968602
Address
929, Higashicho, Kamogawa, Chiba, Japan
TEL
04-7092-2211
kei.7.nakashima@gmail.com
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Nakashima |
Organization
Kameda Medical Center
Division name
Department of Pulmonology
Zip code
2968602
Address
929, Higashicho, Kamogawa, Chiba, Japan
TEL
04-7092-2211
Homepage URL
kei.7.nakashima@gmail.com
Sponsor or person
Institute
Department of Pulmonology, Kameda Medical Center
Institute
Department
Personal name
Kei Nakashima
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Research Ethics Committee of Kameda Medical Center
Address
929, Higashicho, Kamogawa, Chiba, Japan
Tel
0470922211
clinical_research@kameda.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20-064-200923
Org. issuing International ID_1
the Research Ethics Committee of Kameda Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
亀田総合病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1341321X23001708
Number of participants that the trial has enrolled
24
Results
Influenza vaccination in the 23 patients included in the immunogenicity analyses significantly increased geometric mean titer for all strains, and seroprotection rate, seroresponse rate, and seroconversion rate were 52% to 91%, 26% to 39%, and 26% to 35%, respectively. In the 24 patients included in the safety analyses, 7 (29%) and 5 (21%) patients exhibited systemic and local reactions, respectively. Only one patient (4%) (hypothyroidism, grade 2) showed post-vaccination immune-related adverse events.
Results date posted
| 2023 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 20 | Day |
Baseline Characteristics
Their median age was 71 years, and 22 of the patients (96.0%) were men. Fifteen patients (65%) received influenza vaccination in the 2019/2020 season. The median body mass index (kg/m2) was 22.4. Adenocarcinoma was the most common histological type of lung cancer (48%). Pembrolizumab, atezolizumab, and durvalumab were administered to 10 (44%), 7 (30%), and 5 (22%) patients, respectively, whereas nivolumab was administered to 1 (4%) patient.
Participant flow
24 patients were registered. One patient received steroids for radiation pneumonitis treatment before the collection of serum samples at S1. Thus, serum samples at 4 to 6 weeks post vaccination were collected from 23 patients with lung cancer, exceeding the pre required sample size of 22 cases for immunogenicity analysis. All 24 patients were evaluated for safety analyses. During the study period, no subject reported laboratory confirmed influenza or influenza like illness.
Adverse events
Regading adverse reactions, systemic reactions were observed in seven patients (29%); all systemic reactions were of grades 1 and 2 and were resolved within a few days. Local reactions were observed in five patients (21%). Local reactions such as erythema, swelling, induration, and itching were all grade 1, and the pain was grades 1 and 2, all of which were resolved within 5 days. An irAE was observed in one patient (4%) (hypothyroidism, grade 2) within 6 months post-vaccination.
Outcome measures
The Mean Fold Rise (MFR) was 3.5 for A(H1N1), 3.3 for A(H3N2), 2.5 for B(Yamagata), and 3.2 for B(Victoria); significant increases were observed in the MFR for all four strains. Regarding the primary endpoint, the seroprotection rate was 65% for A(H1N1), 91% for A(N3N2), 70% for B(Yamagata), and 52% for B(Victoria). For A(H3N2), the seroprotection rate was 91% (95% CI, 72% to 99%), as we hypothesized, and the lower 95% CI limit exceeded 60%, meeting the FDA(The U.S. Food and Drug Administration) criteria for the elderly population. The response rate and seroconversion rate were 26% to 39% and 26% to 35%, respectively. Furthermore, when evaluated based on the EMA (European medicines angency) criteria, the MFR for all strains exceeded 2.0; except B(Victoria), all strains met sP > 60%; and except B(Yamagata), all strains met sC > 30%. Therefore, it can be concluded that all strains meet the EMA criteria.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Patients will be given a first blood draw before influenza vaccination and a second blood draw 3 to 5 weeks later. The serum is stored and the influenza antibody titer is measured in March 2021. We evaluate side reactions and immune-related adverse events (within six months of vaccination).
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047847
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